- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07334938
Effects of Far Infrared Rays and Transcutaneous Electrical Nerve Stimulation on Short Term Prognosis of Head and Neck Cancer Patients Receiving Curative Treatment
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Hualien County
-
Hualien City, Hualien County, Taiwan, 97002
- Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
routine care
|
|
|
Active Comparator: Transcutaneous Electrical Nerve Stimulation (TENS)
|
Transcutaneous electrical nerve stimulation is applied to the neck region twice daily, in the morning and evening, for five consecutive days.
|
|
Experimental: 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.
Far-infrared therapy is applied to the neck region twice daily, in the morning and evening, for five consecutive days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: Preoperative baseline (before surgery), postoperative day 10, and postoperative day 15
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck range of motion (ROM)
Time Frame: Preoperative baseline (before surgery), postoperative day 10, and postoperative day 15
|
Active neck range of motion will be measured in degrees, including flexion, extension, bilateral rotation, and bilateral lateral flexion.
|
Preoperative baseline (before surgery), postoperative day 10, and postoperative day 15
|
|
Inflammatory markers (LMR, NLR)
Time Frame: Preoperative baseline (before surgery), postoperative day 10, and postoperative day 15
|
Inflammatory markers will be calculated from complete blood counts, including the Lymphocyte-to-monocyte ratio(LMR) and neutrophil-to-lymphocyte ratio (NLR)
|
Preoperative baseline (before surgery), postoperative day 10, and postoperative day 15
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB113-052-A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Head and Neck Cancer (H&N)
-
Medical University of South CarolinaSiemens Medical SolutionsSuspended
-
Royal College of Surgeons, IrelandActive, not recruitingHead and Neck Cancer (H&N)Ireland
-
Institute of Oncology LjubljanaCompletedHead and Neck Cancer (H&N)Slovenia
-
Institute of Cancer Research, United KingdomNot yet recruitingLymph Nodes | Head and Neck Cancer (H&Amp;Amp;N)
-
Instituto OncoclinicasOswaldo Cruz Foundation; Hospital Sírio-Libânes, São Paulo, BrazilEnrolling by invitationOral Mucositis | Radiotherapy Side Effects | Head and Neck Cancer (H&N)Brazil
-
University of TennesseeRegional One Health; Methodist University Hospital; UTHSC Center for Cancer ResearchNot yet recruitingHead and Neck Neoplasms | Head and Neck Cancer (H&N) | Emergency Department PresentationUnited States
-
Jules Bordet InstituteUniversité Libre de BruxellesNot yet recruiting
-
University of Alabama at BirminghamNot yet recruitingHead and Neck Cancer (H&N)United States
-
King Hussein Cancer CenterNot yet recruitingAcute Radiation Dermatitis | Sarcomas | Head and Neck Cancer (H&N)Jordan
-
Chung Shan Medical UniversityNot yet recruitingSupportive Care | Radiation-induced Oral Mucositis | Radiotherapy Side Effects | Nursing Interventions | Head and Neck Cancer (H&Amp;Amp;N)Taiwan
Clinical Trials on Transcutaneous Electrical Nerve Stimulation (TENS)
-
Karolinska University HospitalActive, not recruitingHip Fractures | Orthopedic Disorder | Post Operative Pain | Arthroplasty, Replacement, Hip | Internal FixationSweden
-
University Hospital, ToulouseMinistry of Health, FranceTerminatedPeripheral Artery DiseaseFrance
-
Université de SherbrookeCompleted
-
Institut Cancerologie de l'OuestTerminated
-
Hawra Al-DandanRecruitingOveractive Bladder SyndromeSaudi Arabia
-
University of the Sinos ValleyNot yet recruitingHip Fractures | Femoral Neck Fractures | Intertrochanteric Femur Fracture
-
Hawaii Pacific HealthUnknownAnalgesia | Cesarean Section | Transcutaneous Electric Nerve StimulationUnited States
-
Tufts Medical CenterRecruitingAnalgesia | Pain, Acute | Patient Preference | IUDUnited States
-
Fatih Sultan Mehmet Training and Research HospitalCompleted
-
European University of LefkeCompletedLateral Epicondylitis (Tennis Elbow) Bilateral | Pain in Arm, Unspecified | Tenosynovitis Elbow