Healthy
Conditions
Brief summary
Placebo responses are now recognized for their clinical and physiological significance. Non-pharmacological cues such as sound may enhance or induce these responses. This trial aims to assess the effect of sound on the placebo-induced hypoalgesia elicited by a deactivated TENS device in healthy individuals.
Interventions
PROCEDUREGroup A Deactivated TENS with beeping sound (15-second interval)
Deactivated TENS with beeping sound (15-second interval)
PROCEDUREGroup B
Deactivated TENS without sound
Sponsors
Aegean College, Athens, Greece
Coventry University, United Kingdom
Institute of Health and Resilience
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participant and assessor blinded
Intervention model description
A healthy volunteer pilot study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* No history of TENS use
Exclusion criteria
* Current medication use * Orthopedic, neurological, or systemic conditions * Pregnancy (current and planned)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain pressure threshold (PPT) at L2 (lumbar spine) from baseline to post-intervention. | From Baseliine to 5 minutes | Change in pain pressure threshold (PPT) at L2 (2nd lumbar vertebra) from baseline to post-intervention. Measured using pressure algometer (Wagner Force Dial FDK/FDN Series). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of gender on placebo response | From Baseliine to 5 minutes | Effect of gender on placebo response (ANOVA analysis on post-treatment PPT) |
Outcome results
None listed