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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
Oslo University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain, Widespread

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 17, 2017
    Last Updated
    January 22, 2018
    Sponsor
    Oslo University Hospital
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    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

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

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