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IRCT20150131020888N9 IRCT 2018-08-04 Isfahan University of Medical Sciences, Vice Chancellery of Research and Technology The Effect of low level LASER on pain and function in subjects with anterior knee pain Comparison of the Effect of low level laser and placebo laser on pain and function in subjects with patellofemoral pain syndrome: A Pilot Randomized Clinical Trial 2018-06-28 anticipated 60 Complete https://irct.ir/trial/32325 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The volunteers will be assigned to three groups randomly using the random numbered table codes. an unaware person in the research method will select the codes from the random numbers table, Blinding description: This study is a Triple-blind randomized clinical trial (participant, examiner and analyzer) with a parallel design. LASER is performed by a physical therapist in two groups of laser and placebo. This person has no role in evaluating participants, other sections of treatment and recording information. Participants can not recognize, whether LASER devices is on or off. The same physical therapist who is blind to study groups will supervise standard physical therapy in all groups. to ensure participant blinding to study groups they all will receive therapeutic ultrasound in OFF state. A comprehensive clinical assessment will be performed by a physical therapist who is unaware of the research groups (student ). Data analysis will be done by an unknown person in the research method. N/A patellofemoral pain syndrome. Intervention 1: Intervention group: standard physical therapy plus low-level LASER group:Participants in this group receive active LASER plus standard physical therapy. LASERs will be used at the beginning of the session before any other intervention. Subjects will receive LASER in supine position. The probe will be in direct and full contact with the tissue at 90 ° angle. The LASER group will be treated with low level Gallium-Aluminum-Arsenide (Ga-Al-As) LASER, with a wavelength of 808 nm, output power of 200 mW, continuous mode, Beam spot size of 1 cm2, dose of 4 J/cm2 (each point), and energy of 4J for 20 seconds on each point. LASER will be radiated over five points around the patella. The total energy and total radiation time for each session will be 20 Jules and 100 seconds (one minute and 40 seconds) respectively. Participants will receive standard physical therapy after completing laser therapy. At first OFF ultrasound will be used over the patella. According to Manchester consensus statement, therapeutic exercises is the treatment of choice for patellofemoral pain syndrome. Each training session will begin with 5 minutes’ warm up, continue with stretching and strengthening exercises, and finally, cool down for 5 minutes. ­Stretching exercises for hamstring, plantar flexors, quadriceps and iliotibial band: 3 repetitions of 30s for each muscle. ­Strengthening exercises: semi squat (0-45 degrees), Seated knee extension (90-45 degrees), SLR , hip abduction with weights (side lying), hip abduction against elastic band (standing), hip lateral rotation against elastic band (sitting).Each exercise will be performed in three sets of 10 repetitions. Interval for rest and recovery between sets will be 3 minutes. External resistance during training will be standardized as 70% of the 1-repetition maximum (1RM). The elastic band resistant will be individualized as maximum resistant which each subject can perform in 10 repetitions (10 RM for Thera Band). Intervention 2: Intervention group: standard physical therapy plus placebo LASER group: The participants in this group receive LASER off plus standard physical therapy. In this group, the LASER device will turn off all the time. Participants will receive standard physical therapy after completing the LASER off Program. At first OFF ultrasound will be used over the patella. According to Manchester consensus statement, therapeutic exercises is the treatment of choice for patellofemoral pain syndrome. Each training session will begin with 5 minutes’ warm up, continue with stretching and strengthening exercises, and finally, cool down for 5 minutes. ­Stretching exercises for hamstring, plantar flexors, quadriceps and iliotibial band: 3 repetitions of 30s for each muscle. ­Strengthening exercises: semi squat (0-45 degrees), Seated knee extension (90-45 degrees), SLR , hip abduction with weights (side lying), hip abduction against elastic band (standing), hip lateral rotation against elastic band (sitting).Each exercise will be performed in three sets of 10 repetitions. Interval for rest and recovery between sets will be 3 minutes. External resistance during training will be standardized as 70% of the 1-repetition maximum (1RM). The elastic band resistant will be individualized as maximum resistant which each subject can perform in 10 repetitions (10 RM for Thera Band). Intervention 3: Control group: standard physical therapy alone: Participants in this group will receive only standard physical therapy. At first OFF ultrasound will be used over the patella. According to Manchester consensus statement, therapeutic exercises are the treatment of choice for patellofemoral pain syndrome. Each training session will begin with 5 minutes’ warm up, continue with stretching and strengthening exercises, and finally, cool down for 5 minutes. ­Stretching exercises for hamstring, plantar flexors, quadriceps and iliotibial band: 3 repetitions of 30s for each muscle. ­Strengthening exercises: semi squat (0-45 degrees), Seated knee extension (90-45 degrees), SLR , hip abduction with weights (side lying), hip abduction against elastic band (standing), hip lateral rotation against elastic band (sitting).Each exercise will be performed in three sets of 10 repetitions. Interval for rest and recovery between sets will be 3 minutes. External resistance during training will be standardized as 70% of the 1-repetition maximum (1RM). The elastic band resistant will be individualized as maximum resistant which each subject can perform in 10 repetitions (10 RM for Thera Band). No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Dr. Zahra Sadat Rezaeian
Hezar Jarib Ave. Isfahan University of Medical Sciences, Faculty of Rehabilitation Sciences
Isfahan Iran (Islamic Republic of) 81745-164 00983137925012; 00983137925042 zrezaeian@yahoo.com Esfahan University of Medical Sciences scientific Dr. Zahra Sadat Rezaeian
Hezar Jarib Ave. Isfahan University of Medical Sciences, Faculty of Rehabilitation Sciences
Isfahan Iran (Islamic Republic of) 81745-164 00983137925012; 00983137925042 zrezaeian@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Presence anterior or retro patellar pain only in one limb The report of pain during a day at least in 2 functional activities including prolonged sitting, climbing stairs, squatting, running, double kneeling, jumping Score of at least 3 on the visual analog scale (VAS) The pain will be reported in the squat on one leg for 10 seconds Subjects have anterior knee pain at least in the past three months Age from 18 to 40 years 18 years 40 years Both Traumatic injuries of the low back and lower extremities Any signs or symptoms or MRI findings based on intra-articular pathologic conditions such as effusion, meniscal, or cruciate or collateral ligament involvement Subluxation and dislocation of the patella Other musculoskeletal injuries in lower extremities hip or lumbar referred pain Any symptoms or evidence of knee osteoarthritis in X-rays Infectious disease, rheumatoid arthritis, autoimmune disease, cancer and systemic diseases Corticosteroid injections and received physical therapy in the last 3 months, and received opioid and analgesic drugs in the last 72 hours Epilepsy, heart problems and heart pacemaker Active athlete BMI>30kg⁄m^2 Surgery of the lower limbs and lower back History the use of LASERs due to prejudices about the effect of the intervention M22.4 Chondromalacia patellae Rehabilitation Rehabilitation Rehabilitation Intervention group: standard physical therapy plus low-level LASER group:Participants in this group receive active LASER plus standard physical therapy. LASERs will be used at the beginning of the session before any other intervention. Subjects will receive LASER in supine position. The probe will be in direct and full contact with the tissue at 90 ° angle. The LASER group will be treated with low level Gallium-Aluminum-Arsenide (Ga-Al-As) LASER, with a wavelength of 808 nm, output power of 200 mW, continuous mode, Beam spot size of 1 cm2, dose of 4 J/cm2 (each point), and energy of 4J for 20 seconds on each point. LASER will be radiated over five points around the patella. The total energy and total radiation time for each session will be 20 Jules and 100 seconds (one minute and 40 seconds) respectively. Participants will receive standard physical therapy after completing laser therapy. At first OFF ultrasound will be used over the patella. According to Manchester consensus statement, therapeutic exercises is the treatment of choice for patellofemoral pain syndrome. Each training session will begin with 5 minutes’ warm up, continue with stretching and strengthening exercises, and finally, cool down for 5 minutes. ­Stretching exercises for hamstring, plantar flexors, quadriceps and iliotibial band: 3 repetitions of 30s for each muscle. ­Strengthening exercises: semi squat (0-45 degrees), Seated knee extension (90-45 degrees), SLR , hip abduction with weights (side lying), hip abduction against elastic band (standing), hip lateral rotation against elastic band (sitting).Each exercise will be performed in three sets of 10 repetitions. Interval for rest and recovery between sets will be 3 minutes. External resistance during training will be standardized as 70% of the 1-repetition maximum (1RM). The elastic band resistant will be individualized as maximum resistant which each subject can perform in 10 repetitions (10 RM for Thera Band). Intervention group: standard physical therapy plus placebo LASER group: The participants in this group receive LASER off plus standard physical therapy. In this group, the LASER device will turn off all the time. Participants will receive standard physical therapy after completing the LASER off Program. At first OFF ultrasound will be used over the patella. According to Manchester consensus statement, therapeutic exercises is the treatment of choice for patellofemoral pain syndrome. Each training session will begin with 5 minutes’ warm up, continue with stretching and strengthening exercises, and finally, cool down for 5 minutes. ­Stretching exercises for hamstring, plantar flexors, quadriceps and iliotibial band: 3 repetitions of 30s for each muscle. ­Strengthening exercises: semi squat (0-45 degrees), Seated knee extension (90-45 degrees), SLR , hip abduction with weights (side lying), hip abduction against elastic band (standing), hip lateral rotation against elastic band (sitting).Each exercise will be performed in three sets of 10 repetitions. Interval for rest and recovery between sets will be 3 minutes. External resistance during training will be standardized as 70% of the 1-repetition maximum (1RM). The elastic band resistant will be individualized as maximum resistant which each subject can perform in 10 repetitions (10 RM for Thera Band). Control group: standard physical therapy alone: Participants in this group will receive only standard physical therapy. At first OFF ultrasound will be used over the patella. According to Manchester consensus statement, therapeutic exercises are the treatment of choice for patellofemoral pain syndrome. Each training session will begin with 5 minutes’ warm up, continue with stretching and strengthening exercises, and finally, cool down for 5 minutes. ­Stretching exercises for hamstring, plantar flexors, quadriceps and iliotibial band: 3 repetitions of 30s for each muscle. ­Strengthening exercises: semi squat (0-45 degrees), Seated knee extension (90-45 degrees), SLR , hip abduction with weights (side lying), hip abduction against elastic band (standing), hip lateral rotation against elastic band (sitting).Each exercise will be performed in three sets of 10 repetitions. Interval for rest and recovery between sets will be 3 minutes. External resistance during training will be standardized as 70% of the 1-repetition maximum (1RM). The elastic band resistant will be individualized as maximum resistant which each subject can perform in 10 repetitions (10 RM for Thera Band). Pain. Timepoint: the first session just before the intervention and at the tenth session after the end of the treatment plan. Method of measurement: Visual Analogue Scale (VAS)-Persian version of Kujala questionnaire. Function. Timepoint: the first session just before the intervention and at the tenth session after the end of the treatment plan. Method of measurement: Persian version of Kujala questionnaire- step down test. Isfahan University of Medical Sciences, Vice Chancellery of Research and Technology Approved 2018-07-04 Ethics Committee of Isfahan University of Medical Sciences Secretariat of the Ethics Committee, Room 209, Second Floor, Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib Street, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)