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IRCT20251001067443N1 IRCT 2025-11-27 Shahed University Can massage therapy help improve the pain and discomfort caused by knee osteoarthritis and increase quality of life? Evaluation of the efficacy of Ghamz therapy for the improvement of clinical symptoms and quality of life in patients with mild to moderate knee osteoarthritis 2025-11-22 anticipated 72 Complete https://irct.ir/trial/86572 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed using a block randomization method with blocks of four and an allocation ratio of 1:1. A statistician will use a computer to generate the random allocation sequence, and no other study personnel will have access to this sequence. Allocation concealment will be ensured using sequentially numbered, opaque, sealed envelopes (SNOSE) to maintain blinding of the allocation sequence, Blinding description: Outcome evaluators have no knowledge of the type of treatment or treatment group administered and only receive the data. N/A Knee osteoarthritis. Intervention 1: Intervention group: Ghamz (a type of deep tissue massage applied to specific points of the body) will be administered for 7 weeks, with one session per week. In parallel, home-based active exercises will be taught and performed for 7 weeks, three times daily (morning, noon, and night). Intervention 2: Control Group:In this group, patients will not receive Ghamz therapy during the study period. After 7 weeks, the control group will also undergo Ghamz therapy—similar to the intervention group—for 7 sessions, once per week. However, in the control group as well, home active exercises will be taught and performed three times daily (morning, noon, and night) from the beginning of the study, and will continue until the end of the treatment period (7 weeks without Ghamz therapy during the study, and 7 weeks with Ghamz therapy after the study). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I am waiting for the approval of the Ethics Committee.
public Alireza Azadkhani
Shahed University, opposite the Holy Shrine of Imam Khomeini (RA), Khalij-e Fars Highway (Beginning of Tehran-Qom Freeway)
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 5080 alireza.azadkhani@gmail.com Shahed University scientific Alireza Azadkhani
Tehran, Khalij-e Fars Highway (Beginning of Tehran-Qom Freeway), opposite the Holy Shrine of Imam Khomeini (RA), Shahed University.
Tehran Iran (Islamic Republic of) 3319118651 +98 21 5121 5080 alireza.azadkhani@gmail.com Shahed University Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) From 36 years old and above Knee pain for more than 3 months, at least 3 on the VAS scale in activities such as going up and down stairs or sitting and squatting Diagnosis of knee osteoarthritis based on clinical criteria + ACR radiography Grade one or two on knee radiographs based on the Kellgren Lawrence system Ability to perform the desired exercises 36 years no limit Both Use of sedatives, narcotics, muscle relaxants, or other undefined analgesics within 2 weeks prior to the start of the study. Intra-articular steroid injection within 3 weeks or systemic steroid administration within 2 weeks prior to the start of the study. Platelet-rich plasma (PRP) injection within the past 6 months. Ozone therapy within the past 3 months. Intra-articular injection of hyaluronic acid gel within the past 6 months. Use of topical herbal treatments, thermal therapy, or acupuncture within 2 weeks prior to the start of the study. Presence of severe neuropathy or significant neuromuscular disease that prevents the patient from tolerating the intervention. Presence of knee pain due to causes other than osteoarthritis. Presence of an open wound on the knee surface. History of severe knee trauma or previous knee or lower limb surgery. History of malignancy. M17.0 Bilateral primary osteoarthritis of knee Treatment - Other Other Intervention group: Ghamz (a type of deep tissue massage applied to specific points of the body) will be administered for 7 weeks, with one session per week. In parallel, home-based active exercises will be taught and performed for 7 weeks, three times daily (morning, noon, and night). Control Group:In this group, patients will not receive Ghamz therapy during the study period. After 7 weeks, the control group will also undergo Ghamz therapy—similar to the intervention group—for 7 sessions, once per week. However, in the control group as well, home active exercises will be taught and performed three times daily (morning, noon, and night) from the beginning of the study, and will continue until the end of the treatment period (7 weeks without Ghamz therapy during the study, and 7 weeks with Ghamz therapy after the study). WOMAC questionnaire score. Timepoint: Before the start of the intervention, after 7 weeks of intervention, and at the end of week 11. Method of measurement: WOMAC questionnaire. Pain. Timepoint: Before the start of the intervention, after 7 weeks of intervention, and at the end of week 11. Method of measurement: Visual Analysis Score(VAS). Knee range of motion (ROM). Timepoint: Before the start of the intervention, after 7 weeks of intervention, and at the end of week 11. Method of measurement: Goniometer. Quality of Life. Timepoint: Before the start of the intervention, after 7 weeks of intervention, and at the end of week 11. Method of measurement: Quality of Life Questionnaire(SF12). Diclofenac consumption. Timepoint: Before the start of the intervention, after 7 weeks of intervention, and at the end of week 11. Method of measurement: Patient self-report. Shahed University Approved 2025-10-13 Research Ethics Committee Faculty of Medicine Shahed University Persian Gulf Highway (beginning of Tehran-Qom Freeway), opposite the Holy Shrine of Imam Khomeini (RA), Shahed University, Faculty of Medicine Teheran Tehran Iran (Islamic Republic of)