]>
IRCT20240907062968N3 IRCT 2025-04-07 Islamic Azad University Investigating the Effect of Swedish Massage and Hydrotherapy on Symptoms and Motor Ability in Individuals with Knee Osteoarthritis Comparing the effect of Swedish massage with and without hydrotherapy on pain intensity, knee range of motion, muscle strength, quality of life, and physical ability in people with knee osteoarthritis. 2025-04-19 anticipated 90 Complete https://irct.ir/trial/82659 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The randomization method will be web-based. Subjects who meet the inclusion criteria for the study will be randomly assigned to the first experimental group, the second experimental group, and the control group using the website randomization method (Social Psychology Network, Connecticut, USA) www.randomizer.org. The randomization will be simple. Concealment of random allocation will be done using a computer-generated blocked random number table where number 1 will be defined for the Swedish massage exercise group, number 2 for the Swedish massage exercise group with hydrotherapy, and number 3 for the control group. Subsequently, the website output will randomly divide individuals into 3 equal groups. Also, according to the assignment of groups, the intervention will be continued by the researcher, Blinding description: Participants, while reviewing the consent form in a 30-minute session, are informed about the study groups and voluntarily participate in this study without having the option to choose a group. The names of the patients are randomly divided into three equal groups using the website http://randomizer.org by a person unaware of the individuals' identity and physical characteristics, and each group is placed in sealed envelopes separately. Then, appropriate training and exercises are provided to each individual based on their assigned group. The analyst and outcome assessor also evaluate the changes that occur before and after eight weeks without knowledge of the hypotheses, study methods, or patient characteristics. N/A Knee Osteoarthritis. Intervention 1: Intervention group: The first intervention group receives Swedish massage for 8 weeks, 3 sessions per week, for 45 minutes. Intervention 2: Intervention group: The second intervention group, which receives Swedish massage plus hydrotherapy, for 8 weeks and 3 sessions per week. Intervention 3: Control group: They will not receive any intervention and will only participate in the pre-test and post-test assessments. Yes - There is a plan to make this available What will be shared: The data related to the subjects of the control and intervention groups in the pre-test and post-test are shared in an unidentifiable way When: Six months after the publication of articles To whom: The data will be available for physiotherapists working in academic institutions, as well as clinicians working in the field of musculoskeletal disorders, and all researchers. Use of the data is permitted with source citation. Conditions: The raw data and results of this study may be used in systematic review studies. Therefore, the raw data and results of this study will be accessible to researchers who are active in the field related to this study. Where to obtain: Vahid.mazloum@yahoo.com How to obtain: Applicants must accurately explain their project and how the data/documents of this study will be used in their project. Subsequently, the data/document files will be sent to the applicants via email upon request. This process may take 10-12 business days. Comments:
public Vahid Mazloum
Islamic Azad university of Karaj, Moazzen Blvd,
Karaj Iran (Islamic Republic of) 3149968111 +98 26 3425 9571 Vahid.mazloom@kiau.ir Islamic Azad University scientific Vahid Mazloum
Islamic Azad university of Karaj, Moazzen Blvd
Karaj Iran (Islamic Republic of) 3149968111 +98 26 3425 9571 Vahid.mazloom@kiau.ir Islamic Azad University Iran (Islamic Republic of) Suffering from knee osteoarthritis with grade three from the Kellgren & Lawrence grading system (in all three groups). Having knee pain at least a three out of ten on a visual analog pain scale. General eligibility for participation in the research has been confirmed by a doctor. 45 years 60 years Female Having any contraindications for hydrotherapy, such as kidney disorders. Use of non-steroidal anti-inflammatory drugs Onset or worsening of pain and disability during assessment and implementation of an exercise program. N/A N/A N/A Intervention group: The first intervention group receives Swedish massage for 8 weeks, 3 sessions per week, for 45 minutes. Intervention group: The second intervention group, which receives Swedish massage plus hydrotherapy, for 8 weeks and 3 sessions per week. Control group: They will not receive any intervention and will only participate in the pre-test and post-test assessments Active range of motion of the knee. Timepoint: Before and after intervention. Method of measurement: A goniometer was used to measure the active range of motion of the knee joint in flexion and extension movements. The fixed arm of the goniometer was placed along the outer surface of the thigh, and the moving arm was placed along the fibula towards the lateral malleolus. For extension assessment, the participant lay prone on the bed with the knee in a straight position. For flexion, the participant was asked to flex the knee as much as possible, and the resulting angle was recorded. Quadriceps muscle strength assessment. Timepoint: Before and after intervention. Method of measurement: Isometric strength of the quadriceps muscles was measured at a 90-degree knee flexion angle using a dynamometer. The participant sat on a chair, and one end of the dynamometer was connected to their ankle 5 cm above the malleolus, while the other end was fixed to the wall. The participant then performed knee extension through isometric contraction. The average of three repetitions was recorded as the final muscle strength score. Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire for assessing quality of life. Timepoint: Before and after intervention. Method of measurement: The standardized KOOS questionnaire was used to evaluate therapeutic outcomes in patients with knee osteoarthritis. This tool includes 42 patient-centered questions in five domains: other symptoms (7 questions), pain (9 questions), activities of daily living (17 questions), sports and recreational activities (5 questions), and knee-related quality of life (4 questions). Responses were scored on a five-point Likert scale (from 0 to 4), and the scores for each subscale were calculated as a percentage between 0 and 100; such that a higher score indicates a better condition and fewer problems for the patient. The Persian version of this questionnaire has validated validity and reliability in domestic studies and has been localized for the Iranian population. 6-Minute Walk Test. Timepoint: Before and after intervention. Method of measurement: The 6-minute walk test (6MWT) was performed to assess the participant's physical and functional capacity. In this test, the individual walked on a flat surface for 6 minutes at their maximum tolerable speed, and was allowed to rest if needed. At the end, the distance covered in 6 minutes was recorded as an indicator of physical performance. Islamic Azad University Approved 2023-11-07 Ethics Committee of Islamic Azad University Karaj branch Karaj Branch, Islamic Azad University, Mo'azen Boulevard, Rajai Shahr, Karaj City Alborz Province Karaj Alborz Iran (Islamic Republic of)