CoccydyniaNCT07898514
Shock Wave Therapy Versus High-Intensity Laser Therapy for Coccydynia (Tailbone Pain)
A study testing Extracorporeal Shock Wave Therapy and High-Intensity Laser Therapy in people with Coccydynia and Coccygodynia, run by Ahmet Sümen at 1 site in Turkey (Türkiye).
Trial summary
This study compares shock wave therapy with high-intensity laser therapy for tailbone pain, also called coccydynia. It includes adults aged 18 to 65 years who have had tailbone pain for at least 3 months and continue to have symptoms despite previous standard treatments. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coccydynia, Coccygodynia
- What is being tested?
- Extracorporeal Shock Wave Therapy and High-Intensity Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Oct 2026to 16 Dec 2028
- 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 to 65 years.
- Diagnosis of coccydynia.
- Coccygeal pain persisting for at least 3 months.
- Persistent symptoms despite previous standard treatments.
- Voluntary agreement to participate and provision of written informed consent.
- Ability to attend regular follow-up visits.
Who cannot join
- Recent coccygeal fracture or severe coccygeal dislocation.
- An injection, interventional procedure, or similar treatment to the coccygeal region within the preceding 3 months.
- Previous extracorporeal shock wave therapy (ESWT) or high-intensity laser therapy (HILT) for coccydynia.
- Another significant condition that could explain the pain, such as lumbar disc herniation, nerve compression, or significant hip or lumbar disease.
- Suspicion that the pain originates from a non-coccygeal source, including gastrointestinal, urinary, gynecological, infectious, or tumor-related causes.
- History of spinal or pelvic surgery.
Show all 9Show fewer
- Severe neurological disease, active infection, cancer, a severe bleeding disorder, or pregnancy.
- Another condition causing widespread pain, such as fibromyalgia.
- Inability to attend regular follow-up visits.
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
Ahmet Sümen, MD - Private Medical Practice
Istanbul, Kartal, 34860
Ahmet Sümen, MD, +90 212 660 80, drasumen@gmail.com
About this study
Official title: Comparison of the Effects of Extracorporeal Shock Wave Therapy and High-Intensity Laser Therapy on Pain, Function, and Clinical Outcomes in Patients With Coccydynia
This study compares shock wave therapy with high-intensity laser therapy for tailbone pain, also called coccydynia. It includes adults aged 18 to 65 years who have had tailbone pain for at least 3 months and continue to have symptoms despite previous standard treatments.
The main question is whether the two treatments differ in how much they reduce tailbone pain while sitting. The main comparison will be between pain before treatment and pain 3 months after the final treatment session. The study will also examine earlier pain relief, daily activities, and sitting ability.
Read more
Participants will be assigned by chance to one of two treatment groups. One group will receive 6 shock wave therapy sessions, with 2 sessions per week. The other group will receive 10 high-intensity laser therapy sessions, with 3 sessions per week. Both treatments will be applied to the tailbone area by an experienced physician.
Participants will be assessed before the first treatment session and 1 and 3 months after the final treatment session. They will rate their overall tailbone pain and pain while sitting on scales from 0 to 10. They will also complete questionnaires about how pain affects daily activities. At follow-up visits, participants will report changes in their condition and satisfaction with treatment.
The study will also record sitting duration, the ability to sit for 30 minutes, pain medicine use, the need for additional treatment, and any unwanted symptoms or medical problems.
Read the detailed description
This is a single-center, prospective, randomized, controlled, open-label, parallel-group study conducted at a private medical practice in Istanbul, Türkiye. The study compares extracorporeal shock wave therapy (ESWT) with high-intensity laser therapy (HILT) for pain, function, and clinical outcomes in adults with coccydynia.
Eligible participants provide written informed consent and are randomly assigned in a 1:1 ratio to the ESWT or HILT group. Both treatments are administered to the coccygeal region by an experienced physician.
Baseline demographic and clinical data include age, sex, height, weight, body mass index, occupation, symptom duration, trauma history, postpartum association, prolonged sitting at work, previous treatments, and analgesic use.
Baseline assessments are performed before the first treatment session. Follow-up assessments are performed 1 and 3 months after completion of the assigned treatment course. For each participant, follow-up intervals are calculated from the date of the final treatment session, rather than from enrollment or the first treatment session.
The primary outcome is the change in sitting-related coccygeal pain intensity on the 11-point Numeric Rating Scale (NRS-11) from pretreatment baseline to 3 months after the final treatment session. The primary comparison is the difference in mean change between the ESWT and HILT groups. Change is calculated as the follow-up score minus the baseline score, with negative values indicating pain reduction.
Secondary assessments include the change in sitting-related pain at 1 month, changes in overall coccygeal pain at 1 and 3 months, functional limitations, patient-perceived improvement, treatment satisfaction, and sitting capacity. Assessment instruments include the Oswestry Disability Index (ODI), the Paris Functional Coccydynia Impact Questionnaire (PFCIQ), the Patient Global Impression of Change (PGIC), and a five-point Likert treatment satisfaction scale. Unsupported sitting duration and the ability to sit for 30 minutes are also recorded. Analgesic use, the need for additional treatment, and adverse events are documented during follow-up.
An a priori sample size calculation was performed using G*Power version 3.1.9 for a two-sided comparison of two independent means. The calculation used a standardized effect size of 0.8586162 derived from descriptive statistics reported in a published coccydynia trial, an alpha level of 0.05, 90% power, and an allocation ratio of 1:1. Under these assumptions, the minimum required sample size was 60 participants, with 30 participants per group.
Statistical analyses will be performed using IBM SPSS Statistics version 27.0. Statistical significance will be set at p < 0.05. The distribution of continuous variables will be assessed visually using histograms and Q-Q plots. Normally distributed continuous variables will be summarized as mean and standard deviation, non-normally distributed continuous variables as median with the first and third quartiles, and categorical variables as frequencies and percentages.
Between-group comparisons of continuous variables will use Student's t-test or the Mann-Whitney U test, according to the distribution of the data. Categorical variables will be compared using the chi-square test or Fisher's exact test. Two-way repeated-measures analysis of variance will be used to evaluate within-group and between-group effects for normally distributed repeated measurements. The Friedman test will be used for non-normally distributed repeated measurements, and Cochran's Q test is planned for categorical comparisons in the repeated-measures analyses.
- Conditions
- Coccydynia, Coccygodynia
- Being tested
- Extracorporeal Shock Wave Therapy, High-Intensity Laser Therapy
- Keywords
- Coccygodynia, Tailbone Pain, Coccygeal Pain, Extracorporeal Shock Wave Therapy, High-Intensity Laser Therapy, Coccydynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal Shock Wave TherapyDevice
Also called ESWT, Swiss DolorClast SMART20
Extracorporeal shock wave therapy is applied to the painful area surrounding the coccyx. Approximately 2,000 pulses are delivered per session at a frequency of 8-9 Hz. Pressure is initially set at approximately 1.5 bar and is gradually increased according to the participant's tolerance, up to 2.5-3.0 bar.
High-Intensity Laser TherapyDevice
Also called HILT, HIRO TT
High-intensity laser therapy using a 1064-nm Nd:YAG laser is applied to the coccygeal region in two phases. The analgesic phase is delivered at a frequency of 25 Hz and an energy density of 12 J/cm2 for approximately 4 minutes. This is followed by a biostimulatory phase at a frequency of 25 Hz and an energy density of 70 J/cm2 for approximately 5 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Extracorporeal Shock Wave Therapy (ESWT) | Experimental | Participants assigned to this arm receive six sessions of extracorporeal shock wave therapy, administered twice weekly to the painful area around the coccyx. Treatment is administered by an experienced physician. Receives: Device: Extracorporeal Shock Wave Therapy |
| High-Intensity Laser Therapy (HILT) | Experimental | Participants assigned to this arm receive ten sessions of high-intensity laser therapy, administered on three days per week to the coccygeal region. Each session includes an analgesic phase and a biostimulatory phase. Treatment is administered by an experienced physician. Receives: Device: High-Intensity Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Sitting-Related Coccygeal Pain on the Numeric Rating Scale at 3 Months After Treatment Completion
Sitting-related coccygeal pain is assessed using the 11-point Numeric Rating Scale (NRS-11), ranging from 0 to 10, with higher scores indicating more severe pain. Change is calculated as the score 3 months after the final treatment session minus the pretreatment baseline score. Negative change scores indicate pain reduction. The primary comparison is the difference in mean change between the extracorporeal shock wave therapy and high-intensity laser therapy groups.
Measured: Baseline (before the first treatment session) and 3 months after the final treatment session
Secondary outcomes (11)
Change From Baseline in Sitting-Related Coccygeal Pain on the Numeric Rating Scale at 1 Month After Treatment Completion
Sitting-related coccygeal pain is assessed using the 11-point Numeric Rating Scale (NRS-11), ranging from 0 to 10, with higher scores indicating more severe pain. Change is calculated as the score 1 month after the final treatment session minus the pretreatment baseline score. Negative change scores indicate pain reduction.
Measured: Baseline (before the first treatment session) and 1 month after the final treatment session
Change From Baseline in Overall Coccygeal Pain on the Numeric Rating Scale
Overall coccygeal pain is assessed separately from sitting-related pain using the 11-point Numeric Rating Scale (NRS-11), ranging from 0 to 10. Higher scores indicate more severe pain. Change is calculated separately at each follow-up as the follow-up score minus the pretreatment baseline score. Negative change scores indicate pain reduction.
Measured: Baseline (before the first treatment session), and 1 and 3 months after the final treatment session
Change From Baseline in Oswestry Disability Index Percentage Score
The Oswestry Disability Index (ODI) assesses pain-related disability across 10 sections, each scored from 0 to 5. The percentage score is calculated as the sum of section scores divided by five times the number of answered sections, multiplied by 100. Scores range from 0 to 100%, with higher scores indicating greater disability. Change is calculated separately at each follow-up as the follow-up percentage score minus the baseline percentage score. Changes are expressed in percentage points, with negative values indicating reduced disability.
Measured: Baseline (before the first treatment session), and 1 and 3 months after the final treatment session
Change From Baseline in Paris Functional Coccydynia Impact Questionnaire Score
The Paris Functional Coccydynia Impact Questionnaire (PFCIQ) assesses the impact of coccydynia during sitting, rising from sitting, standing or walking, traveling, and nighttime. In the five-item study form, item scores are summed and multiplied by 10 to obtain a total score from 0 to 100. Higher scores indicate greater symptom impact. Change is calculated separately at each follow-up as the follow-up score minus the baseline score. Negative changes indicate improvement.
Measured: Baseline (before the first treatment session), and 1 and 3 months after the final treatment session
Patient Global Impression of Change Score
The Patient Global Impression of Change (PGIC) is a single-item assessment of the participant's overall change in condition since treatment began. The study form uses seven response categories scored from -3 (very much worse) to +3 (very much improved), with 0 indicating no change. Higher scores indicate greater perceived improvement. The score is assessed at each follow-up; no pretreatment PGIC score is subtracted.
Measured: 1 and 3 months after the final treatment session
Treatment Satisfaction on a Five-Point Likert Scale
Participants rate their satisfaction with the assigned treatment using a five-point Likert scale: 1, not at all satisfied; 2, not satisfied; 3, undecided; 4, satisfied; and 5, very satisfied. Higher scores indicate greater treatment satisfaction. Satisfaction is assessed separately at each follow-up visit.
Measured: 1 and 3 months after the final treatment session
Change From Baseline in Unsupported Sitting Duration
Unsupported sitting duration is recorded in minutes. Change is calculated separately at each follow-up as the recorded follow-up duration minus the pretreatment baseline duration. Positive changes indicate an increase in sitting duration.
Measured: Baseline (before the first treatment session), and 1 and 3 months after the final treatment session
Percentage of Participants Able to Sit for 30 Minutes
The ability to sit for 30 minutes is recorded as yes or no at each assessment. The outcome is the percentage of participants with a yes response at each time point.
Measured: Baseline (before the first treatment session), and 1 and 3 months after the final treatment session
Percentage of Participants Using Analgesics
Analgesic use for coccygeal pain is recorded as yes or no at baseline and follow-up assessments. The outcome is the percentage of participants with analgesic use recorded as yes at each assessment. This is a binary measure, not a measure of dose or tablet count.
Measured: Baseline (before the first treatment session), and 1 and 3 months after the final treatment session
Percentage of Participants Requiring Additional Treatment
The need for additional treatment for coccydynia is recorded as yes or no at each follow-up assessment. The outcome is the percentage of participants with a documented need for additional treatment at each follow-up. This measure concerns treatment need rather than confirmation that an additional treatment was received.
Measured: 1 and 3 months after the final treatment session
Percentage of Participants With Adverse Events or Complications
The outcome is the percentage of participants with at least one adverse event or complication recorded during the observation period. The case report form records the presence or absence of an adverse event or complication. Each affected participant is counted once for this outcome, regardless of the number of events.
Measured: From the first treatment session through 3 months after the final treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start16 Oct 2026
- Primary completion16 Sep 2028 (estimated)
- Study completion16 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CoccydyniaStudies 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
- This is a single-center, two-arm, randomized, open-label, parallel-group study. Participants are assigned in a 1:1 ratio to receive either extracorporeal shock wave therapy (ESWT) or high-intensity laser therapy (HILT). Assessments are performed before treatment and 1 and 3 months after each participant's final treatment session.
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahmet Sümen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmet Sümen, Ahmet Sümen, MD - Private Medical Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07898514
- Sponsor's protocol ID
- AS-COCCY-2026-01
- Other IDs
- 1151
- Status last verified
- Oct 2026
- First submitted
- 16 Oct 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lin SF, Chen YJ, Tu HP, Lee CL, Hsieh CL, Wu WL, Chen CH. The Effects of Extracorporeal Shock Wave Therapy in Patients with Coccydynia: A Randomized Controlled Trial. PLoS One. 2015 Nov 10;10(11):e0142475. doi: 10.1371/journal.pone.0142475. eCollection 2015.
PubMed 26556601
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Extracorporeal Shock Wave Therapy and High-Intensity Laser Therapy on Pain, Function, and Clinical Outcomes in Patients With Coccydynia
- ClinicalTrials.gov ID
- NCT07898514
- Acronym / sponsor ID
- AS-COCCY-2026-01
- Conditions
- Coccydynia, Coccygodynia
- Keywords
- Coccygodynia, Tailbone Pain, Coccygeal Pain, Extracorporeal Shock Wave Therapy, High-Intensity Laser Therapy, Coccydynia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ahmet SümenUniversity, hospital or other
- Study start
- 16 Oct 2026 (actual)
- Primary completion
- 16 Sep 2028 (estimated)
- Study completion
- 16 Dec 2028 (estimated)
- First posted
- 27 Oct 2026 (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 study compares shock wave therapy with high-intensity laser therapy for tailbone pain, also called coccydynia. It includes adults aged 18 to 65 years who have had tailbone pain for at least 3 months and continue to have symptoms despite previous standard treatments.
The main question is whether the two treatments differ in how much they reduce tailbone pain while sitting. The main comparison will be between pain before treatment and pain 3 months after the final treatment session. The study will also examine earlier pain relief, daily activities, and sitting ability.
Participants will be assigned by chance to one of two treatment groups. One group will receive 6 shock wave therapy sessions, with 2 sessions per week. The other group will receive 10 high-intensity laser therapy sessions, with 3 sessions per week. Both treatments will be applied to the tailbone area by an experienced physician.
Participants will be assessed before the first treatment session and 1 and 3 months after the final treatment session. They will rate their overall tailbone pain and pain while sitting on scales from 0 to 10. They will also complete questionnaires about how pain affects daily activities. At follow-up visits, participants will report changes in their condition and satisfaction with treatment.
The study will also record sitting duration, the ability to sit for 30 minutes, pain medicine use, the need for additional treatment, and any unwanted symptoms or medical problems.
Detailed description
This is a single-center, prospective, randomized, controlled, open-label, parallel-group study conducted at a private medical practice in Istanbul, Türkiye. The study compares extracorporeal shock wave therapy (ESWT) with high-intensity laser therapy (HILT) for pain, function, and clinical outcomes in adults with coccydynia.
Eligible participants provide written informed consent and are randomly assigned in a 1:1 ratio to the ESWT or HILT group. Both treatments are administered to the coccygeal region by an experienced physician.
Baseline demographic and clinical data include age, sex, height, weight, body mass index, occupation, symptom duration, trauma history, postpartum association, prolonged sitting at work, previous treatments, and analgesic use.
Baseline assessments are performed before the first treatment session. Follow-up assessments are performed 1 and 3 months after completion of the assigned treatment course. For each participant, follow-up intervals are calculated from the date of the final treatment session, rather than from enrollment or the first treatment session.
The primary outcome is the change in sitting-related coccygeal pain intensity on the 11-point Numeric Rating Scale (NRS-11) from pretreatment baseline to 3 months after the final treatment session. The primary comparison is the difference in mean change between the ESWT and HILT groups. Change is calculated as the follow-up score minus the baseline score, with negative values indicating pain reduction.
Secondary assessments include the change in sitting-related pain at 1 month, changes in overall coccygeal pain at 1 and 3 months, functional limitations, patient-perceived improvement, treatment satisfaction, and sitting capacity. Assessment instruments include the Oswestry Disability Index (ODI), the Paris Functional Coccydynia Impact Questionnaire (PFCIQ), the Patient Global Impression of Change (PGIC), and a five-point Likert treatment satisfaction scale. Unsupported sitting duration and the ability to sit for 30 minutes are also recorded. Analgesic use, the need for additional treatment, and adverse events are documented during follow-up.
An a priori sample size calculation was performed using G*Power version 3.1.9 for a two-sided comparison of two independent means. The calculation used a standardized effect size of 0.8586162 derived from descriptive statistics reported in a published coccydynia trial, an alpha level of 0.05, 90% power, and an allocation ratio of 1:1. Under these assumptions, the minimum required sample size was 60 participants, with 30 participants per group.
Statistical analyses will be performed using IBM SPSS Statistics version 27.0. Statistical significance will be set at p < 0.05. The distribution of continuous variables will be assessed visually using histograms and Q-Q plots. Normally distributed continuous variables will be summarized as mean and standard deviation, non-normally distributed continuous variables as median with the first and third quartiles, and categorical variables as frequencies and percentages.
Between-group comparisons of continuous variables will use Student's t-test or the Mann-Whitney U test, according to the distribution of the data. Categorical variables will be compared using the chi-square test or Fisher's exact test. Two-way repeated-measures analysis of variance will be used to evaluate within-group and between-group effects for normally distributed repeated measurements. The Friedman test will be used for non-normally distributed repeated measurements, and Cochran's Q test is planned for categorical comparisons in the repeated-measures analyses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a single-center, two-arm, randomized, open-label, parallel-group study. Participants are assigned in a 1:1 ratio to receive either extracorporeal shock wave therapy (ESWT) or high-intensity laser therapy (HILT). Assessments are performed before treatment and 1 and 3 months after each participant's final treatment session.
| Arm | Type | Receives |
|---|---|---|
| Extracorporeal Shock Wave Therapy (ESWT) | Experimental | Device: Extracorporeal Shock Wave TherapyParticipants assigned to this arm receive six sessions of extracorporeal shock wave therapy, administered twice weekly to the painful area around the coccyx. Treatment is administered by an experienced physician. |
| High-Intensity Laser Therapy (HILT) | Experimental | Device: High-Intensity Laser TherapyParticipants assigned to this arm receive ten sessions of high-intensity laser therapy, administered on three days per week to the coccygeal region. Each session includes an analgesic phase and a biostimulatory phase. Treatment is administered by an experienced physician. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 to 65 years.
- Diagnosis of coccydynia.
- Coccygeal pain persisting for at least 3 months.
- Persistent symptoms despite previous standard treatments.
- Voluntary agreement to participate and provision of written informed consent.
Key exclusion criteria (9 listed)
- Recent coccygeal fracture or severe coccygeal dislocation.
- An injection, interventional procedure, or similar treatment to the coccygeal region within the preceding 3 months.
- Previous extracorporeal shock wave therapy (ESWT) or high-intensity laser therapy (HILT) for coccydynia.
- Another significant condition that could explain the pain, such as lumbar disc herniation, nerve compression, or significant hip or lumbar disease.
- Suspicion that the pain originates from a non-coccygeal source, including gastrointestinal, urinary, gynecological, infectious, or tumor-related causes.
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 TherapyAlso: ESWT, Swiss DolorClast SMART20Extracorporeal shock wave therapy is applied to the painful area surrounding the coccyx. Approximately 2,000 pulses are delivered per session at a frequency of 8-9 Hz. Pressure is initially set at approximately 1.5 bar and is gradually increased according to the participant's tolerance, up to 2.5-3.0 bar. | Device | Extracorporeal Shock Wave Therapy (ESWT) |
| High-Intensity Laser TherapyAlso: HILT, HIRO TTHigh-intensity laser therapy using a 1064-nm Nd:YAG laser is applied to the coccygeal region in two phases. The analgesic phase is delivered at a frequency of 25 Hz and an energy density of 12 J/cm2 for approximately 4 minutes. This is followed by a biostimulatory phase at a frequency of 25 Hz and an energy density of 70 J/cm2 for approximately 5 minutes. | Device | High-Intensity Laser Therapy (HILT) |
Primary outcome
Change From Baseline in Sitting-Related Coccygeal Pain on the Numeric Rating Scale at 3 Months After Treatment Completion
Time frame: Baseline (before the first treatment session) and 3 months after the final treatment session
Sitting-related coccygeal pain is assessed using the 11-point Numeric Rating Scale (NRS-11), ranging from 0 to 10, with higher scores indicating more severe pain. Change is calculated as the score 3 months after the final treatment session minus the pretreatment baseline score. Negative change scores indicate pain reduction. The primary comparison is the difference in mean change between the extracorporeal shock wave therapy and high-intensity laser therapy groups.
11 secondary outcomes
Change From Baseline in Sitting-Related Coccygeal Pain on the Numeric Rating Scale at 1 Month After Treatment Completion
Time frame: Baseline (before the first treatment session) and 1 month after the final treatment session
Change From Baseline in Overall Coccygeal Pain on the Numeric Rating Scale
Time frame: Baseline (before the first treatment session), and 1 and 3 months after the final treatment session
Change From Baseline in Oswestry Disability Index Percentage Score
Time frame: Baseline (before the first treatment session), and 1 and 3 months after the final treatment session
Change From Baseline in Paris Functional Coccydynia Impact Questionnaire Score
Time frame: Baseline (before the first treatment session), and 1 and 3 months after the final treatment session
Patient Global Impression of Change Score
Time frame: 1 and 3 months after the final treatment session
Treatment Satisfaction on a Five-Point Likert Scale
Time frame: 1 and 3 months after the final treatment session
Change From Baseline in Unsupported Sitting Duration
Time frame: Baseline (before the first treatment session), and 1 and 3 months after the final treatment session
Percentage of Participants Able to Sit for 30 Minutes
Time frame: Baseline (before the first treatment session), and 1 and 3 months after the final treatment session
Percentage of Participants Using Analgesics
Time frame: Baseline (before the first treatment session), and 1 and 3 months after the final treatment session
Percentage of Participants Requiring Additional Treatment
Time frame: 1 and 3 months after the final treatment session
Percentage of Participants With Adverse Events or Complications
Time frame: From the first treatment session through 3 months after the final treatment session
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 29 Oct 2026.
- Background: PubMed 26556601Lin SF, Chen YJ, Tu HP, Lee CL, Hsieh CL, Wu WL, Chen CH. The Effects of Extracorporeal Shock Wave Therapy in Patients with Coccydynia: A Randomized Controlled Trial. PLoS One. 2015 Nov 10;10(11):e0142475. doi: 10.1371/journal.pone.0142475. eCollection 2015.
- Individual participant dataSharing planned: No
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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.
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 and High-Intensity Laser Therapy in people with Coccydynia and Coccygodynia, run by Ahmet Sümen 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 6 inclusion and 9 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 29 Oct 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 Ahmet Sümen, MD (+90 212 660 80 70, drasumen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Sitting-Related Coccygeal Pain on the Numeric Rating Scale at 3 Months After Treatment Completion (time frame: Baseline (before the first treatment session) and 3 months after the final treatment session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07898514, which also lists 1 linked publication.
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 29 Oct 2026.