Low Back PainNCT06959394
Comparison of the Effectiveness of Therapeutic Ultrasound and Phonophoresis in Chronic Low Back Pain
A study testing Ultrasound and Phonophoresis in people with Low Back Pain, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of therapeutic ultrasound and phonophoresis applications on pain, range of motion, flexibility and functional capacity in patients with chronic low back pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Ultrasound and Phonophoresis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2025to 30 Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals with low back pain for more than 3 months and pain intensity more than 5 according to VAS will be included in the study
Who cannot join
- patients who have undergone surgical operations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effectiveness of Therapeutic Ultrasound and Phonophoresis Applications in Patients With Chronic Low Back Pain
The aim of this study is to evaluate the effects of therapeutic ultrasound and phonophoresis applications on pain, range of motion, flexibility and functional capacity in patients with chronic low back pain. The study is planned as the first scientific study comparing the effectiveness of these two physiotherapy methods in the treatment of chronic low back pain. It is aimed to make national and international publications with the data obtained at the end of the study.
The study will be conducted in a randomised single-blind, placebo-controlled design. 60 patients aged 18-30 years with chronic low back pain will be divided into 3 groups: therapeutic ultrasound (US) application, phonophoresis application and placebo US group. In addition to ultrasound and phonophoresis, TENS, infrared and low back exercises will be applied to all groups as treatment. Pain intensity (VAS), functional status (Oswestry disability index), flexibility (Sit-to-Sit test) and range of motion (goniometric measurements) will be assessed throughout the treatment period.
The study aims to make an important contribution from a clinical and economic point of view, given the increasing prevalence of low back pain worldwide and the need for treatment. The findings may guide the development of future treatment modalities.
- Conditions
- Low Back Pain
- Being tested
- Ultrasound, Phonophoresis, Placebo
- 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.
UltrasoundOther
Participants will receive ultrasound at 1.5 W/cm2 for 6 minutes (transmitter agent aquasonic gel) 5 sessions per week for 2 weeks.
PhonophoresisOther
Participants will receive ultrasound with 1.5 W/cm2, 6 min (transmitter diclofenac gel) for 5 sessions per week for 2 weeks.
PlaceboOther
Participants will receive 0 W/cm2, 6 min ultrasound, 5 sessions per week for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| US | Experimental | Participants will be treated with 1.5 W/cm2, 6 min (transmitting agent aquasonic gel) ultrasound. Receives: Other: Ultrasound |
| Phonophoresis | Experimental | Not described Receives: Other: Phonophoresis |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain severity
Visual Analog Scale
Measured: Baseline and after 2 weeks intervation
Secondary outcomes (3)
functional state
Oswestry Disability Index
Measured: Baseline and after 2 weeks intervation
Flexibility
Sit and Reach Test
Measured: Baseline and after 2 weeks intervation
range of motion of the joint
Goniometry
Measured: Baseline and after 2 weeks intervation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 Sep 2025
- Primary completion1 Dec 2025
- Study completion30 Dec 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Savaş Torlak, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06959394
- Sponsor's protocol ID
- KaratayMST
- Status last verified
- Jun 2025
- First submitted
- 28 Apr 2025
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Therapeutic Ultrasound and Phonophoresis Applications in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06959394
- Acronym / sponsor ID
- KaratayMST
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 6 May 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.
The aim of this study is to evaluate the effects of therapeutic ultrasound and phonophoresis applications on pain, range of motion, flexibility and functional capacity in patients with chronic low back pain. The study is planned as the first scientific study comparing the effectiveness of these two physiotherapy methods in the treatment of chronic low back pain. It is aimed to make national and international publications with the data obtained at the end of the study.
The study will be conducted in a randomised single-blind, placebo-controlled design. 60 patients aged 18-30 years with chronic low back pain will be divided into 3 groups: therapeutic ultrasound (US) application, phonophoresis application and placebo US group. In addition to ultrasound and phonophoresis, TENS, infrared and low back exercises will be applied to all groups as treatment. Pain intensity (VAS), functional status (Oswestry disability index), flexibility (Sit-to-Sit test) and range of motion (goniometric measurements) will be assessed throughout the treatment period.
The study aims to make an important contribution from a clinical and economic point of view, given the increasing prevalence of low back pain worldwide and the need for treatment. The findings may guide the development of future treatment modalities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| US | Experimental | Other: UltrasoundParticipants will be treated with 1.5 W/cm2, 6 min (transmitting agent aquasonic gel) ultrasound. |
| Phonophoresis | Experimental | Other: Phonophoresis |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals with low back pain for more than 3 months and pain intensity more than 5 according to VAS will be included in the study
Key exclusion criteria (1 listed)
- patients who have undergone surgical operations
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 |
|---|---|---|
| UltrasoundParticipants will receive ultrasound at 1.5 W/cm2 for 6 minutes (transmitter agent aquasonic gel) 5 sessions per week for 2 weeks. | Other | US |
| PhonophoresisParticipants will receive ultrasound with 1.5 W/cm2, 6 min (transmitter diclofenac gel) for 5 sessions per week for 2 weeks. | Other | Phonophoresis |
| PlaceboParticipants will receive 0 W/cm2, 6 min ultrasound, 5 sessions per week for 2 weeks. | Other | Placebo |
Primary outcome
pain severity
Time frame: Baseline and after 2 weeks intervation
Visual Analog Scale
3 secondary outcomes
functional state
Time frame: Baseline and after 2 weeks intervation
Flexibility
Time frame: Baseline and after 2 weeks intervation
range of motion of the joint
Time frame: Baseline and after 2 weeks intervation
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 6 Mar 2026.
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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 Ultrasound and Phonophoresis in people with Low Back Pain, run by KTO Karatay University 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 1 inclusion and 1 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 6 Mar 2026. 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. Some participants in this study may receive a placebo. 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 severity (time frame: Baseline and after 2 weeks intervation). 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 6 Mar 2026.