Chronic Pain Clinical Trial
— TOPIOOfficial 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
Verified date | May 2024 |
Source | Lund University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 140 |
Est. completion date | December 30, 2025 |
Est. primary completion date | August 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Sweden | Paincentre Sahlgrenska University Hospital | Gothenburg | Västra Götaland |
Sweden | Pain and rehabilitation centre Linköping University Hospital | Linköping | Östergötland |
Sweden | Lund University Hospital | Lund | Skåne |
Lead Sponsor | Collaborator |
---|---|
Lund University Hospital | Lund University, Sahlgrenska University Hospital, Sweden, University Hospital, Linkoeping |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hospital Anxiety and Depression scale (HADS) | 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. | 12 months | |
Other | Tampa Scale for Kinesiophobia (TSK) | 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. | 12 months | |
Other | Pain Catastrophizing Scale (PCS) | 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. | 12 months | |
Other | Chronic Pain Acceptance Questionnaire (CPAQ-8) | 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. | 12 months | |
Other | Perceptions of health | 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. | 12 months | |
Primary | Opioid consumption | Data retrieved from National Boars of Health and Welfare, collected prescribed opioid drugs | 12 months | |
Primary | Opioid consumption | Self reported consumption | 4 months | |
Secondary | Numeric Pain Rating Scale (NPRS) | 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. | 12 months |
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