NCT03413501

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 29, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2018

Completed
Last Updated

December 6, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

December 17, 2017

Last Update Submit

December 5, 2023

Conditions

Chronic Pain, Widespread

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in EQ-5D

    Change in score on inclusion and 1 week after completion of intervention or control group

  • Change in Oswestry disability index

    Change in score on inclusion and 1 week after completion of intervention or control group

Study Arms (2)

Treatment as usual

NO INTERVENTION

Receives treatment as usual at the clinic

MUD-PI

EXPERIMENTAL

Receives multi-disciplinary pain intervention, agroup-based, multi-disciplinary treatment

Behavioral: MUD-PI

Interventions

MUD-PIBEHAVIORAL
MUD-PI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 30465720DERIVED

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 17, 2017

First Posted

January 29, 2018

Study Start

September 20, 2016

Primary Completion

March 20, 2017

Study Completion

June 4, 2018

Last Updated

December 6, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share