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 1CompletedNCT06981260

Institute of Health and Resilience38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Group A Deactivated TENS with beeping sound (15-second interval)PROCEDURE

Deactivated TENS with beeping sound (15-second interval)

Group BPROCEDURE

Deactivated TENS without sound

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * No history of TENS use Exclusion Criteria: * Current medication use * Orthopedic, neurological, or systemic conditions * Pregnancy (current and planned)

Outcomes

Primary Outcomes

Change in pain pressure threshold (PPT) at L2 (lumbar spine) from baseline to post-intervention.

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).

Time frame: From Baseliine to 5 minutes

Secondary Outcomes

Effect of gender on placebo response

Effect of gender on placebo response (ANOVA analysis on post-treatment PPT)

Time frame: From Baseliine to 5 minutes

Data from ClinicalTrials.gov

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