Chronic Low Back PainESWTNCT07132762
The Effect of ESWT Added to Conservative Treatment on Pain, Disability, and Ultrasonographic Outcomes in Chronic Low Back Pain
A study testing Radial Extracorporeal Shock Wave Therapy and Conventional rehabilitation in people with Chronic Low Back Pain, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
Chronic low back pain (CLBP) is a major public health concern worldwide, leading to reduced quality of life and significant work loss. It is defined as pain lasting more than 12 weeks between the lumbar and sacral spinal segments. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Radial Extracorporeal Shock Wave Therapy and Conventional rehabilitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2025to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years
- Non-specific low back pain lasting more than three months
Who cannot join
- Specific lumbar spine diseases (radicular pain, spinal stenosis, infection)
- History of trauma, fracture, surgery, or presence of scar tissue in the lumbar region
- Presence of a disease that may affect muscle stiffness, such as collagen tissue disorders, hemiplegia, multiple sclerosis, or myopathies
- Malignancy, pregnancy, severe hypertension
- Coagulopathy, chronic heart disease
- Ankylosing spondylitis
- Diseases that may initially affect lumbar mobility and pain, such as leg length discrepancy, hip prosthesis, or scoliosis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Pamukkale University
Denizli
About this study
Official title: The Effect of Extracorporeal Shock Wave Therapy (ESWT) Added to Conservative Treatment on Pain, Disability, and Ultrasonographic Outcomes in Chronic Low Back Pain: A Randomized Controlled Trial
Chronic low back pain (CLBP) is a major public health concern worldwide, leading to reduced quality of life and significant work loss. It is defined as pain lasting more than 12 weeks between the lumbar and sacral spinal segments. The global prevalence of CLBP ranges from 13.1% to 20.3%, and the number of affected individuals has increased from 370 million in 1990 to 570 million in 2017.
Core muscles, including the multifidus, erector spinae, transversus abdominis, psoas major, and quadratus lumborum, play a key role in spinal stabilization. In patients with CLBP, dysfunction and loss of synergy among these muscles can compromise spinal balance. Prolonged poor posture can reduce the strength and endurance of the lumbar erector spinae, multifidus, and transversus abdominis, leading patients to compensate by overusing the erector spinae, rectus abdominis, and oblique abdominal muscles. This compensation is considered one of the primary contributors to chronic low back pain.
Read more
These deep core muscles can be objectively evaluated using ultrasonography (USG), a non-invasive, inexpensive, and accessible imaging method. Strain elastography, a quantitative ultrasonographic technique, is increasingly used to assess tissue stiffness and monitor structural changes in muscle over time.
Conventional treatments for CLBP include pharmacotherapy, exercise, and physical therapy. In recent years, extracorporeal shock wave therapy (ESWT) has emerged as a non-invasive, easily applicable, and low-risk treatment method. ESWT is widely used in various musculoskeletal conditions such as lateral epicondylitis, patellar tendinopathy, and calcific tendinitis of the shoulder. Studies have shown that ESWT provides pain relief and functional improvement in patients with CLBP through its angiogenic, anti-inflammatory, analgesic, and tissue-regenerative effects.
Several studies have demonstrated the positive impact of ESWT on pain reduction and functional recovery in CLBP. A recent meta-analysis reported that ESWT significantly reduces pain in CLBP patients and may be superior to other conservative treatments. Yue et al. (2021) highlighted the short-term benefits of ESWT in reducing pain and disability, while also emphasizing the need for well-designed randomized controlled trials (RCTs) to establish high-quality evidence. Similarly, Wu et al. (2023) underscored the necessity of including objective outcomes in future RCTs to better evaluate the efficacy of ESWT.
Although numerous studies have assessed the effects of ESWT on pain, disability, and functional outcomes in CLBP, to date, no study has objectively evaluated its effectiveness using ultrasonographic strain elastography focusing on the elasticity and stiffness of core muscles.
This study aims to be one of the first to assess the long-term effects of ESWT using objective measures. Its contribution to the literature lies in evaluating the efficacy of ESWT, when added to conventional physical therapy, through long-term monitoring with ultrasonographic strain elastography in patients with CLBP.
- Conditions
- Chronic Low Back Pain
- Being tested
- Radial Extracorporeal Shock Wave Therapy, Conventional rehabilitation
- Keywords
- Extracorporeal Shockwave Therapy treatment (ESWT), Elastography, physical therapy, chronic low back pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radial Extracorporeal Shock Wave TherapyDevice
A total of 6 sessions of ESWT, applied twice a week. Each ESWT session will last approximately 15 minutes. ESWT will be administered with the patient in the prone position, using an energy density of 0.15 mJ/mm², at 4 Hz frequency, and 1,500 shock waves per session.
The ESWT application will be performed on the right and left paravertebral muscles between the L3 and S1 segments.
Conventional rehabilitationOther
A total of 15 sessions of conventional physical therapy will be administered, five times per week. Each session will include 20 minutes of hot pack application, 20 minutes of conventional transcutaneous electrical nerve stimulation (TENS), 5 minutes of ultrasound therapy at 1.5 W/cm², and core stabilization exercises performed under the supervision of a physiotherapist. The treatment will be applied over a total period of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| ESWT + Conventional Physical Therapy Group | Experimental | A total of 6 sessions of extracorporeal shock wave therapy (ESWT) will be administered twice a week, along with 15 sessions of conventional physical therapy applied five times per week. Each conventional physical therapy session will include 20 minutes of hot pack application, 20 minutes of conventional transcutaneous electrical nerve stimulation (TENS), 5 minutes of ultrasound therapy at an intensity of 1.5 W/cm², and core stabilization exercises performed under the supervision of a physiotherapist. The treatment program will be carried out over a total period of 3 weeks. Each ESWT session will last approximately 15 minutes. ESWT will be applied with the patient positioned in the prone position, using an energy density of 0.15 mJ/mm², at a frequency of 4 Hz, and delivering 1,500 shock waves per session. The application will target the right and left paravertebral muscles between the L3 and S1 spinal segments. Receives: Device: Radial Extracorporeal Shock Wave Therapy; Other: Conventional rehabilitation |
| Conventional Physical Therapy Group | Active comparator | A total of 15 sessions of conventional physical therapy will be administered, five times per week. Each session will include 20 minutes of hot pack application, 20 minutes of conventional transcutaneous electrical nerve stimulation (TENS), 5 minutes of ultrasound therapy at 1.5 W/cm², and core stabilization exercises performed under the supervision of a physiotherapist. The treatment will be applied over a total period of 3 weeks. Receives: Other: Conventional rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS), a valid and reliable method for measuring pain intensity, will be used. VAS is a 10-centimeter-long horizontal line that allows patients to assess their pain or symptoms. The left end of the line (0 cm) typically represents "No Pain" or "Painless," while the right end (10 cm) indicates "Unbearable Pain" or "Worst Possible Pain." Participants will be asked to mark a point on the line that corresponds to their current level of pain or symptoms. The marked point is then measured and recorded as a score ranging from 0 to 10. The resulting VAS scores will be used to quantitatively assess the severity of participants' pain or symptoms.
Measured: Baseline, 3rd week, 12th week
Secondary outcomes (2)
Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) will be used for evaluation. The ODI is used to measure the degree of functional limitations caused by pain in patients with low back pain. It assesses pain intensity, personal care (such as washing and dressing), lifting, walking, sitting or standing, sleeping, sexual life, social life, and traveling/mobility. Each component is scored on a scale from 0 to 5, with 5 indicating the highest level of disability. The index is calculated by dividing the total score by the maximum possible score and multiplying the result by 100 to obtain a percentage score representing the level of disability.
Measured: Baseline, 3rd week, 12th week
Sonoelastography -Strain Index:
Sonoelastography strain index, which is a quantitative analysis method used to measure elasticity, will be used. With elastographic quantitative analysis, a software feature of the ultrasound system, the color distribution in a selected area is numerically measured through single or multiple boxes, and an elasticity index is calculated for the measured area. The elasticity index is a value between 0.0 and 6.0 and is determined by the reflected color distribution within the selected region. A higher value indicates greater stiffness and is represented predominantly by the color blue on the screen. While the elasticity index is calculated separately for the reference area and the muscle, the system automatically calculates the elasticity ratio as muscle/reference area.
Measured: Baseline, 3rd week ,12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start10 Oct 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Füsun Ardıç, Pamukkale University
- Investigators
- Füsun Ardıç, Professor, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132762
- Sponsor's protocol ID
- PamukkaleU.ftr-FArdıç-002
- Acronym
- ESWT
- Status last verified
- Feb 2026
- First submitted
- 13 Aug 2025
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Extracorporeal Shock Wave Therapy (ESWT) Added to Conservative Treatment on Pain, Disability, and Ultrasonographic Outcomes in Chronic Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07132762
- Acronym / sponsor ID
- ESWT / PamukkaleU.ftr-FArdıç-002
- Conditions
- Chronic Low Back Pain
- Keywords
- Extracorporeal Shockwave Therapy treatment (ESWT), Elastography, physical therapy, chronic low back pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 20 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.
Chronic low back pain (CLBP) is a major public health concern worldwide, leading to reduced quality of life and significant work loss. It is defined as pain lasting more than 12 weeks between the lumbar and sacral spinal segments. The global prevalence of CLBP ranges from 13.1% to 20.3%, and the number of affected individuals has increased from 370 million in 1990 to 570 million in 2017.
Core muscles, including the multifidus, erector spinae, transversus abdominis, psoas major, and quadratus lumborum, play a key role in spinal stabilization. In patients with CLBP, dysfunction and loss of synergy among these muscles can compromise spinal balance. Prolonged poor posture can reduce the strength and endurance of the lumbar erector spinae, multifidus, and transversus abdominis, leading patients to compensate by overusing the erector spinae, rectus abdominis, and oblique abdominal muscles. This compensation is considered one of the primary contributors to chronic low back pain.
These deep core muscles can be objectively evaluated using ultrasonography (USG), a non-invasive, inexpensive, and accessible imaging method. Strain elastography, a quantitative ultrasonographic technique, is increasingly used to assess tissue stiffness and monitor structural changes in muscle over time.
Conventional treatments for CLBP include pharmacotherapy, exercise, and physical therapy. In recent years, extracorporeal shock wave therapy (ESWT) has emerged as a non-invasive, easily applicable, and low-risk treatment method. ESWT is widely used in various musculoskeletal conditions such as lateral epicondylitis, patellar tendinopathy, and calcific tendinitis of the shoulder. Studies have shown that ESWT provides pain relief and functional improvement in patients with CLBP through its angiogenic, anti-inflammatory, analgesic, and tissue-regenerative effects.
Several studies have demonstrated the positive impact of ESWT on pain reduction and functional recovery in CLBP. A recent meta-analysis reported that ESWT significantly reduces pain in CLBP patients and may be superior to other conservative treatments. Yue et al. (2021) highlighted the short-term benefits of ESWT in reducing pain and disability, while also emphasizing the need for well-designed randomized controlled trials (RCTs) to establish high-quality evidence. Similarly, Wu et al. (2023) underscored the necessity of including objective outcomes in future RCTs to better evaluate the efficacy of ESWT.
Although numerous studies have assessed the effects of ESWT on pain, disability, and functional outcomes in CLBP, to date, no study has objectively evaluated its effectiveness using ultrasonographic strain elastography focusing on the elasticity and stiffness of core muscles.
This study aims to be one of the first to assess the long-term effects of ESWT using objective measures. Its contribution to the literature lies in evaluating the efficacy of ESWT, when added to conventional physical therapy, through long-term monitoring with ultrasonographic strain elastography in patients with CLBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESWT + Conventional Physical Therapy Group | Experimental | Device: Radial Extracorporeal Shock Wave Therapy, Other: Conventional rehabilitationA total of 6 sessions of extracorporeal shock wave therapy (ESWT) will be administered twice a week, along with 15 sessions of conventional physical therapy applied five times per week. Each conventional physical therapy session will include 20 minutes of hot pack application, 20 minutes of conventional transcutaneous electrical nerve stimulation (TENS), 5 minutes of ultrasound therapy at an intensity of 1.5 W/cm², and core stabilization exercises performed under the supervision of a physiotherapist. The treatment program will be carried out over a total period of 3 weeks. Each ESWT session will last approximately 15 minutes. ESWT will be applied with the patient positioned in the prone position, using an energy density of 0.15 mJ/mm², at a frequency of 4 Hz, and delivering 1,500 shock waves per session. The application will target the right and left paravertebral muscles between the L3 and S1 spinal segments. |
| Conventional Physical Therapy Group | Active comparator | Other: Conventional rehabilitationA total of 15 sessions of conventional physical therapy will be administered, five times per week. Each session will include 20 minutes of hot pack application, 20 minutes of conventional transcutaneous electrical nerve stimulation (TENS), 5 minutes of ultrasound therapy at 1.5 W/cm², and core stabilization exercises performed under the supervision of a physiotherapist. The treatment will be applied over a total period of 3 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 years
- Non-specific low back pain lasting more than three months
Key exclusion criteria (7 listed)
- Specific lumbar spine diseases (radicular pain, spinal stenosis, infection)
- History of trauma, fracture, surgery, or presence of scar tissue in the lumbar region
- Presence of a disease that may affect muscle stiffness, such as collagen tissue disorders, hemiplegia, multiple sclerosis, or myopathies
- Malignancy, pregnancy, severe hypertension
- Coagulopathy, chronic heart disease
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 |
|---|---|---|
| Radial Extracorporeal Shock Wave TherapyA total of 6 sessions of ESWT, applied twice a week. Each ESWT session will last approximately 15 minutes. ESWT will be administered with the patient in the prone position, using an energy density of 0.15 mJ/mm², at 4 Hz frequency, and 1,500 shock waves per session. The ESWT application will be performed on the right and left paravertebral muscles between the L3 and S1 segments. | Device | ESWT + Conventional Physical Therapy Group |
| Conventional rehabilitationA total of 15 sessions of conventional physical therapy will be administered, five times per week. Each session will include 20 minutes of hot pack application, 20 minutes of conventional transcutaneous electrical nerve stimulation (TENS), 5 minutes of ultrasound therapy at 1.5 W/cm², and core stabilization exercises performed under the supervision of a physiotherapist. The treatment will be applied over a total period of 3 weeks. | Other | Conventional Physical Therapy Group, ESWT + Conventional Physical Therapy Group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Baseline, 3rd week, 12th week
The Visual Analog Scale (VAS), a valid and reliable method for measuring pain intensity, will be used. VAS is a 10-centimeter-long horizontal line that allows patients to assess their pain or symptoms. The left end of the line (0 cm) typically represents "No Pain" or "Painless," while the right end (10 cm) indicates "Unbearable Pain" or "Worst Possible Pain." Participants will be asked to mark a point on the line that corresponds to their current level of pain or symptoms. The marked point is then measured and recorded as a score ranging from 0 to 10. The resulting VAS scores will be used to quantitatively assess the severity of participants' pain or symptoms.
2 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: Baseline, 3rd week, 12th week
Sonoelastography -Strain Index:
Time frame: Baseline, 3rd week ,12th week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 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.
Füsun Ardıç, Professor study director
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radial Extracorporeal Shock Wave Therapy and Conventional rehabilitation in people with Chronic Low Back Pain, run by Pamukkale 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 2 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: looking for participants now, as of the sponsor's last update on 6 Feb 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Füsun Ardıç, Professor (+905342197714, ardicf@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Baseline, 3rd week, 12th week). 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 Feb 2026.