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

22 maggio 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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

Tipo di studio

Interventistico

Iscrizione (Stimato)

63

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

      • Cairo, Egitto
        • Faculty of physical therapy in Cairo university
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Heba Ahmad Awad, PhD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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
Sperimentale: 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 .
Sperimentale: 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

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
pain severity
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Heba Ahmad Awad, PhD, Cairo University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

1 luglio 2027

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

22 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

22 maggio 2026

Primo Inserito (Effettivo)

29 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • P.T.REC/012/006479

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

sensitive patient data

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Prove cliniche su Group A: Therapeutic exercise group

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