Low back pain Musculoskeletal Diseases Dorsalgia
Conditions
Interventions
1. Usual GP care intervention group (Treatment 0):
All participants entering the cohort who are not randomised to receive active treatment will constitute the usual care group. These participants will
this is a self help book for LBP frequently distributed by health care professionals. These participants will not be provided with manual therapy or acupuncture through the trial. Data will be collect
Sponsors
University of York (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Individuals aged between 18 - 65 years of age, either sex 2. Individuals registered with a GP practice participating in the trial 3. Individuals who have consulted their GP with mechanical or simple low back pain (LBP) in the preceding eighteen months 4. Individuals suffering with LBP for between six weeks and eighteen months 5. Individuals with referred pain into the leg will be included in the study (if there was no indication of any serious neurological conditions when they were assessed by their GP) 6. Individuals with pain present on assessment and pain that is persistent in nature (i.e. occurring at least once daily for eighty percent of the days in the history of their recent painful episode) 7. Individuals who agree to avoid physical treatments other than the study interventions for the ten to twelve week period of the pilot study (active treatment participants only) 8. Individuals with a score of four or more on the Roland-Morris disability questionnaire at baseline (UkBeam 2004)
Exclusion criteria
Exclusion criteria: 1. Individuals with clinical indications of serious spinal or neurological pathology, as assessed by their GP 2. Individuals with a history of spinal surgery (as this may alter clinical outcome) 3. Pregnant women or those who have given birth in the last twelve weeks (as this may alter clinical outcome) 4. Individuals who had received manual therapy or acupuncture in the preceding three months, (as this may alter clinical outcome) 5. Individuals with blood disorders, receiving anti-coagulants or anti-platelets (as a relative contraindication to acupuncture) 6. Individuals who are immuno-compromised, (as a relative contraindication to acupuncture) 7. Individuals with metal allergy (as a relative contraindication to acupuncture) 8. Individuals who are unable to provide consent 9. Individuals who are unable to converse in English, due to funding limitations of the study 10. Individuals with a history of psychosis or alcohol abuse (due to difficulty in assessing outcome) 11. Individuals who have a needle phobia 12. Individuals with valvular heart disease or demand pacemakers (as an absolute contraindication to acupuncture)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate recruitment rates and assess any issues with retention to inform a full scale trial | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the main clinical outcome measure: 1. Roland-Morris disability questionnaire, (specific low back pain measure) 2. Modified Oswestry Disability Index, (specific low back pain measure) Both outcome measures are frequently used in research and both have been shown to be valid and reproducible, however they each have strengths and limitations in different aspects (Longo, Loppini et al. 2010). As this is a pilot study, both of the above measures will be used, to investigate which would be a more favourable and informative measure to use in a full scale study of manual therapy and acupuncture for the treatment of LBP. A comparison of the two questionnaires to assess their reliability to each other as similar measures for LBP will be performed. Additionally the information gained from the questionnaires will be analysed with regard to usable patient information that could inform a full-scale trial, clinical choice and effectiveness. 3. Visual Analogue Scale (VAS) pain scales, (pain specific measure) 4. SF 12, (quality of life questionnaire) 5. Euro-Qol (EQ-5D), (generic measure of health for clinical and economic appraisal) 6. Patient use of body chart and additional treatment information Measeured every three months for an 18month period, so baseline, then 3months, 6, 9,12,15,18months. | — |
Countries
United Kingdom
Outcome results
None listed