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IRCT20220510054814N1 IRCT 2022-06-06 Rheumatology Research Center (RRC), Dr. Shariati Hospital Effect of exercises and pain neuroscience education in Heal of knee osteoarthritis. Effectiveness and durability of intervention pain neuroscience education and selected exercises based on weight management on pain, function and psychological factors in patients with knee osteoarthritis 2022-06-15 anticipated 129 Complete https://irct.ir/trial/63839 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: The patient will have to report agreement to participate in the study and signed the formal consent to participate, a Rheumatologist will run the assessment to determine eligibility. After this initial assessment (blinded assessor), we will enter the number of sets want on the website http://randomizer.org/ (Social Psychology Network, Connecticut, USA) (Four sets of numbers are required: 1. Selected exercise group 2. pain neuroscience education group 3. Selected exercise combine pain neuroscience education group 4. Control). Participants will randomly be assigned to the control group or 1 of the intervention groups using a randomized permuted block design of block size 8 each participant’s group. Another researcher, blind to the baseline examination, opens an envelope and processed with treatment according to the group assignment, Blinding description: Assessor data analyzer will be blind to group allocation. Participants will not blind to exercise study however they were not aware which treatment will be considered as therapeutic. A blinded outcome assessor who will not know the hypothesis and study methods, measures outcome at baseline, after 3 month post-intervention, and 6 month follow-up. N/A Knee osteoarthritis. Intervention 1: Intervention group 1: In selected exercise using booster sessions (in follow-up) group: The participants will be submitted to a program of 3-month (36 sessions+ 1 education) of selected exercises (mixed of cardio, strength, neuromuscular, breathing, mobility, balance exercises). The program will be carried out three a week, and will be a telerehabilitation program (Online and home exercise). Then, after the past of 1-month (12-sessions) of initial program, the participants will be invited to perform some functional activities (progression walking program+ step up and down+ semi squat) at home, in addition to the main exercise intervention. Each session will last between 45 to 75 minutes, and always movements will be checked with a physical therapist (Online connection). The participants in 2 groups (Selected exercise and Combined group) will receive booster sessions (through phone call and video call) during at follow-up: 8 sessions in the first 9 weeks at follow-up period, 2 booster sessions at between 8 weeks to end of follow-up period. On the all groups, participants will be received an educations program comprised of the self-management, an anatomy, heat therapy and physiology (except PNE in control group), daily activities ergonomic, and encouragement to be active. Also, in all the groups and during all the sessions, participants will support by automated text messages (for remember sessions and exercises). Intervention 2: Intervention group 2: pain neuroscience education (PNE) group: In this group, 3 introductory sessions will be held to teach pain management approaches. In this study, 3 training sessions will be held in 2 weeks, which will be conducted by the researcher. The schedule is the same for all two treatment groups. The first session will be an online group session (duration 30 minutes to an hour) with a maximum of 6 participants in each group, led by a researcher using a PowerPoint presentation. Participants will then be asked to read an instruction booklet containing the same information at home. The second session is home-based online e-learning, which includes 3 explanatory videos. These videos explain the same PowerPoint that was shown during the first session along with its screening. Therefore, in the second session, which is held online, the same issue discussed in the first group session will be explained again. After each clip, participants are asked to complete a questionnaire that will assess their understanding and opinion of the film. The third session will include a 30-minute one-to-one conversation focusing on patients' personal needs: The questions in the second session questionnaire will be analyzed. And how to use this information in the patient's daily life is discussed. On three interventions groups, will be teaching about effect of heat therapy for pain reduced in patient. As well as, In this group, participants will also receive a nutrition education booklet with 60 min education about nutrition. On the all groups, participants will be received an educations program comprised of the self-management, an anatomy and physiology (except PNE in control group), daily activities ergonomic, and encouragement to be active. Also, in all the groups and during all the sessions, participants will support by automated text messages (for remember sessions and exercises). Intervention 3: Intervention group 3: In combine group (pain neuroscience education and selected exercises): The interventions of this group, will be a combination of two groups (pain neuroscience education and selected exercises). The participants in 2 groups (Selected exercise and Combined group) will receive booster sessions during at follow-up: 8 sessions in the first 9 weeks at follow-up period, 2 booster sessions at between 8 weeks to end of follow-up period. On three interventions groups, will be teaching about effect of heat therapy for pain reduced in patient. On the all groups, participants will be received an educations program comprised of the self-management, an anatomy and physiology (except PNE in control group), daily activities ergonomic, and encouragement to be active. Also, in all the groups and during all the sessions, participants will support by automated text messages (for remember sessions and exercises). Intervention 4: Control group: 4 group: In this group, participants will be received an educations program comprised of the self-management, an anatomy and physiology (except PNE), heat therapy, daily activities ergonomic, and encouragement to be active (1-session, 60 to 75 minutes). Also, in all the groups and during all the sessions, participants will support by automated text messages (for remember sessions). Yes - There is a plan to make this available What will be shared: Only part of the data, such as the dependent variables, The average of all samples, can be shared in scientific articles. When: Access period starts 6 months after the results are published. To whom: Personal information is confidential and general results are available to anyone in the article. Conditions: Information is not available to anyone. General results are available to anyone in the article. Where to obtain: Zohreh Gholami 00989196099164 Email: Zzohreh.Ggholami@gmail.com How to obtain: 6 months after the publication of the results, the applicant can have the data by sending an email. Comments:
public Zohreh Gholami
Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport Complex, Tehran, Iran
Tehran Iran (Islamic Republic of) 1544733111 +98 21 2222 8001 Zzohreh.Ggholami@gmail.com The University of Kharazmi scientific Zohreh Gholami
Center for Human Movement Sciences Kharazmi University Mirdamad, Sout Razan Street, Hesari Street, Keshvari Sport Complex, Tehran, Iran
Tehran Iran (Islamic Republic of) 1544733111 +98 21 2222 8001 Zzohreh.Ggholami@gmail.com The University of Kharazmi Iran (Islamic Republic of) Age 40 years or older A clinical diagnosis of knee osteoarthritis (defined as knee pain for >3 months and minimum 3 times a week, early morning stiffness <30 minutes, crepitus, bony tenderness, and no palpable warmth) Radiographically established knee osteoarthritis (determined by Kellgren and Lawrence grade 1 to 3 on the 1-4 scale) Ability to read and write Persian and having access to and ability to use a smartphone or tablet for a period of follow up or the presence of a person next to the patient to help her/him No participation in formal strength training or physical therapy for more than 30 minutes a week in the past 6-month 40 years no limit Both Illiterate patients without caregivers (child, nurse, caregiver) Severe osteoporosis Clinical history of tumors or cancer Patients in the post-surgery period or submitted to previous physical therapy (over 30 min) in the past six months or to any health/pain education strategy Active Inflammatory joint diseases (rheumatoid arthritis, gout, calcium pyrophosphate deposition disease) Underwent any lower extremity joint replacement Procedure Alzheimer diseases Severe Patellofemoral osteoarthritis Neurological diseases (parkinson's disease, stroke, multiple sclerosis, muscular dystrophy, motor neurone disease, huntington's disease) Autoimmune disease, and mental illnesses M17 Osteoarthritis of knee Treatment - Other Treatment - Other Treatment - Other Treatment - Other Intervention group 1: In selected exercise using booster sessions (in follow-up) group: The participants will be submitted to a program of 3-month (36 sessions+ 1 education) of selected exercises (mixed of cardio, strength, neuromuscular, breathing, mobility, balance exercises). The program will be carried out three a week, and will be a telerehabilitation program (Online and home exercise). Then, after the past of 1-month (12-sessions) of initial program, the participants will be invited to perform some functional activities (progression walking program+ step up and down+ semi squat) at home, in addition to the main exercise intervention. Each session will last between 45 to 75 minutes, and always movements will be checked with a physical therapist (Online connection). The participants in 2 groups (Selected exercise and Combined group) will receive booster sessions (through phone call and video call) during at follow-up: 8 sessions in the first 9 weeks at follow-up period, 2 booster sessions at between 8 weeks to end of follow-up period. On the all groups, participants will be received an educations program comprised of the self-management, an anatomy, heat therapy and physiology (except PNE in control group), daily activities ergonomic, and encouragement to be active. Also, in all the groups and during all the sessions, participants will support by automated text messages (for remember sessions and exercises). Intervention group 2: pain neuroscience education (PNE) group: In this group, 3 introductory sessions will be held to teach pain management approaches. In this study, 3 training sessions will be held in 2 weeks, which will be conducted by the researcher. The schedule is the same for all two treatment groups. The first session will be an online group session (duration 30 minutes to an hour) with a maximum of 6 participants in each group, led by a researcher using a PowerPoint presentation. Participants will then be asked to read an instruction booklet containing the same information at home. The second session is home-based online e-learning, which includes 3 explanatory videos. These videos explain the same PowerPoint that was shown during the first session along with its screening. Therefore, in the second session, which is held online, the same issue discussed in the first group session will be explained again. After each clip, participants are asked to complete a questionnaire that will assess their understanding and opinion of the film. The third session will include a 30-minute one-to-one conversation focusing on patients' personal needs: The questions in the second session questionnaire will be analyzed. And how to use this information in the patient's daily life is discussed. On three interventions groups, will be teaching about effect of heat therapy for pain reduced in patient. As well as, In this group, participants will also receive a nutrition education booklet with 60 min education about nutrition. On the all groups, participants will be received an educations program comprised of the self-management, an anatomy and physiology (except PNE in control group), daily activities ergonomic, and encouragement to be active. Also, in all the groups and during all the sessions, participants will support by automated text messages (for remember sessions and exercises). Intervention group 3: In combine group (pain neuroscience education and selected exercises): The interventions of this group, will be a combination of two groups (pain neuroscience education and selected exercises). The participants in 2 groups (Selected exercise and Combined group) will receive booster sessions during at follow-up: 8 sessions in the first 9 weeks at follow-up period, 2 booster sessions at between 8 weeks to end of follow-up period. On three interventions groups, will be teaching about effect of heat therapy for pain reduced in patient. On the all groups, participants will be received an educations program comprised of the self-management, an anatomy and physiology (except PNE in control group), daily activities ergonomic, and encouragement to be active. Also, in all the groups and during all the sessions, participants will support by automated text messages (for remember sessions and exercises). Control group: 4 group: In this group, participants will be received an educations program comprised of the self-management, an anatomy and physiology (except PNE), heat therapy, daily activities ergonomic, and encouragement to be active (1-session, 60 to 75 minutes). Also, in all the groups and during all the sessions, participants will support by automated text messages (for remember sessions). Pain (Visual Analog Scale, Western Ontario and McMaster Universities Osteoarthritis index in knee osteoarthritis), Stiffness and physical functional (Western Ontario and McMaster Universities Osteoarthritis index in knee osteoarthritis). Timepoint: All the primary outcomes will be measured at the initial evaluation, after the end of 36 session exercise intervention, and after the end of 6-month follow up. Method of measurement: Pain: Visual Analogue Scale, and Western Ontario and McMaster Universities Osteoarthritis index in knee osteoarthritis. Stiffness and physical functional: Western Ontario and McMaster Universities Osteoarthritis index in knee osteoarthritis. Psychological factors (Pain Self-Efficacy Questionnaire (PSEQ), Scales Stress and Anxiety, Depression (DASS), Tampa Scale for Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS)). Timepoint: All the primary outcomes will be measured at the initial evaluation, after the end of 36 session exercise intervention, and after the end of 6-month follow up. Method of measurement: Psychological factors: Pain Self-Efficacy Questionnaire (PSEQ), Scales Stress and Anxiety, Depression (DASS), Tampa Scale for Kinesiophobia (TSK), Pain Catastrophizing Scale (PCS). Physical Function (30 Second Sit to Stand Test and Timed UP and Go). Timepoint: All the primary outcomes will be measured at the initial evaluation, after the end of 36 session exercise intervention, and after the end of 6-month follow up. Method of measurement: Physical Function: 30 Second Sit to Stand Test and Timed UP and Go. Active Range of motion (goniometer). Timepoint: The range of motion will be measured at the initial evaluation, after the end of 36 session exercise intervention, and after the end of 6-month follow-up. Method of measurement: Range of motion: goniometer. Muscle strength (dynamometer). Timepoint: The muscle strength will be measured at the initial evaluation, after the end of 36 session exercise intervention, and after the end of 6-month follow-up. Method of measurement: Muscle strength: dynamometer. Exercise Adherence (The Exercise Adherence Rating scale (EARS)). Timepoint: The adherence to exercise will be measured after the end of 6-month follow-up. Method of measurement: Exercise Adherence: The Exercise Adherence Rating scale (EARS). Quality of life (Quality of life: Short Form Health Survey (SF-12)). Timepoint: The quality of life will be measured at the initial evaluation, after the end of 36 session exercise intervention, and after the end of 6-month follow-up. Method of measurement: Quality of life: Short Form Health Survey (SF-12). Risk of fall (Short Falls Efficacy Scale International (FES-I)). Timepoint: The Risk of fall will be measured at the initial evaluation, after the end of 36 session exercise intervention, and after the end of 6-month follow-up. Method of measurement: Risk of fall: Short Falls Efficacy Scale International (FES-I). Rheumatology Research Center (RRC), Dr. Shariati Hospital Approved 2022-05-21 Research Ethics Committees of Sport Sciences Research Institute (SSRI) Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)