Osteopathy, Mindfulness and Acceptance-based Programme for Patients With Persistent Pain

NCT02121587 | Completed DMC

• 2 other identifiers: OsteoMAP 1AIMS 2527190
• Study Type: observational
• Target: 255
• Locations: 1 country
• Sites: 3

Brief Summary

The purpose of this pre and post intervention observational study is to evaluate patient-reported outcomes from an new clinical course which integrates Mindfulness and Acceptance-based approaches from '3rd wave' Cognitive Behavioural Therapy with osteopathic manual therapy treatment for patients with persistent pain. It is being conducted by the British School of Osteopathy (BSO) in London. In Stage 1 (in progress, June 2013 to August 2014), a course was developed for self-referring patients attending the BSO Clinic. In Stage 2 (September 2014 to May 2016), delivery will be expanded to evaluate outcomes for patients attending National Health Service (NHS) General Practitioner (GP) surgeries in South East London. The intervention consists of a pre-course screening interview; a structured course of six, weekly, one-hour treatment sessions for individual patients; and an optional follow-up interview after three months. The evaluation study is being conducted by an independent study team from the National Council for Osteopathic Research. Patients complete a set of standardised questionnaires before the course and after six months to assess self-reported changes in quality of life, well-being, activity levels, mindfulness and use of health resources. A sample of patients will be invited to provide consent for a treatment session to be observed and/or recorded, or to attend a follow-up interview after six months, to evaluate the quality of course delivery. This is an observational study of patient-reported outcomes from a new intervention in a single cohort of patients, so there is no formal study hypothesis but it is anticipated that outcomes will include increased quality of life, well-being, and active engagement with valued activities.

Conditions

Musculoskeletal Pain; Chronic Pain

Keywords

Musculoskeletal Pain, Osteopathy, Mindfulness

Outcome Measures

Primary Outcomes (1)

• European Quality of Life Questionnaire (EQ5D)

  To assess changes in quality of life from before the start of the six week course to six months after the course ends.

  Pre-course baseline at week 0 to 30 weeks

Secondary Outcomes (4)

• Activity Avoidance Questionnaire (AAQ-IIR) Questionnaire

  Pre-course week 0 to week 30

• Freiburg Mindfulness Inventory for mindfulness skills

  Pre-course week 0 to week 30

• Bournemouth Questionnaire for pain-related beliefs and behaviour

  Pre-course week 0 to week 30

• Self-reported changes in health resource utilisation

  Single measure at 30 weeks

Study Arms (1)

Pain self-management course

This is a single group observational cohort study. Participants are adults with persistent musculoskeletal pain who choose to participate in an optional, six week pain self-management course which integrates mindfulness and acceptance-based exercises into osteopathic manual therapy treatment for individual patients.

Behavioral: Pain self-management course

Interventions

Pain self-management course BEHAVIORAL

This is an observational study of patient-reported outcomes from an experiential pain self-management course which integrates mindfulness and acceptance-based exercises into osteopathic manual therapy treatment. The intervention consists of six, individual, one-hour osteopathic evaluation and treatment sessions which incorporate pain education, the development of mindfulness skills to enhance body awareness, and the identification of personal values to promote compassionate self-care and sustain commitment to active coping strategies. The intervention aims to enhance patients' well-being and resilience through developing psychological and behavioural flexibility in response to persistent pain.

Pain self-management course

Eligibility Criteria

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

Study Population

Adults with musculoskeletal pain for more than six months Pain or pain-related beliefs limit activity Suitable for osteopathic manual therapy Able to attend the British School of Osteopathy in London or Attend selected National Health Service doctors' surgeries in South East London

You may qualify if:

• Adults over the age of 18
• Persistent musculoskeletal pain for more than six months duration
• Known medical diagnosis and stable condition
• Pain or pain-related behaviour limits activity
• Can identify scope for change
• Motivated to participate in a six week, experiential self-management course
• Suitable for osteopathic manual therapy
• Able to provide informed consent
• Sufficient spoken English to participate in consultations without an interpreter
• Able to attend the selected clinic locations when appointments are available

You may not qualify if:

• Active, uncontrolled alcohol or substance abuse
• Active uncontrolled psychotic mental health problem
• Undergoing or awaiting further diagnostic medical investigations
• Currently attending a pain clinic or other psychological support service

Sponsors & Collaborators

• University College of Osteopathy: lead

Study Sites (3)

The British School of Osteopathy Clinical Centre

London, SE1 0BQ, United Kingdom

Location

Iveagh House Surgery

London, SW9 6AF, United Kingdom

Location

Stockwell Group Practice

London, SW9 9TJ, United Kingdom

Location

Related Publications (1)

• Abbey H & Nanke L. The development of a chronic pain self-management course within the British School of Osteopathy Clinic. International Journal of Osteopathic Medicine 16: e5-e6, 2013.

  BACKGROUND

Related Links

• The BSO is the largest osteopathic school in the United Kingdom, founded in 1917. It provides undergraduate and postgraduate osteopathy training, healthcare for the local community, and promotes national and international osteopathic research.

MeSH Terms

Conditions

Musculoskeletal Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hilary Abbey, M.Sc.

  University College of Osteopathy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2014
• First Posted: April 23, 2014
• Study Start: September 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 31, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)