Myofascial Versus Conventional Physiotherapy (MYONAMASTE)
Myofascial Versus Conventional Physiotherapy in Post-mastectomy Patients: a Randomized Controlled Trial
A total of 61 patients who underwent total mastectomy for breast cancer with axillar lymph dissection and adjuvant radiotherapy were enrolled in this trial.
The patients were randomized by toss of a coin to the treatment (n=30) or control (n=26) groups; of these, 48 met all study protocol requirements, including the final assessment. Inclusion criteria were: presence of functional difficulties in the shoulder area and/or upper torso on the surgical side, and 2) eligibility for physiotherapy (determined by the treating physician). Patients with recurrent disease and/or inflammatory or acute ailments were excluded. All patients gave their informed consent to participate in the study.
The treatment group received myofascial treatment while patients in the control group received conventional therapy consisting of exercise and massage.
調査の概要
状態
詳細な説明
Treatment duration in both groups was a mean of 4 weeks. Therapy was performed daily excluding weekends and consisted of 45 minutes of individual work with an oncological physiotherapist. In the treatment group, manual myofascial techniques were used to decrease muscle tension and increase elasticity of the soft tissues in the surgical area as well as in tissues that could affect range of motion (ROM) and cause pain. Fascial techniques were used together with the following techniques: deep massage of neck and shoulder girdle muscles; trigger point therapy; tissue scar treatment in the vicinity of the scar and directly on the scar, by stretching, breaking, pulling, as well as static and dynamic rolling; post-isometric relaxation (stretching) of shoulder and neck muscles; active release technique of the chest and shoulder; selected fascial distortion model techniques; and fascial manipulation techniques consisting of developing specific CC-center of coordination and CF-center of fusion points in the operated area and the shoulder on the same side. The exact sequence and number of procedures differed in each patient according to need as determined by prior functional examination. The control group underwent kinesiotherapeutic procedures that included various floor gymnastic exercises with gymnastic stick, balls, and/or elastic tapes, conventional massage of neck and shoulder girdle muscles and therapeutic exercises to increase ROM in the upper limb and in the chest area. Both groups before or after every of the treatment procedure underwent ten-minute manual lymphatic drainage in the limb on the mastectomy side.
Patient interviews and diagnostic examinations were performed at baseline (pre-treatment) and after treatment finalization. The following variables were assessed during the diagnostic examination of the muscle length with Janda's protocol:
Pectoralis Major - pars clavicularis - the normal length of these fibers allows the patient's arm (in an extended position close to the body) to rest below the horizontal.
Pectoralis Major - pars sternocostalis - the normal length of these fibers allows the abducted the patient's arm to 90° to rest below the horizontal.
Pectoralis Major - pars abdomen - the normal length of these pectoral fibers allows the abducted the patient's arm to 150° with slight external rotation to rest in a horizontal position.
Latissimus dorsi - the normal length allows the arm to rest horizontally to the table with the lumbar spine flat on the table.
Descending part of trapezius - the length is assessed qualitatively by noting the end-feel resistance. The normal end feel is gradual rather than abrupt.
Levator scapulae - the length is assessed qualitatively by noting the end-feel resistance. The normal end feel is gradual rather than abrupt.
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
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Wielkopolska
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Poznań、Wielkopolska、ポーランド、61-866
- Greater Poland Cancer Centre
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- presence of functional difficulties in the shoulder area and/or upper torso on the surgical side
- eligibility for physiotherapy (determined by the treating physician)
- signed informed consent to participate in the study.
Exclusion Criteria:
- patients with recurrent disease and/or inflammatory or acute ailments were excluded.
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:支持療法
- 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 |
|---|---|
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実験的:TREATMENT GROUP
Fascial techniques were used together with the following techniques: deep massage of neck and shoulder girdle muscles; trigger point therapy; tissue scar treatment in the vicinity of the scar and directly on the scar, by stretching, breaking, pulling, as well as static and dynamic rolling; post-isometric relaxation (stretching) of shoulder and neck muscles; active release technique of the chest and shoulder; selected fascial distortion model techniques; and fascial manipulation techniques consisting of developing specific CC-center of coordination and CF-center of fusion points in the operated area and the shoulder on the same side.
The exact sequence and number of procedures differed in each patient according to need as determined by prior functional examination.
Before or after every of the treatment procedure treatment group patients underwent ten-minute manual lymphatic drainage in the limb on the mastectomy side.
|
Fascial techniques were used together with the following techniques: deep massage of neck and shoulder girdle muscles; trigger point therapy; tissue scar treatment in the vicinity of the scar and directly on the scar, by stretching, breaking, pulling, as well as static and dynamic rolling; post-isometric relaxation (stretching) of shoulder and neck muscles; active release technique of the chest and shoulder; selected fascial distortion model techniques; and fascial manipulation techniques consisting of developing specific CC-center of coordination and CF-center of fusion points in the operated area and the shoulder on the same side.
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他の:CONTROL GROUP
Treatment duration was a mean of 4 weeks.
Therapy was performed daily excluding weekends and consisted of 45 minutes of individual work with an oncological physiotherapist.
The control group underwent kinesiotherapeutic procedures that included various floor gymnastic exercises with gymnastic stick, balls, and/or elastic tapes, conventional massage of neck and shoulder girdle muscles and therapeutic exercises to increase ROM in the upper limb and in the chest area.
Before or after every of the treatment procedure control group patients underwent ten-minute manual lymphatic drainage in the limb on the mastectomy side.
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Underwent kinesiotherapeutic procedures that included various floor gymnastic exercises with gymnastic stick, balls, and/or elastic tapes, conventional massage of neck and shoulder girdle muscles and therapeutic exercises to increase ROM in the upper limb and in the chest area.
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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 |
|---|---|---|
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muscle length
時間枠:2 years
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muscle length with Janda's protocol Pectoralis Major - pars clavicularis - the normal length of these fibers allows the patient's arm (in an extended position close to the body) to rest below the horizontal. Pectoralis Major - pars sternocostalis - the normal length of these fibers allows the abducted the patient's arm to 90° to rest below the horizontal. Pectoralis Major - pars abdomen - the normal length of these pectoral fibers allows the abducted the patient's arm to 150° with slight external rotation to rest in a horizontal position. Latissimus dorsi - the normal length allows the arm to rest horizontally to the table with the lumbar spine flat on the table. Descending part of trapezius - the length is assessed qualitatively by noting the end-feel resistance. The normal end feel is gradual rather than abrupt. Levator scapulae - the length is assessed qualitatively by noting the end-feel resistance. The normal end feel is gradual rather than abrupt [Page et al. 2010]. |
2 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Active ROM in the shoulder joint on the surgical side
時間枠:2 years
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complete pathological response (pCR, pathologic Complete Response)
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2 years
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pathological response
時間枠:2 years
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ROM of the shoulder joint on the surgical side (flexion; extension; abduction; internal rotation; external rotation in horizontal flexion
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2 years
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Pain intensity
時間枠:2 years
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VAS - A tool used to help a person rate the intensity of certain sensations and feelings, such as pain.
The visual analog scale for pain is a straight line with one end meaning no pain (0) and the other end meaning the worst pain imaginable (10) .
A patient marks a point ( 0 to 10) on the line that matches the amount of pain she feels."
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2 years
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Scar mobility
時間枠:2 years
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Made by the centimeter measure as difference of distance from the bone point, to the most limited place in the scar.
It was measured in directions: cranial (distance from the ridge of the coracoid) and in the transverse direction (the distance from the xiphoidal process).
The centimeter measure was the distance from the bone point (xiphoid process and coracoid), to the most limited place in the scar (which was marked on the patient's examination card so that the measurement could be repeated to the same place
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2 years
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Presence of the visual dysfunction of scar (retraction) and presence of the axillary web syndrome
時間枠:2 years
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Was observed presence of the visual dysfunction of scar (retraction) and presence of the axillary web syndrome
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2 years
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協力者と研究者
捜査官
- 主任研究者:Sławomir Marszałek, PhD、Greater Poland Cancer Centre
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
- MYONAMASTE
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?
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
米国で製造され、米国から輸出された製品。
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治療の臨床試験
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Swansea University完了A Bite of ACT' (BOA) Acceptance and Commitment Therapy オンライン心理教育コース | 待機リスト コントロールイギリス
manual myofascial techniquesの臨床試験
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Royal Brompton & Harefield NHS Foundation TrustNational Institute for Health Research, United Kingdom完了