The Role of Sound in Enhancing or Disabling the Placebo Effect of a Deactivated Transcutaneous Electrical Nerve Stimulator (TENS) Device on Hypoalgesia in Healthy Volunteers

Early Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT06981260
• Lead Sponsor: Institute of Health and Resilience

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-13
• Primary Completion: 2016-06-14
• Study Completion: 2016-06-14
• Status Verified: 2025-05
• Study First Submitted: 2025-05-07
• Study First Submitted QC: 2025-05-19
• Last Update Submitted: 2025-05-19
• Study First Posted: 2025-05-20
• Last Update Posted: 2025-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• No history of TENS use

Exclusion Criteria

• Current medication use
• Orthopedic, neurological, or systemic conditions
• Pregnancy (current and planned)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Effect of gender on placebo response	From Baseliine to 5 minutes	Effect of gender on placebo response (ANOVA analysis on post-treatment PPT)