NCT07334938

Brief Summary

The goal of this clinical trial is to determine whether far-infrared therapy and transcutaneous electrical nerve stimulation (TENS) can improve postoperative side effects in patients with head and neck cancer. The main questions this study aims to answer are: Can far-infrared therapy and transcutaneous electrical nerve stimulation reduce pain and improve neck range of motion? Can far-infrared therapy and transcutaneous electrical nerve stimulation reduce inflammation? Researchers will compare three groups: Group A: control group; Group B: transcutaneous electrical nerve stimulation; Group C: far-infrared therapy combined with transcutaneous electrical nerve stimulation, to evaluate differences in pain, neck range of motion, and inflammation. Participants will receive the assigned intervention in the morning and evening for five consecutive days. Outcome measurements will be conducted on the first and fifth days.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

May 1, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

January 13, 2026

Status Verified

December 1, 2025

Enrollment Period

1.6 years

First QC Date

December 16, 2025

Last Update Submit

January 11, 2026

Conditions

Keywords

Head and Neck Cancer (H&N)far infraredtranscutaneous electrical nerve stimulation

Outcome Measures

Primary Outcomes (1)

  • Pain intensity

    Pain intensity will be assessed using a numeric rating scale (NRS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable).

    Preoperative baseline (before surgery), postoperative day 10, and postoperative day 15

Secondary Outcomes (2)

  • Neck range of motion (ROM)

    Preoperative baseline (before surgery), postoperative day 10, and postoperative day 15

  • Inflammatory markers (LMR, NLR)

    Preoperative baseline (before surgery), postoperative day 10, and postoperative day 15

Study Arms (3)

Control Group

NO INTERVENTION

routine care

Transcutaneous Electrical Nerve Stimulation (TENS)

ACTIVE COMPARATOR
Device: Transcutaneous Electrical Nerve Stimulation (TENS)

TENS Combined With Far-Infrared Therapy

EXPERIMENTAL
Device: Transcutaneous Electrical Nerve Stimulation (TENS)Device: Far-Infrared Therapy

Interventions

Far-infrared therapy is applied to the neck region twice daily, in the morning and evening, for five consecutive days.

TENS Combined With Far-Infrared Therapy

Transcutaneous electrical nerve stimulation is applied to the neck region twice daily, in the morning and evening, for five consecutive days.

TENS Combined With Far-Infrared TherapyTranscutaneous Electrical Nerve Stimulation (TENS)

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 30 to 85 years with a confirmed diagnosis of head and neck cancer.
  • Patients scheduled to undergo surgical resection.
  • Patients who are conscious, able to communicate verbally or in writing, and willing to complete questionnaires and comply with all study procedures.

You may not qualify if:

  • Presence of open wounds or skin lesions at the sites where transcutaneous acupoint electrical stimulation electrodes would be applied.
  • Contraindications to transcutaneous acupoint electrical stimulation, including a history of epilepsy, brain tumors, arteriovenous malformations, or implanted cardiac pacemakers or defibrillators, to avoid potential adverse effects of electrical stimulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, Hualien County, 97002, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2025

First Posted

January 12, 2026

Study Start

May 1, 2024

Primary Completion

November 30, 2025

Study Completion

March 31, 2026

Last Updated

January 13, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations