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

• ClinicalTrials.gov Identifier: NCT03413501
• Recruitment Status: Unknown
• First Posted: January 29, 2018
• Last Update Posted: January 29, 2018
• Sponsor: Oslo University Hospital
• Information provided by (Responsible Party): Lars-Petter Granan, Oslo University Hospital

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain, Widespread	Behavioral: MUD-PI	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-disciplinary Pain Intervention (MUD-PI) for Patients With Chronic Widespread Primary Pain
• Actual Study Start Date: September 20, 2016
• Estimated Primary Completion Date: February 20, 2018
• Estimated Study Completion Date: February 20, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change in Patient generated index [ Time Frame: Change in score on inclusion and 1 week after completion of intervention or control group ]
   Individualised patient reported outcome

Secondary Outcome Measures :

1. Change in EQ-5D [ Time Frame: Change in score on inclusion and 1 week after completion of intervention or control group ]
   standardised patient reported outcome
2. Change in Oswestry disability index [ Time Frame: Change in score on inclusion and 1 week after completion of intervention or control group ]
   standardised patient reported outcome

Eligibility Criteria

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

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tschudi-Madsen H, Rødevand LN, Bøymo Kaarbø 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.

• Responsible Party: Lars-Petter Granan, Principal investigator, Oslo University Hospital
• ClinicalTrials.gov Identifier: NCT03413501
• Other Study ID Numbers: OsloUH Smerteklinikken
• First Posted: January 29, 2018
• Last Update Posted: January 29, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations