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Набор скоро начнётся NCT07613749

MECHANICAL TRACTION APPLIED BEFORE VERSUS AFTER THERAPEUTIC EXERCISES IN PRIMARY KNEE OSTEOARTHRITIS

Без фазы С лечением Knee Osteoarthritis Mechanical Traction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Group A: Therapeutic exercise group, Group B: mechanical traction followed by therapeutic exercise, Group C: therapeutic exercise followed by mechanical traction.
Кому может быть актуально
Состояния в реестре: Knee Osteoarthritis, Mechanical Traction. Базовые параметры: 50 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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.

Подробное описание

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

Вмешательства

  • Поведенческое Group A: Therapeutic exercise group
    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, ankl
  • Поведенческое Group B: mechanical traction followed by therapeutic exercise
    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 initia
  • Поведенческое Group C: therapeutic exercise followed by mechanical traction
    This group will receive the same therapeutic exercises of 1st group followed by mechanical knee joint traction

Первичные конечные точки

  • pain severity [Срок оценки: pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention post-treatment; 24-48 hrs.]
  • Disability [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: at baseline pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention(post-treatment; 24-48 hrs]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Faculty of physical therapy in Cairo university — Cairo

Публикации

  • Takahashi T, Baboolal TG, Lamb J, Hamilton TW, Pandit HG. Is Knee Joint Distraction a Viable Treatment Option for Knee OA?-A Literature Review and Meta-Analysis. J Knee Surg. 2019 Aug;32(8):788-795. doi: 10.1055/s-0038-1669447. Epub 2018 Aug 29. PMID 30157528
  • Riyad, M. R., Elnaggar, I. M., & Hassan, K. A. (2024). Effect of Mechanical Traction and Therapeutic Exercises in Treatment of Primary Knee Osteoarthritis. Muscles, Ligaments & Tendons Journal (MLTJ), 14(2).
  • Florjancic K, Vauhnik R. Effects of Standard Physiotherapy with the Addition of Mechanical Traction on Pain, Physical Activity and Quality of Life in Patients with Knee Osteoarthritis. Medicina (Kaunas). 2025 Mar 15;61(3):507. doi: 10.3390/medicina61030507. PMID 40142318
  • Norouzi P, Ravanbod R, Torkaman G. Investigating the effects of mechanical traction and high intensity laser therapy on pain, muscle activity, and functional balance in knee osteoarthritis. Physiother Theory Pract. 2026 Feb;42(2):263-275. doi: 10.1080/09593985.2025.2566935. Epub 2025 Oct 2. PMID 41037487
  • Nejati P, Farzinmehr A, Moradi-Lakeh M. The effect of exercise therapy on knee osteoarthritis: a randomized clinical trial. Med J Islam Repub Iran. 2015 Feb 25;29:186. eCollection 2015. PMID 26034739
  • Sheikhhoseini R, Dadfar M, Shahrbanian S, Piri H, Salsali M. The effects of exercise training on knee repositioning sense in people with knee osteoarthritis: a systematic review and meta-analysis of clinical trials. BMC Musculoskelet Disord. 2023 Jul 19;24(1):592. doi: 10.1186/s12891-023-06712-3. PMID 37468853
  • Runhaar J, Luijsterburg P, Dekker J, Bierma-Zeinstra SM. Identifying potential working mechanisms behind the positive effects of exercise therapy on pain and function in osteoarthritis; a systematic review. Osteoarthritis Cartilage. 2015 Jul;23(7):1071-82. doi: 10.1016/j.joca.2014.12.027. Epub 2015 Apr 9. PMID 25865391
  • Brosseau L, Taki J, Desjardins B, Thevenot O, Fransen M, Wells GA, Mizusaki Imoto A, Toupin-April K, Westby M, Alvarez Gallardo IC, Gifford W, Laferriere L, Rahman P, Loew L, De Angelis G, Cavallo S, Shallwani SM, Aburub A, Bennell KL, Van der Esch M, Simic M, McConnell S, Harmer A, Kenny GP, Paterson G, Regnaux JP, Lefevre-Colau MM, McLean L. The Ottawa panel clinical practice guidelines for the PMID 28183213

Идентификаторы

NCT: NCT07613749 · P.T.REC/012/006479

Первоисточники (государственные реестры)

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