A Multi-disciplinary Pain Intervention (MUD-PI) for Patients With Chronic Widespread Primary Pain (MUD-PI)
Primary Purpose
Chronic Pain, Widespread
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MUD-PI
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain, Widespread
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Treatment as usual
MUD-PI
Arm Description
Receives treatment as usual at the clinic
Receives multi-disciplinary pain intervention, agroup-based, multi-disciplinary treatment
Outcomes
Primary Outcome Measures
Change in Patient generated index
Individualised patient reported outcome
Secondary Outcome Measures
Change in EQ-5D
standardised patient reported outcome
Change in Oswestry disability index
standardised patient reported outcome
Full Information
NCT ID
NCT03413501
First Posted
December 17, 2017
Last Updated
January 22, 2018
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03413501
Brief Title
A Multi-disciplinary Pain Intervention (MUD-PI) for Patients With Chronic Widespread Primary Pain
Acronym
MUD-PI
Official Title
A Multi-disciplinary Pain Intervention (MUD-PI) for Patients With Chronic Widespread Primary Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2016 (Actual)
Primary Completion Date
February 20, 2018 (Anticipated)
Study Completion Date
February 20, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oslo University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Widespread
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual
Arm Type
No Intervention
Arm Description
Receives treatment as usual at the clinic
Arm Title
MUD-PI
Arm Type
Experimental
Arm Description
Receives multi-disciplinary pain intervention, agroup-based, multi-disciplinary treatment
Intervention Type
Behavioral
Intervention Name(s)
MUD-PI
Primary Outcome Measure Information:
Title
Change in Patient generated index
Description
Individualised patient reported outcome
Time Frame
Change in score on inclusion and 1 week after completion of intervention or control group
Secondary Outcome Measure Information:
Title
Change in EQ-5D
Description
standardised patient reported outcome
Time Frame
Change in score on inclusion and 1 week after completion of intervention or control group
Title
Change in Oswestry disability index
Description
standardised patient reported outcome
Time Frame
Change in score on inclusion and 1 week after completion of intervention or control group
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30465720
Citation
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.
Results Reference
derived
Learn more about this trial
A Multi-disciplinary Pain Intervention (MUD-PI) for Patients With Chronic Widespread Primary Pain
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