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Does targeting pain-related beliefs in people with knee osteoarthritis increase physical activity? A pilot, feasibility trial.

Does targeting pain-related beliefs in people with knee osteoarthritis increase physical activity? A randomised, sham-controlled, feasibility trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001149257
Enrollment
20
Registered
2018-07-12
Start date
2018-07-13
Completion date
2018-08-24
Last updated
2021-11-01

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

Conditions

None listed

Brief summary

The primary purpose of this pilot study is to assess the feasibility of successfully conducting a randomised controlled trial that investigates the effect of adding Explain Pain (vs adding sham ultrasound) to an individualised, physiotherapist-led physical activity and general education program in people with painful knee osteoarthritis. Our primary feasibility objectives relate to participant eligibility and recruitment, participant follow-up rates, feasibility of objective physical activity measurement using wrist-based accelerometry in this population (i.e., valid wear time), and the fidelity of intervention delivery. Our primary pilot objectives relate to the perceived credibility of the sham intervention (inactive ultrasound with inert gel) and the acceptability of Explain pain content and its delivery format for participants and treating clinicians. Our secondary objectives are to identify barriers to study participation and to determine treatment effect estimates for pain intensity and physical activity. This information will help us to calculate the required sample size for a full-scale randomised controlled trial. Participants will be randomised to one of two groups: Explain Pain or Standard Education & Sham Ultrasound Control group. Both groups will receive 4, in-person treatment sessions with a physiotherapist, followed by 4 weeks of at-home activities (weekly check-in by physiotherapist). Both groups will receive general education about osteoarthritis and the importance of physical activity for general health and osteoarthritis benefits. Both groups will also receive a graded walking program. The Explain Pain group will receive enhanced pain education to supplement general education. Specifically, the overall aim of Explain Pain is to shift participants’ conceptualisation of pain from that of a marker of tissue damage to that of a marker of the perceived need to protect the body. The Participants will receive the Explain Pain Handbook. During the at-home sessions, participants will complete an interactive workbook called the Protectometer. The Standard Education & Sham Ultrasound group will receive standard education about osteoarthritis, pain and physical activity as per Arthritis Australia recommendations. They will also receive sham ultrasound (inactive ultrasound and inert gel) to 4 locations on the most painful knee (5 mins each). This will be performed to match time with the therapist between groups. Participants will receive the Arthritis Australia osteoarthritis and physical activity handbook. During the at-home sessions, participants will complete an general workbook that asks questions about osteoarthritis and activity. Outcome measures (pain, physical activity, function, pain beliefs, etc..) will be assessed at baseline, at 4 weeks, 8 weeks, and 6 months by an outcome assessor blinded to treatment group. Treatment efficacy will not be evaluated (between group comparisons) given that this is a feasibility study.

Interventions

Explain Pain Group (enhanced education + graded walking program) Participants randomised to this group will attend four, 60-90 minute, one-on-one sessions with a Physiotherapist at weekly intervals, during which they will receive enhanced pain education (Explain Pain) as well as receiving a graded walking program. The overall aim of Explain Pain is to shift participants’ conceptualisation of pain from that of a marker of tissue damage to that of a marker of the perceived need to protect the bod

Explain Pain Group (enhanced education + graded walking program) Participants randomised to this group will attend four, 60-90 minute, one-on-one sessions with a Physiotherapist at weekly intervals, during which they will receive enhanced pain education (Explain Pain) as well as receiving a graded walking program. The overall aim of Explain Pain is to shift participants’ conceptualisation of pain from that of a marker of tissue damage to that of a marker of the perceived need to protect the body. The Explain Pain enhanced education will also expand upon general information about osteoarthritis and activity (received by control group). The physiotherapist will have received specific training in Explain Pain including a 2-day course and 4 months of specific training with the research team. Explain Pain is a cutting edge educational approach that moves away from didactic lectures/seminars. It aims to educate participants that pain is a protective feature of our system, not a ‘damage-meter’; thus, pain can be modulated by other things besides tissue damage and danger messages (i.e. nociception). It will aim to reduce the perceived danger associated with the knee, using proven principles and strategies of conceptual change science. Conceptual change strategies informed by contemporary theory will be used, including: challenging existing knowledge and refining learning strategies for new concepts using principles of multimedia learning will be used. A detailed curricula has been created for this intervention. The following pain education topics will be covered in the one-on-one sessions: Basic nervous system anatomy/function; distinction between nociception and pain; protective function of pain; peripheral/central sensitization; up-regulation of brain mechanisms that serve protection; the state of ‘hyper-protection’ offered by normal bio-logical adaptations; the concept of an internal ‘Protectometer’ (modulated by multifaceted danger and safety cues). Further, a discussion of the participants’ own knee xray will be undertaken with the aim being to ‘de-threaten’ radiological findings (e.g., focusing on positive features such as excellent bone density) using standardised wording. Education about the poor correlation between x-ray findings and pain will be provided. Specific education about physical activity will be provided, namely that it does not increase joint damage but does have wide-ranging health benefits and OA-specific benefits. Last, it will be discussed that physical activity is key to bioplasticity – i.e., inducing changes in our system – and that it decreases overprotectiveness of our system, a change that often occurs with persistent pain. Participants will receive the Explain Pain book to take home which discusses concepts from this intervention. In the one-on-one sessions, participants will also receive a graded walking problem. This will involve first establishing participant’s baseline walking tolerance (i.e. how far, on average, they are able to walk before their pain level increases). They will then reduce this time/distance by 20% - with this activity level becoming their ‘start’ walking level. Participants will be guided to set a weekly program (beginning at this ‘start’ level) and then plan gradual weekly increases at a rate of approximately 10% each week. Participants will also be guided to set activity-related short and long-term goals. One of these goals will be a walking goal (if appropriate) – such that the ‘pacing’ approach can be demonstrated and practiced. Following completion of the one-on-one sessions, participants will perform 4 weeks of at-home workbook activities combined with further progression of a graded walking program. This will include weekly individualised walking goals that aim to promote graded activity progression. Participants will also receive the Protectometer handbook, which is an interactive and educational Explain Pain workbook. Participants will be asked to complete tasks at home which will involve using the Protectometer handbook to identify the unique safety and danger cues that are present for activity tasks and that may influence pain levels during activity. During the 4 weeks of at-home treatment activities, the treating clinician will call participants 1x/week to check in and follow their progress. A home diary will be used to record workbook/walking goal completion.

Sponsors

Dr Tasha Stanton
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

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

Inclusion criteria

- Adults aged 50yrs and older - Painful knee OA of at least 6 months duration that meets the American College of Rheumatology (ACR) clinical criteria for knee OA. - Average knee pain (overall and/or during walking) over one week rated as greater than or equal to 40mm on a 0-100mm visual analogue scale (VAS)

Exclusion criteria

- Conditions that prevent safe participation in physical activity (e.g., severe cardiac/lung disease); neurological disorders affecting lower limb (e.g., stroke, multiple sclerosis); inflammatory arthritis; fibromyalgia - Cognitive impairment (e.g., Alzheimer’s, dementia); severe depression (>21 on DASS24) - Previous knee replacement (on painful knee) or planned knee replacement or surgery (next 6 months) - Recent intra-articular therapy (past 3 months) - Report moderate/vigorous activity levels above guideline recommendation (>150mins/wk; assessed via International Physical Activity Questionnaire; IPAQ) - Do not have a radiograph or other imaging report of their affected knee

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026