Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
70

Summary

Conditions
  • Analgesics Opioid
  • Chronic Pain
  • Opioid Use
  • Opioid Withdrawal
  • Substance Use Disorders
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Chronic non-cancer pain is a major problem in society and a common cause to seek health care. The suffering is complex as it, besides pain, often includes psychological symptoms and may decrease the ability to participate in work life. Pharmacological treatments have limited possibilities to ease su...

Chronic non-cancer pain is a major problem in society and a common cause to seek health care. The suffering is complex as it, besides pain, often includes psychological symptoms and may decrease the ability to participate in work life. Pharmacological treatments have limited possibilities to ease suffering. Opioids used in this population have evidence to ease pain and to some extent increase physical ability when used in limited treatment periods and in selected patients. Medium to long-term opioid therapy, extended beyond three months, lack evidence of easing pain or increase physical ability. The current study is conducted on a specialized pain care unit (Skane University Hospital; Lund) and aims at taper long-term opioid therapy with support from physician and nurse and study the effects of tapering. Method: Randomized controlled study, without concealment. Waiting-list constitutes the control-group. Intervention means tapering with a motivated patient. Follow up at four and twelve months. Primary end-point: collected opioid prescriptions registered in The National Board of Health and Welfare registry expressed in milligram of morphine equivalent. Secondary end-point: Data will be retrieved from the Swedish Quality Registry for Pain Rehabilitation. The database contains participants' self-report of variables measuring the impact of rehabilitation on depressive symptoms, anxiety, rating of pain and acceptance to pain. Assessments are made prior to, at the end of and one year after discharge of the rehabilitation program. As denying tapering or participation is shown to be as common as decision to taper drugs at baseline an extended ethical approval was acquired also retrospective. This approval covers obtaining collected prescribed medication and prescribed opioid replacement therapy (Buprenorphine or Methadone) after one year. The study may describe the excluded population better this way.

Tracking Information

NCT #
NCT03485430
Collaborators
Lund University
Investigators
Study Chair: Patrik Midlöv, MD, PhD Lund University