A Multi-disciplinary Pain Intervention (MUD-PI) for Patients With Chronic Widespread Primary Pain (MUD-PI)

Patients who fulfilled inclusion criteria and consented to participate received either treatment as usual at the clinic, or were enrolled in a group-therapy based intervention, the multi-disciplinary pain intervention, led by a Medical doctor, physiotherapist and psychologist at the clinic.

Study Overview

• Status: Completed
• Conditions: Chronic Pain, Widespread
• Intervention / Treatment: Behavioral: MUD-PI

Detailed Description

The Department of Pain Management and Research at Oslo University Hospital is Norway's largest outpatient pain clinic. It treats around one thousand new patients annually suffering from chronic pain of all aetiologies. Many of the patients receive interdisciplinary care based on a biopsychosocial framework, by at least two health care providers (physician, physiotherapist, psychologist, occupational therapist and/or nurse).

Participants were recruited through referrals from primary or secondary care, which were identified by an established interdisciplinary team. Patients found potentially eligible for the study were contacted by the research team and consulted with a research physician. Patients who fulfilled the inclusion criteria were invited to participate in the study and signed a consent form. Patients who declined to participate and non-eligible patients received usual care.

Inclusion criteria were 1) age 18 or more; 2) pain in at least three out of five bodily regions (defined as the four quadrants and axially); 3) pain persisting three months or more; 4) the patient was able to give informed consent and benefit from group therapy (including sufficient cognitive capacity and language skills); 5) no other medical condition could better explain the symptoms.

Subjects were randomised either to treatment as usual or a group-based multidisciplinary pain intervention (the MUD-PI).

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 or more
• Pain in at least three out of five bodily regions (defined as the four quadrants and axially)
• Pain persisting three months or more
• The patient was able to give informed consent and benefit from group therapy (including sufficient cognitive capacity and language skills
• No other medical condition could better explain the symptoms.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as usual; Receives treatment as usual at the clinic
Experimental: MUD-PI; Receives multi-disciplinary pain intervention, agroup-based, multi-disciplinary treatment	Behavioral: MUD-PI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient generated index	Individualised patient reported outcome	Change in score on inclusion and 1 week after completion of intervention or control group

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in EQ-5D	standardised patient reported outcome	Change in score on inclusion and 1 week after completion of intervention or control group
Change in Oswestry disability index	standardised patient reported outcome	Change in score on inclusion and 1 week after completion of intervention or control group

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Publications and helpful links

General Publications

• Tschudi-Madsen H, Rodevand LN, Boymo Kaarbo M, Granan LP. Chronic Widespread Pain in a tertiary pain clinic: classification overlap and use of a patient generated quality of life instrument. Scand J Pain. 2019 Apr 24;19(2):245-255. doi: 10.1515/sjpain-2018-0097.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2016
• Primary Completion (Actual): March 20, 2017
• Study Completion (Actual): June 4, 2018

Study Registration Dates

• First Submitted: December 17, 2017
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 29, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: OsloUH Smerteklinikken

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No