NCT07825298

Brief Summary

The goal of this clinical trial is to learn whether adding TECAR therapy to traditional physiotherapy is more effective than traditional physiotherapy alone for reducing pain and functional disability and improving physical performance in adults with chronic low back pain. The main questions it aims to answer are: Does adding TECAR therapy to traditional physiotherapy reduce pain intensity compared with traditional physiotherapy alone? Does adding TECAR therapy to traditional physiotherapy reduce functional disability? Does adding TECAR therapy improve core muscle endurance, back proprioception, back range of motion, and functional exercise capacity? Participants will: Receive 12 treatment sessions of either traditional physiotherapy with TECAR therapy or traditional physiotherapy alone. Have their pain intensity and functional disability assessed before and after treatment. Have their core muscle endurance, back proprioception, back range of motion, and functional exercise capacity assessed before and after treatment.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Oct 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

First Submitted

Initial submission to the registry

September 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

October 20, 2026

Expected
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2027

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

10 months

First QC Date

September 9, 2026

Last Update Submit

September 16, 2026

Conditions

Keywords

Radiofrequency TherapyTECAR TherapyRehabilitationBack pain

Outcome Measures

Primary Outcomes (2)

  • Pain Intensity Measured Using the Visual Analogue Scale (VAS)

    Low back pain will be measured using the visual analogue scale (VAS) before and after the treatment. VAS is a scale ranging from 0 to 10 where 0 indicates no pain and 10 indicates severe pain.

    Baseline, after 1 week and after 12 weeks

  • Pain threshold measured using the pressure algometer.

    Pain threshold will be measured before and after treatment using a pressure algometer.

    Baseline, 1 week and after 12 weeks

Secondary Outcomes (6)

  • Back range of motion measured using BROM device.

    Baseline, 1 week and after 12 weeks

  • Functional disability measured using the Oswestry Disability Index

    Baseline, 1 week and after 12 weeks

  • Quality of Life Measured Using the Short Form-36 Health Survey (SF-36)

    Baseline, 1 week and after 12 weeks

  • Core Muscle Endurance Measured Using the McGill Core Endurance Test

    Baseline, 1 week and after 12 weeks

  • Back Proprioception Measured Using the Back Range of Motion (BROM) Device

    Baseline, 1 week and after 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Control Group

SHAM COMPARATOR
Device: Control Group

TECAR Group

ACTIVE COMPARATOR
Device: TECAR therapy

Interventions

Apply sham TECAR and physical therapy programmes, including core training exercises, myofascial release, and mobilisation exercises for three sessions per week for four weeks.

Control Group

In addition to the programme given in the control group, the TECAR group, therapy was delivered using the TECAR device in resistive mode with a frequency of 500 kHz. A flexible, self-adhesive return electrode (10 cm × 18 cm) was placed on the abdomen as a reference electrode. The power output was gradually increased from approximately 30% to 60% of the device's maximum output (100 W), with adjustments based on patient-reported thermal feedback to ensure a consistent perception of mild to moderate warmth. Each quadrant of the lumbar region was treated for approximately 5 min, to 20 min per session

TECAR Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • localised pain between the 12th rib and the gluteal fold
  • low back pain for more than three months

You may not qualify if:

  • neuropathic pain extending along the lower limb
  • previous spine surgery
  • history of spine trauma or fracture,
  • implanted pacemakers.
  • pregnancy
  • cancer
  • systemic musculoskeletal diseases,
  • neurodegenerative diseases.
  • epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Batterjee Medical college

Jeddah, 21442, Saudi Arabia

Location

MeSH Terms

Conditions

Low Back PainBack Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 17, 2026

Study Start (Estimated)

October 20, 2026

Primary Completion (Estimated)

August 20, 2027

Study Completion (Estimated)

August 20, 2027

Last Updated

September 17, 2026

Record last verified: 2026-09

Locations