Return to Work - Will Brief Intervention Reduce Opioid-induced Back Pain?

NCT05437861 | Unknown

• 1 other identifier: 21/08211
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid Dependence; Low Back Pain; Opioid Use

Outcome Measures

Primary Outcomes (2)

• Feasibility of the study protocol

  Feasibility of the pilot study protocol will be defined as absence of premature discontinuation of treatment. Semi structured interviews will be conducted to collect the therapists and the participants experience in relation to strengths and weaknesses of the protocol. This will help optimize the design for a full scale study. Also questions will be added pertaining to the participants experience of the intervention. This will be uncovered through a conversation at the end of the study.

  4 months

• Power and sample size calculations

  Estimate the appropriate sample size for a full-scale study. This will be conducted utilizing a 2-sample t-test

  4 months

Secondary Outcomes (7)

• Hopkins symptom check list (HSCL-25)

  baseline, 1 month and 4 months

• Gene expression analysis

  baseline and 1 month

• Severity of dependence scale

  baseline, 1 month and 4 months

• Questions about substance abuse (DSM-IV)

  baseline, 1 month and 4 months

• Teppers abusive supervision scale

  baseline, 1 month and 4 months

Study Arms (2)

Treatment as usual

NO INTERVENTION

Brief Intervention

EXPERIMENTAL

Behavioral: Brief Intervention

Interventions

Brief Intervention BEHAVIORAL

A short conversation with the participant regarding their use of opioids will be conducted. During the conversation the participants potential drug dependency will be uncovered. Further the pros and cons of weaning of the medication will be explained and a new treatment plan will be proposed.

Brief Intervention

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Et liv i bevegelse (ELIB): collaborator

MeSH Terms

Conditions

Opioid-Related Disorders; Low Back Pain

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 29, 2022
• Study Start: August 1, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: June 29, 2022

Record last verified: 2022-06