Opioid DependenceNCT05437861
Return to Work - Will Brief Intervention Reduce Opioid-induced Back Pain?
A study testing Brief Intervention in people with Opioid Dependence and Low Back Pain, run by University Hospital, Akershus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Dependence, Low Back Pain, Opioid Use
- What is being tested?
- Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Aug 2022to Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- cauda equina syndrome
- recent surgery (within 1 month)
- pregnancy
- psychiatric disease
- rheumatic disease
- diabetic polyneuropathy
Show all 9Show fewer
- cancer
- insufficient proficiency in the Norwegian language
- no remaining work potential and/or permanent sick pension.
About this study
Official title: Return to Work - Will Brief Intervention Reduce Opioid-induced Back Pain? A RCT Pilot Study
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.
Read more
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
- Being tested
- Brief Intervention
- Medical subject headings
- Opioid-Related Disorders, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment as usual | No intervention | Not described |
| Brief Intervention | Experimental | Not described Receives: Behavioral: Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 4 months
Secondary outcomes (7)
Hopkins symptom check list (HSCL-25)
Assess for changes in questionnaire response regarding change in mental distress, anxiety and/or depression between the 3 time points and feasibility of use of questionnaire battery. Higher score means worse outcome. 4-point likert scale with 25 items.
Measured: baseline, 1 month and 4 months
Gene expression analysis
This analysis explores gene expression levels from blood samples. The investigaters collect blood samples which are prepared and shipped to the United Kingdom for RNA sequencing. This is conducted by the commercial company Novogene, UK. For updated information about tools and equipment used for RNA sequencing please confer with the company's website (https://en.novogene.com/)
Measured: baseline and 1 month
Severity of dependence scale
Assess for changes in medication dependence by investigating questionnaire response between the 3 time points and feasibility of use of questionnaire battery. Higher score means worse outcome.
Measured: baseline, 1 month and 4 months
Questions about substance abuse (DSM-IV)
Assess for changes in medication use by investigating questionnaire response between the 3 time points and feasibility of use of questionnaire battery. Higher score means worse outcome.
Measured: baseline, 1 month and 4 months
Teppers abusive supervision scale
Assess for changes in questionnaire response between the 3 time points and feasibility of use of questionnaire battery. Higher score means worse outcome. 5 items on a 5 point likert scale.
Measured: baseline, 1 month and 4 months
Health related quality of life (EuroQoL 5D)
Assess for changes in health related quality of life by investigating questionnaire response between the 3 time points and feasibility of use of questionnaire battery. Higher score means better outcome.
Measured: baseline, 1 month and 4 months
Visual analogue scale
Assess for changes in reported pain levels by investigating questionnaire response between the 3 time points and feasibility of use of questionnaire battery. Higher score means worse outcome. Score 0-10.
Measured: baseline, 1 month and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study startAug 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Et liv i bevegelse (ELIB)
- Responsible party
- Principal investigator, Johannes Gjerstad, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437861
- Sponsor's protocol ID
- 21/08211
- Status last verified
- Jun 2022
- First submitted
- 30 May 2022
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Work - Will Brief Intervention Reduce Opioid-induced Back Pain? A RCT Pilot Study
- ClinicalTrials.gov ID
- NCT05437861
- Acronym / sponsor ID
- 21/08211
- Conditions
- Opioid Dependence, Low Back Pain, Opioid Use
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Et liv i bevegelse (ELIB)
- Study start
- Aug 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment as usual | No intervention | – |
| Brief Intervention | Experimental | Behavioral: Brief Intervention |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- cauda equina syndrome
- recent surgery (within 1 month)
- pregnancy
- psychiatric disease
- rheumatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief InterventionA 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. | Behavioural | Brief Intervention |
Primary outcome
Feasibility of the study protocol
Time frame: 4 months
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.
Power and sample size calculations
Time frame: 4 months
Estimate the appropriate sample size for a full-scale study. This will be conducted utilizing a 2-sample t-test
7 secondary outcomes
Hopkins symptom check list (HSCL-25)
Time frame: baseline, 1 month and 4 months
Gene expression analysis
Time frame: baseline and 1 month
Severity of dependence scale
Time frame: baseline, 1 month and 4 months
Questions about substance abuse (DSM-IV)
Time frame: baseline, 1 month and 4 months
Teppers abusive supervision scale
Time frame: baseline, 1 month and 4 months
Health related quality of life (EuroQoL 5D)
Time frame: baseline, 1 month and 4 months
Visual analogue scale
Time frame: baseline, 1 month and 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Intervention in people with Opioid Dependence and Low Back Pain, run by University Hospital, Akershus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the study protocol (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.