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IRCT20210214050356N2 IRCT 2021-10-17 Tehran University of Medical Sciences Comparison of the Manual Therapy and Muscle Contraction in the treatment of Patients with Knee Arthrosis Comparison of the Non-thrust Manipulation VS. Muscle Energy Techniques in the Management of Patients with Knee Osteoarthritis: A Randomized Clinical Trial. 2021-10-23 anticipated 42 Complete https://irct.ir/trial/59025 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: After the baseline assessment, the participants will be randomized into one of the two intervention groups using simple randomization procedure. Forty two cards will be collected inside a ball with no clinical involvement in the study to ensure allocation concealment. A computer generated list of random number will be used. Receptionists dispense either non-thrust manipulation or MET according to a computer generated randomization list includes the sequential numbers using an online randomization website (https://www.graphpad.com/quickcalcs/randomize1.cfm). Each number and it's allocate group will be written on a piece of paper and will be concealed in an opaque envelope. The receptionist will inform the treating therapist about patients’ allocation according to the selected index card, Blinding description: As mentioned above, the study will be double-blinded. In this way, the participants do not know in which group they are. Another physiotherapist will do the baseline and post-treatment evaluations without knowing which patients belonged to which groups (assessor-blinded).The data analyzer is also unaware of which study group the data belongs to. N/A Knee Osteoarthritis. Intervention 1: Intervention group: Group A: will receive non-thrust manipulation supplemented with supervised exercises and TENS program at the clinic (three times a week), consisting of 10 sessions of approximately 50 min. Non thrust manipulation included Tibiofemoral Distraction, Anterior glide, Posterior glide of the tibia on the femur with grades II and III will be applied with the knee in slight flexion supported with using a pillow and Patellofemoral Joint glide in all directions based on the observation that in patients with patellofemoral joint osteoarthritis. This will be given for three repetitions of 1 minute each with a 30 second break between each repetition. Each direction will be repeated two times. Intervention 2: Intervention group: Group B: Contract–relax agonist contract (CRAC) which is one of muscle energy techniques will be used in this study supplemented with supervised exercises and electrical stimulation at the clinic (three times a week), consisting of 10 sessions of approximately 50 min. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: Access period starts 3 months after the articles are published. To whom: For researchers working in academic, scientific and hospital institutions and clinicians. Conditions: Researchers working in the field of musculoskeletal disorders rehabilitation and manual therapies. Where to obtain: Applicants for documentation can contact Dr. Sara Fereydoonnia via email. S-fereydounnia@sina.tums.ac.ir How to obtain: Once they have the necessary criteria, the information will be provided to them within a month. Comments:
public Sara Fereydounnia
School of Rehabilitation, Piche- Shemiran, Enghelab Street
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7752 8468 S-fereydounnia@sina.tums.ac.ir Tehran University of Medical Sciences scientific Azadeh Shadmehr
School of Rehabilitation, Piche- Shemiran, Enghelab Street
Tehran Iran (Islamic Republic of) 1148965111 +98 21 7752 8468 Shadmehr@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with knee OA (diagnosed already) Age 35 -65 years Grade 2 Kellgren-Lawrence radiographic confirmed OA Unilateral or bilateral knee OA. Chronic stages of knee pain. Patients who scored 30mm out of 100mm knee pain or greater on the VAS with activity intervention at baseline. Those who consented were able to ambulate at least 30 meters on an even surface with or without a walking device and were able to perform physical exercises with minimal support. WOMAC score above 10. Knee extension lack 10 degrees or more. 35 years 65 years Both Acute pain and inflammation. Recent fractures. Patients having other major musculoskeletal problems and having with red flag signs and patients with recent history of knee trauma.• Prolonged immobilization. Uncontrolled hypertension. Severe cardiopulmonary disease. Mentally challenged. Severe osteoporosis. Rheumatoid arthritis. Neurological disorders affecting lower limb. Individuals with impaired function such as stroke, neoplastic disorder and hip or knee arthroplasty. Gout or Psedo-gout. Hyper/ hypo-thyroidism. M17.1 Unilateral primary osteoarthritis of knee Rehabilitation Rehabilitation Intervention group: Group A: will receive non-thrust manipulation supplemented with supervised exercises and TENS program at the clinic (three times a week), consisting of 10 sessions of approximately 50 min. Non thrust manipulation included Tibiofemoral Distraction, Anterior glide, Posterior glide of the tibia on the femur with grades II and III will be applied with the knee in slight flexion supported with using a pillow and Patellofemoral Joint glide in all directions based on the observation that in patients with patellofemoral joint osteoarthritis. This will be given for three repetitions of 1 minute each with a 30 second break between each repetition. Each direction will be repeated two times. Intervention group: Group B: Contract–relax agonist contract (CRAC) which is one of muscle energy techniques will be used in this study supplemented with supervised exercises and electrical stimulation at the clinic (three times a week), consisting of 10 sessions of approximately 50 min. Pain Intensity (at rest). Timepoint: Before intervention- After the 10th intervention session (last session). Method of measurement: Visual Analogue Scale. Pain Intensity (during activities). Timepoint: Before intervention- After the 10th intervention session (last session). Method of measurement: Visual Analogue Scale. Knee Extension Lack. Timepoint: Before intervention- After the 10th intervention session (last session). Method of measurement: Passive Knee Extension Test by using Goniometer. Functional impairment. Timepoint: Before intervention- After the 10th intervention session (last session). Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Distance Covered. Timepoint: Before intervention- After the 10th intervention session (last session). Method of measurement: Six Minutes Walking Test (6MWT). Chair Stand Repetition. Timepoint: Before intervention- After the 10th intervention session (last session). Method of measurement: 30 Seconds Chair Stand Test (30CST). Knee Mal-alignment. Timepoint: Before intervention- After the 10th intervention session (last session). Method of measurement: Tibio-Femoral Angle (TFA) by using Goniometer. Tehran University of Medical Sciences Approved 2021-09-26 Ethics Committee of Tehran University of Medical Sciences Vice Chancellor for Research, 6th Floor, Central University Organization, Corner of Ghods St, Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)