The Maintaining Musculoskeletal Health Study

NCT02668003 | Completed Results

• 4 other identifiers: 02/004/142074816/SW/0019184303
• Study Type: interventional
• Target: 1,002
• Locations: 1 country
• Sites: 3

Brief Summary

It is known from many studies that when patients have developed chronic widespread pain (CWP) or fibromyalgia that managing such symptoms is extremely challenging for both doctors and patients. The investigators have shown in a recently completed study funded by Arthritis Research UK that a course of Cognitive Behaviour Therapy delivered by telephone (tCBT) or an exercise regime can substantially improve the chances of the symptoms improving. The investigators now plan to offer this therapy to patients who are at a high risk of developing CWP (but who have not developed it yet) to see whether its onset can be prevented.

Conditions

Widespread Chronic Pain

Keywords

Prevention trial; Cognitive Behaviour Therapy; CWP; Chronic widespread pain; RCT; Fibromyalgia; Prevention

Outcome Measures

Primary Outcomes (1)

• Development of Chronic Widespread Pain Assessed by Questionnaire

  The development of new chronic widespread pain, as defined by ACR 1990 criteria for fibromyalgia and assessed by questionnaire, at follow-up will be compared between participants in the two treatment arms. A participant was counted as having chronic widespread pain if they said they had pain in the last month that had lasted a day or more, indicated on a paper manikin that the pain that was on both the left and right hand sides, and above and below the waist, and in the axial skeleton, and answered that they had this pain for more than 3 months. If they did not have pain that was that above and below the waist and on the left and right hand sides, and in the axial skeleton, or they did not say they had the pain for more than 3 months, then they did not have chronic widespread pain.

  12 months after treatment start

Secondary Outcomes (30)

• Pain Assessed by Questionnaire

  3 months after treatment start

• Pain Assessed by Questionnaire

  12 months after treatment start

• Pain Assessed by Questionnaire

  24 months after treatment start

• Illness Behaviour Assessed by Illness Behaviour Scale

  3 months after treatment start

• Illness Behaviour Assessed by Illness Behaviour Scale

  12 months after treatment start

Study Arms (2)

Cognitive Behavioural Therapy

EXPERIMENTAL

Brief Cognitive Behavioural Therapy delivered by telephone

Behavioral: Cognitive Behavioural Therapy

Treatment as usual

NO INTERVENTION

The group allocated to usual care will receive no additional intervention - this will reflect the fact there is no specific intervention provided to patients currently for the prevention of CWP. Participants in this group will receive usual care and there will be no restriction on what this can involve. CBT is not readily available within the NHS and is generally restricted to persons who have developed specific conditions rather than persons at risk of those conditions.

Interventions

Cognitive Behavioural Therapy BEHAVIORAL

The CBT intervention, delivered by telephone, will consist of an initial assessment, 6 weekly sessions, and then booster sessions at 3 and 6 months. The intervention will be delivered by trained and accredited therapists. Participants will be supported by a self-management CBT manual. There will be a patient-centred assessment by the therapist for problem identification, risk assessment and development of a shared formulation of the current health problem. The sessions will involve education about musculoskeletal pain, somatic symptoms and specific CBT techniques such as pacing of activity, behavioural activation, diary keeping, identifying and challenging negative and unhelpful thinking patterns and the development of a longer term management plan.

Also known as: Telephone-delivered Cognitive Behavioural Therapy

Cognitive Behavioural Therapy

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A 'high-risk' profile for developing CWP as identified on the screening survey, i.e.:
• Have pain for which the patient has sought consultation to primary care in the last 6 months
• Any 2 of the following: Illness Behaviour Score \> 4; Somatic Symptom Score \> 2; Sleep Problem Score \> 4
• Access to a land-line telephone or mobile telephone
• Ability to understand English sufficiently to participate in the intervention
• Ability to give informed consent
• Aged 25 years or over

You may not qualify if:

• Meeting American College of Rheumatology definition of CWP in the 1990 criteria for fibromyalgia (as assessed by the screening questionnaire)
• Medical conditions which would make the proposed intervention unsuitable (e.g. cognitive ability)

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (3)

NHS Grampian

Aberdeen, United Kingdom

Location

NHS Greater Glasgow & Clyde

Glasgow, United Kingdom

Location

NHS Highland

Inverness, United Kingdom

Location

Related Publications (3)

• Macfarlane GJ, Beasley M, Scott N, Chong H, McNamee P, McBeth J, Basu N, Hannaford PC, Jones GT, Keeley P, Prescott GJ, Lovell K. Maintaining musculoskeletal health using a behavioural therapy approach: a population-based randomised controlled trial (the MAmMOTH Study). Ann Rheum Dis. 2021 Jul;80(7):903-911. doi: 10.1136/annrheumdis-2020-219091. Epub 2021 Feb 1.

  PMID: 33526434 DERIVED

• Fraser C, Beasley M, Macfarlane G, Lovell K. Telephone cognitive behavioural therapy to prevent the development of chronic widespread pain: a qualitative study of patient perspectives and treatment acceptability. BMC Musculoskelet Disord. 2019 May 10;20(1):198. doi: 10.1186/s12891-019-2584-2.

  PMID: 31077168 DERIVED

• Macfarlane GJ, Beasley M, Prescott G, McNamee P, Keeley P, Artus M, McBeth J, Hannaford P, Jones GT, Basu N, Norrie J, Lovell K. The Maintaining Musculoskeletal Health (MAmMOTH) Study: Protocol for a randomised trial of cognitive behavioural therapy versus usual care for the prevention of chronic widespread pain. BMC Musculoskelet Disord. 2016 Apr 26;17:179. doi: 10.1186/s12891-016-1037-4.

  PMID: 27113442 DERIVED

MeSH Terms

Conditions

Chronic Pain; Fibromyalgia

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Professor Gary Macfarlane
• Organization: University of Aberdeen

g.j.macfarlane@abdn.ac.uk

01224 437 143

Study Officials

• Gary J Macfarlane, MBChB PhD MD

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2016
• First Posted: January 29, 2016
• Study Start: May 1, 2016
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 10, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (3)