Comparison of the Effectiveness of Various Deep Heating Modalities in the Management of Chronic Low Back Pain

NCT ID: NCT07136480

Last Updated: 2025-08-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-17

Study Completion Date

2025-08-04

Brief Summary

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This quasi-experimental, non-randomized, parallel-group clinical trial aims to compare the effectiveness of various deep heating modalities-microwave diathermy, shortwave diathermy, and therapeutic ultrasound-when combined with a standard lumbar exercise program in patients with chronic low back pain. The study will evaluate their effects on pain, functional disability, kinesiophobia, and quality of life. Outcomes will be assessed at baseline and after the 3-week treatment period.

Detailed Description

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Chronic low back pain (CLBP) is one of the most prevalent musculoskeletal conditions, often leading to long-term disability, reduced quality of life, and significant socioeconomic burden. Deep heating modalities, such as microwave diathermy, shortwave diathermy, and therapeutic ultrasound, are widely used in physiotherapy practice to reduce pain, improve tissue extensibility, and enhance function. However, direct comparisons of these modalities in CLBP are limited.

This quasi-experimental, non-randomized, parallel-group study will allocate participants to one of four groups:

Microwave diathermy + standard lumbar exercise program

Shortwave diathermy + standard lumbar exercise program

Therapeutic ultrasound + standard lumbar exercise program

Standard lumbar exercise program only (control)

The allocation will be performed in a non-systematic manner without a formal randomization sequence. All participants will receive a standardized home-based lumbar stabilization exercise program, while the intervention groups will also receive their respective deep heating modality in 15 treatment sessions (5/week for 3 weeks).

Primary outcomes will include pain intensity (Visual Analog Scale) and functional disability (Oswestry Disability Index). Secondary outcomes will include kinesiophobia (Tampa Scale for Kinesiophobia) and quality of life (SF-12 PCS and MCS). Assessments will be conducted at baseline and week 3 (post-treatment).

Conditions

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Low Back Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This trial was designed as a quasi-experimental, parallel-group study. Participants were allocated to one of the intervention groups in a non-systematic manner, without the use of a formal randomization sequence or allocation concealment. The allocation process aimed to distribute participants evenly across the study arms but did not follow a predefined randomization protocol.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Microwave diathermy + standard lumbar exercise program

Continuous mode microwave diathermy (2,450 MHz) will be applied to the lumbar region using a standard physiotherapy unit.

Group Type EXPERIMENTAL

Microwave Diathermy

Intervention Type DEVICE

Continuous mode microwave diathermy (2,450 MHz) will be applied to the lumbar region using a standard physiotherapy unit. Each session will last 20 minutes, 5 sessions per week for 3 consecutive weeks, in addition to a standardized lumbar stabilization exercise program.

Lumbar Stabilization and Flexibility Exercise

Intervention Type BEHAVIORAL

Participants will perform a home-based lumbar stabilization exercise program, including stretching, core strengthening, and posture correction exercises, supervised weekly by a physiotherapist. The program will be performed 3 sessions per week for 4 consecutive weeks.

Shortwave diathermy + standard lumbar exercise program

Group Type EXPERIMENTAL

Shortwave Diathermy

Intervention Type DEVICE

Continuous mode shortwave diathermy (27.12 MHz) will be delivered to the lumbar region using capacitive or inductive electrodes according to manufacturer guidelines. Each session will last 20 minutes, 5 sessions per week for 3 consecutive weeks, in addition to a standardized lumbar stabilization exercise program.

Lumbar Stabilization and Flexibility Exercise

Intervention Type BEHAVIORAL

Participants will perform a home-based lumbar stabilization exercise program, including stretching, core strengthening, and posture correction exercises, supervised weekly by a physiotherapist. The program will be performed 3 sessions per week for 4 consecutive weeks.

Therapeutic ultrasound + standard lumbar exercise program

Group Type EXPERIMENTAL

Therapeutic Ultrasound

Intervention Type DEVICE

Continuous mode therapeutic ultrasound at 1 MHz frequency and 1.5 W/cm² intensity will be applied to the lumbar paraspinal muscles with slow circular movements using a coupling gel. Treatment will last 10 minutes per session, 5 sessions per week for 3 consecutive weeks, in addition to a standardized lumbar stabilization exercise program.

Lumbar Stabilization and Flexibility Exercise

Intervention Type BEHAVIORAL

Participants will perform a home-based lumbar stabilization exercise program, including stretching, core strengthening, and posture correction exercises, supervised weekly by a physiotherapist. The program will be performed 3 sessions per week for 4 consecutive weeks.

Standard lumbar exercise program only (control)

Group Type ACTIVE_COMPARATOR

Lumbar Stabilization and Flexibility Exercise

Intervention Type BEHAVIORAL

Participants will perform a home-based lumbar stabilization exercise program, including stretching, core strengthening, and posture correction exercises, supervised weekly by a physiotherapist. The program will be performed 3 sessions per week for 4 consecutive weeks.

Interventions

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Microwave Diathermy

Continuous mode microwave diathermy (2,450 MHz) will be applied to the lumbar region using a standard physiotherapy unit. Each session will last 20 minutes, 5 sessions per week for 3 consecutive weeks, in addition to a standardized lumbar stabilization exercise program.

Intervention Type DEVICE

Shortwave Diathermy

Continuous mode shortwave diathermy (27.12 MHz) will be delivered to the lumbar region using capacitive or inductive electrodes according to manufacturer guidelines. Each session will last 20 minutes, 5 sessions per week for 3 consecutive weeks, in addition to a standardized lumbar stabilization exercise program.

Intervention Type DEVICE

Therapeutic Ultrasound

Continuous mode therapeutic ultrasound at 1 MHz frequency and 1.5 W/cm² intensity will be applied to the lumbar paraspinal muscles with slow circular movements using a coupling gel. Treatment will last 10 minutes per session, 5 sessions per week for 3 consecutive weeks, in addition to a standardized lumbar stabilization exercise program.

Intervention Type DEVICE

Lumbar Stabilization and Flexibility Exercise

Participants will perform a home-based lumbar stabilization exercise program, including stretching, core strengthening, and posture correction exercises, supervised weekly by a physiotherapist. The program will be performed 3 sessions per week for 4 consecutive weeks.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age 18-65 years

Diagnosis of non-specific CLBP \>12 weeks

Able to participate in exercise program

Voluntary informed consent provided

Exclusion Criteria

Specific spinal pathology (tumor, fracture, infection, inflammatory disease)

Lumbar surgery within last 12 months

Pregnancy

Pacemaker or implanted metallic/electronic devices

Neurological deficits

Skin lesions or contraindications to deep heating modalities

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role lead

Responsible Party

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Dilara Ekici Zincirci

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi

Istanbul, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Low Back Pain

Identifier Type: -

Identifier Source: org_study_id

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