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Clinical Trials/NCT07082660
NCT07082660
Completed
Not Applicable

A Randomized Controlled Trial On Lumbal Disc Herniation Using Tecar Therapy: Effects On Pain And Functionality

Şebnem Nur Alkan1 site in 1 country30 target enrollmentStarted: January 1, 2023Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Şebnem Nur Alkan
Enrollment
30
Locations
1
Primary Endpoint
Lumbar functionality

Overview

Brief Summary

This randomized controlled trial investigates the effects of Tecar therapy on pain intensity and functional status in patients with lumbar disc herniation. The intervention group received Tecar therapy combined with conventional physiotherapy, while the control group received only conventional physiotherapy. Outcome measures include pain intensity, lumbar mobility, and functional disability. The study aims to determine whether Tecar therapy provides additional benefits compared to standard care in the early rehabilitation of individuals with lumbar disc herniation.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Masking Description

Participants were masked to their group assignments throughout the intervention period. Both groups received treatment in a similar clinical environment, and the application of TECAR therapy was performed using identical procedures and equipment setup to prevent participants from discerning their allocation. The physiotherapist administering the intervention was aware of group assignments, but outcome assessments were standardized to minimize bias.

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Pain intensity(Baseline - 4 weeks)

Investigators

Sponsor
Şebnem Nur Alkan
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Şebnem Nur Alkan

Assistant Professor of Physiotherapy, Atlas University

Atlas University

Study Sites (1)

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