Clinical trial NCT05437861: Return to Work - Will Brief Intervention Reduce Opioid-induced Back Pain?
Official title: Return to Work - Will Brief Intervention Reduce Opioid-induced Back Pain? A RCT Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Dependence
Low Back Pain
Opioid Use
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Et liv i bevegelse (ELIB)
First posted: 2022-06-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Background Back pain is among the most common cause for sick leave in the working population and is the main cause of years lived with disability globally. In Norway, about 30% report to live with chronic pain and women are affected more than men. Pharmacological strategies for pain management e.g., opioid medications, is a common treatment method. This is despite clinical guidelines suggesting limiting pharmacological treatment in management of chronic back pain. Long-term use of opioids is linked to opioid-induced hyperalgesia, paradoxically. However, it is suggested that RNA sequencing (seq.) profiling may identify individuals that are at risk of opioid-induced hyperalgesia. To help reduce medication intake brief intervention (BI), a method for discontinuing long-term medication use, has shown to be successful. In this pilot RCT the investigators aim to investigate the feasibility of a full scale RCT and observational study using BI on opioid-using patients with back pain and concurrently study if the response can be predicted by RNA seq.

Method Ten outpatients aged 18-67 years with back pain will be recruited from the orthopaedic department at Akershus University Hospital. Inclusion criteria includes daily use of opioids for more than two weeks consecutively, and sufficient language (Norwegian) skills. Exclusion criteria includes severe medical or surgical condition such as cauda equina syndrome, rheumatic disease, psychiatric disease, or recent surgery. The patients will be randomised into two groups (5+5) where one group receives the BI and the other gets treatment as usual. Data collection will be conducted at three-time points; baseline, four weeks follow-up and three months follow-up (end of trial). The primary outcome for this pilot RCT is to test feasibility and estimate effect size for a later full-scale study. Secondary outcomes include subjective and objective findings from the data collection.

Results Primary results concerning feasibility are mainly qualitative and will be presented as such. Secondary results including demographic information as well as tentative effect size, patient reported outcomes such as pain intensity, anxiety, depression, quality of life, psychosocial stressors in the workplace and the RNA seq will be presented descriptively.

Conclusion The results from this pilot study will assist in constructing the optimal design for a full-scale RCT.


Eligibility criteria: Inclusion Criteria:

* age 18-67 years, admitted from their GP to Ahus due to back pain,
* daily use of opioids such as ≥ 30 mg codeine or ≥ 45 mg tramadol or ≥ 3 mg oxycodone or other opioids corresponding to a morphine equivalent dose ≥ 10-20 mg

Exclusion Criteria:

* cauda equina syndrome
* recent surgery (within 1 month)
* pregnancy
* psychiatric disease
* rheumatic disease
* diabetic polyneuropathy
* cancer
* insufficient proficiency in the Norwegian language
* no remaining work potential and/or permanent sick pension.

Primary outcomes:
measure: Feasibility of the study protocol
timeFrame: 4 months
measure: Power and sample size calculations
timeFrame: 4 months
Secondary outcomes:
measure: Hopkins symptom check list (HSCL-25)
timeFrame: baseline, 1 month and 4 months
measure: Gene expression analysis
timeFrame: baseline and 1 month
measure: Severity of dependence scale
timeFrame: baseline, 1 month and 4 months
measure: Questions about substance abuse (DSM-IV)
timeFrame: baseline, 1 month and 4 months
measure: Teppers abusive supervision scale
timeFrame: baseline, 1 month and 4 months
measure: Health related quality of life (EuroQoL 5D)
timeFrame: baseline, 1 month and 4 months
measure: Visual analogue scale
timeFrame: baseline, 1 month and 4 months
Other outcomes:
Locations:
Study officials:
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