Low Back PainNCT07245498
ESWT for Low Back Pain
A study testing extracorporeal shock wave therapy in people with Low Back Pain and Physical Therapy, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The goal of this interventional study is to compare the effects of ESWT in women and men between the age 18-65 with non radicular non specific low back pain . The main question it aims to answer is: Is intervention ESWT more effective than conventional physical therapy agents. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Physical Therapy, Extracorporeal Shock Wave Therapy
- What is being tested?
- extracorporeal shock wave therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2024to 1 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
- Male and female patients between the ages of 18 and 65 who have had low back pain for at least three months and have been diagnosed with chronic low back pain.
- Patients who consent to participate in the study according to the informed consent form will be included in the study.
Who cannot join
- Diagnosis of spondylolisthesis, spondylolysis, spinal tumors, intervertebral disc infections, severe osteoporosis, or lumbar vertebral fractures and patients with a history of prior spine surgery,
- Currently using anti-inflammatory drugs or analgesics in last four weeks,
- Local skin infection or damage at the treatment site,
- Inflammatory rheumatic diseases,
- Pregnancy
- Concomitant mental diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Extracorporeal Shock Wave Therapy in Chronic Non-radicular Low Back Pain
The goal of this interventional study is to compare the effects of ESWT in women and men between the age 18-65 with non radicular non specific low back pain . The main question it aims to answer is:
Is intervention ESWT more effective than conventional physical therapy agents. Patients were divided into 2 groups; Group 1 ESWT+conventional physical therapy and group 2: sham ESWT+conventional physical therapy. Study follow up time before treatment, 0 week after treatment, and 1 month after treatment.
- Being tested
- extracorporeal shock wave therapy
- Keywords
- low back pain,, Extracorporeal shock wave therapy, Conventional 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.
extracorporeal shock wave therapyOther
Shock wave probe applied perpendicularly to the quadratus lumborum, the sacroiliac joint, and the regions of the patient's lumbar area where pain is localized, following the application of coupling gel to facilitate the transmission of pressure waves generated by the device through the skin via its metallic applicator head
| Study group | Role | What they receive |
|---|---|---|
| Ekstra corporeal shock wave therapy(ESWT) | Active comparator | Ekstra corporeal shock wave therapy + conventional physical therapy +exercise Receives: Other: extracorporeal shock wave therapy |
| sham Ekstra corporeal shock wave therapy | Sham comparator | sham Ekstra corporeal shock wave therapy+ conventional physical therapy +exercise Receives: Other: extracorporeal shock wave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale(VAS)
The VAS is a validated tool for assessing pain intensity. It consists of a 10-cm horizontal line anchored by "no pain" (0) at the left end and "worst imaginable pain" (10) at the right end. Participants indicate their perceived pain level by marking a point on the line, which is then measured in centimeters to provide a continuous pain score from 0 to 10.
Measured: Before treatment, Baseline and 1month after treatment
Secondary outcomes (2)
oswestry disability score(ODI),
The ODI is a widely used, validated questionnaire designed to measure disability related to low back pain. It consists of 10 sections covering domains such as pain intensity, personal care, lifting, walking, sitting, standing, sleeping, social life, traveling, and employment/homemaking. Each section is scored from 0 to 5, with higher scores indicating greater disability. The total score is expressed as a percentage, with 0% representing no disability and 100% representing maximum disability.
Measured: Before treatment, Baseline, 1st month after treatment
hospital anxiety and depression scale(HADS)
The HADS is a self-administered questionnaire developed to detect states of anxiety and depression in patients with physical health problems. It consists of 14 items, divided into two subscales: anxiety (HADS-A, 7 items) and depression (HADS-D, 7 items). Each item is scored on a 4-point scale (0-3), giving a maximum score of 21 for each subscale. Higher scores indicate greater levels of anxiety or depression, with established cutoffs used to classify symptom severity.
Measured: Before treatment, Baseline, 1st month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start1 Sep 2024
- Primary completion1 Jun 2025
- Study completion1 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1: Radial ESWT+conventional physical therapy+exercise Group 2: sham ESWT+conventional physical therapy+exercise Assesments: before treatment, after treatment and 1th month after treatment primer outcome: VAS seconder outcomes: Oswestry disability index, hospital axiety and depression scale
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07245498
- Sponsor's protocol ID
- TABED 2-24-246
- Status last verified
- Nov 2025
- First submitted
- 1 Oct 2025
- Last updated
- 24 Nov 2025
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Extracorporeal Shock Wave Therapy in Chronic Non-radicular Low Back Pain
- ClinicalTrials.gov ID
- NCT07245498
- Acronym / sponsor ID
- TABED 2-24-246
- Keywords
- low back pain,, Extracorporeal shock wave therapy, Conventional physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 24 Nov 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 goal of this interventional study is to compare the effects of ESWT in women and men between the age 18-65 with non radicular non specific low back pain . The main question it aims to answer is:
Is intervention ESWT more effective than conventional physical therapy agents. Patients were divided into 2 groups; Group 1 ESWT+conventional physical therapy and group 2: sham ESWT+conventional physical therapy. Study follow up time before treatment, 0 week after treatment, and 1 month after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group 1: Radial ESWT+conventional physical therapy+exercise Group 2: sham ESWT+conventional physical therapy+exercise Assesments: before treatment, after treatment and 1th month after treatment primer outcome: VAS seconder outcomes: Oswestry disability index, hospital axiety and depression scale
| Arm | Type | Receives |
|---|---|---|
| Ekstra corporeal shock wave therapy(ESWT) | Active comparator | Other: extracorporeal shock wave therapyEkstra corporeal shock wave therapy + conventional physical therapy +exercise |
| sham Ekstra corporeal shock wave therapy | Sham comparator | Other: extracorporeal shock wave therapysham Ekstra corporeal shock wave therapy+ conventional physical therapy +exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male and female patients between the ages of 18 and 65 who have had low back pain for at least three months and have been diagnosed with chronic low back pain.
- Patients who consent to participate in the study according to the informed consent form will be included in the study.
Key exclusion criteria (6 listed)
- Diagnosis of spondylolisthesis, spondylolysis, spinal tumors, intervertebral disc infections, severe osteoporosis, or lumbar vertebral fractures and patients with a history of prior spine surgery,
- Currently using anti-inflammatory drugs or analgesics in last four weeks,
- Local skin infection or damage at the treatment site,
- Inflammatory rheumatic diseases,
- Pregnancy
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 |
|---|---|---|
| extracorporeal shock wave therapyShock wave probe applied perpendicularly to the quadratus lumborum, the sacroiliac joint, and the regions of the patient's lumbar area where pain is localized, following the application of coupling gel to facilitate the transmission of pressure waves generated by the device through the skin via its metallic applicator head | Other | Ekstra corporeal shock wave therapy(ESWT), sham Ekstra corporeal shock wave therapy |
Primary outcome
visual analog scale(VAS)
Time frame: Before treatment, Baseline and 1month after treatment
The VAS is a validated tool for assessing pain intensity. It consists of a 10-cm horizontal line anchored by "no pain" (0) at the left end and "worst imaginable pain" (10) at the right end. Participants indicate their perceived pain level by marking a point on the line, which is then measured in centimeters to provide a continuous pain score from 0 to 10.
2 secondary outcomes
oswestry disability score(ODI),
Time frame: Before treatment, Baseline, 1st month after treatment
hospital anxiety and depression scale(HADS)
Time frame: Before treatment, Baseline, 1st month after treatment
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 24 Nov 2025.
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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 extracorporeal shock wave therapy in people with Low Back Pain and Physical Therapy, run by Ankara City Hospital Bilkent 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 6 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 24 Nov 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. 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?
visual analog scale(VAS) (time frame: Before treatment, Baseline and 1month after treatment). 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 24 Nov 2025.