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IRCT20261011071387N1 IRCT 2026-11-06 - University of Isfahan Comparing Motor Control and Postural Restoration Exercises for Pain, Daily Function, Movement Control, and Walking in Women with Chronic Non-Specific Low Back Pain MCE-PRE Trial برگرفته از - MCE: Motor Control Exercises- PRE: Postural Restoration Exercises Comparing the effect of eight weeks motor control and postural restoration exercises on pain, disability, motor control, and gait kinetics in women with chronic nonspecific low back pain 2026-05-22 anticipated 45 Complete https://irct.ir/trial/94570 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is a three-arm, parallel-group randomized controlled clinical trial with a pretest-posttest design and a two-month follow-up. Forty-five eligible women with chronic nonspecific low back pain will be randomly allocated to three equal groups of 15 participants: motor control exercises, postural restoration exercises, and a control group receiving abdominal drawing-in maneuver exercises. The intervention period will last eight weeks, with three exercise sessions per week, each lasting approximately 40 to 60 minutes. Outcome measurements will be performed before the intervention, immediately after the intervention, and two months later to evaluate the maintenance of intervention effects, Randomization description: In this randomized controlled clinical trial, 45 eligible women with chronic nonspecific low back pain will be allocated to three groups of 15 participants each using matched randomization based on baseline pain intensity. The unit of randomization will be the individual participant. Participants will first be ranked according to their baseline pain intensity scores and then arranged into groups of three with similar pain levels. Within each matched triplet, participants will be randomly assigned to one of three groups: motor control exercises, postural restoration exercises, or the control group receiving abdominal drawing-in maneuver exercises. The random allocation will be performed using random numbers generated by the RV.UNIFORM function in SPSS statistical software. This procedure aims to balance baseline pain intensity across the three study groups and minimize its potential confounding effect. The study protocol does not specify a separate allocation concealment procedure, Blinding description: In this randomized controlled clinical trial, blinding of participants and the outcome assessor is planned. A total of 45 eligible women will be randomly allocated to three groups: motor control exercises, postural restoration exercises, and a control group receiving abdominal drawing-in maneuver exercises. To facilitate participant blinding, the control group will also receive an exercise intervention to maintain comparable conditions across all three groups. Participants will not be informed about the group allocation procedures or the exercise protocols assigned to the other groups. The outcome assessor will remain unaware of participants' group assignments and the specific exercises performed in each group. Participants will be instructed not to discuss their exercise protocols with participants from other groups or with the outcome assessor. The study protocol does not explicitly specify blinding of the principal investigator, exercise supervisors, or data analysts. N/A Chronic nonspecific low back pain. Intervention 1: Intervention Group 1: Motor control exercises based on Kolar's approach, focusing on the interaction between the central nervous system and the musculoskeletal system during movement. The selected exercises aim to improve joint control and coordination between joints and their supporting muscles. The intervention will last eight weeks, with three sessions per week, each lasting 40 to 60 minutes. Each session will include 10 minutes of warm-up, 25 to 45 minutes of exercises, and 5 minutes of cool-down. Exercise intensity will be monitored using the Borg Rating of Perceived Exertion Scale after each session. The selected exercises are described in Appendix 6 of the study protocol. Intervention 2: Intervention Group 2: Postural restoration exercises based on the Postural Restoration Institute approach. The program aims to normalize musculoskeletal asymmetries, restore muscle balance, and improve movement patterns. The selected exercises, approved by specialists, include left side lying trunk lift, right straight leg raise with crossover movement, 90/90 hip lift with tilt, left side lying hip adduction with simultaneous activation of the left abdominal muscles, right gluteus maximus activation in left side lying, left leg posterior pulling in right side lying, hip lift with right arm reach and balloon, standing right gluteus maximus activation with resistance against the proximal left hamstring and left knee flexion, reverse step-up with the left leg, quadruped hand and foot walking with abdominal lift, supported left acetabular femoral internal rotation with right acetabular femoral adduction, resisted trunk rotation with left hip internal rotation, and paraspinal muscle release with left hamstring stretching. The intervention will last eight weeks, with three sessions per week, each lasting 40 to 60 minutes, including 10 minutes of warm-up, 25 to 45 minutes of main exercises, and 5 minutes of cool-down. Exercise intensity will be monitored using the Borg Rating of Perceived Exertion Scale. Intervention 3: Control Group: Abdominal drawing-in maneuver. A corrective exercise specialist will provide an instructional session to explain the technique. Participants will slowly draw the lower abdominal region inward, below the navel, while avoiding movement of the upper abdomen, pelvis, and back. The exercises will be performed in four positions: supine with knees extended and flexed, prone, quadruped, and standing. Initially, the exercise will be performed in the supine position with verbal and tactile feedback. After correct breathing and performance are established, the exercise will progress to the other positions. The intervention will last eight weeks, with three sessions per week, each lasting 40 to 60 minutes. Each session will include 10 minutes of warm-up, 25 to 45 minutes of exercises, and 5 minutes of cool-down. Exercise intensity will be monitored using the Borg Rating of Perceived Exertion Scale. Yes - There is a plan to make this available What will be shared: Not applicable. No separate data dictionary or coding manual is defined for this study. When: Not applicable. No data dictionary is planned for sharing. To whom: Not applicable. No data dictionary is designated for sharing. Conditions: Not applicable. No separate data dictionary is defined for this study. Where to obtain: Not applicable. No document is designated for sharing under this category. How to obtain: Not applicable. No access request procedure is defined because no data dictionary is planned for sharing. Comments: No separate data dictionary is specified for sharing in the study protocol.
public Reza Mahdavinejad
University of Isfahan, Daneshgah Street, Azadi Square, Isfahan, Iran
isfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۴۱ +98 913 214 2319 R.mahdavinejad@spr.ui.ac.ir university of isfahan scientific Reza Mahdavinejad
University of Isfahan, Daneshgah Street, Azadi Square, Isfahan, Iran
isfahan Iran (Islamic Republic of) ۸۱۷۴۶۷۳۴۴۱ +98 913 214 2319 R.mahdavinejad@spr.ui.ac.ir University of Isfahan Iran (Islamic Republic of) Women aged 35 to 55 years Absence of menopausal symptoms according to the Menopause Rating Scale (MRS) History of chronic nonspecific low back pain for at least three months confirmed by a specialist physician Pain intensity between 3 and 5 based on the Visual Analog Scale (VAS) Provision of informed consent to participate in the study No use of analgesic medications or other treatment methods Meeting the requirements of the PAR-Q questionnaire 35 years 55 years Female History of disc herniation History of spondylolisthesis History of lumbar osteoarthritis History of osteoporosis History of inflammatory rheumatic diseases History of spinal surgery Presence of any structural spinal abnormalities Presence of medical or ethical contraindications to exercise participation, including visual or hearing impairments, cardiopulmonary disorders, communication difficulties, balance disorders, or similar conditions M54.5 Low back pain Rehabilitation Rehabilitation Rehabilitation Intervention Group 1: Motor control exercises based on Kolar's approach, focusing on the interaction between the central nervous system and the musculoskeletal system during movement. The selected exercises aim to improve joint control and coordination between joints and their supporting muscles. The intervention will last eight weeks, with three sessions per week, each lasting 40 to 60 minutes. Each session will include 10 minutes of warm-up, 25 to 45 minutes of exercises, and 5 minutes of cool-down. Exercise intensity will be monitored using the Borg Rating of Perceived Exertion Scale after each session. The selected exercises are described in Appendix 6 of the study protocol. Intervention Group 2: Postural restoration exercises based on the Postural Restoration Institute approach. The program aims to normalize musculoskeletal asymmetries, restore muscle balance, and improve movement patterns. The selected exercises, approved by specialists, include left side lying trunk lift, right straight leg raise with crossover movement, 90/90 hip lift with tilt, left side lying hip adduction with simultaneous activation of the left abdominal muscles, right gluteus maximus activation in left side lying, left leg posterior pulling in right side lying, hip lift with right arm reach and balloon, standing right gluteus maximus activation with resistance against the proximal left hamstring and left knee flexion, reverse step-up with the left leg, quadruped hand and foot walking with abdominal lift, supported left acetabular femoral internal rotation with right acetabular femoral adduction, resisted trunk rotation with left hip internal rotation, and paraspinal muscle release with left hamstring stretching. The intervention will last eight weeks, with three sessions per week, each lasting 40 to 60 minutes, including 10 minutes of warm-up, 25 to 45 minutes of main exercises, and 5 minutes of cool-down. Exercise intensity will be monitored using the Borg Rating of Perceived Exertion Scale. Control Group: Abdominal drawing-in maneuver. A corrective exercise specialist will provide an instructional session to explain the technique. Participants will slowly draw the lower abdominal region inward, below the navel, while avoiding movement of the upper abdomen, pelvis, and back. The exercises will be performed in four positions: supine with knees extended and flexed, prone, quadruped, and standing. Initially, the exercise will be performed in the supine position with verbal and tactile feedback. After correct breathing and performance are established, the exercise will progress to the other positions. The intervention will last eight weeks, with three sessions per week, each lasting 40 to 60 minutes. Each session will include 10 minutes of warm-up, 25 to 45 minutes of exercises, and 5 minutes of cool-down. Exercise intensity will be monitored using the Borg Rating of Perceived Exertion Scale. Low back pain intensity. Timepoint: During the screening phase, before randomization and the start of the intervention. Method of measurement: A 10 cm horizontal Visual Analogue Scale ranging from 0 (no pain) to 10 (worst possible pain). Participants mark their perceived low back pain intensity on the scale. Functional disability due to low back pain. Timepoint: 48 hours before the start of training, immediately after completion of the eight-week training program, and two months after the intervention. Method of measurement: Using the Oswestry Disability Questionnaire, consisting of 10 sections, each with six response options scored from 0 to 5. The sum of the scores is multiplied by two to obtain the final disability score, ranging from 0 to 100. Spinal movement control impairment score. Timepoint: 48 hours before the start of training, immediately after completion of the eight-week training program, and two months after the intervention. Method of measurement: Using the Luomajoki movement control test, consisting of six tests. Each test is performed three times and photographed. Three specialists evaluate the photographs and assign scores of 1 (no impairment), 2 (mild impairment), or 3 (severe impairment) to each performance. The mean of the nine ratings is calculated for each test. Percentage of total foot pressure during static standing. Timepoint: 48 hours before the start of training, immediately after completion of the eight-week training program, and two months after the intervention. Method of measurement: Using the Payatek Gait Analysis System equipped with a pressure platform and dedicated software. The participant stands barefoot on the platform with both feet positioned naturally at hip width and body weight evenly distributed between both lower limbs. The percentage of total foot pressure is recorded and extracted by the system software. Percentage of forefoot pressure during static standing. Timepoint: 48 hours before the start of training, immediately after completion of the eight-week training program, and two months after the intervention. Method of measurement: Using the Payatek Gait Analysis System equipped with a pressure platform and dedicated software. The participant stands barefoot with body weight evenly distributed between both lower limbs. The software divides the foot into anatomical regions and records the percentage of pressure applied to the forefoot. Percentage of rearfoot pressure during static standing. Timepoint: 48 hours before the start of training, immediately after completion of the eight-week training program, and two months after the intervention. Method of measurement: Using the Payatek Gait Analysis System equipped with a pressure platform and dedicated software. The participant stands barefoot with body weight evenly distributed between both lower limbs. The software divides the foot into anatomical regions and records the percentage of pressure applied to the rearfoot. Mean total foot pressure during static standing. Timepoint: 48 hours before the start of training, immediately after completion of the eight-week training program, and two months after the intervention. Method of measurement: Using the Payatek Gait Analysis System equipped with a pressure platform and dedicated software. The participant stands barefoot with body weight evenly distributed between both lower limbs. Mean total foot pressure is calculated and extracted by the system software. Mean forefoot pressure during static standing. Timepoint: 48 hours before the start of training, immediately after completion of the eight-week training program, and two months after the intervention. Method of measurement: Using the Payatek Gait Analysis System equipped with a pressure platform and dedicated software. The participant stands barefoot with body weight evenly distributed between both lower limbs. Mean forefoot pressure is calculated and extracted by the system software. Mean rearfoot pressure during static standing. Timepoint: 48 hours before the start of training, immediately after completion of the eight-week training program, and two months after the intervention. Method of measurement: Using the Payatek Gait Analysis System equipped with a pressure platform and dedicated software. The participant stands barefoot with body weight evenly distributed between both lower limbs. Mean rearfoot pressure is calculated and extracted by the system software. Total foot contact area during dynamic walking. Timepoint: 48 hours before the start of training, immediately after completion of the eight-week training program, and two months after the intervention. Method of measurement: Using the Payatek Gait Analysis System equipped with a pressure platform and dedicated software. The participant walks barefoot across the platform at their preferred natural speed. Total foot contact area during the stance phase of the gait cycle is recorded. Each test is repeated three times, and the mean of valid trials is calculated. Forefoot contact area during dynamic walking. Timepoint: 48 hours before the start of training, immediately after completion of the eight-week training program, and two months after the intervention. Method of measurement: Using the Payatek Gait Analysis System equipped with a pressure platform and dedicated software. The participant walks barefoot across the platform at their preferred natural speed. Forefoot contact area during the stance phase of the gait cycle is recorded. Each test is repeated three times, and the mean of valid trials is calculated. Midfoot contact area during dynamic walking. Timepoint: 48 hours before the start of training, immediately after completion of the eight-week training program, and two months after the intervention. Method of measurement: Using the Payatek Gait Analysis System equipped with a pressure platform and dedicated software. The participant walks barefoot across the platform at their preferred natural speed. Midfoot contact area during the stance phase of the gait cycle is recorded. Each test is repeated three times, and the mean of valid trials is calculated. Rearfoot contact area during dynamic walking. Timepoint: 48 hours before the start of training, immediately after completion of the eight-week training program, and two months after the intervention. Method of measurement: Using the Payatek Gait Analysis System equipped with a pressure platform and dedicated software. The participant walks barefoot across the platform at their preferred natural speed. Rearfoot contact area during the stance phase of the gait cycle is recorded. Each test is repeated three times, and the mean of valid trials is calculated. Percentage of forefoot pressure during dynamic walking. Timepoint: 48 hours before the start of training, immediately after completion of the eight-week training program, and two months after the intervention. Method of measurement: Using the Payatek Gait Analysis System equipped with a pressure platform and dedicated software. The participant walks barefoot across the platform at their preferred natural speed. The percentage of forefoot pressure during the stance phase of the gait cycle is recorded. Each test is repeated three times, and the mean of valid trials is calculated. Percentage of rearfoot pressure during dynamic walking. Timepoint: 48 hours before the start of training, immediately after completion of the eight-week training program, and two months after the intervention. Method of measurement: Using the Payatek Gait Analysis System equipped with a pressure platform and dedicated software. The participant walks barefoot across the platform at their preferred natural speed. The percentage of rearfoot pressure during the stance phase of the gait cycle is recorded. Each test is repeated three times, and the mean of valid trials is calculated. - University of Isfahan Approved 2026-02-23 Bioethics Committee of the University of Isfahan niversity of Isfahan, University Street, Azadi Square, Isfahan Isfahan Isfehan Iran (Islamic Republic of)