Low Back PainNCT07136480
Comparison of the Effectiveness of Various Deep Heating Modalities in the Management of Chronic Low Back Pain
A study testing Microwave Diathermy, Shortwave Diathermy and Therapeutic Ultrasound in people with Low Back Pain, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Microwave Diathermy, Shortwave Diathermy and Therapeutic Ultrasound
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Dec 2024to 4 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- Diagnosis of non-specific CLBP >12 weeks
- Able to participate in exercise program
- Voluntary informed consent provided
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi
Istanbul, Istanbul
About this study
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.
Read the 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).
- Conditions
- Low Back Pain
- Being tested
- Microwave Diathermy, Shortwave Diathermy, Therapeutic Ultrasound, Lumbar Stabilization and Flexibility Exercise
- Keywords
- low back pain, deep heating modalities, physical therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microwave DiathermyDevice
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 DiathermyDevice
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 UltrasoundDevice
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 ExerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Microwave Diathermy; Behavioral: Lumbar Stabilization and Flexibility Exercise |
| Shortwave diathermy + standard lumbar exercise program | Experimental | Not described Receives: Device: Shortwave Diathermy; Behavioral: Lumbar Stabilization and Flexibility Exercise |
| Therapeutic ultrasound + standard lumbar exercise program | Experimental | Not described Receives: Device: Therapeutic Ultrasound; Behavioral: Lumbar Stabilization and Flexibility Exercise |
| Standard lumbar exercise program only (control) | Active comparator | Not described Receives: Behavioral: Lumbar Stabilization and Flexibility Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: baseline-3 week
Secondary outcomes (2)
Kinesiophobia (Tampa Scale for Kinesiophobia, TSK)
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
Measured: baseline-3 week
Quality of Life (SF-12 PCS & MCS)
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.
Measured: baseline-3 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start17 Dec 2024
- Primary completion4 Aug 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilara Ekici Zincirci, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136480
- Sponsor's protocol ID
- Low Back Pain
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Various Deep Heating Modalities in the Management of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT07136480
- Acronym / sponsor ID
- Low Back Pain
- Conditions
- Low Back Pain
- Keywords
- low back pain, deep heating modalities, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Prof. Dr. Cemil Tascıoglu Education and Research Hospital OrganizationUniversity, hospital or other
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Microwave diathermy + standard lumbar exercise program | Experimental | Device: Microwave Diathermy, Behavioral: Lumbar Stabilization and Flexibility ExerciseContinuous mode microwave diathermy (2,450 MHz) will be applied to the lumbar region using a standard physiotherapy unit. |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- Diagnosis of non-specific CLBP >12 weeks
- Able to participate in exercise program
- Voluntary informed consent provided
Key exclusion criteria (7 listed)
- Specific spinal pathology (tumor, fracture, infection, inflammatory disease)
- Lumbar surgery within last 12 months
- Pregnancy
- Pacemaker or implanted metallic/electronic devices
- Neurological deficits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microwave DiathermyContinuous 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. | Device | Microwave diathermy + standard lumbar exercise program |
| Shortwave DiathermyContinuous 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. | Device | Shortwave diathermy + standard lumbar exercise program |
| Therapeutic UltrasoundContinuous 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. | Device | Therapeutic ultrasound + standard lumbar exercise program |
| Lumbar Stabilization and Flexibility ExerciseParticipants 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. | Behavioural | Microwave diathermy + standard lumbar exercise program, Shortwave diathermy + standard lumbar exercise program, Standard lumbar exercise program only (control), Therapeutic ultrasound + standard lumbar exercise program |
Primary outcome
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
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.
2 secondary outcomes
Kinesiophobia (Tampa Scale for Kinesiophobia, TSK)
Time frame: baseline-3 week
Quality of Life (SF-12 PCS & MCS)
Time frame: baseline-3 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microwave Diathermy, Shortwave Diathermy and Therapeutic Ultrasound in people with Low Back Pain, run by Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (VAS) (time frame: baseline- 3 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.