NCT06981260

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for early_phase_1 healthy

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 13, 2016

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2016

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 20, 2025

Completed
Last Updated

May 20, 2025

Status Verified

May 1, 2025

Enrollment Period

1 day

First QC Date

May 7, 2025

Last Update Submit

May 19, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • 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).

    From Baseliine to 5 minutes

Secondary Outcomes (1)

  • Effect of gender on placebo response

    From Baseliine to 5 minutes

Study Arms (2)

Group A: Placebo with sound

EXPERIMENTAL

Deactivated transcutaneous electrical nerve stimulation (TENS) with beeping sound (15-second interval)

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

Group B: Placebo with no sound

EXPERIMENTAL

Group B: Deactivated transcutaneous electrical nerve stimulation (TENS) without sound

Procedure: Group B

Interventions

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

Deactivated TENS with beeping sound (15-second interval)

Group A: Placebo with sound
Group BPROCEDURE

Deactivated TENS without sound

Group B: Placebo with no sound

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No history of TENS use

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participant and assessor blinded
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A healthy volunteer pilot study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 20, 2025

Study Start

June 13, 2016

Primary Completion

June 14, 2016

Study Completion

June 14, 2016

Last Updated

May 20, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share