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NCT Number: NCT07613749

MECHANICAL TRACTION APPLIED BEFORE VERSUS AFTER THERAPEUTIC EXERCISES 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.

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Key information

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group A: Therapeutic exercise group

Behavioral

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

Group B: mechanical traction followed by therapeutic exercise

Behavioral

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 .

Group C: therapeutic exercise followed by mechanical traction

Behavioral

This group will receive the same therapeutic exercises of 1st group followed by mechanical knee joint traction

Primary outcomes

  1. pain severity

    Time frame: 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

  2. Disability

    Time frame: 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)

  3. Knee Joint Range Of Motion

    Time frame: at baseline (pre-treatment; 24-48 hrs before the first treatment session and after 6 weeks of intervention (post-treatment

    Easy Angle Digital Goniometer

  4. Knee Joint Position Sense (JPS

    Time frame: 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

  5. Isometric Knee Muscle Strength

    Time frame: 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

  6. Functional performance

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Heba Ahmad Awad, PhD

CONTACT

[email protected]

+ 201011526524

Heba Ahmad Awad, PhD

CONTACT

[email protected]

+201011526524

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: MT-KOA

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 29, 2026
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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