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Tapering From Long-term Opioid Therapy in Chronic Pain Population. Randomized Controlled Trial With 12 Months Follow up (TOPIO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03485430
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : September 2, 2020
Lund University
Information provided by (Responsible Party):
Lund University Hospital

Brief Summary:
This randomized controlled study compares tapering of long-term opioid therapy in a population with chronic non-cancer pain with control group constituted of waiting list. Half of participants receives intervention at baseline and the other half are controls but receives intervention after 4 months. Ethical approval to follow up excluded participants denying tapering at baseline.

Condition or disease Intervention/treatment Phase
Chronic Pain Analgesics, Opioid Opioid Withdrawal Opioid Use Substance Use Disorders Behavioral: Tapering Not Applicable

Detailed 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Tapering of Prescribed Opioids in Patients With Long-term Non-malignant Pain - Efficacy and Effects on Pain, Pain Cognitions, and Quality of Life (TOPIO): a Study Protocol for a Randomized Controlled Clinical Trial With a 12 Month Follow-up
Actual Study Start Date : March 22, 2018
Estimated Primary Completion Date : March 20, 2023
Estimated Study Completion Date : March 20, 2024

Arm Intervention/treatment
Active Comparator: Intervention
Receives tapering of opioid dose at baseline
Behavioral: Tapering
Tapering with follow up by nurse at weekly basis in beginning of tapering. Tapering may also be conducted in inpatient setting. Follow-up to doctor after four months.

No Intervention: Control
Waiting-list. Receives tapering after 4 months.

Primary Outcome Measures :
  1. Opioid consumption [ Time Frame: 12 months ]
    Data retrieved from National Boars of Health and Welfare, collected prescribed opioid drugs

  2. Opioid consumption [ Time Frame: 4 months ]
    Self reported consumption

Secondary Outcome Measures :
  1. Numeric Pain Rating Scale (NPRS) [ Time Frame: 12 months ]
    NPRS was used to capture the patient's level of pain intensity. Patients rate their average level of pain the last week. The 11-point scale spans from the left with the phrase "no pain" i.e. 0 and on the right to the phrase "worst imaginable pain" i.e. 10.

Other Outcome Measures:
  1. Hospital Anxiety and Depression scale (HADS) [ Time Frame: 12 months ]
    HADS was constructed for patients in medical settings. It entails 14-item measures of anxiety (7 items) and depression (7 items) symptoms over the course of a week. Items are rated on a four-point scale (0 = not all; 3 = very often) and the anxiety and depression subscales range from 0 to 21. Higher scores indicate greater severity.

  2. Tampa Scale for Kinesiophobia (TSK) [ Time Frame: 12 months ]
    The TSK employs a 4-point Likert scale, with scoring options ranging from 1 (strongly disagree) to 4 (strongly agree) and encompasses 17 items related to pain, fear of movement and re-injury. The total score of the original 17-item version ranges between 17 and 68, with a higher score indicating a higher degree of Kinesiophobia.

  3. Pain Catastrophizing Scale (PCS) [ Time Frame: 12 months ]
    The PCS comprises 13 items that are rated from 0 to 4 with the endpoints 0 ("Never") to 4 ("All the time") and was constructed to assess pain-related catastrophizing (48). Catastrophizing include three factors: (a) Helplessness i.e. perceived helplessness in situations when pain is present (six items); (b) Rumination, concerning vigilance toward the pain experience (four items) ; and (c) Magnification i.e. the tendency to magnify the threat value of pain (three items). The total score ranges from 0-52 points with a higher score indicating a higher degree of catastrophizing.

  4. Chronic Pain Acceptance Questionnaire (CPAQ-8) [ Time Frame: 12 months ]
    Pain acceptance measures two main classes of behaviors represented by respective subscales: Activity Engagement (score range: 0-24), and Pain Willingness (inverted score range: 0-24). The items are rated from 0 (never true) to 6 (always true) and higher values indicate higher acceptance to chronic pain.

  5. Perceptions of health [ Time Frame: 12 months ]
    RAND-36 is a modern translation of SF-36. RAND-36 encompasses questions from eight domains (subscales) i.e. physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE) and mental health (MH). The scores are subsequently transformed in a standardized way into a 0-100 scale where higher scores indicate better health.

Information from the National Library of Medicine

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

Inclusion Criteria:

A long-term opioid therapy with daily intake due to chronic pain condition, by prescription. Willing to enter an intervention aiming at taper opioid therapy.

Exclusion Criteria:

No daily intake of opioids. Shorter duration of opioid therapy than 3 months. Repeated intake of non-prescribed opioids or other illegal drugs. Refusal to perform drug-screening Perceived medical risks of waiting with tapering of opioids (e.g: raising opioid doses after acute pancreatitis caused by excessive alcohol intake or kidney disease stage 4-5 in combination with excessive alcohol intake and high doses of opioids).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03485430

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Contact: Henrik Grelz, MD +46703002832
Contact: Åsa Ringqvist, MD, PhD

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Lund University Hospital Recruiting
Lund, Skåne, Sweden, 22100
Contact: Henrik Grelz, MD    +4646172289   
Contact: Åsa Ringqvist, MD PhD   
Principal Investigator: Henrik Grelz, MD         
Sub-Investigator: Åsa Ringqvist, MD PhD         
Sub-Investigator: Marcelo Rivano Fischer, PhD         
Sponsors and Collaborators
Lund University Hospital
Lund University
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Study Chair: Patrik Midlöv, MD, PhD Lund University
Additional Information:
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Responsible Party: Lund University Hospital Identifier: NCT03485430    
Other Study ID Numbers: 7206093515
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Pain
Substance-Related Disorders
Neurologic Manifestations
Chemically-Induced Disorders
Mental Disorders