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Can non-invasive brain stimulation enhance the effect of exercise on knee osteoarthritis (OA) pain?

Can a single session of 2mA active transcranial Direct Current Stimulation (tDCS) over the primary motor cortex enhance exercise induced hypoalgesia (EIH) compared to sham tDCS in individuals with knee osteoarthritis (OA)?

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621000787886
Acronym
None
Enrollment
14
Registered
2021-06-22
Start date
2022-03-29
Completion date
2023-03-30
Last updated
2022-08-09

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

Conditions

None listed

Brief summary

Osteoarthritis (OA) is the most common cause of chronic pain and disability in older adults and is associated with muscle weakness, functional limitations, psychological distress, fear of movement and reduced quality of life. Knee OA accounts for the majority of the burden of OA worldwide. Exercise can effectively reduce pain in knee OA and is universally recommended as a first-line treatment by international evidence based treatment guidelines. Exercise also produces immediate, short term reductions in pain sensitivity after a single bout of exercise, called exercise induced hypoalgesia (EIH). However, higher levels of EIH variability can be seen in chronic pain conditions such as knee OA, with some people experiencing no change or even an increase in pain after exercise. Recent evidence in a healthy pain-free population has shown that a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS), can enhance EIH. The effects of such an intervention have not yet been examined in an OA population, where EIH is known to be more variable. We will therefore conduct a double blind randomised controlled cross-over trial examining the effect of active tDCS on EIH compared to sham tDCS in people with OA. Each participant will attend two clinical visits (1-2 hours) at Auckland University of Technology a minimum of 7 days apart. The order of sessions (active/sham tDCS) will be randomised for each participant. In the active tDCS session, participants will receive 20 min of 2 mA anodal stimulation. In the sham tDCS session, participants will receive 20 min of sham tDCS. After this, EIH will be measured in response to a standardised bout of resistance exercise. All assessments will be performed by a blinded assessor. The study will test whether a single session of 2mA active tDCS over the primary motor cortex enhance EIH compared to sham tDCS in individuals with knee OA.

Interventions

The order of interventions (active vs sham tDCS) will be randomised for each participant using a computer generated randomisation such that an equal number of participants have active and sham tDCS in their first session. In this crossover trial, all participants will partake in two treatment sessions, (‘Session 1’ and ‘Session 2’) delivered by a postgraduate qualified physiotherapist, with a minimum 7 day washout. Each of the two treatment sessions will last approximately 1-2 hours and will be

The order of interventions (active vs sham tDCS) will be randomised for each participant using a computer generated randomisation such that an equal number of participants have active and sham tDCS in their first session. In this crossover trial, all participants will partake in two treatment sessions, (‘Session 1’ and ‘Session 2’) delivered by a postgraduate qualified physiotherapist, with a minimum 7 day washout. Each of the two treatment sessions will last approximately 1-2 hours and will be closely matched in duration for the intervention and comparison groups. Participant adherence will be monitored during both sessions using a session attendance checklist. Participants will be comfortably seated in a chair while receiving transcranial Direct Current Stimulation (tDCS) and will be asked to remain quiet for the duration of the intervention whilst they watch a nature documentary. Participants in the active (intervention) tDCS group will receive 20 min of 2 mA anodal stimulation. Stimulation will be applied using an HDCell (MagStim Co, UK) and 7 x 5 cm electrodes. The electrode sponges will be soaked in saline solution prior to application. The anode will be placed over the C3 or C4 scalp location according to the International 10–20 EEG system, contralateral to the affected knee. The cathode will be placed over the contralateral supraorbital region. Stimulation intensity will be ramped up to 2 mA over 30s, applied for 20 min and then ramped down to 0 mA over 30s. Immediately following the tDCS participants will complete a bout of isometric exercise where they will be instructed to maintain a target force until failure, defined as unable to sustain 25% of their maximum voluntary contraction for greater than or equal to 5-s, or a maximum of 5 minutes. After a minimum of 7 days, to ensure washout, the participant shall return to receive the crossover sham tDCS intervention.

Sponsors

Auckland University of Technology, North Shore Campus
Lead SponsorUniversity

Study design

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

Eligibility

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

Inclusion criteria

Participants will be included if they are males and females greater than or equal to 40 years of age, meet The National Institute for Health and Care Excellence clinical criteria for the diagnosis of knee OA, have ongoing knee pain for greater than or equal to 3 months, and have an average pain intensity of greater than or equal to 3/10 numerical rating scale (NRS) in the last week at the time of screening. In the instance where participants have bilateral knee OA, the most painful knee will become the index knee.

Exclusion criteria

Participants will be excluded if they have an inability to speak or write English; conditions preventing safe participation in physical activity (Failed Physical Activity Readiness Questionnaire (PAR-Q), are physically unable to climb 2 flights of stairs, have ever had a total knee replacement, had recent knee surgery (past 6 months), a history of lower limb resistance training (greater than or equal to 2 times per week for a minimum of 6 weeks within the past 6 months); any other form of arthritis (e.g. rheumatoid arthritis); a history of musculoskeletal pain or injury in the lower limb (other than osteoarthritis) in the past 6 months; any neurological condition; any unstable/uncontrolled cardiovascular condition; a current diagnosis of a major psychiatric disorder; any cognitive impairment; contraindications to tDCS (e.g., epilepsy, specific medications, frequent headaches).

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 4, 2026