Efficacy of Activator Trigger Point and Shock Wave Therapy on Pain and Function in Active Upper Trapezius Trigger Points: A Randomized Controlled Study
This study will be conducted as a randomized controlled trial to evaluate the efficacy of trigger point activator and extracorporeal shock wave therapy in patients with active myofascial trigger points in the upper fibers of the trapezius muscle. Participants who meet the inclusion criteria will be recruited and informed consent will be obtained prior to participation. The subjects will then be randomly allocated into two equal groups. Group A: will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle. Group B: will receive extracorporeal shock wave therapy applied to the same region.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period. Outcome measures will be assessed before the beginning of the treatment program and after completion of the intervention period. Pain intensity and pressure pain threshold will be assessed using an algometer. Functional disability related to the neck will be evaluated using the Neck Disability Index (NDI). All collected data will be recorded and statistically analyzed to determine the effectiveness of both treatment modalities in reducing pain and improving functional outcomes.
調査の概要
詳細な説明
This study will be conducted as a randomized controlled trial to evaluate the efficacy of trigger point activator and extracorporeal shock wave therapy in patients with active myofascial trigger points in the upper fibers of the trapezius muscle. Participants who meet the inclusion criteria will be recruited and informed consent will be obtained prior to participation. The subjects will then be randomly allocated into two equal groups. Group A: will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle. Group B: will receive extracorporeal shock wave therapy applied to the same region.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period. Outcome measures will be assessed before the beginning of the treatment program and after completion of the intervention period. Pain intensity and pressure pain threshold will be assessed using an algometer. Functional disability related to the neck will be evaluated using the Neck Disability Index (NDI). All collected data will be recorded and statistically analyzed to determine the effectiveness of both treatment modalities in reducing pain and improving functional outcomes. 15. Participants of the study:
- The number of participants: 200 (50 per group to ensure 40 completers per arm after attrition).
Important characteristics
- Adult (27:40 years):
- Gender: both gender
Diagnosis: Active upper trapezius trigger points Inclusion criteria
- Male or female participants aged between 25 and 40 years.
- Body Mass Index (BMI) between 20 and 30 kg/m².
- Presence of active myofascial trigger points in the upper fibers of the trapezius muscle confirmed by clinical examination.
- Complaints of neck pain associated with upper trapezius trigger points.
- Ability and willingness to participate in the treatment sessions and follow the study protocol.
Exclusion criteria:
- History of neck trauma, cervical spine fracture, or cervical spine surgery.
- Presence of neurological disorders affecting the cervical region.
- Presence of cervical disc prolapse or severe cervical spine pathology.
- Diagnosis of fibromyalgia or systemic musculoskeletal disorders.
- Presence of skin diseases, wounds, or infections at the treatment area.
- Patients with malignancy or severe systemic diseases.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Mina Wahba, phD
- 電話番号:+062 3707068
- メール:mina.magdy@the.suezuni.edu.eg
研究場所
-
-
-
Suez、エジプト
- Suez Uni
-
コンタクト:
- Doha Hamed, PhD
- メール:dohahamed@buc.edu.eg
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
1. Male or female participants aged between 25 and 40 years. 2. Body Mass Index (BMI) between 20 and 30 kg/m². 3.Presence of active myofascial trigger points in the upper fibers of the trapezius muscle confirmed by clinical examination.
- Complaints of neck pain associated with upper trapezius trigger points. 5. Ability and willingness to participate in the treatment sessions and follow the study protocol.
Exclusion Criteria:
- 1. History of neck trauma, cervical spine fracture, or cervical spine surgery. 2. Presence of neurological disorders affecting the cervical region. 3. Presence of cervical disc prolapse or severe cervical spine pathology. 4. Diagnosis of fibromyalgia or systemic musculoskeletal disorders. 5. Presence of skin diseases, wounds, or infections at the treatment area. 6. Patients with malignancy or severe systemic diseases.
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:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的:treatment
receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle.
|
will receive treatment using the trigger point activator applied to the active trigger points of the upper trapezius muscle.
|
|
アクティブコンパレータ:Shockwave
will receive extracorporeal shock wave therapy applied to the same region.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period.
|
will receive extracorporeal shock wave therapy applied to the same region.
12.
The treatment will be applied according to standardized therapeutic parameters for a predetermined number of sessions over the study period.
|
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 |
|---|---|---|
|
Neck Disability Index (NDI)
時間枠:6 weeks
|
Questionnaire assessing neck function valid and reilable
|
6 weeks
|
|
VAS
時間枠:6 weeks
|
Pain score
|
6 weeks
|
協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
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
追加の関連 MeSH 用語
その他の研究ID番号
- SuezU1
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?
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米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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