OSCAR (Osteopathic Single CAse Research) - Assessing the Effects of Standard and Biopsychosocially-informed Osteopathic Management for Patients With Non-specific Low Back Pain: A Single Case Experimental Design (SCED)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 9
- Locations
- 2
- Primary Endpoint
- The Patient Specific Functional Scale changes during the treatment phase (max 6 weeks) and follow-up period (12 weeks)
Study Overview
Brief Summary
This study aims to collect primary data from patients with low back pain to assess the effect of standard osteopathic management and biopsychosocially-informed osteopathic care using a Single-Case Experimental Design.
Detailed Description
After being informed about the study and potential risks, all osteopaths and patient participants giving written consent will be screened for eligibility. When entering the trial, patients will be randomised to early, intermediate or late intervention with either standard osteopathic management or biopsychosocially-informed osteopathic management.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The statistician will be blinded to which group patients were allocated to.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 or more years old
- •agree to take part in the study and provide formal online consent after having been assessed as capable of providing informed consent by the osteopath
- •Being fluent enough in English to be able to understand content of consent forms (and participate in osteopathic treatment without an interpreter)
- •Presenting with non-specific low back pain of a duration of a minimum of 12 weeks)
- •NRS score between 5 and 9 on a 11-point scale
- •PSFS score between 2 and 7 at baseline
- •Who can be contacted by email
- •Available for an appointment within two days around the randomisation date
Exclusion Criteria
- •Lacking capacity to give consent
- •Presenting with low back pain with a known or suspected pathological cause (e.g. infection, cancer or fracture)
- •People for whom osteopathic treatment may be contra-indicated (as assessed by the osteopath in the initial consultation) or who disclose information during their course of treatment which requires referral for other medical investigations or care
- •LBP of less than 12 weeks
- •NRS score below 5 or above 9
- •PSFS score above below 2 or above 7
- •Patients providing less than 3 data points during baseline
Outcomes
Primary Outcomes
The Patient Specific Functional Scale changes during the treatment phase (max 6 weeks) and follow-up period (12 weeks)
Time Frame: Up to 18 weeks
PSFS measures functional change in patients with musculoskeletal disorders. Patients choose to list up to 5 activities that they have difficulty with or are unable to perform. They will be asked to continue recording data for the originally chosen activities but can add extra activities if goals change (e.g. due to improving or worsening symptoms). Patients will rate current level of difficulty for each activity on an 11-point scale, where 0 = unable to perform and 10 = able to perform at previous level. Mean averages are calculated by summing the difficulty ratings and dividing by the number of activities. The PSFS is reliable and responsive for patients with chronic low back pain and a Minimum Detectable Change (MDC) is considered to be 3 points for 1 activity or 2 points for the average of 2 or more activities.
Numeric Pain Rating Scale changes during the treatment phase (max 6 weeks) and follow-up period (12 weeks)
Time Frame: Up to 18 weeks
11-item unidimensional measure of pain intensity. The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations will be used, i.e. patients will be presented with the numbers from 0 to 10, with 0 meaning 'No pain' and '10' meaning 'Pain as bad as you can imagine,' accompanied by the instructions "Please rate your pain by indicating the number that best describes your pain on average in the last 24h". NPRS is an acceptable measure but should not be used on its own as patients with chronic pain find it does not capture the complexity of their pain experience. It has a high test-retest reliability and a good validity. Patients will be asked to complete the NPRS every day, taking approx. 1 min.
Secondary Outcomes
- The Pain Attitudes and Beliefs Scale (for the osteopaths)(6 months)
- Measure Your Medical Outcome Profile 2(Up to 18 weeks)
- The Depression, Anxiety, and Positive Outlook Scale(Up to 18 weeks)
- The Arthritis Research UK Musculoskeletal Health Questionnaire(Up to 18 weeks)