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Completed

NCT Number: NCT07136480

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi

Istanbul, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

microwave diathermy

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.

Shortwave Diathermy

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.

Therapeutic Ultrasound

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

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.

Primary outcomes

  1. Pain Intensity (VAS)

    Time frame: baseline- 3 week

    Pain intensity will be measured using a 100 mm Visual Analog Scale (VAS), where 0 mm represents "no pain" and 100 mm represents "worst imaginable pain

  2. Functional Disability (ODI)

    Time frame: baseline-3 week

    Oswestry Disability Index - ODI: Disability will be evaluated using the ODI (0-100%), where higher percentages indicate greater disability.

Secondary outcomes

  1. Kinesiophobia (Tampa Scale for Kinesiophobia, TSK)

    Time frame: baseline-3 week

    Tampa Scale for Kinesiophobia - TSK:The TSK (17-item version) ranges from 17 to 68 points, with higher scores indicating greater fear of movement/reinjury

  2. Quality of Life (SF-12 PCS & MCS)

    Time frame: baseline-3 week

    Health-Related Quality of Life (Short Form-12 - SF-12 PCS & MCS):The SF-12 provides two component scores: Physical Component Summary (PCS) and Mental Component Summary (MCS). Higher scores indicate better quality of life.

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 22, 2025
Registry last updated
Aug 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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