- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07596953
Efficacy of TECAR Therapy on Patient With Mechanical Neck Pain
Influence of TECAR Therapy on Cervical Mobility and Functional Disability in Patients With Mechanical Neck Pain: Randomized Control Study
The goal of this clinical trial is to evaluate the effectiveness of TECAR therapy in improving pain intensity, cervical range of motion, and functional disability in individuals with mechanical neck pain. It will also assess whether TECAR therapy provides additional clinical benefits compared with conventional physical therapy treatment. The main questions it aims to answer are:
- Does TECAR therapy reduce pain intensity in patients with mechanical neck pain?
- Does TECAR therapy improve cervical range of motion (CROM)?
- Does TECAR therapy reduce functional disability as measured by the Neck Disability Index (NDI)? Researchers will compare participants receiving TECAR therapy combined with conventional physical therapy to participants receiving conventional physical therapy alone to determine the effectiveness of TECAR therapy in managing mechanical neck pain.
Participants will:
- Attend scheduled treatment sessions during the study period
- Receive either TECAR therapy with conventional physical therapy or conventional physical therapy alone
- Undergo assessment of pain intensity, cervical range of motion, and neck disability before and after treatment
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Mechanical neck pain is one of the most common musculoskeletal disorders and is frequently associated with pain, restricted cervical mobility, and reduced functional performance, which may negatively affect daily activities and quality of life. Conventional physical therapy interventions are commonly used to manage mechanical neck pain; however, interest has recently increased in the use of TECAR therapy as a non-invasive modality that may enhance tissue healing, improve circulation, reduce pain, and restore function.
This single-blind randomized controlled trial aims to investigate the clinical effectiveness of TECAR therapy in individuals with mechanical neck pain. Participants who meet the eligibility criteria will be randomly assigned to either an experimental group receiving TECAR therapy in combination with conventional physical therapy or a control group receiving conventional physical therapy alone.
Outcome measures will be assessed before and after the intervention period and will include pain intensity, cervical range of motion (CROM), and functional disability using the Neck Disability Index (NDI). The study seeks to determine whether adding TECAR therapy to a conventional rehabilitation program provides superior improvements in pain reduction, cervical mobility, and functional outcomes in patients with mechanical neck pain.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed A Abdel Ghafar, Ph.D.
- Phone Number: 00966531513909
- Email: Pt12.jed@bmc.edu.sa
Study Locations
-
-
Al Zahraa
-
Jeddah, Al Zahraa, Saudi Arabia, 23623
- Saudi German Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Presence of neck pain for at least 3 months
- Limited cervical range of motion associated with neck pain
- Ability to understand and follow study instructions Willingness to participate and sign the informed consent form
Exclusion Criteria:
- History of cervical spine surgery or fracture
- Cervical radiculopathy or other neurological disorders
- Presence of inflammatory, rheumatic, or systemic diseases affecting the cervical spine
Severe cervical disc prolapse or spinal instability Current participation in another treatment program for neck pain Pregnancy Presence of pacemakers, metal implants, or contraindications to TECAR therapy Skin disorders or open wounds in the treatment area
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TECAR Therapy Group for Mechanical Neck Pain
Participants will receive TECAR therapy combined with a conventional physical therapy program for mechanical neck pain.
|
Participants in the TECAR group received TECAR therapy in capacitive and resistive modes targeting superficial and deep tissues of the affected area.
Each session lasted 20-30 minutes, with intensity adjusted to produce a comfortable thermal effect without pain.
TECAR therapy was applied three times/week for 12 weeks, alongside a standardized exercise program identical to the control group.
Participants in the control group received a standardized therapeutic exercise program.
The program included stretching, strengthening, and functional exercises targeting the affected region.
Each session lasted 20-30 minutes and was performed three times/week for 12 weeks.
|
|
Active Comparator: Conventional Physical Therapy Group for Mechanical Neck Pain
Participants will receive a conventional physical therapy program only.
|
Participants in the control group received a standardized therapeutic exercise program.
The program included stretching, strengthening, and functional exercises targeting the affected region.
Each session lasted 20-30 minutes and was performed three times/week for 12 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: Assessments will be conducted at baseline (pre-treatment), immediately post-intervention (after 12 sessions), and follow-up (1 month after completion)
|
Pain intensity was measured using the Visual Analog Scale (VAS) to assess changes in neck pain intensity throughout the study period.
The VAS is a self-reported pain assessment tool consisting of a 10-cm horizontal line, with scores ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain."
Higher scores represent greater pain intensity and therefore a worse outcome.
|
Assessments will be conducted at baseline (pre-treatment), immediately post-intervention (after 12 sessions), and follow-up (1 month after completion)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cervical Range of Motion (CROM)
Time Frame: Baseline (pre-treatment), immediately post-intervention (after 12 sessions), and follow-up (1 month after completion)
|
Measured using a Cervical Range of Motion device to evaluate changes in cervical flexion, extension, lateral flexion, and rotation.
|
Baseline (pre-treatment), immediately post-intervention (after 12 sessions), and follow-up (1 month after completion)
|
|
Functional Disability
Time Frame: Assessment will be conducted at baseline (pre-treatment), immediately post-intervention (after 12 sessions), and follow-up (1 month after completion)
|
Functional disability was measured using the Neck Disability Index (NDI) to assess changes in functional limitations associated with mechanical neck pain.
The NDI is a self-administered questionnaire consisting of 10 items related to daily activities and pain.
Each item is scored from 0 to 5, with a total score ranging from 0 to 50, where 0 indicates no disability and 50 indicates complete disability.
Higher scores represent greater functional disability and therefore a worse outcome.
|
Assessment will be conducted at baseline (pre-treatment), immediately post-intervention (after 12 sessions), and follow-up (1 month after completion)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
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
- BMCSGHTECAR
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.
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