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

NCT07136480 | Completed

• 1 other identifier: Low Back Pain
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

low back pain; deep heating modalities; physical therapy

Outcome Measures

Primary Outcomes (2)

• Pain Intensity (VAS)

  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

  baseline- 3 week

• Functional Disability (ODI)

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

  baseline-3 week

Secondary Outcomes (2)

• Kinesiophobia (Tampa Scale for Kinesiophobia, TSK)

  baseline-3 week

• Quality of Life (SF-12 PCS & MCS)

  baseline-3 week

Study Arms (4)

Microwave diathermy + standard lumbar exercise program

EXPERIMENTAL

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

Device: Microwave Diathermy; Behavioral: Lumbar Stabilization and Flexibility Exercise

Shortwave diathermy + standard lumbar exercise program

EXPERIMENTAL

Device: Shortwave Diathermy; Behavioral: Lumbar Stabilization and Flexibility Exercise

Therapeutic ultrasound + standard lumbar exercise program

EXPERIMENTAL

Device: Therapeutic Ultrasound; Behavioral: Lumbar Stabilization and Flexibility Exercise

Standard lumbar exercise program only (control)

ACTIVE COMPARATOR

Behavioral: Lumbar Stabilization and Flexibility Exercise

Interventions

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.

Microwave diathermy + standard lumbar 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.

Shortwave diathermy + standard lumbar 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.

Therapeutic ultrasound + standard lumbar 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.

Microwave diathermy + standard lumbar exercise program; Shortwave diathermy + standard lumbar exercise program; Standard lumbar exercise program only (control); Therapeutic ultrasound + standard lumbar exercise program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• Diagnosis of non-specific CLBP \>12 weeks
• Able to participate in exercise program
• Voluntary informed consent provided

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Ultrasonic Therapy

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diathermy; Hyperthermia, Induced; Therapeutics

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: August 13, 2025
• First Posted: August 22, 2025
• Study Start: December 17, 2024
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

TU (1)