Osteopathic Manual Therapy Versus Ganglion Impar Block for Chronic Coccygodynia (COCCY-OMT)
Comparison of Osteopathic Manual Therapy and Ganglion Impar Block in Patients With Chronic Coccygodynia: A Prospective Randomized Controlled Trial
The goal of this clinical trial is to compare two treatment methods for chronic coccygodynia (tailbone pain) in adults. The study aims to determine which treatment provides better pain relief and functional improvement.
The main questions it aims to answer are:
Does osteopathic manual therapy reduce pain and disability in people with chronic coccygodynia?
Does ganglion impar block reduce pain and disability in people with chronic coccygodynia?
Which treatment provides more sustained improvement during follow-up?
Researchers will compare osteopathic manual therapy with ganglion impar block to evaluate their effects on pain, function, quality of life, and patient satisfaction.
Participants will:
Be randomly assigned to one of the two treatment groups.
Receive either osteopathic manual therapy or ganglion impar block.
Complete pain, disability, neuropathic pain, and quality-of-life assessments before treatment and during follow-up visits.
Attend follow-up evaluations at 3 weeks and 3 months after treatment.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Chronic coccygodynia is persistent pain in the tailbone region that can significantly affect daily activities and quality of life. Common treatments include physical therapy, manual therapy techniques, injections, and surgical procedures. However, evidence directly comparing osteopathic manual therapy and ganglion impar block remains limited.
This prospective randomized controlled trial will compare the effectiveness of osteopathic manual therapy and ganglion impar block in adults with chronic coccygodynia lasting at least three months and not responding adequately to conservative treatment.
Eligible participants will be randomly assigned to one of two groups. The osteopathic manual therapy group will receive a structured treatment program including manual mobilization and soft tissue techniques. The ganglion impar block group will receive a fluoroscopy-guided ganglion impar injection.
Outcomes will be assessed using pain intensity, disability, neuropathic pain, quality of life, and patient satisfaction measures. Evaluations will be performed at baseline, 3 weeks, and 3 months after treatment.
The primary objective is to compare changes in pain and disability between the two treatment groups. Secondary objectives include comparison of neuropathic pain symptoms, quality of life, and patient satisfaction.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Istanbul
-
Istanbul, Istanbul, Tyrkia (Türkiye)
- Istanbul Atlas University
-
-
Kadiköy
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Istanbul, Kadiköy, Tyrkia (Türkiye)
- Istanbul Atlas University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
Age 18-75 years Chronic coccygodynia persisting for at least 3 months Unresponsive to previous conservative treatment Baseline NRS score ≥4 Baseline ODI score ≥20 Written informed consent
Exclusion Criteria:
Acute coccygodynia Previous coccygeal or spinal surgery Malignancy Pelvic fracture Pregnancy Coagulation disorders Severe psychiatric disease Previous osteopathic manual therapy or ganglion impar block Structural pathology identified on MRI or dynamic radiography
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Osteopathic Manual Therapy
Participants received a 6-week osteopathic manual therapy program including coccygeal mobilization, levator ani muscle techniques, myofascial release, and neural stretching exercises.
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A 6-week osteopathic manual therapy program including coccygeal mobilization, levator ani muscle techniques, myofascial release, and neural stretching exercises.
|
|
Aktiv komparator: Ganglion Impar Block
Participants received a fluoroscopy-guided ganglion impar block with local anesthetic and corticosteroid injection.
|
A fluoroscopy-guided ganglion impar block performed with local anesthetic and corticosteroid injection for pain management in chronic coccygodynia.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Oswestry Disability Index (ODI) Score
Tidsramme: Baseline and 3 months
|
Assessment of functional disability related to chronic coccygodynia using the Oswestry Disability Index.
|
Baseline and 3 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Numeric Rating Scale (NRS) Pain Score
Tidsramme: Baseline, 3 weeks, and 3 months
|
Assessment of pain intensity using the Numeric Rating Scale (NRS).
Participants rate their pain on a scale from 0 (no pain) to 10 (worst possible pain).
|
Baseline, 3 weeks, and 3 months
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: mert sancar, MD, Istanbul Atlas University Faculty of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- COCCY-OMT-GIB-2025
- 2025/03-03 (Annen identifikator: Istanbul Atlas University Clinical Research Ethics Committee)
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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