]>
IRCT20201119049444N1 IRCT 2020-12-13 Iran University of Medical Sciences Recovery of muscle size and pain improvement in patients with a chronic low back pain Measurements of lumbar multifidus muscle thickness using ultrasound in chronic low back pain patients, before and after physical therapy exercises 2018-01-10 anticipated 24 Complete https://irct.ir/trial/52485 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: With consideration of the minimum subjects needed for a reliable statistical analysis, a total of 24 participants who were eligible for random allocation between two groups, were selected. To avoid potential bias in allocation of the participants, their hospital admission IDs were shuffled using MicroSoft Office Excel software package. Then, the first 12 participants appeared in the resultant output column of the software were allocated to the first group (control group) and the second 12 participants appeared in that column were allocated to the second group (intervention group), Blinding description: The patients did not know whether they are receiving the conventional treatment or the interventional treatment. The radiologist who performed muscle thickness measurements also did not the group a patient was coming from. The data analyst knew the group as 1 and 2, so he also did not know which group is conventional and which one is interventional. N/A Chronic low back pain. Intervention 1: Intervention group: hip abductor strengthening exercises 3 times a week and total period of 8 weeks (24 sessions). Each session started with 10 min warm-up period consisted of 5 min stationary biking at a moderate pace and 5 min back stretching exercises. During the back stretching, the low back sustained rotation from supine position, single and double knee to chest from supine position, alternate spinal flexion-extension from 4-point kneeling position, trunk forward stretching while sitting on the heels and with trunk parallel to the floor, side bending in standing position with and without contralateral arm elevation. Then, the patients received the hip abductor strengthening exercises consisting of abduction during four separate positions: supine, side lying, and standing. Intervention 2: Control group: Stabilization exercises 3 times a week and total period of 8 weeks (24 sessions). The stabilization exercises were performed in 6 steps including: 1) segmental control exercises (SCE) with emphasis on training of isolated contraction of the transversus abdominis, multifidus, and pelvic floor muscles, 2) SCE with emphasis on co-contractions of the above-mentioned muscles in the prone, supine, and four-point kneeling positions, 3) SCE as a closed kinematic chain, 4) SCE extension by adding a low weight (0.5-1.5 kg) to create leverage of the limbs, 5) application of SCE in functional situation, and 6) co-contraction of the transversus abdominis and multifidus, muscles during application of an external load, complication of movements, increased load with the lumbar spine in the correct position, and addition of a co-contraction pattern to light aerobic activities such as walking. Yes - There is a plan to make this available What will be shared: Results of multifidus muscle size measurements and pain intensity in chronic low back pain patients before and after stabilization and hip abductor strengthening treatments When: From January 2021 To whom: Public but mainly medical scientists and healthcare providers Conditions: Non-profit Where to obtain: Email corresponding author How to obtain: Within 2 business days after receiving the email request Comments:
public Mahnaz Aboufazeli
Iran University of Medical Sciences, School of Rehabilitation Sciences, Maddadkaran St., Shahid Nazari St., Mirdamad Blvd., Mother Square
Tehran Iran (Islamic Republic of) 1348715459 +98 21 2222 7124 m.aboufazeli111@gmail.com Iran University of Medical Sciences scientific Mahnaz Aboufazeli
Iran University of Medical Sciences, School of Rehabilitation Sciences, Maddadkaran St., Shahid Nazari St., Mirdamad Blvd., Mother Square
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 2059 m.aboufazeli111@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Female chronic low back pain patients with a pain intensity above 3 score when using Visual Analog Scale 20 years 50 years Female patients with a history of sacroiliac dysfunction, invasive surgical operations with alteration of the normal anatomy of the patient (e.g., implant)major surgeries on abdomen, pelvis, and lower extremity, respiratory diseases, neurological disorders, pelvic fracture and dislocation, scoliosis and structural deformities of spine, spine surgery, malignancies, rheumatic diseases, or other systemic diseases, acute back trauma, spondylolysis and spondylolisthesis, and pregnancy or caesarian section in the last two months were excluded. Rehabilitation Rehabilitation Intervention group: hip abductor strengthening exercises 3 times a week and total period of 8 weeks (24 sessions). Each session started with 10 min warm-up period consisted of 5 min stationary biking at a moderate pace and 5 min back stretching exercises. During the back stretching, the low back sustained rotation from supine position, single and double knee to chest from supine position, alternate spinal flexion-extension from 4-point kneeling position, trunk forward stretching while sitting on the heels and with trunk parallel to the floor, side bending in standing position with and without contralateral arm elevation. Then, the patients received the hip abductor strengthening exercises consisting of abduction during four separate positions: supine, side lying, and standing. Control group: Stabilization exercises 3 times a week and total period of 8 weeks (24 sessions). The stabilization exercises were performed in 6 steps including: 1) segmental control exercises (SCE) with emphasis on training of isolated contraction of the transversus abdominis, multifidus, and pelvic floor muscles, 2) SCE with emphasis on co-contractions of the above-mentioned muscles in the prone, supine, and four-point kneeling positions, 3) SCE as a closed kinematic chain, 4) SCE extension by adding a low weight (0.5-1.5 kg) to create leverage of the limbs, 5) application of SCE in functional situation, and 6) co-contraction of the transversus abdominis and multifidus, muscles during application of an external load, complication of movements, increased load with the lumbar spine in the correct position, and addition of a co-contraction pattern to light aerobic activities such as walking. Thickness of the lumbar multifidus muscle, pain intensity, and disability index. Timepoint: 8 weeks with 3 sessions each (24 sessions). Method of measurement: An ultrasound device is used for muscle thickness measurements, a linear scale is used for marking the pain intensity by patients (Visual Analog Scale), and finally a questionnaire is used to record the disability index (Oswestry). Iran University of Medical Sciences Approved 2016-12-10 Ethics committee of the Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)