Osteopathic Manual Therapy vs Ganglion Impar Block for Chronic Coccydynia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIstanbul Medeniyet University
About this trial
Chronic coccydynia is a condition characterized by persistent pain in the coccyx region that can significantly impair sitting tolerance, daily activities, and quality of life. Various conservative and interventional treatment options have been described, including manual therapy techniques and ganglion impar block. However, the comparative effectiveness of these approaches remains unclear.
The aim of this randomized controlled study is to compare the effects of osteopathic manual therapy and ganglion impar block on pain intensity and functional disability in patients with chronic coccydynia. Participants will be randomly assigned to one of the two treatment groups. Pain severity will be assessed using the Numeric Rating Scale (NRS), and functional status will be evaluated with the Oswestry Disability Index (ODI) at baseline, week 3, and month 3.
The results of this study are expected to provide evidence regarding the relative effectiveness of these two commonly used treatment methods and to guide clinicians in selecting appropriate management strategies for patients with chronic coccydynia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18-75 years
Chronic coccygodynia ≥3 months
Baseline NRS ≥4
ODI ≥20
Disqualifiers
Acute coccygodynia
Prior spinal or coccygeal surgery
Malignancy
Pelvic fracture
Trial design
Design model
Parallel
Treatments tested in this trial
Osteopathic Manual Therapy
Procedure/SurgeryOsteopathic manual therapy was applied to the sacrococcygeal region. Techniques included myofascial release, ligamentous tension balancing, and gentle mobilization. Treatment was performed once weekly for three consecutive weeks by a certified practitioner.
Ganglion Impar Block
Procedure/SurgeryA single ganglion impar block was performed under fluoroscopic guidance using local anesthetic combined with corticosteroid. The procedure was carried out under sterile conditions without additional manual therapy.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Osteopathic Manual TherapyExperimental treatment 1 intervention
Group B: Ganglion Impar BlockExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Oswestry Disability Index (ODI) change from baseline
Change in functional disability measured by the Oswestry Disability Index (ODI, 0-100; 0 = no disability, 100 = maximum disability; higher scores indicate worse disability). Mean change from baseline to 3 months will be compared between groups.
Time frame
Baseline and 3 monthsSecondary outcomes
1
Numeric Rating Scale (NRS) pain change at 3 weeks
Change in pain intensity measured by the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain; higher scores indicate worse pain). Mean change from baseline to 3 weeks will be compared between groups.
Time frame
Baseline and 3 weeks2
Numeric Rating Scale (NRS) pain change at 3 months
Change in pain intensity measured by the Numeric Rating Scale (NRS, 0-10; higher scores indicate worse pain). Mean change from baseline to 3 months will be compared between groups.
Time frame
Baseline and 3 months3
Oswestry Disability Index (ODI) change at 3 weeks
Change in functional disability measured by the Oswestry Disability Index (ODI, 0-100; higher scores indicate worse disability). Mean change from baseline to 3 weeks will be compared between groups.
Time frame
Baseline and 3 weeks4
Patient Global Impression of Change (PGIC) score
Patient Global Impression of Change (PGIC; 7-point scale from 1 = very much improved to 7 = very much worse; lower scores indicate better outcome). Mean PGIC score will be compared between groups.
Time frame
3 weeks and 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov