Osteopathic Single CAse Research for Patients With Chronic Low Back Pain

NCT05120921 | Completed

• 1 other identifier: OSCAR_LBP
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Outcome Measures

Primary Outcomes (2)

• Numeric Pain Rating Scale changes during the treatment phase (max 6 weeks) and follow-up period (12 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.

  Up to 18 weeks

• The Patient Specific Functional Scale changes during the treatment phase (max 6 weeks) and follow-up period (12 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.

  Up to 18 weeks

Secondary Outcomes (4)

• Measure Your Medical Outcome Profile 2

  Up to 18 weeks

• The Arthritis Research UK Musculoskeletal Health Questionnaire

  Up to 18 weeks

• The Depression, Anxiety, and Positive Outlook Scale

  Up to 18 weeks

• The Pain Attitudes and Beliefs Scale (for the osteopaths)

  6 months

Other Outcomes (3)

• Survey about experience of osteopathic treatment and of participating in the SCED study (for patients)

  6 weeks

• Prognostic surveys (for the osteopaths)

  6 weeks

• Survey of SCED feasibility and acceptability and impact of the e-learning course on patient care (for the osteopaths)

  9 months

Study Arms (2)

standard osteopathic manual treatment

ACTIVE COMPARATOR

Pragmatic individualised osteopathic manual treatment which is a system of diagnosis and treatment for a wide range of musculoskeletal conditions. Osteopaths take a detailed case history and perform a thorough clinical examination to help understand the nature of patients' pain and symptoms so that they can arrive at a diagnosis. Practitioners use touch, physical manipulation, stretching and massage to help increase the mobility of joints, to relieve muscle/joint tension and pain. Osteopaths often combine a range of other treatment techniques in their approach, such as rehabilitative exercises, advice about how patients can self-manage their condition and educational approaches to help them understand their pain. Osteopathy is a regulated profession (regulated by the General Osteopathic Council) in the UK

Other: Osteopathic Manual Treatment; Other: Self-management; Other: Reassurance

biopsychosocially informed osteopathic manual treatment

ACTIVE COMPARATOR

As for the active comparator + biopsychosocial management: after having a completed a 8-10 hour e-learning on the biopsychosocial model for the management of low back pain, osteopaths will use the same approaches as in the active comparator group, plus techniques to help patients making sense of their symptoms, to develop patients' self-efficacy, and psychosocial management skills.

Other: Osteopathic Manual Treatment; Other: Self-management; Other: Reassurance; Other: Biopsychosocial management

Interventions

Osteopathic Manual Treatment OTHER

includes touch, joint manipulations, stretching and massage

Also known as: Osteopathic Manipulative Technique

biopsychosocially informed osteopathic manual treatment; standard osteopathic manual treatment

Self-management OTHER

Providing rehabilitative exercises to patients to do at home

Also known as: Therapeutic exercises

biopsychosocially informed osteopathic manual treatment; standard osteopathic manual treatment

Reassurance OTHER

Reassuring patients on their symptoms, diagnosis and prognosis.

Also known as: cognitive reassurance; affective reassurance

biopsychosocially informed osteopathic manual treatment; standard osteopathic manual treatment

Biopsychosocial management OTHER

Giving a central place to the patient in the decision-making to help them to get back to valued activities.

Also known as: Enactive approach

biopsychosocially informed osteopathic manual treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University College of Osteopathy: lead
• Osteopathic Foundation: collaborator

Study Sites (1)

University College of Osteopathy

London, SE1 1JE, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34517916 BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Interventions

Self-Management; Exercise Therapy

Intervention Hierarchy (Ancestors)

Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Jerry RF Draper-Rodi, D.Prof.(Ost)

  University College of Osteopathy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will be blinded to which group patients were allocated to.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The first group of patients will receive standard osteopathic management. The second group will receive biopsychosocially informed osteopathic management.

Study Record Dates

• First Submitted: October 21, 2021
• First Posted: November 16, 2021
• Study Start: November 5, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From publication of the results and up to 6 years after trial completion.
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be directed to jerry.draper-rodi@uco.ac.uk To gain access, data requestors will need to sign a data access agreement.

Locations

GB (1)