None listed
Conditions
Brief summary
This study investigated whether the belief a healthcare practitioner holds about the treatment they are delivering influences the pain relief their patient experiences. Forty-five adults with knee pain attended a single appointment at one of two clinics in Adelaide and were each treated by one of twelve qualified practitioners; all patients received the same sham (non-penetrating) dry needling treatment. Practitioners at one clinic were told they were delivering real dry needling; practitioners at the other clinic were told they were delivering sham dry needling, while patients in both arms were informed they had a 50/50 chance of receiving real or sham dry needling. We hypothesised that patients treated by practitioners who believed they were delivering real dry needling would experience greater reductions in pain at rest and movement-evoked pain than patients treated by practitioners who knew they were delivering sham dry needling. Pain at rest and movement-evoked pain were assessed before treatment, immediately after treatment, and at 24-hour follow-up, with pressure pain thresholds also measured before and after treatment.
Interventions
Intervention: All participants received a single session of sham dry needling delivered by a qualified practitioner. The intervention used non-penetrating sham needles that produce a tactile sensation comparable to real dry needling without piercing the skin, providing tactile realism while ensuring the physical intervention was inert across both arms.
Manipulated variable: Practitioner belief about the authenticity of the treatment they were delivering. Prior to the session, practitioners were
Intervention: All participants received a single session of sham dry needling delivered by a qualified practitioner. The intervention used non-penetrating sham needles that produce a tactile sensation comparable to real dry needling without piercing the skin, providing tactile realism while ensuring the physical intervention was inert across both arms. Manipulated variable: Practitioner belief about the authenticity of the treatment they were delivering. Prior to the session, practitioners were instructed (by the study team) that they were delivering either real dry needling or sham dry needling, in accordance with their cluster-randomised assignment. The session, including patient interaction, examination, palpation, and needle application, then proceeded as a typical dry needling consultation. Who delivered the intervention: The intervention was delivered by twelve qualified allied health practitioners, each accredited with a recognised professional body (for example, registered with the Australian Health Practitioner Regulation Agency) and with formal training in dry needling. All practitioners completed a standardised study training session before delivering the intervention. Mode of delivery: Face-to-face, individual (one-on-one) consultation at the study clinic. Number, duration, and structure of sessions: Each patient received a single in-person session. Within the session, the practitioner conducted a standardised palpation assessment of the knee and surrounding tissues, identified the most tender point on the lateral thigh, and marked it with a marker pen. Dry needling was then delivered with up to four needles, at least one of which was inserted at the marked tender point; practitioners had discretion over the total number of needles used (within the four-needle maximum) and the location of any additional needles, in line with their usual clinical practice for the patient's presenting knee pain. Needles remained in situ for six minutes. A 24-hour follow-up was conducted by online questionnaire; no further in-person treatment was provided. Location: The two study clinic sites were the Physiotherapy and Podiatry teaching clinics within the Centenary Building, Adelaide University (formerly University of South Australia) City East campus, corner of Frome Road and North Terrace, Adelaide, South Australia 5000. Adherence and fidelity: Adherence to the in-person treatment session was supported by the standardised structure of the protocol (palpation, tender-point marking, needle-count limit, six-minute dwell time) and verified post-hoc through video-recording of all sessions (with patient consent). Adherence to the 24-hour follow-up questionnaire was supported by an automated reminder email sent to each patient at 24 hours after their treatment session, prompting completion of the follow-up survey.
Sponsors
University of South Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patient inclusion: - Adults aged 18 to 80 years (inclusive). - Knee pain reproducible with at least one of four standardised movements: squatting; stepping up onto a step; stepping down from a step; or jumping. - Self-reported pain intensity of 2 or more out of 10 on the Numerical Pain Rating Scale (NPRS) with movement. - No previous experience of dry needling in the lower limbs. - Sufficient English fluency to complete questionnaires and follow study procedures. - Willing and able to travel to the study clinic in Adelaide for a single in-person visit. Practitioner inclusion: - Accreditation with a recognised professional body (e.g., AHPRA-registered). - Completion of formal dry-needling training within the past 18 months.
Exclusion criteria
Patient exclusion: - Any previous experience of dry needling to the lower limbs (at any time prior to enrolment). - Required use of a walking aid for ambulation. - Diagnosed psychiatric or psychological disease that, in the participant's judgement, would interfere with study participation. - Insufficient English fluency to complete the screening survey, study questionnaires, and follow study procedures. - Unable or unwilling to travel to the study clinic.
Outcome results
None listed