Osteopathic Single CAse Research for Patients With Chronic Low Back Pain (OSCAR)

University College of Osteopathy

Status: Completed

Conditions: Chronic Low-back Pain

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05120921

OSCAR_LBP

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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9 participants in 2 patient groups

standard osteopathic manual treatment

Active Comparator group

Description:

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

Treatment:

Other: Self-management

Other: Osteopathic Manual Treatment

Other: Reassurance

biopsychosocially informed osteopathic manual treatment

Active Comparator group

Description:

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.

Treatment:

Other: Self-management

Other: Biopsychosocial management

Other: Osteopathic Manual Treatment

Other: Reassurance