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Digital Support For People With Chronic Pain Who Are Reducing Prescription Opioids

Digital Support For People With Chronic Pain Who Are Reducing Prescription Opioids - A Double-Blind Randomised Controlled Trial Evaluating The Feasibility, Acceptability, And Efficacy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622001423707
Enrollment
78
Registered
2022-11-07
Start date
2023-03-10
Completion date
2024-06-11
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This double-blind randomised controlled trial will investigate the the feasibility, acceptability, and efficacy of digital support to improve pain and well-being of people with chronic pain who are reducing prescription opioids. Participants will be patients with chronic non-cancer pain who are commencing prescription opioid tapering (dose reduction). 74 participants who meet the selection criteria will be randomized to receive either an educational video followed by text messages for 12 weeks (group 1) or an educational video (group 2) in addition to their usual care. The digital support intends to increase the self-efficacy to taper prescription opioids. This includes pain management and opioid tapering information, as well as supportive content. The study will evaluate the efficacy of the intervention in improving pain and well-being as the primary objective.

Interventions

Patients with chronic non-cancer pain on long-term opioid therapy who are tapering opioids under supervision of their doctor will be randomised to two groups. Participants randomised to group 1 will initially receive an educational video of approximately 10 minutes to watch. The video which is specifically designed for this study has information about a) Chronic pain and opioid medications, b) What to expect while reducing opioid dose? c) How reducing opioid dose can help? d) Pain management te

Patients with chronic non-cancer pain on long-term opioid therapy who are tapering opioids under supervision of their doctor will be randomised to two groups. Participants randomised to group 1 will initially receive an educational video of approximately 10 minutes to watch. The video which is specifically designed for this study has information about a) Chronic pain and opioid medications, b) What to expect while reducing opioid dose? c) How reducing opioid dose can help? d) Pain management techniques that can help while reducing opioid dose, e) What did other patients experience when they reduced their opioid dose? The video will be followed by daily text messages sent to their mobile phone for 12 weeks, twice per day, between 9 AM and 5 PM. These messages will provide further information, education, and support mentioned above. All participants in group 1 will receive the same messages in the same order. Participants are not required to respond to the SMS system (i.e., one-way message). Participants in group 1 will receive all scheduled messages, unless they choose to withdraw from the study or from receiving text messages. Delivery of the text messages will be automatically logged by the SMS software.

Sponsors

University of Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

- A resident of Australia - Age greater than or equal to 18 years - Having a chronic (greater than or equal to 3 months) non-cancer pain condition - Using opioid analgesics for at least four weeks before enrolment - Has started or is starting voluntarily reducing opioid dose under the supervision of a physician (GP or Specialist) - Willing to provide contact details of their physician (GP or Specialist) - Able to understand written and spoken English well - Owns a mobile phone that can receive text messages - Has access to the internet via their mobile phone - Able to give informed consent and comply with the study procedures

Exclusion criteria

- Having opioid or other substance use disorder - Having a poorly controlled or unstable mental illness - Suicidal ideation or attempt in the past 12 months - Major surgery in the past 6 months or scheduled in the next 3 months - Participation in another clinical trial concurrently - Pregnant

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 8, 2026