Coccyx InjuryNCT05157022
Comparative Effects of Radial and Focused Extracorporeal Shock-wave Therapies in Coccydynia
A study testing ESWT in people with Coccyx Injury, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
Comparison of the efficacy of coccydynia treatment with two different probes of the ESWT device Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coccyx Injury
- What is being tested?
- ESWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2021to 27 Apr 2022
- 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
- Clinical diagnosis of coccydynia by clinical examination and X-ray imaging.
- be aged ≥18 at the time of diagnosis
- be give informed consent
Who cannot join
- Malignancy
- Those who have received ESWT treatment before
- Pediatric patients
- Patients with infection.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yüzüncü Yıl Üniversitesi Tıp Fakültesi
Van, 65080
About this study
Comparison of the efficacy of coccydynia treatment with two different probes of the ESWT device
- Conditions
- Coccyx Injury
- Being tested
- ESWT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWTDevice
Extracorporeal Shock-wave Therapy
| Study group | Role | What they receive |
|---|---|---|
| Focus extracorporeal shock wave therapy | Active comparator | A total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area Receives: Device: ESWT |
| Radial extracorporeal shock wave therapy | Active comparator | A total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area Receives: Device: ESWT |
| Sham extracorporeal shock wave therapy | Sham comparator | A total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area Receives: Device: ESWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
pain evaluation, higher scores mean worse outcome.
Measured: 1 minute
Oswestry Low Back Pain Disability Questionnaire
higher scores mean better outcome.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start15 Aug 2021
- Primary completion15 Mar 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coccyx InjuryStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Şah, Yuzuncu Yil University
- Investigators
- Volkan Şah, Study director, Yüzüncü Yıl Üniversitesi Tıp Fakültesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05157022
- Sponsor's protocol ID
- Yuzuncu Yıl
- Status last verified
- Apr 2022
- First submitted
- 13 Oct 2021
- Last updated
- 28 Apr 2022
- 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 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Radial and Focused Extracorporeal Shock-wave Therapies in Coccydynia
- ClinicalTrials.gov ID
- NCT05157022
- Acronym / sponsor ID
- Yuzuncu Yıl
- Conditions
- Coccyx Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 14 Dec 2021 (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.
Comparison of the efficacy of coccydynia treatment with two different probes of the ESWT device
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Focus extracorporeal shock wave therapy | Active comparator | Device: ESWTA total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area |
| Radial extracorporeal shock wave therapy | Active comparator | Device: ESWTA total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area |
| Sham extracorporeal shock wave therapy | Sham comparator | Device: ESWTA total of 4 sessions of ESWT at 1-week intervals were applied to to the sacrococcygeal area |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of coccydynia by clinical examination and X-ray imaging.
- be aged ≥18 at the time of diagnosis
- be give informed consent
Key exclusion criteria (4 listed)
- Malignancy
- Those who have received ESWT treatment before
- Pediatric patients
- Patients with infection.
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 |
|---|---|---|
| ESWTExtracorporeal Shock-wave Therapy | Device | Focus extracorporeal shock wave therapy, Radial extracorporeal shock wave therapy, Sham extracorporeal shock wave therapy |
Primary outcome
Visual Analogue Scale
Time frame: 1 minute
pain evaluation, higher scores mean worse outcome.
Oswestry Low Back Pain Disability Questionnaire
Time frame: 5 minutes
higher scores mean better outcome.
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 28 Apr 2022.
- Individual participant dataSharing planned: Undecided
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.
Volkan Şah study director
Yüzüncü Yıl Üniversitesi Tıp Fakültesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT in people with Coccyx Injury, run by Yuzuncu Yil 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 3 inclusion and 4 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 28 Apr 2022. 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 Analogue Scale (time frame: 1 minute). 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 28 Apr 2022; AzTrials last refreshed its copy on 7 Nov 2026.