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

NCT ID: NCT05437861

Last Updated: 2022-06-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-31
• Study Completion Date: 2023-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Treatment as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Brief Intervention

Group Type: EXPERIMENTAL

Brief Intervention

Intervention Type: 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.

Interventions

Brief Intervention

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 67 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Et liv i bevegelse (ELIB)

UNKNOWN

Sponsor Role: collaborator

University Hospital, Akershus

OTHER

Sponsor Role: lead

Responsible Party

Johannes Gjerstad

Project manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

21/08211

Identifier Type: -

Identifier Source: org_study_id