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NCT07898514
Shock Wave Therapy Versus High-Intensity Laser Therapy for Coccydynia (Tailbone Pain)
Conditions: Coccydynia, Coccygodynia
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: Ahmet Sümen
Location: Ahmet Sümen, MD - Private Medical Practice Istanbul Kartal
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.
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
* 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.
Source: ClinicalTrials.gov (NCT07898514). StuddyBuddy aggregates publicly available trial information.