Clinical trial NCT05120921: Osteopathic Single CAse Research for Patients With Chronic Low Back Pain
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Lead sponsor: University College of Osteopathy
Sponsor class: OTHER
Collaborators: name: Osteopathic Foundation
First posted: 2021-11-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The first group of patients will receive standard osteopathic management. The second group will receive biopsychosocially informed osteopathic management.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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:

* Under 18
* 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

Primary outcomes:
measure: Numeric Pain Rating Scale changes during the treatment phase (max 6 weeks) and follow-up period (12 weeks)
timeFrame: Up to 18 weeks
measure: The Patient Specific Functional Scale changes during the treatment phase (max 6 weeks) and follow-up period (12 weeks)
timeFrame: Up to 18 weeks
Secondary outcomes:
measure: Measure Your Medical Outcome Profile 2
timeFrame: Up to 18 weeks
measure: The Arthritis Research UK Musculoskeletal Health Questionnaire
timeFrame: Up to 18 weeks
measure: The Depression, Anxiety, and Positive Outlook Scale
timeFrame: Up to 18 weeks
measure: The Pain Attitudes and Beliefs Scale (for the osteopaths)
timeFrame: 6 months
Other outcomes:
measure: Survey about experience of osteopathic treatment and of participating in the SCED study (for patients)
timeFrame: 6 weeks
measure: Prognostic surveys (for the osteopaths)
timeFrame: 6 weeks
measure: Survey of SCED feasibility and acceptability and impact of the e-learning course on patient care (for the osteopaths)
timeFrame: 9 months
Locations:
city: London
country: United Kingdom
facility: University College of Osteopathy
Study officials:
affiliation: University College of Osteopathy
name: Jerry RF Draper-Rodi, D.Prof.(Ost)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Draper-Rodi J, Vogel S, Bishop A. Effects of an e-learning programme on osteopaths' back pain attitudes: a mixed methods feasibility study. Pilot Feasibility Stud. 2021 Sep 13;7(1):174. doi: 10.1186/s40814-021-00901-4.
citation: Draper-Rodi, J., Vogel, S. and Bishop, A., 2018. Design and development of an e-learning programme: An illustrative commentary. International Journal of Osteopathic Medicine, 29, pp.36-40.