Chronic low back pain in musculoskeletal medicine Musculoskeletal Diseases Chronic low back pain
Conditions
Interventions
1. Spinal Rehabilitation Programme (SRP)
The content of the SRP has been developed following previous research, review of the literature and collaboration with service providers. Service users have no
Sponsors
Middlesex University (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and female subjects between ages of 20-65 years. This is a standard adult age range used in CLBP studies investigating the effect of exercise and /or manual therapy 2. CLBP for >3 months 3. Motivated and willing to attend both the physiotherapy programmes
Exclusion criteria
Exclusion criteria: 1. Cardiac, respiratory, kidney, blood pressure or blood circulatory problems which may prevent participation in any strenuous exercise programme 2. Recent spinal surgery within one year which may affect the ability to participate in group exercise programmes. These patients are usually excluded from CLBP studies 3. Acute fracture or recent trauma require specialist management and would not be suitable for group rehabilitation programmes 4. Inflammatory or infectious diseases of the spine 5. Metabolic or bone disease such as osteoporosis Both 4 and 5 conditions are a contraindication to physiotherapy and would require further investigation and onward referral 6. Neurological signs or symptoms such as sensation loss in a specific dermatome, myotomal muscle weakness or abnormal reflexes. These neurological deficits may require further investigation or monitoring and would not be appropriate for an extensive exercise programme or manual therapy 7. Advanced rheumatoid arthritis or uncontrolled diabetes. These conditions are contraindicated to manual therapy and exercise programmes. These conditions would also require specialist review 8. Subjects who were pregnant or attempting to become pregnant 9. Chronic pain syndrome patients with severe physical or psychological impairment. This includes the group of patients presenting with widespread sensory hypersensitivity mediated by central pain mechanisms. These patients are unlikely to respond to exercise and/or manual therapy and may need to be referred for multimodal pain management programmes or pain clinic 10. Participated in a regular exercise programme or had previous physiotherapy or any other treatment within the last six months 11. Any spinal condition requiring further investigation or on-ward referral and not likely to respond to conservative treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured pre-treatment, post-treatment (3 and 6 months) and at one year follow-up: 1. Function, measured by the Functional Rating Index (FRI) which is a valid and reliable measure used to monitor change in spinal conditions. The FRI has ten items with a 5-point Likert scale (i.e. 0 none to 4 severe) for each item. Scores for each item (maximum of 4) are totalled to give an index score. There are ten items. This index score out of 40 is multiplied by 100 to give a percentage. Higher percentage scores indicate higher perceived dysfunction and pain. If only 9 items are completed then an index score out of 36 can be multiplied by 100 to give a percentage score. This may be applicable as one item relates to work. Some patients do not work and therefore would not be able to answer this question. However, the FRI would be invalid if less than 9 items were completed. The FRI scale also estimates disability. 0-20% is classified as minimal disability, 21-40% moderate disability, 41-60% severe disability and greater than 61% very severe disability. 2.1. Quality of life, measured using the EQ-5D-5L. This is a new version of the EQ-5D which includes five levels of severity in the existing five dimensions in order to reduce ceiling effects. The EQ-5D-5L is a standardised instrument for use as a measure of health outcome. It is applicable to a wide range of health conditions and treatments. Added 17/01/2017: 2.2. Quality of life, measured using the EQ-VAS. The EQ-VAS is part of the EQ-5D-5L and is a self-rating scale which records the respondent’s own assessment of their health status that day. 3. Pain, measured using the Numerical Pain Rating Scale (NPRS), an 11-point pain rating scale ranging from 0 (no pain) to 10 (worse pain imaginable). The NPRS was used to assess the participant’s current pain intensity as well as the best and worst level of pain during the last 24 hours. These three levels were averaged to give the participant’s pain score. All outcomes measured pre-treat | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures will evaluate patient?s perceptions and experiences of the treatments they received. These measures will be administered post-treatment. As of 23/02/2016: 1. Patient satisfaction - Patient?s' perception of their treatment will be measured using a modified version of the Participant Satisfaction Reporting Scale (PSRS). The PSRS is a 5-item report questionnaire (total score out of 25) which allows patients to rate their satisfaction with their treatment but also to rate their satisfaction with improvement. For example, this instrument rates a patient?s attitude toward their treatment they received from completely satisfied to completely dissatisfied. The higher the score the more satisfied they are. 2. Participants?' perceptions of the group programmes will be explored qualitatively by the use of focus group interviews once the recruitment process has finished and all participants have completed their group programme sessions. All participants will be invited to take part by letter. It is expected to have two focus groups (one for each group programme) consisting of 6-8 participants based on response rates and attendance with similar studies. Participants in these focus groups will have the opportunity to discuss their experiences with aim of exploring the impact of the programme on them as individuals. Previous: 1. Patient satisfaction - Patient?s' perception of their treatment will be measured using a modified version of the Participant Satisfaction Reporting Scale (PSRS). The PSRS is a 5-item report questionnaire (total score out of 25) which allows patients to rate their satisfaction with their treatment but also to rate their satisfaction with improvement. For example, this instrument rates a patient?s attitude toward their treatment they received from completely satisfied to completely dissatisfied. The higher the score the more satisfied they are. 2. Community Patient Experience Survey (CPES) - a questionnaire based on a version us | — |
Countries
United Kingdom
Outcome results
None listed