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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Istanbul
-
Istanbul、Istanbul、トルコ（Türkiye）
- Istanbul Atlas University
-
-
Kadiköy
-
Istanbul、Kadiköy、トルコ（Türkiye）
- Istanbul Atlas University
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
A 6-week osteopathic manual therapy program including coccygeal mobilization, levator ani muscle techniques, myofascial release, and neural stretching exercises.
|
|
アクティブコンパレータ：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Oswestry Disability Index (ODI) Score
時間枠：Baseline and 3 months
|
Assessment of functional disability related to chronic coccygodynia using the Oswestry Disability Index.
|
Baseline and 3 months
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Numeric Rating Scale (NRS) Pain Score
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：mert sancar, MD、Istanbul Atlas University Faculty of Medicine
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- COCCY-OMT-GIB-2025
- 2025/03-03 (その他の識別子：Istanbul Atlas University Clinical Research Ethics Committee)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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