NCT07082660

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
Last Updated

July 24, 2025

Status Verified

July 1, 2025

Enrollment Period

3 months

First QC Date

July 15, 2025

Last Update Submit

July 23, 2025

Conditions

Keywords

Lumbal disk herniationCapasitive and resistive electric transfer therapyexercise training

Outcome Measures

Primary Outcomes (1)

  • Lumbar functionality

    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 Outcomes (1)

  • Pain intensity

    Baseline - 4 weeks

Study Arms (2)

TECAR Therapy Combined with Lumbal Stabilization Exercises

EXPERIMENTAL

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).

Device: High-Frequency Capacitive-Resistive Diathermic Current Therapy (TECAR)

Lumbal Stabilization Exercises Only

ACTIVE COMPARATOR

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.

Behavioral: Lumbal Stabilization Exercise Program

Interventions

20 minutes per session, 3 times per week for 4 weeks

TECAR Therapy Combined with Lumbal Stabilization Exercises

3 sessions per week for 4 weeks, each session includes core stabilization and lumbar control exercises (12 sessions total).

Lumbal Stabilization Exercises Only

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 \[24\].

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atlas University

Istanbul, Kagıthane, 34403, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned to two parallel groups receiving either TECAR + lumbar stabilization or lumbar stabilization only.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor of Physiotherapy, Atlas University

Study Record Dates

First Submitted

July 15, 2025

First Posted

July 24, 2025

Study Start

January 1, 2023

Primary Completion

March 30, 2023

Study Completion

May 20, 2023

Last Updated

July 24, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Individual participant data (IPD) that underlie the results reported in the article (after deidentification) will be shared with other researchers upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The IPD and supporting documents will be available beginning 6 months after publication of the primary results and will be accessible for a period of 3 years.

Locations