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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07136480
Enrollment
93
Registered
2025-08-22
Start date
2024-12-17
Completion date
2025-08-04
Last updated
2025-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low Back Pain

Keywords

low back pain, deep heating modalities, physical therapy

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.

Detailed description

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).

Interventions

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.

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.

DEVICETherapeutic 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.

BEHAVIORALLumbar 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.

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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 \-

Design outcomes

Primary

MeasureTime frameDescription
Pain Intensity (VAS)baseline- 3 weekPain 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
Functional Disability (ODI)baseline-3 weekOswestry Disability Index - ODI: Disability will be evaluated using the ODI (0-100%), where higher percentages indicate greater disability.

Secondary

MeasureTime frameDescription
Kinesiophobia (Tampa Scale for Kinesiophobia, TSK)baseline-3 weekTampa Scale for Kinesiophobia - TSK:The TSK (17-item version) ranges from 17 to 68 points, with higher scores indicating greater fear of movement/reinjury
Quality of Life (SF-12 PCS & MCS)baseline-3 weekHealth-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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026