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IRCT20211118053098N1 IRCT 2021-12-13 Iran University of Medical Sciences Effectiveness of Dry Needling in Patients With Chronic Nonspecific Low Back Pain Effectiveness of Dry Needling on Pain, Functional Disability, Postural Control, and Pain Pressure Threshold in patients with Chronic Nonspecific Low Back Pain: A Double-blind Randomized Controlled Trial 2022-01-01 anticipated 40 Complete https://irct.ir/trial/60133 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All eligible chronic nonspecific low back pain patients will be randomized to an experimental group (dry needling of the lumbar multifidus muscle and standard physical therapy) and a control group (sham dry needling of the lumbar multifidus muscle and standard physical therapy) using the block balanced randomization with an allocation ratio of 1:1. Random allocation will be executed by a researcher not involved in the assessments or interventions. The random allocation method consists of four-letter blocks made of letters A and B (A letter shows dry needling and standard physical thearpy and letter B indicates sham dry needling and standard physical therapy). then, the randomization schedule will be placed in sequentially numbered opaque sealed envelopes. the treatment will be performed according to the number and letters of each envelope, Blinding description: In this study the participants, outcome assessor and data analyzer will be blinded. A) Participants: The Participants will be blinded to which group they belong to. At the end of the study procedure, true dry needling will be performed for the participants in the control group. B) Outcome assessor: The examiner will be blinded to the grouping information and intervention procedure. C) Data analyzer: The data analyzer will be blinded to the grouping information and intervention procedure. N/A Chronic Nonspecific low back pain. Intervention 1: Intervention group: The experimental group will comprise 20 participants with chronic non-specific low back pain. The treatment will include dry needling of the lumbar multifidus muscle and routine physical therapy. DRY NEEDLING METHOD: The patients will be placed in a prone position with a pillow under their belly to accommodate lumbar lordosis. Two lengths of sterile, disposable, 0.30 mm x 75 mm and 0.30 mm x 50 mm solid filament needle (Tony, China) will be used in this study. The length of the needle for each participant will be selected based on the size of the participant. The needles will be inserted into the lumbar multifidus muscle, 1.5 - 2 cm lateral to the spinous process of two or three painful segments, perpendicular to lamina (after piercing the skin, needles are directed inferomedially). The needles will be inserted to obtain local twitch response, and this process will continue until no more local twitch response occurs in each session. Then the needles will be left in place for 20 minutes.ROUTINE PHYSICAL THERAPY: Routine physical therapy will include low level laser therapy and motor control training. The diode laser device with 850 nm wavelength, 800 milliwatt power, pulse wave with 80% duty cycle and an average energy density of 50 J/cm2 will be utilized for the treatment procedure. The laser will be applied 1.5 to 2 cm lateral to the L1-L5 spinous process, each point for 1 minute and a total of 10 minutes. Motor control training consists of three stages of exercises. First stage exercises include abdominal drawing, abdominal bracing and alternative arm and leg lift. Second stage exercises include unilateral bridging, sideway bridging, quadruped contralateral arm and leg lift, curl up, diagonal curl up and sit back. Third stage exercises include bridging on swiss ball, diagonal curl up with elastic band, trunk extension on swiss ball, unilateral bridging with weight cuff and forward step up. Each exercise will repeat 10 times and each repetition will last 10 seconds and there will be one minute rest between each exercise. The treatment will last 3 weeks, 6 sessions, twice a week. Intervention 2: Control group: The control group will comprise 20 participants with chronic non-specific low back pain. The treatment will include "sham" dry needling of the lumbar multifidus muscle and routine physical therapy. The sham dry needling method consists of the insertion of the needles subcutaneously and no local twitch response will be obtained. The needles will be left in the place for 20 minutes. Routine physical therapy will include low level laser therapy and motor control training. Routine physical therapy will include low level laser therapy and motor control training. The diode laser device with 850 nm wavelength, 800 milliwatt power, pulse wave with 80% duty cycle and an average energy density of 50 J/cm2 will be utilized for the treatment procedure. The laser will be applied 1.5 to 2 cm lateral to the L1-L5 spinous process, each point for 1 minute and a total of 10 minutes. Motor control training consists of three stages of exercises. First stage exercises include abdominal drawing, abdominal bracing and alternative arm and leg lift. Second stage exercises include unilateral bridging, sideway bridging, quadruped contralateral arm and leg lift, curl up, diagonal curl up and sit back. Third stage exercises include bridging on swiss ball, diagonal curl up with elastic band, trunk extension on swiss ball, unilateral bridging with weight cuff and forward step up. Each exercise will repeat 10 times and each repetition will last 10 seconds and there will be one minute rest between each exercise. The treatment will last 3 weeks, 6 sessions, twice a week. Yes - There is a plan to make this available What will be shared: Deidentified individual participant data collected for the primary and secondary outcome measures will be shared if necessary. When: Starting 6 months after publication. To whom: The data will be available for physical therapists working in academic institutions and also clinicians working in the field of musculoskeletal disorders. Conditions: The raw data and results of this study can be used in future relevant systematic reviews. Thus, the raw data and results of this study will be available for researchers working in the field of low back pain. Where to obtain: Applicants can contact Dr. Mohammad Reza Pourahmadi by email. Email address: pourahmadipt@gmail.com How to obtain: Applicants should explain in detail about their project and how the data/documents of this study will be used in their project. Then, the data/documents files will be sent by email to applicants on request. This process may takes 10-12 working days. Comments:
public Bahareh Firouzeh
School of rehabilitation, No. 5, Madadkaran Ave, Shahnazari Ave, Madar Sq., Mirdamad Blvd., Tehran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2225 6434 baharefirouze74@gmail.com3 Iran University of Medical Sciences scientific Mohammadreza Pourahmadi
School of rehabilitation, No. 5, Madadkaran Ave, Shahnazari Ave, Madar Sq., Mirdamad Blvd., Tehran
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 7124 pourahmadi.m@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Patients age between 18 to 45 years. Moderate pain at rest (between 30 and 60 in NPRS). Patients with trigger points in the lumbar multifidus muscle. Patients have the ability to speak and read Persian. 18 years 45 years Both known pregnancy. Currently taking anticoagulant medications. Specific low back pain (Neurogenic low back pain, Spinal stenosis, cauda equina syndrome, spondylolisthesis, and Presence of any signs or symptoms of non-musculoskeletal pathology e.g. cancer, infection and fracture in low back and lower extremities based on paraclinical findings). Prior surgery to the lumbosacral spine. Inability to obtain prone lying. Severe malalignments in the cervical, thoracic, lumbar or pelvic region and the lower limbs. History of uncorrected vision impairment, vestibular, hearing or cognitive impairments. Leg length discrepancy which disturbs balance. Systemic diseases, such as diabetes, fibromyalgia, rheumatoid arthritis, degenerative diseases and other rheumatoid diseases. Needle phobia. Sacroiliac pain as identified with six clinical tests: compression, distraction, sacral thrust, thigh thrust, Gaenslen's and FABER's. M54.5 Low back pain Rehabilitation Rehabilitation Intervention group: The experimental group will comprise 20 participants with chronic non-specific low back pain. The treatment will include dry needling of the lumbar multifidus muscle and routine physical therapy. DRY NEEDLING METHOD: The patients will be placed in a prone position with a pillow under their belly to accommodate lumbar lordosis. Two lengths of sterile, disposable, 0.30 mm x 75 mm and 0.30 mm x 50 mm solid filament needle (Tony, China) will be used in this study. The length of the needle for each participant will be selected based on the size of the participant. The needles will be inserted into the lumbar multifidus muscle, 1.5 - 2 cm lateral to the spinous process of two or three painful segments, perpendicular to lamina (after piercing the skin, needles are directed inferomedially). The needles will be inserted to obtain local twitch response, and this process will continue until no more local twitch response occurs in each session. Then the needles will be left in place for 20 minutes.ROUTINE PHYSICAL THERAPY: Routine physical therapy will include low level laser therapy and motor control training. The diode laser device with 850 nm wavelength, 800 milliwatt power, pulse wave with 80% duty cycle and an average energy density of 50 J/cm2 will be utilized for the treatment procedure. The laser will be applied 1.5 to 2 cm lateral to the L1-L5 spinous process, each point for 1 minute and a total of 10 minutes. Motor control training consists of three stages of exercises. First stage exercises include abdominal drawing, abdominal bracing and alternative arm and leg lift. Second stage exercises include unilateral bridging, sideway bridging, quadruped contralateral arm and leg lift, curl up, diagonal curl up and sit back. Third stage exercises include bridging on swiss ball, diagonal curl up with elastic band, trunk extension on swiss ball, unilateral bridging with weight cuff and forward step up. Each exercise will repeat 10 times and each repetition will last 10 seconds and there will be one minute rest between each exercise. The treatment will last 3 weeks, 6 sessions, twice a week. Control group: The control group will comprise 20 participants with chronic non-specific low back pain. The treatment will include "sham" dry needling of the lumbar multifidus muscle and routine physical therapy. The sham dry needling method consists of the insertion of the needles subcutaneously and no local twitch response will be obtained. The needles will be left in the place for 20 minutes. Routine physical therapy will include low level laser therapy and motor control training. Routine physical therapy will include low level laser therapy and motor control training. The diode laser device with 850 nm wavelength, 800 milliwatt power, pulse wave with 80% duty cycle and an average energy density of 50 J/cm2 will be utilized for the treatment procedure. The laser will be applied 1.5 to 2 cm lateral to the L1-L5 spinous process, each point for 1 minute and a total of 10 minutes. Motor control training consists of three stages of exercises. First stage exercises include abdominal drawing, abdominal bracing and alternative arm and leg lift. Second stage exercises include unilateral bridging, sideway bridging, quadruped contralateral arm and leg lift, curl up, diagonal curl up and sit back. Third stage exercises include bridging on swiss ball, diagonal curl up with elastic band, trunk extension on swiss ball, unilateral bridging with weight cuff and forward step up. Each exercise will repeat 10 times and each repetition will last 10 seconds and there will be one minute rest between each exercise. The treatment will last 3 weeks, 6 sessions, twice a week. Pain intensity. Timepoint: before the intervention and one week after the intervention. Method of measurement: The 0-100 Numeric Pain Rating Scale (NPRS) will be used to evaluate changing in level of pain from the baseline to one week after the intervention. Zero indicates no pain and 100 indicates maximum pain that the patient experiences. The NPRS has the responsiveness to measure the level of pain in people with low back pain. Functional disability. Timepoint: before the intervention and one week after the intervention. Method of measurement: The Persian version of The Oswestry Disability Index will be used to evaluate changing in functional disability.This questionnaire includes 10 activities of daily living and a total score of 100. A score below 25 indicates the lowest level of disability, 25 to 50 moderate disability, 50 to 75 severe disability, and 75 to 100 acute disability. The validity and the reliability of the Persian version of this questionnaire has been shown in the previous studies. Postural control. Timepoint: before the intervention and one week after the intervention. Method of measurement: The force platform (Germany, Kistler, 9260AA6) will be used to evaluate postural control. Postural control will be evaluated in four different trials in double-leg stance position: 1-Eyes open on a firm surface. 2-Eyes closed on a firm surface. 3-Eyes open on a foam surface. 4-Eyes closed on a foam surface. The duration of each trial will be 90 s, three times repetition, with one minute rest interval between each trial. The variables of postural control in this investigation will be COP excursion in anteroposterior and mediolateral direction, COP amplitude Standard Deviation (dispersion) in anteroposterior and mediolateral direction and mean velocity of COP. Pain pressure threshold. Timepoint: before the intervention and one week after the intervention. Method of measurement: The pressure algometer will be used to evaluate the Pain Pressure Threshold (PPT). The patients will be placed in a prone position and the algometer will be applied perpendicular to the muscle belly of the lumbar multifidus, approximately 1.5 cm lateral to the spinous process of the painful segments. The patients will be asked to signal verbally after perception of force change from pressure to pain. The PPT at each location will be taken three times and the mean of three repetitions will be used for statistical analysis. The validity and reliability of the pressure algometer has been shown in previous studies. NCT05100381 مرکز ثبت کارآزمائي هاي باليني ايالات متحده آمريکا Iran University of Medical Sciences Approved 2021-08-29 . Ethical committee of Iran University of Medical Sciences 5th floor, central committee, Iran University of Medical Sciences, Hemmat Expy. Tehran Tehran Iran (Islamic Republic of)