Low back pain (LBP) is usually defined as pain localised below the costal margin (ribs) and above the inferior gluteal folds (buttock crease). It is the leading cause of disability worldwide and is becoming increasingly prevalent (Harkness et al. 2005, Hoy et al. 2012, Vos et al. 2012). Chronic low back pain (CLBP) is variously defined as lasting longer than 7-12 weeks, to 3 months (Anderrson 1999, Frymoyer 1988). LBP is typically classified as “specific” or “non-specific”. Specific LBP refers to symptoms caused by specific pathophysiologic causes, such as hernia nucleus, infection, inflammatory disease, osteoporosis, rheumatoid arthritis, fracture or tumour (Van Tulder and Koes 2010). There is no effective cure for non-specific low back pain (NSCLBP) (Van Middelkoop et al. 2011) and this represents the 90% of the LBP population that cannot be classified as specific LBP (Deyo et al. 1992). Most guidelines are based on the assumption that symptoms resolve spontaneously and that return to work equals recovery (Anderrson 1999, Van Tulder et al. 2006). However, when pain is assessed it appears patients may be returning to work despite their pain (Bowey-Morris 2011), and whilst spontaneous recovery occurs in approximately a third of patients after 3 months, 71% still have pain after 1 year (Itz et al. 2013).
CLBP patients with psychosocial, psychological and social, risk factors are known to have poorer outcomes and increased management costs (Grimmer-Somers 2006, Nicholas et al. 2011). The term “yellow flags” was originally used to describe psychosocial risk factors that predict disability in LBP patients (Kendall et al. 1999). These risk factors are predictors of return to work and disability in CLBP patients (Glattacker et al. 2013). The risk factors can be identified using a questionnaire or a clinical diagnosis (Watson and Kendall 2000). Questions cover beliefs that are associated with delayed return to work and disability. These include fears about pain, injury, recovery and being despondent or anxious. It is suggested that having a few strongly held negative beliefs or several weaker ones could be used to identify at risk patients (Nicholas et al. 2011). These beliefs increase a patient’s perception of threat and modern neuroscience suggests that pain is the conscious interpretation that tissue is in danger (Moseley 2007). These beliefs can be viewed as “thought viruses” (Butler and Moseley 2013). The term yellow flag has now been refined to encompass psychological factors that a physiotherapist could manage, whereas orange flags are now used for psychopathology, which requires specialist psychological management. Alternatively, when the yellow flag belief is positive, for example, an expectation that they will recover; it can be viewed as a positive “pink flag” (Gifford 2005). The more subjective components of the workplace such as perception are termed “blue flags”, and the more objective risk factors such as the nature of the work are termed “black flags” (Main et al. 2004).
Yellow flags are now included in most LBP guidelines although there is wide variation in suggestions in how to assess and manage these patients (Koes et al. 2010). The New Zealand guidelines (National Health Committee 2004) suggest assessment with the acute low back screening tool and the Canadian guidelines are similarly specific (Rossignol et al. 2007), suggesting assessment at 4 weeks or straight away if chronic. However, the other guidelines are less specific in their assessment. The Australian, American, Dutch, French, German and United Kingdom guidelines suggest early assessment but are not specific about how to assess (Australian Acute Musculoskeletal Pain Guidelines Group 2003, Chou et al. 2007, The Dutch Institute for Healthcare Improvement (CBO) 2003, Agence Nationale d’Accreditation et d’Evaluation en Sante 2000, Drug Committee of the German Medical Society 2007, NHS 2008). Similarly, the Finnish and Norwegian guidelines list signs of “yellow flags” and are even more ambiguous on assessment (Malmivaara et al. 2008, Laerum et al. 2007). The European guidelines propose an initial assessment of “yellow flags” and then a review in detail if there is no progress in acute and sub acute low back pain (van Tulder et al. 2006) or assess initially in chronic patients (Airaksinen et al. 2006). In contrast the Italian guidelines recommend assessing psychosocial factors after 2 weeks (Negrini et a 2006) and after 2-6 weeks is suggested in the Spanish guidelines (Spain, the Spanish Back Pain Research Network 2005). The Austrian guidelines are less specific and they suggest patients who do not progress over time should be assessed (Friedrich and Likar 2007). In treatment patients with yellow flags are not specifically addressed but all guidelines at least briefly state the need for re-assurance and return to normal activities, which may aid yellow flag management. The European guidelines suggest the inclusion of a cognitive behavioural approach and the German guidelines suggest psychotherapy may be an education option for referral for multi-disciplinary treatment. Thus within the guidelines the importance of yellow flags is appreciated in assessment and for triage but there is ambiguity in the specifics of management.
The differences seen across the full range of physiotherapy approaches is far greater than within the guidelines. Within physiotherapy there are many different approaches to managing these patients as shown in table 2.1.
Table 2.1 Matrix of different Physiotherapy Approaches
|More focused on the local tissue
||Maitland (2013), Society of Musculoskeletal Medicine (Atkins et al. 2010)
||McKenzie (McKenzie and May 2003)
||McGill (2007),Sahrmann (2002)
||Lee/ Vleeming (2001), O’Sullivan (Fersum et al. 2009)
|More focused on central processes
||Neuro-developmental (Kolar et al. 2014)
||NOI/ Mind body group (Butler and Moseley 2013)
The Maitland and McKenzie approaches are the most utilised in the UK (Foster et al. 1999). These approaches and the traditional orthopaedic medicine approach (Atkins et al. 2010) are perhaps the most bio-medical focused, placing emphasis on finding and treating the tissues that is the cause. Other approaches such as that derived by O’Sullivan (Fersum et al. 2009) and, Lee and Vleeming (Lee 2001) attempt to classify patients that need more psychosocial input. With the new clinical model 4, the Society of Musculoskeletal Medicine is moving in the same direction (Atkins et al. In Press). The Neuro Orthopaedic Institute and Mind In Body groups place the most emphasis on a hands-off approach to psychosocial aspects (Butler and Moseley 2013). This approach is based on an understanding of the importance a patient’s perception has on their symptoms and thus the benefits of education and a graded return to normal activities. In contrast Dorko (2003) is a proponent of a hands-on approach to addressing the psychosocial aspects. Clinicians are aware of the importance of psychosocial factors in these patients (Scheermesser at al. 2012) but feel underprepared and may sometimes stigmatise these patients (Synnott et al. 2015). Thus whilst yellow flags are clearly important there remains a lack of clarity for clinicians looking at how to specifically manage these patients from guidelines and clinicians are using an incredibly varied set of approaches. This study aims to investigate how and why different physiotherapists choose to use the different approaches.
3. Literature Review
The literature review was undertaken with grounded theory in mind. The aim was to get an overview of the various different methods currently used in practice to provide context for the interviews. Issues around clinical reasoning and motivation to practice to were not reviewed so that the exploration of these areas would be more inductive.
3.1 Search strategy
Three approaches were used for retrieving literature. Searches were conducted initially using the terms yellow flags and low back pain, and treatment, or assessment, or management, using the databases PubMed, Embase, PEDro and CINHAL up to September 2015. This however did not identify any papers and it became clear that whilst the term yellow flags is used in the assessment literature it is not used in treatment papers. As such the searches were repeated using the term psychosocial and low back pain, and treatment, or assessment, or management. In addition content experts were consulted to ensure no additional papers were missed and citation tracking was implemented. No time limit was set for papers and foreign language papers that were identified using the English terms were included. Refworks was used to store and remove duplicates from the searches.
3.2 Selection of studies
The student researcher, KM, initially screened the title and abstract of the identified studies. The full text was then analysed. Studies were selected on the basis of the following selection criteria;
- Primary experimental design study of human participants with chronic (>12weeks) or recurrent (repeated episodes over 12 months) low back pain
- Participants must have yellow flags or measured psychosocial status commensurate with yellow flags
- Studies must cover the management of patients
Studies were excluded if;
1. The intervention group did not have yellow flags or measurable psychosocial factors
2. Looked at post surgical patients
3. Mixed groups of sub-acute and chronic patients
4. Mixed groups of neck and CLBP patients
5. The intervention was purely psychological (CBT) and outside the scope of traditional physiotherapy practice
3.3 Data management
Risk of bias was assessed as suggested by the Cochrane Back Review Group (Bendix et al. 1996) as shown in table 4.1. Studies with a score above 6 were considered low risk of bias. Studies with a score below 6 were considered high risk. Where any doubt remained an author of the study was contacted via email.
Table 3.1 Criteria for risk of bias analysis
||Was the method of randomisation adequate?
||Was the treatment allocation concealed?Was knowledge of the allocated interventions adequately prevented during the study?
||Was the patient blinded to the intervention?
||Was the care provider blinded to the intervention?
||Was the outcome assessor blinded to the intervention?Were incomplete outcome data adequately addressed?
||Was the drop-out rate described and acceptable?
||Were all randomised participants analysed in the group to which they were allocated?
||Are reports of the study free of suggestion of selective outcome reporting?Other sources of potential bias:
||Were the groups similar at baseline regarding the most important prognostic indicators?
||Were co-interventions avoided or similar?
||Was the compliance acceptable in all groups?
||Were the timing of the outcome assessment similar in all groups?
3.4 Search Results
In total 367 studies were identified, after screening titles and abstracts 11 remained. All 11 papers met the inclusion criteria. One foreign language paper met the inclusion criteria was included (Pfingsten and Hilderbrandt 2001), this paper was translated using google translate so that it could be included in the analysis. One paper (Bergstrom et al. 2012) was excluded as it included both neck and back patients in one homogenous group with no separate analysis of back pain patients. A clear limitation is that these studies look at groups of CLBP patients that show yellow flags on average, but within each cohort there will have likely been patients with very few yellow flags and possibly some with very significant yellow flags. Using table 4.1 of the Cochrane Back Review Group (Bendix et al. 1996) the studies were classified as high or low risk. One paper was high risk (Pfingsten and Hilderbrandt 2001) and nine were classified as low risk. The oldest trial that met the selection criteria was Alantra et al. (1994) as despite it’s age it met all quality criteria for selection. The 10 studies all looked at patients of 18 years or older with CLBP, using at least 6 months follow up. All but three were randomised controlled trials, with two being cohort studies (Pfingsten and Hilderbrandt 2001, O’Sullivan et al. 2015) and another with no randomisation (Vowles et al. 2007).
Figure 4.1 Flow diagram of literature review
The studies identified cover a broad spectrum of biopsychosocial interventions, with some focusing on more biomedical interventions, psychosocial interventions or a combination. Six studies looked at a predominantly biomedical approach.
3.5.1 Biomedical approaches: Passive approaches
Two studies with a low risk of bias from the same group have examined a passive biomedical intervention. Weiner et al. (2003, 2008) conducted randomised controlled trials of percutaneous electrical nerve stimulation (PENS). This involves delivering a low voltage electrical current through a specially designed needle to the adipose layer close to the nerves near the site of pain. In both studies patients were aged 65 or older, lived in the community and experienced moderate CLBP almost every day for more than 3-months. In their earlier study (Weiner et al. 2003) the authors measured psychosocial factors with the Geriatric Depression Scale and the mean score was 6.81, which equates to mild depression, indicative of yellow flags. In their later study (Weiner et al. 2008) psychosocial function measures showed mild to moderate levels of psychosocial stress across the Geriatric Depression Scale, the Chronic Pain Self-Efficacy Scale, the Catastrophizing Scale of the Cognitive Strategies Questionnaire and the Fear-Avoidance Beliefs Questionnaire. The combination of the scores across these measures shows these patients had yellow flags.
In their earlier study subjects were randomised to receive 6-weeks of twice weekly PENS and physical therapy or sham PENS stimulation and physical therapy (Weiner et al. 2003). The PENS and physical therapy group had significant reductions in pain intensity and pain related disability, the sham PENS and physical therapy group did not. These improvements remained at 3-month follow up. Furthermore, significant improvements in sit to stand, psychosocial function and lifting endurance were also seen in the PENS and physical therapy group. In their later study (Weiner et al. 2008) they had 200 participants, randomised to receive either PENS, brief PENS to control for treatment expectancy, PENS with general conditioning or brief PENS and general conditioning. All interventions were done twice a week for 6 weeks. The general conditioning consisted of up to 30-minutes walking and a further nine motor control exercises for 2-minutes each with 1-minute rest. This was accompanied by a home exercise programme of 12 stretches to be done for 3 repetitions, 3 times a day, and 30 minutes of additional walking above normal activity levels. After the 6-week intervention all four groups produced statistically significant improvements in present, average and greatest pain intensity measured on the short form McGill Pain Questionnaire. Interestingly the brief PENS of 5-minutes produced an equal improvement to that of the 30-minute PENS. Furthermore, the general conditioning protocol had no additional benefit on pain measures above that of the PENS interventions, however it did significantly improve fear avoidance in comparison to PENS. These studies suggest that whilst sham PENS is ineffective, 5-minutes is sufficient to have treatment effect, casting significant doubt over the authors proposed mechanism of effect and suggesting the effects may be more centrally driven. Furthermore they indicate the potential benefits of active interventions, in particular general conditioning, on fear avoidance beliefs.
3.5.2 Biomedical approaches: Exercise-based interventions
Four of the studies examined exercise-based interventions. Murtezani et al. (2011) found high intensity aerobic exercise outperformed a passive electrotherapy group not dissimilar to the approach of Weiner and colleagues. They randomised 101 patients to either a high intensity aerobic exercise group or a passive modalities group. They used the Hospital Anxiety and Depression Scale to measure psychosocial factors. The scores suggest the patient’s as a group were indicative of patients with yellow flags. The active group produced a 3.9 mean decrease in the visual analogue scale. Interestingly the control group produced no improvements in pain intensity, toe touch, anxiety and depression scores and disability. Suggesting the passive intervention was far less effective than that the results seen in Weiner and colleague’s studies (2003, 2008). Nonetheless the high intensity aerobic exercise intervention produced improvements across all these measures.
In contrast the other two low risk of bias studies looking low intensity aerobic interventions found no significant difference between their intervention and control groups. Hurley et al (2015) conducted a 3-arm assessor blind RCT of an individualised walking programme, an exercise group intervention and usual care physiotherapy, in 246 patients aged 18-62 with CLBP. Participants were recruited from those seeking help at the local hospital and this was used as a baseline as opposed to trials from the general population, which require a baseline pain score for inclusion. The psychosocial baseline assessment of these patients suggests as a group they were representative of patients with yellow flags. The walking programme was individualised and education on functional restoration and addressing fears around movement and the patient’s understanding of their problem were addressed. Patients were given a pedometer to measure their initial activity. From then on they had weekly contact with a physiotherapist, with the aim to progress them to 30-minutes total daily walking 5 times a week. This is in line with the recommendations of the American College of Sports Medicine and previous studies (Garber et al 2011, Tully et al. 2005, 2007). The exercise group attended a class based on the back to fitness programme (Moffett and Frost 2000) endorsed by the UK National Institute of Clinical Excellence guidelines, once per week for eight consecutive weeks. The physiotherapists providing the usual physiotherapy were free to prescribe education, advice, manipulation and exercise as usual but could not refer patients to an exercise group or a walking programme. Similarly, Mannion et al. (1999) compared modern active physiotherapy, muscle reconditioning on training devices, and low-impact aerobics, each done twice a week over 3-months. Modern active physiotherapy was considered to be 30 minutes of individual therapy focused on improving functional capacity and instructions on ergonomic principles. This involved isometric exercises, Theraband exercises and use of general-strength training devices. In addition patients were given home exercises and encouraged to perform them. As is quite typical in many studies the specifics of what was actually done in terms of exercises and all acute variables remains a mystery. Muscle reconditioning involved 12-weeks on the David Back Clinic programme in groups of two to three, which uses progressive isoinertial strengthening in all three planes of motion in a patient’s pain free range of motion. Sessions are proceed by a 5-10 minute cycling or stepping warm up, and relaxation and further undefined strengthening exercises were done between isoinertial exercises. The aerobics and stretching class consisted of a class with 12 people maximum, lasting 1-hour done to music. The initial 20 minutes was used for static stretching and low intensity whole body aerobic exercise. This was followed by 30 minutes of exercises targeted primarily at the legs and trunk. The last 15 minutes was used for cool down and relaxation. 148 participants met the inclusion criteria and 16, 10.8%, dropped out during the study. The three groups did not differ significantly in terms of compliance with 84.1% completing all 24 sessions. Interestingly in both studies all interventions were equally efficacious, despite all three interventions targeting different aspects of physical conditioning. Mannion et al. (1999) suggest this shows that the mechanism of benefit may be more central and possibly due to challenging beliefs around physical activity and chronic low back pain. This is further supported by the correlation between improvement in fear avoidance beliefs and self rated disability. Furthermore these correlations were also present in the devices and aerobics group where these effects were still seen at 6-months, but not in the active physiotherapy group where they were not seen. There were also improvements in spinal flexion and these improvements were correlated with improvements in pain and intensity and self-rated disability. Hurley et al. (2015) highlight that whilst there was no difference in outcomes, the walking programme had the greatest adherence and the lowest costs.
Vincent et al. (2014) compared total body resistance training with lumbar extensor training and a control group in obese individuals. Resistance training sessions were carried out three times a week for 4-months. The total body training group did one set of 12 exercises, for 15 repetitions at 60% of repetition maximum, with 60 seconds rest between sets. Load was increased approximately 2% every week to maintain a BORG perceived exertion from 16-18. The lumbar extension group did just the lumbar extension exercise from the total body resistance-training group. For the first week they did two sets once a week and after that they did one set once a week with same acute variables as the total body group. As is typical in these studies no information on the tempo of the exercises was provided. The control group received advice on healthy nutrition via leaflet from the American Heart Association, information about back pain and information on bodyweight back strengthening exercises. The total body training group had greater reductions in self-reported disability as measured on the Oswestry Disability Index and Roland Morris Disability Questionnaire. Pain Catastrophizing Scale scores decreased in the total body training group more than in the control group at age 4-months. Lumbar extensor training and total body training both decreased walking and chair rise pain severity significantly more than the control. From this it is tempting to imply that the lumbar extensor training was sufficient to improve physical function whilst the total body training provided additional benefits to perceived disability and psychosocial factors.
3.5.3 Psychosocial approaches: Pain education
Five studies looked at more directly addressing the psychosocial component of patient’s pain experiences, two of which looked specifically at the effects of pain education and were considered low risk of bias. Moseley and colleagues (2004) conducted a randomised controlled trial comparing pain neurophysiology education with traditional back school education. Each subject took part in a 3-hour 1:1 education session, which included a 20-minute break for a drink. Diagrams and hypothetical examples were used to convey ideas. The experimental neurophysiology education focused on the functional significance of the nervous system, nociception, synapses and how chemicals talk to each other, and the plasticity of the nervous system including peripheral and central sensitisation and movement control. The control group received more typical back education. This covered the anatomy of the spine including the vertebrae, intervertebral discs, trunk and back muscles, normal spinal curves, posture and movement. This included analysis of lifting technique in terms of joint forces and intradiscal pressures, lifting techniques loads and ergonomic advice, as well as advice on stretching, strengthening, endurance and fitness. No information on the nervous system was included. At the end of the session participants were given a 10 section workbook and asked to complete one section a day, each week day for 2-weeks, and then asked to answer the three questions at the end of each section. Subjects returned for assessment 15-week days after the initial assessment. This resulted in significant improvements in pain attitudes, pain catastrophizing scale, straight leg raise and forward bend. Roland Morris Disability Questionnaire was statistically significantly improved although the authors suggest this probably was not a clinically significant improvement. Thus suggesting significant benefits in nervous system based education
Vowles et al. (2007) looked at the effect of pain acceptance, pain control and continued practice instruction strategies on physical impairment, in 74 unemployed individuals on workers compensation with LBP for greater than 3 months. Participants were sent a Beck Depression Inventory, Fear of Pain Questionnaire Short-Form, Pain Anxiety Symptoms Scale-20, McGill Pain Short Form Questionnaire, Chronic Pain Acceptance Questionnaire and the Physical Impairment Index to complete before attending their appointment. The Physical Impairment Index involves seven standardised physical tests; spinal tenderness, a 10 seconds hold of both feet 6 inches off the floor in supine, a 10 seconds hold of both shoulders 6 inches off the floor in supine, total flexion, total extension, total side flexion and passive straight leg raise. After each task patients were asked to rate their pain on a scale of 0-10. These scores were added to create a composite pain score. The instructions for the first test were the same for all participants. For the second test participants were randomised in to three different groups, pain control, pain acceptance and continued practice. The pain control group instructions emphasised that it was possible to control pain through mental strategies or efforts and asked patients to prevent pain during tasks. The pain acceptance group instructions emphasised that pain did not need to influence activity and asked participants not to let pain influence their performance. The continued practice group were asked to continue as they had before, and were informed that improvements can occur with practice. At Baseline the acceptance group had significantly higher levels of physical impairment than the continued practice group. There was no significant difference with the pain control group. After the intervention the pain acceptance group reduced their scores by 16.3%, whilst there was a worsening of 8.3% in the pain control group and 2.5% reduction in the continued practice group. Interestingly there was no significant difference across groups in terms of pain during the tasks. This suggests that the pain acceptance strategy allowed the patients to improve their physical performance without any increase in pain. Conversely it suggests the pain control group had increased physical impairment with no improvement in pain. The authors note that 124 people in total were asked to start the trial and only 91 started. They state that authors experience suggested that the patients that refused to take part were afraid of exacerbating their symptoms. This skews the population of the study towards those who were more likely to do well with this intervention. Nonetheless it provides what appears to be an immediately useful approach for clinicians to use in explaining how to approach pain during exercise and activities of daily living. The combination of pain acceptance with pain neurophysiology education may prove even more advantageous but this remains to be seen.
3.5.4 Psychosocial approaches: Intensive cognitive behavioural therapy and functional restoration programmes
Three studies looked at what could be considered intensive rehabilitation programmes, with functional restoration and CBT components. Pfingsten and Hilderbrandt (2001) reported on the results of the functional restoration programme which they trialled over 10 years with 762 CLBP patients, from 1990 to 2000. This was lowest quality study of those identified, with no randomisation, blinding and no explanation of drop outs. Nonetheless, studies such as this provide inform us of methods utilised with this patient group. As expected patients who were off work had increased psychosocial and pain symptoms compared with working patients. Their programme consisted of a 3 week pre-programme of education, stretching and bodyweight exercises followed by an intensive 7 hours a day outpatient programme for 5 weeks. This involved aerobic, functional strength and endurance exercises, back school education, cognitive behavioural group therapy, relaxation training and vocational counselling. The programme reduced Numerical Rating Scale, Pain Disability Index, Allgemiene Depressionsskala (amount of depression), psychological distress (Fear Avoidance Beliefs Questionnaire) and healthcare utilisation. Furthermore work capability significantly improved. However, when they modified it to remove the work hardening component there were no such improvements. These results remained stable at 12-month follow up.
Two studies with a low risk of bias using intensive psychosocial based physiotherapy interventions were identified (Alaranta et al. 1994 and Lee et al. 2013). Alaranta et al. (1994) looked at a combined psychosocial activation and physical intervention in CLBP compared with an inpatient rehabilitation programme in 152 patients, with a control group of 141. All patients had been referred to receive inpatient rehabilitation in Finland. Subjects were stratified according to sex and age and randomised to either group. Both interventions started 3-weeks after assessment and lasted 3-weeks. The intervention group received 37-hours of guided self-controlled physical exercises, without passive physical therapy and 5 hours of discussion groups a week, and individual consultations for work problems. The programme included a range of cardiovascular activities and games, strength and endurance training based off the patients 1 repetition maximum, stretching, relaxation and cognitive-behavioural disability management groups. This group did not receive any passive physiotherapy. The inpatient therapy involved a large amount of passive therapy as well as back education, pool exercises, indoor and outdoor activities. The authors considered this programme to be 40-50% of the intensity of the intervention group. The other study (Lee et al. 2013) directly assessed psychosocial treatment in CLBP patients aged 18-55, with Orebro Musculoskeletal Pain Questionnaire scores of 106-145 indicating moderate psychosocial risk factors. Patients were randomised to either an integrated work rehabilitation group or the conventional treatment group. Physiotherapists in this study had postgraduate qualifications and had received training in the cognitive behavioural approach. Patients received individual treatment for up to 3 months. Conventional treatment typically involved a combination of electrophysical agents, lumbar traction, manual therapy, and exercise therapy. Dictated by the patients’ symptoms at presentation and on their response to treatment. The cognitive behavioural approach group received an individualised graded activity programme, pacing techniques, work conditioning, return-to-work goal setting, self-management strategies, job analysis, and ergonomic advice. The aim was to improve their physical and functional capabilities with thorough attention to return to work. The researchers took the step of calling patients who missed an appointment to remind of them of their next appointment. Patients were discharged when they were able to return to work, had a subjective improvement of 70% or greater or they reached a plateau.
In both studies the authors suggest the results for the primary intervention group are clinically significant. Alaranta et al. (1994) found that at 3-months lateral trunk flexion, trunk rotation and hamstring flexibility was 11-12% increased in the combined group compared with 2-9% in the inpatient group. Abdominal, back and squatting strength improved significantly more in the intervention group in comparison to the inpatient group. These trends remained at 1-year follow up. The intervention group had greater decreases in pain at 3-month (17.1 vs 9.1) and 12-month (15.9 vs 8.9) follow up as measured using the Million index. Usage of physiotherapy and medical services was significantly decreased in both groups with the intervention group performing best. Mean days of sick leave per year decreased by 14 days in the intervention group, although this was not statistically superior to the inpatient group. At baseline to 3-months and at 12-month follow-up there were significant improvements in depression, subjective symptoms, aspects of personality, beliefs in disease and control and psychosocial adjustment in both groups. Similarly Lee et al. (2013) found that at discharge, the patients in the cognitive behavioural approach group made significant improvements in work recovery expectation, pain self-efficacy, and were more satisfied than the conventional treatment group.
3.5.5 Classification based approaches
Two trials with low risk of bias using a classification-based approach were identified (O’Sullivan et al. 2015 and Vibe Fersum et al. 2013). Both approaches used the Cognitive Functional Therapy (CFT) approach developed by O’Sullivan (Dankaerts and O’Sullivan 2011).
O’Sullivan et al. (2015) recruited 47 patients with at least a 1 year history of NSCLBP to a waiting list. 26 met all the selection criteria and underwent an initial 3-months on waiting list where they repeated the baseline assessments at 6-weekly intervals. The study did not have a control group, but went to extensive lengths to establish that participants had a stable condition and establish a clear baseline for the group. Based on the STarT Back screening tool scores, 14 patients were high risk, eight were moderate, and four were considered low risk. These scores indicate that these patients had yellow flags. They were then put through a cognitive functional therapy programme, which, focused on improving functional movements and postures, and tackling pain behaviours. In addition they took patients through cognitive reconceptualisation of their NSCLBP experience. Questioning of beliefs around pain, their relationship to pain, pain coping, and the relationship of stress with their pain were assessed. The primary outcomes were the Oswestry Disability Index and the Brief Pain Inventory, the average of four pain scores, maximum, minimum, average and current pain in the last 24 hours. An average of 7.7 treatments was conducted over 12 weeks. Oswestery Disability Index scores were 22 points lower after treatment, 23 points lower after 3 and 6 months and 24 points lower after 12 months. The initial reduction equates to a 54% reduction from baseline. Pain scores were 1.6 points lower after treatment, 1.5 and 1.6 points lower after 3 and 6 months and 1.7 points lower 12 months. All these results represented statistically significant reductions.
Vibe Fersum et al. (2013) unusually specified that participant’s pain was provoked and relieved by specific activities, movements or postures. The numerical rating scale needed to average at least 2/10 over the proceeding 14 days and the Oswestry Disability Index needed to be greater than 14%. The authors state the selection criteria designed this way to select patients whose movement behaviour had a clear association with their pain disorder. Patients with greater than 4 months sick leave were excluded on the grounds that they would require a specific return to work programme. 121 participants met the inclusion criteria and were randomised to receive either a cognitive behavioural functional therapy or manual therapy and exercise. The three physiotherapists delivering the approach were experienced exponents of using a multidimensional classification system. Based on the classification system each patient received a tailored intervention targeted at improving the cognitive, movement or lifestyle component the classification system suggested was maladaptive or provocative. The Oreboro Musculoskeletal Pain Questionnaire was also used to target psychosocial interventions. The intervention had four main components. For each patient their vicious cycle of pain was explained in a personalised diagram based on their assessment findings. Specific movement exercises designed to normalise their maladaptive movement behaviours were given based on their movement classification diagnosis. Functional restoration based on the movements they reported avoiding or provocative, and a physical activity programme tailored to the movement classification. The initial session was 1 hour and follow-ups were 30-45 minutes. Patients were initially seen once a week for 2-3 weeks and then progressed to follow-ups every 2-3 weeks over the course of the 12-week intervention. The comparison group received joint mobilisation or manipulation techniques to the spine or pelvis as delivered by specialists in orthopaedic manual therapy with an average of 25.7 years experience. These physiotherapists had no prior experience of the classification system or cognitive behavioural functional therapy. 82.5% of the patients received exercises based on the physiotherapists’ findings. Initial appointments in this group were 1 hour and follow-ups lasted 30 minutes. Both sets of therapists underwent a half-day of training with a clinical psychologist on the concepts of a best practice cognitive approach to managing back pain. Both groups received 8 sessions on average. Their primary outcome measures were pain was measured using the pain intensity rating scale and the Oswestry Disability Index. A validated 15-item scale to self-evaluate back specific function. There is some confusion over the pain scale used as the test suggests it was average pain over the proceeding two weeks, whilst the table reporting the data suggests it was one week. There was no difference in medication usage between groups before or after treatment. A lack of compliance withdrawal was set at 50%, leading to 27.1% of the manual therapy and exercise group, and 17.7% from the cognitive functional therapy group failing to complete treatment, which precluded an intention to treat analysis. After the intervention average pain over the last week decreased from 5.3 to 3.8 and stayed 3.8 at 12-month follow up, in the manual therapy group. In cognitive functional therapy group it went from 4.9 to 1.7, and crept back to 2.3 at 12-month follow up. The Oswestry Disability Index decreased from 24.0 to 18.5 after intervention and was 19.7 at 12-month follow up in the manual therapy and exercise group. In the cognitive functional therapy group it decreased from 21.3 to 7.6 and was 9.9 at 12-month follow up. These results were all statistically significant in favour of cognitive functional therapy over manual therapy and exercise. It is clear which intervention they were hoping to prove effective and it is possible that increased effort consciously or unconsciously may have gone in to the treatment group. Further the clinicians treating the control may well have been less invested in the outcome of the subjects they treated. This may account for the treatment group receiving 30-45 minutes for follow-ups compared to 30 minutes in the control group. Nonetheless the results are in keeping with those of O’Sullivan et al. (2015) highlighting the benefit of a classification-based approach.
Given the significant nature of the problem of chronic low back pain it is surprising only 10 studies met the inclusion criteria. These studies show a consistent pattern that a variety of interventions are able to decrease psychosocial symptoms, improve function and decrease perceived pain. Disappointingly none of the research on the popular Maitland and McKenzie approaches met the inclusion criteria. Of the studies included the reporting of how interventions were carried out is often not sufficient to allow reproducibility or use in practice.
Of all the studies those using the CFT approach had the most positive effects as measured by disability and pain. The other particularly effective approach was the walking programme of Hurley and colleagues (2015) which had the same effect as their exercise group and usual physiotherapy interventions for pain, disability and psychosocial measures but the walking programme had greater adherence and lower costs. This fits with some of the emerging research in whiplash pain which suggests a low cost telephone based intervention was equal to a more expensive and time intensive motor control intervention (Michaelef et al. 2014).
The admittedly very limited selection of two studies (Weiner et al. 2003, 2008) suggests that whilst passive interventions could positively affect pain, the addition of general conditioning was required to reduce fear avoidance. Similarly, Vincent et al. (2014) found that the lumbar extensor strengthening was sufficient to increase physical function but the total body programme was required to improve perceived disability and psychosocial measures. Improvements in fear avoidance beliefs are often associated with improved function (Crombez et al. 1999) nonetheless in these studies it appears that active treatment such as walking or whole body exercise is required to improve psychosocial measures. There were only two education-based studies but the positive results suggest pain acceptance and neurophysiology education in combination should be useful. The results from intensive functional restoration and CBT programmes suggests these kind of multidisciplinary programmes are effective across all measures, with Pfingsten and Hilderbrandt (2001) noting the importance of work hardening in promoting return to work.
Considering that CLBP is the leading cause of disability worldwide and those with yellow flags are known to suffer the worst and contribute most to societal cost it is surprising how few studies met the selection criteria. This review has shown that whilst the term yellow flags are used in the assessment literature and guidelines, the term psychosocial and the factors that make it up are used in the treatment literature. The studies selected highlight that passive, active; more comprehensive and simple education interventions can all positively impact the pain experience of this patient group. While passive interventions can improve pain, more whole body active approaches such whole body weight training or walking may be necessary to positively impact the psychosocial aspects. Comprehensive CBT and functional restorations are effective but the inclusion of work hardening may significantly aid in return to work. Pain education approaches involving pain neurophysiology education and pain acceptance were both effective compared with more traditional back school and pain avoidance approaches respectively. A combination of these may be useful clinically. The CFT approach was the most effective in terms of disability and self reported pain. Thus despite the lack of investigation in to several of the most prominent approaches this review shows the breadth of approaches available to clinicians.