Osteopathic Single CAse Research for Patients With Chronic Low Back Pain

NCT ID: NCT05120921

Last Updated: 2025-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-05

Study Completion Date

2023-07-31

Brief Summary

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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

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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.

Conditions

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Chronic Low-back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

The first group of patients will receive standard osteopathic management. The second group will receive biopsychosocially informed osteopathic management.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The statistician will be blinded to which group patients were allocated to.

Study Groups

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standard osteopathic manual treatment

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

Group Type ACTIVE_COMPARATOR

Osteopathic Manual Treatment

Intervention Type OTHER

includes touch, joint manipulations, stretching and massage

Self-management

Intervention Type OTHER

Providing rehabilitative exercises to patients to do at home

Reassurance

Intervention Type OTHER

Reassuring patients on their symptoms, diagnosis and prognosis.

biopsychosocially informed osteopathic manual treatment

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.

Group Type ACTIVE_COMPARATOR

Osteopathic Manual Treatment

Intervention Type OTHER

includes touch, joint manipulations, stretching and massage

Self-management

Intervention Type OTHER

Providing rehabilitative exercises to patients to do at home

Reassurance

Intervention Type OTHER

Reassuring patients on their symptoms, diagnosis and prognosis.

Biopsychosocial management

Intervention Type OTHER

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

Interventions

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Osteopathic Manual Treatment

includes touch, joint manipulations, stretching and massage

Intervention Type OTHER

Self-management

Providing rehabilitative exercises to patients to do at home

Intervention Type OTHER

Reassurance

Reassuring patients on their symptoms, diagnosis and prognosis.

Intervention Type OTHER

Biopsychosocial management

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

Intervention Type OTHER

Other Intervention Names

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Osteopathic Manipulative Technique Therapeutic exercises cognitive reassurance; affective reassurance Enactive approach

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Osteopathic Foundation

UNKNOWN

Sponsor Role collaborator

University College of Osteopathy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jerry RF Draper-Rodi, D.Prof.(Ost)

Role: PRINCIPAL_INVESTIGATOR

University College of Osteopathy

Locations

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University College of Osteopathy

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 34517916 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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OSCAR_LBP

Identifier Type: -

Identifier Source: org_study_id

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