- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07082660
- Original Trial
Tecar Therapy in Lumbar Disc Herniation (LDH-TECAR)
A Randomized Controlled Trial On Lumbal Disc Herniation Using Tecar Therapy: Effects On Pain And Functionality
Study Overview
Status
Conditions
Detailed Description
Background Lumbar disc herniation (LDH) is a prevalent musculoskeletal condition that can significantly impair quality of life due to pain and functional limitations. Rehabilitation strategies often include lumbar stabilization exercises, and adjunct electrotherapies such as capacitive-resistive diathermy (TECAR) have gained interest for their potential therapeutic effects.
Purpose This randomized controlled trial aims to evaluate the effects of adding high-frequency capacitive-resistive diathermic current (TECAR) therapy to lumbar stabilization exercises, compared to lumbar stabilization exercises alone, on pain intensity, functional status, and lumbar range of motion in individuals with chronic LDH.
Methods
Thirty participants with chronic LDH (duration >6 months) and no neurological deficits will be randomly assigned to one of two intervention groups:
TECAR + Exercise Group (TEG, n=15): Participants will receive 12 sessions of TECAR therapy (20 minutes, 3 sessions per week) in combination with lumbar stabilization exercises over 4 weeks.
Exercise Group (EG, n=15): Participants will receive only lumbar stabilization exercises with the same frequency and duration.
Outcome measures will include:
Pain intensity (Visual Analog Scale - VAS)
Functional status (Oswestry Disability Index - ODI)
Lumbar range of motion (goniometry)
All evaluations will be performed pre- and post-intervention by a physiotherapist who is blinded to group allocation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kagıthane
-
Istanbul, Kagıthane, Turkey, 34403
- Atlas University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- aged 20-60 years
- diagnosed with low back pain
- pain localized between L1 and L5
- having low back pain lasting for more than 3 months [24].
Exclusion Criteria:
- having sensory disturbances
- muscle weakness, or reflex loss identified during motor, sensory, or reflex examinations
- history of prior lumbal spine surgery or vertebral fractures
- presence of electronic medical devices such as pacemakers or other implants contraindicated for electrical stimulation or high-frequency diathermy therapy
- patients officially registered as disabled or receiving social benefits due to low back pain, severe osteoporosis, osteomalacia, malignancy, infectious diseases, or systemic musculoskeletal or rheumatological disorders,
- pregnancy,
- cardiovascular conditions preventing exercise, or viscerogenic causes of low back pain
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 Combined with Lumbal Stabilization Exercises
Participants in this group will receive high-frequency capacitive-resistive diathermic current (TECAR) therapy (20 minutes per session, 3 sessions/week for 4 weeks) in addition to a lumbal stabilization exercise program (12 sessions total).
|
20 minutes per session, 3 times per week for 4 weeks
|
|
Active Comparator: Lumbal Stabilization Exercises Only
Participants in this group will receive only the lumbal stabilization exercise program, 3 sessions/week for 4 weeks (12 sessions total), with no TECAR therapy applied.
|
3 sessions per week for 4 weeks, each session includes core stabilization and lumbar control exercises (12 sessions total).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lumbar functionality
Time Frame: Baseline - 4 weeks
|
The Oswestry Disability Index (ODI), validated Turkish version, will be used to assess disability related to low back pain.
The scale consists of 10 items, each scored from 0 to 5, with a total maximum score of 50.
The total score is converted into a percentage using the formula: (total obtained score / maximum possible score) × 100.
Scores range from 0% to 100%, where higher scores indicate greater disability.
Interpretation categories are as follows: 0%-20% indicates minimal disability; 21%-40% indicates moderate disability; 41%-60% indicates severe disability; 61%-80% indicates crippled; and 81%-100% indicates bed-bound status or possible symptom exaggeration.
|
Baseline - 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain intensity
Time Frame: Baseline - 4 weeks
|
The Visual Analog Scale (VAS) will be used to assess pain intensity.
It consists of a 10-centimeter horizontal line representing a continuum from 'no pain' (0) to 'worst imaginable pain' (10).
Participants are asked to mark a point on the line that corresponds to the intensity of their pain.
The distance in centimeters from the 'no pain' anchor to the participant's mark is measured and recorded as the VAS score.
Scores range from 0 to 10, with higher scores indicating greater pain severity.
|
Baseline - 4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ETTBI-LDH-2023-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
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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