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Effects of Clinician- or AI-Delivered Guideline-Concordant Advice on Opioid Use in Acute Low Back Pain: A 2×2 Factorial Randomised Clinical Trial

Effects of Clinician- or AI-Delivered Guideline-Concordant Advice on Opioid Use in Adults who Reported Acute Low Back Pain: A 2×2 Factorial Randomised Clinical Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12626000892314
Enrollment
3136
Registered
2026-07-20
Start date
2026-07-31
Completion date
2026-09-30
Last updated
2026-08-03

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 online randomised controlled trial aims to investigate the effects of advice framing and delivery mode on participants’ intentions to use opioids for acute low back pain. Adults with current or recent (within the past three months) non-specific low back pain who have not sought medical care for this condition in the past year will complete online baseline questionnaires then be randomised to one of four intervention groups in a 2×2 factorial design: 1. Opioids “not recommended/should be avoided” + Clinician-delivered advice (n=784) 2. Opioids as a “last resort” + Clinician-delivered advice (n=784) 3. Opioids “not recommended/should be avoided” + AI-delivered advice (n=784) 4. Opioids as a “last resort” + AI-delivered advice (n=784) Participants in all groups will be given the same hypothetical case of acute low back pain and view a short intervention video corresponding to their allocated group. They will then complete a post-intervention questionnaire including questions on intention to use opioids, treatment credibility, satisfaction, and behavioural intentions. The trial will be conducted entirely online using REDCap.

Interventions

Intervention Participants will be randomly allocated in a 1:1:1:1 ratio to one of four intervention groups. Each participant will receive only one intervention and will view one approximately one minute educational video. Before viewing the video, participants will be asked to read a brief hypothetical scenario describing that they have acute low back pain and are consulting a healthcare professional about pain management. They will then watch the assigned video and complete a post intervention

Intervention Participants will be randomly allocated in a 1:1:1:1 ratio to one of four intervention groups. Each participant will receive only one intervention and will view one approximately one minute educational video. Before viewing the video, participants will be asked to read a brief hypothetical scenario describing that they have acute low back pain and are consulting a healthcare professional about pain management. They will then watch the assigned video and complete a post intervention questionnaire assessing their beliefs and intended use of opioids. The four intervention groups are: Arm 1: Clinician delivered, "avoid opioids" advice: Participants view a video featuring a real clinician delivering evidence based advice that opioids are not recommended and should be avoided for acute low back pain. Arm 2: Clinician delivered, "last resort" advice: Participants view a video featuring a real clinician delivering evidence based advice that opioids should only be considered as a last resort for acute low back pain after other recommended treatments have been tried. Arm 3: AI delivered, "avoid opioids" advice: Participants view a video in which the advice is delivered by an AI generated human avatar with high realism in facial appearance, voice, and movements. The content is identical to Arm 1, recommending that opioids are not recommended and should be avoided for acute low back pain. Arm 4: AI delivered, "last resort" advice: Participants view a video in which the advice is delivered by an AI generated human avatar with high realism in facial appearance, voice, and movements. The content is identical to Arm 2, recommending that opioids should only be considered as a last resort for acute low back pain. Intervention content: All four videos were developed specifically for this study and are approximately one minute in duration. The videos communicate guideline concordant advice regarding opioid use for acute low back pain. The advice provided to participants in the video (to avoid opioids where possible, or use them only as a last resort for acute low back pain) is evidence-based, reflecting current international clinical practice guideline recommendations for the management of non-specific low back pain. Participants are not simply told this is "evidence-based" without basis — the advice itself is derived directly from published guideline recommendations. This is supported by the following reference, which provides an overview of global clinical practice guidelines for non-specific low back pain: Oliveira CB, Koes BW, Pinto RZ, Traeger AC, Machado GC, Lin CC, et al. Towards global clinical practice guidelines for the management of non-specific low back pain in primary care: a review of current guideline recommendations and how they have changed over the last 30 years. Lancet Rheumatol. 2026;8(6):e470-e85. doi: 10.1016/S2665-9913(26)00077-9. PubMed PMID: 42203385. The only differences between intervention groups are: 1. Mode of delivery: real clinician versus AI generated human avatar. 2. Advice framing: opioids should be avoided versus opioids should only be used as a last resort. Apart from these two factors, the script, duration, and overall structure of the videos are standardised across all groups. Total intervention duration: The intervention consists of reading one hypothetical clinical scenario and viewing one approximately one minute educational video. Including the scenario, the intervention takes approximately 2 to 3 minutes to complete. Participants then complete the study questionnaire. Intervention adherence: Intervention delivery is fully automated within REDCap. Participants must view their allocated video before proceeding to the post intervention questionnaire. REDCap records questionnaire completion and study completion status, allowing monitoring of intervention completion and overall participant adherence.

Sponsors

Professor Chung Wei Christine Lin, Institute for Musculoskeletal Health, Sydney Medical School, Faculty of Medicine and Health, The University of Sydney, Australia
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Educational / counselling / training
Masking
Blinded (masking used) (Investigator)

Eligibility

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

Inclusion criteria

Eligibility will be assessed using a screening survey in REDCap. Participants will be eligible if they meet all of the following: • Age 18 years or older • Self-reported an episode of low back pain either currently or within the previous 3 months • Individuals who have not sought care for low back pain from a medical practitioner within the past year (“Have you ever seen a doctor for low back pain within the past 1 year?” Yes/No).

Exclusion criteria

Participants will be excluded if they meet any of the following: • Insufficient English proficiency to understand trial procedures or complete surveys • Sign of contraindications to opioid analgesics (“Have you ever been told by a doctor that you should not take opioid pain medications because they could be risky for you?” Yes/No). • Participants who are planning conception, or are currently pregnant, or breastfeeding

Outcome results

None listed

Source: ANZCTR · Data processed: Aug 10, 2026