N/A N=1,002 Randomized Prevention

The Maintaining Musculoskeletal Health Study

Widespread Chronic Pain

Bottom Line

View on ClinicalTrials.gov: NCT02668003 ↗

Enrolled (actual)

1,002

Serious AEs

0.0%

Results posted

Aug 2021

Primary outcome: Primary: Development of Chronic Widespread Pain Assessed by Questionnaire — 69; 77 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cognitive Behavioural Therapy (Behavioral)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: University of Aberdeen
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Development of Chronic Widespread Pain Assessed by Questionnaire	78; 101	—
SECONDARY Pain Assessed by Questionnaire	305; 376	—
SECONDARY Pain Assessed by Questionnaire	305; 376	—
SECONDARY Pain Assessed by Questionnaire	305; 376	—
SECONDARY Illness Behaviour Assessed by Illness Behaviour Scale	7.75; 8.95	—
SECONDARY Illness Behaviour Assessed by Illness Behaviour Scale	7.75; 8.95	—
SECONDARY Illness Behaviour Assessed by Illness Behaviour Scale	7.75; 8.95	—
SECONDARY Somatic Symptom Reporting Assessed by Somatic Symptoms Scale	184; 219; 82; 90; 44; 68	—
SECONDARY Somatic Symptom Reporting Assessed by Somatic Symptoms Scale	184; 219; 82; 90; 44; 68	—
SECONDARY Somatic Symptom Reporting Assessed by Somatic Symptoms Scale	184; 219; 82; 90; 44; 68	—
SECONDARY Sleep Problems Assessed by Sleep Problem Scale	8.45; 9.06	—
SECONDARY Sleep Problems Assessed by Sleep Problem Scale	8.45; 9.06	—
SECONDARY Sleep Problems Assessed by Sleep Problem Scale	8.45; 9.06	—
SECONDARY EQ-5D	0.74; 0.74	—
SECONDARY EQ-5D	0.74; 0.74	—
SECONDARY EQ-5D	0.74; 0.74	—
SECONDARY Wellbeing	0.91; 0.89	—
SECONDARY Wellbeing	0.91; 0.89	—
SECONDARY Wellbeing	0.91; 0.89	—
SECONDARY Psychological Distress Assessed by GHQ-12	168; 178; 36; 42; 67; 91	—
SECONDARY Psychological Distress Assessed by GHQ-12	168; 178; 36; 42; 67; 91	—
SECONDARY Psychological Distress Assessed by GHQ-12	168; 178; 36; 42; 67; 91	—
SECONDARY Patient Global Impression of Change Assessed by 7-item Scale	14; 15; 76; 48; 132; 91	—
SECONDARY Patient Global Impression of Change Assessed by 7-item Scale	14; 15; 76; 48; 132; 91	—
SECONDARY Patient Global Impression of Change Assessed by 7-item Scale	14; 15; 76; 48; 132; 91	—
SECONDARY Fatigue Assessed by Chalder Fatigue Scale	13.0; 13.9	—
SECONDARY Fatigue Assessed by Chalder Fatigue Scale	13.0; 13.9	—
SECONDARY Fatigue Assessed by Chalder Fatigue Scale	13.0; 13.9	—
SECONDARY Health Care Usage Assessed by Questionnaire	3094.68; 3052.38	—
SECONDARY Development of Chronic Widespread Pain Assessed by Questionnaire	78; 101	—
SECONDARY Development of Chronic Widespread Pain Assessed by Questionnaire	78; 101	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02668003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.