- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07613749
MECHANICAL TRACTION APPLIED BEFORE VERSUS AFTER THERAPEUTIC EXERCISES IN PRIMARY KNEE OSTEOARTHRITIS (MT-KOA)
EFFECT OF MECHANICAL TRACTION APPLIED BEFORE VERSUS AFTER THERAPEUTIC EXERCISES ON CLINICAL AND FUNCTIONAL OUTCOMES IN PRIMARY KNEE OSTEOARTHRITIS
Přehled studie
Postavení
Podmínky
Detailní popis
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
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Heba Ahmad Awad, PhD
- Telefonní číslo: + 201011526524
- E-mail: 10722018467641@pg.cu.edu.eg
Studijní záloha kontaktů
- Jméno: Heba Ahmad Awad, PhD
- Telefonní číslo: +201011526524
- E-mail: 10722018467641@pg.cu.edu.eg
Studijní místa
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Cairo, Egypt
- Faculty of physical therapy in Cairo university
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Kontakt:
- Heba Ahmad Awad, PhD
- Telefonní číslo: +201011526524
- E-mail: 10722018467641@pg.cu.edu.eg
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Kontakt:
- MOAAZ RAGAB RIYAD, Lecturer
- Telefonní číslo: +201007210132
- E-mail: moaaz.elsakka@cu.edu.eg
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Vrchní vyšetřovatel:
- Heba Ahmad Awad, PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: 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
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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
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Experimentální: 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
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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 .
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Experimentální: Group C: Exercise and traction group
Group C: will receive the same therapeutic exercises of 1st group followed by mechanical knee joint traction
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This group will receive the same therapeutic exercises of 1st group followed by mechanical knee joint traction
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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pain severity
Časové okno: pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention post-treatment; 24-48 hrs.
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Arabic Numeric Pain Rating Scale; NPRS-Ar 0-10 scale
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pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention post-treatment; 24-48 hrs.
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Disability
Časové okno: pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention post-treatment; 24-48 hrs
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Arabic Version Of Western Ontario And Mcmaster Universities Osteoarthritis Index (WOMAC-Ar)
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pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention post-treatment; 24-48 hrs
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Knee Joint Range Of Motion
Časové okno: at baseline (pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention (post-treatment
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Easy Angle Digital Goniometer
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at baseline (pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention (post-treatment
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Knee Joint Position Sense (JPS
Časové okno: at baseline (pre-treatment; 24-48 hrs before the first treatment session) and after 6 weeks of intervention post-treatment; 24-48 hrs.
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Digital Inclinometer
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at baseline (pre-treatment; 24-48 hrs before the first treatment session) and after 6 weeks of intervention post-treatment; 24-48 hrs.
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Isometric Knee Muscle Strength
Časové okno: at baseline pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention (post-treatment; 24-48 hrs.
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handheld dynamometer
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at baseline pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention (post-treatment; 24-48 hrs.
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Functional performance
Časové okno: at baseline pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention(post-treatment; 24-48 hrs
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12-step stair climb test (12 _SSCT)
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at baseline pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention(post-treatment; 24-48 hrs
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Heba Ahmad Awad, PhD, Cairo University
Publikace a užitečné odkazy
Obecné publikace
- 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 management of knee osteoarthritis. Part two: strengthening exercise programs. Clin Rehabil. 2017 May;31(5):596-611. doi: 10.1177/0269215517691084. Epub 2017 Feb 1.
- Hunter DJ, Schofield D, Callander E. The individual and socioeconomic impact of osteoarthritis. Nat Rev Rheumatol. 2014 Jul;10(7):437-41. doi: 10.1038/nrrheum.2014.44. Epub 2014 Mar 25.
- 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.
- Giorgino R, Albano D, Fusco S, Peretti GM, Mangiavini L, Messina C. Knee Osteoarthritis: Epidemiology, Pathogenesis, and Mesenchymal Stem Cells: What Else Is New? An Update. Int J Mol Sci. 2023 Mar 29;24(7):6405. doi: 10.3390/ijms24076405.
- Zeng CY, Zhang ZR, Tang ZM, Hua FZ. Benefits and Mechanisms of Exercise Training for Knee Osteoarthritis. Front Physiol. 2021 Dec 16;12:794062. doi: 10.3389/fphys.2021.794062. eCollection 2021.
- 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.
- 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.
- 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.
- 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.
- 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.
- Goh SL, Persson MSM, Stocks J, Hou Y, Lin J, Hall MC, Doherty M, Zhang W. Efficacy and potential determinants of exercise therapy in knee and hip osteoarthritis: A systematic review and meta-analysis. Ann Phys Rehabil Med. 2019 Sep;62(5):356-365. doi: 10.1016/j.rehab.2019.04.006. Epub 2019 May 21.
- Mao Y, Qiu B, Wang W, Zhou P, Ou Z. Efficacy of home-based exercise in the treatment of pain and disability at the hip and knee in patients with osteoarthritis: a systematic review and meta-analysis. BMC Musculoskelet Disord. 2024 Jun 26;25(1):499. doi: 10.1186/s12891-024-07585-w.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
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