このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

MECHANICAL TRACTION APPLIED BEFORE VERSUS AFTER THERAPEUTIC EXERCISES IN PRIMARY KNEE OSTEOARTHRITIS (MT-KOA)

2026年5月22日 更新者:HEBA AHMAD AWAD ABDELRAZEK、Cairo University

EFFECT OF MECHANICAL TRACTION APPLIED BEFORE VERSUS AFTER THERAPEUTIC EXERCISES ON CLINICAL AND FUNCTIONAL OUTCOMES IN PRIMARY KNEE OSTEOARTHRITIS

To study the effect of application of mechanical traction before versus after therapeutic exercises and exercise alone ,on pain severity , disability , knee joint range of motion , knee joint position sense , knee isometric muscle strength and functional performance in patients with primary knee OA.

調査の概要

詳細な説明

OA is widespread condition and a major contributor to disability in the United States and globally . In Egypt, the one-year prevalence of knee OA ranges from 6.6% to 9.25% . OA is associated with functional impairments and diminished quality of life . OA ensues a substantial social and economic burden, including healthcare expenses, lifestyle modifications, and reduced work productivity . Therapeutic exercise is widely recognized as an effective intervention for knee OA. It may slow cartilage degeneration, attenuate inflammation, and reduce the loss of subchondral bone. Growing evidence demonstrates that exercise improves pain, stiffness, joint function and muscle strength in patients with knee OA . Additionally, strong evidence suggests that exercise effectively improve knee proprioception and decrease knee joint repositioning error . Evidence suggests that addition of therapeutic exercise to other noninvasive methods that routinely are used for knee OA have a boosting effect in relieving pain and improving knee function . Recent studies report that mechanical traction can reduce knee pain and enhance physical function in patients with knee OA . It can also provide joint gapping and temporary joint unloading that suppress articular cartilage degeneration . Applying mechanical traction may also stimulate mechanoreceptors, thereby improving joint position sense and neuromuscular control. Despite its clinical use, there is limited evidence regarding the optimal sequencing of mechanical traction in relation to therapeutic exercises. Findings support that the addition and the application of mechanical traction after conventional physiotherapy contributes to better pain reduction and improvement in physical activity in patients with knee OA . Findings also support that the addition and the application of mechanical traction before therapeutic exercises was reported to reduce pain and disability; improve functional performance, isometric quadriceps & hamstring muscle strength in patients with knee OA . Understanding whether the timing of mechanical traction influences pain severity, disability, range of motion, proprioception, muscle strength, and functional performance is essential for optimizing rehabilitation protocols. Previous studies have primarily investigated outcomes such as pain and disability , isometric muscle strength, functional performance However, up to the author's knowledge no study investigated the effect of mechanical knee joint traction on knee proprioception (joint position sense) in patients with knee osteoarthritis.

Therefore, the aim of this randomized controlled trial to investigate the effect of application of mechanical traction before versus after therapeutic exercises and exercise alone ,on pain severity , disability, knee joint range of motion , knee joint position sense , knee isometric muscle strength and functional performance in patients with primary knee OA.

A total of 63 patients aged 50 to 56 years with knee OA. Patients will be randomly assigned into three groups. Group A, exercise group will receive therapeutic exercises Group B ,Traction & exercise group will receive mechanical knee joint traction followed by the same therapeutic exercises of 1st group .Group C, • Exercise & traction group will receive the same therapeutic exercises of 1st group followed by mechanical knee joint traction. All groups will receive 18 sessions, 3 times per week each other day for 6 weeks. Adherence will be ensured using attendance logs and checklists. Outcome measures will include pain severity measured using Arabic Numeric Pain Rating Scale (NPRS-Ar), disability measured using Arabic Version Of Western Ontario And Mcmaster Universities Osteoarthritis Index (WOMAC-Ar) , flexion/ extension knee joint ROM measured using digital goniometer, knee joint position sense (active knee joint repositioning test) measured using Dual digital inclinometer , quadriceps/ hamstring isometric muscle strength measured using hand Held Dynamometer (HHD) and functional performance measured using 12 Steps Stairs Climb Test (12SS_CT).

All assessments will be conducted at baseline (pre-treatment; 24-48 hrs. before the first treatment session) and after 6 weeks of intervention (post-treatment; 24-48 hrs. before the first treatment session

研究の種類

介入

入学 (推定)

63

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

      • Cairo、エジプト
        • Faculty of physical therapy in Cairo university
        • コンタクト:
        • コンタクト:
        • 主任研究者:
          • Heba Ahmad Awad, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

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

いいえ

説明

Inclusion Criteria:

  • Patients with grade II or III primary knee OA .
  • Patients with bilateral primary knee OA, the more painful knee will be selected as the affected knee .
  • Duration of illness will be more than 3 months
  • Age of patients will range from 50-65
  • Body Mass Index (BMI) between 25 and 35 kg/m²

Exclusion Criteria:

  • Rheumatoid arthritis .
  • Intra-articular knee joint injection in the last three months
  • Previous knee surgeries .
  • Malignancy, infections or knee joint instability .
  • Pregnancy .
  • Patients who have received physical therapy on the knee within the last 3 months.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

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
アクティブコンパレータ:Group A : exercise group
Group A : will receive therapeutic exercises (Stretching and Strengthening Exercises for all major lower-limb muscles), Stretching will be performed(Rectus femoris, hamstring, calf muscle) for 1 set of 3 repetitions, 30 seconds hold, a rest period of 30 seconds between repetitions. Stretching will be carried out slowly and in a controlled manner until the feeling of mild tightness or discomfort. Strengthening exercises for (Knee extensors, knee flexor, hip extensor, hip flexor, hip abductor, hip external rotator, ankle dorsi flexor and plantar flexor) will be performed for 3 sets of 10 repetitions each, 10 seconds hold, a rest period of 2 seconds between repetitions and 30 seconds between sets. The resistance will be applied using sandbags and therabands of different weight and tension. The initial resistance will be determined based on 10RM, and the resistance will progress each week
therapeutic exercises (Stretching and Strengthening Exercises for all major lower-limb muscles), Stretching will be performed(Rectus femoris, hamstring, calf muscle) for 1 set of 3 repetitions, 30 seconds hold, a rest period of 30 seconds between repetitions. Stretching will be carried out slowly and in a controlled manner until the feeling of mild tightness or discomfort. Strengthening exercises for (Knee extensors, knee flexor, hip extensor, hip flexor, hip abductor, hip external rotator, ankle dorsi flexor and plantar flexor) will be performed for 3 sets of 10 repetitions each, 10 seconds hold, a rest period of 2 seconds between repetitions and 30 seconds between sets. The resistance will be applied using sandbags and therabands of different weight and tension. The initial resistance will be determined based on 10RM, and the resistance will progress each week
実験的:Group B: Traction and exercise group
Group B : will receive mechanical knee joint traction followed by the same therapeutic exercises of 1st group Mechanical traction will be applied for 20 minutes continuously in the supine lying position with the affected knee flexed at 25-30° (where joint structures are the most relaxed and the maximum amount of joint play is enabled) by a wedge placed under the thigh, before starting, the angle will be measured using a goniometer. The thigh will be stabilized by a strap and the leg will be held by the specially designed greave with the weight of traction hanging throughout the pulley system. The initial traction force will be set at 10% of the body weight. Traction force will be increased each week by 1% of body weight if the patient could tolerate
Mechanical traction will be applied for 20 minutes continuously in the supine lying position with the affected knee flexed at 25-30° (where joint structures are the most relaxed and the maximum amount of joint play is enabled) by a wedge placed under the thigh, before starting, the angle will be measured using a goniometer. The thigh will be stabilized by a strap and the leg will be held by the specially designed greave with the weight of traction hanging throughout the pulley system. The initial traction force will be set at 10% of the body weight. Traction force will be increased each week by 1% of body weight if the patient could tolerate then the same exercise of the firs group will be applied .
実験的:Group C: Exercise and traction group
Group C: will receive the same therapeutic exercises of 1st group followed by mechanical knee joint traction
This group will receive the same therapeutic exercises of 1st group followed by mechanical knee joint traction

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
pain severity
時間枠:pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention post-treatment; 24-48 hrs.
Arabic Numeric Pain Rating Scale; NPRS-Ar 0-10 scale
pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention post-treatment; 24-48 hrs.
Disability
時間枠:pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention post-treatment; 24-48 hrs
Arabic Version Of Western Ontario And Mcmaster Universities Osteoarthritis Index (WOMAC-Ar)
pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention post-treatment; 24-48 hrs
Knee Joint Range Of Motion
時間枠:at baseline (pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention (post-treatment
Easy Angle Digital Goniometer
at baseline (pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention (post-treatment
Knee Joint Position Sense (JPS
時間枠:at baseline (pre-treatment; 24-48 hrs before the first treatment session) and after 6 weeks of intervention post-treatment; 24-48 hrs.
Digital Inclinometer
at baseline (pre-treatment; 24-48 hrs before the first treatment session) and after 6 weeks of intervention post-treatment; 24-48 hrs.
Isometric Knee Muscle Strength
時間枠:at baseline pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention (post-treatment; 24-48 hrs.
handheld dynamometer
at baseline pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention (post-treatment; 24-48 hrs.
Functional performance
時間枠:at baseline pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention(post-treatment; 24-48 hrs
12-step stair climb test (12 _SSCT)
at baseline pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention(post-treatment; 24-48 hrs

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Heba Ahmad Awad, PhD、Cairo University

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年7月1日

一次修了 (推定)

2027年7月1日

研究の完了 (推定)

2027年8月1日

試験登録日

最初に提出

2026年5月22日

QC基準を満たした最初の提出物

2026年5月22日

最初の投稿 (実際)

2026年5月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月29日

QC基準を満たした最後の更新が送信されました

2026年5月22日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • P.T.REC/012/006479

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?

いいえ

IPD プランの説明

sensitive patient data

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

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

購読する