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IRCT20201101049222N1 IRCT 2020-11-27 The University of Lahore Effect of Ergon IASTM technique in treatment of chronic low back pain Effectiveness of Ergon Technique with Neuromuscular Electrical Stimulation in Addition to Routine Physical Therapy on Pain and Functional Mobility in Patients with Non Specific Chronic Low Back Pain 2020-03-09 anticipated 50 Complete https://irct.ir/trial/52186 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study was designed to be a parallel group randomized controlled trial. After baseline assessment, eligible patients were randomly assigned (in a 1:1 ratio) Ergon + NMES + routine physical therapy (ERGON intervention group) or routine physical therapy (control group). Computer generated randomization assignments designed by an independent statistician and randomization was done by one of the research team member who was not involved in patient recruitment or assessment or data analysis. Randomization is without stratification, with the use of permuted-block randomization; the randomization assignments were kept in opaque, sealed envelopes and unsealed by a researcher after baseline testing, Blinding description: After randomisation, study participants were only informed about the content of their allocated programme by their therapist, remaining unaware of the intervention in the other group. Patient information stated that the study purpose was to evaluate the effects of exercise and physical therapy interventions on chronic low back pain, without specifying that one of the programmes was considered a control intervention. Information about the details of both programmes was not provided except for similarities across both groups (exercise regime). Both programmes were personalised to the patient’s abilities to ensure all eligible patients could complete the programme. Outcome assessors were masked to group allocation. Patients were instructed not to talk about the content of their exercise programme during the post intervention visit and could contact their therapist in case of any problems during trial participation. Moreover, if two or more study participants were in the clinic/hospital at the same time, they were assign to different treatment areas without any opportunity to observe each other or their treatment times were rearranged to prevent unintended crossover. N/A Non Specific Chronic Low Back Pain. Intervention 1: Intervention group: ERGON + EMS +RPT. Progression of ERGON Technique from basic to advance using multiple strokes on lower back especially paraspinal muscles, multifidus and transverse abdominis(TrA) for a duration of minimum 20 mins as per patient requirement. The NMES electrodes were placed on multifidus and TrA and parameters were set to produce a pulse frequency of 75 pulses per second, a pulse duration of 250 µs, with a 4-s ramp up and ramp down time, and a 6-s stimulation period at the maximum amplitude, followed by a 50 s rest period to minimize fatigue. Same protocol of exercise and routine physical therapy as in control group except for TENS because of NMES protocol in this group. Intervention 2: Control group: Routine physical therapy. Strengthening exercises of lumbar extensors (10 reps * 2 sets), Stretching Hams (5 sec hold 3reps * 3 sets), Hot pack 10 mins, Lumbar mobility exercises (10 reps * 2 sets), Aerobic exercises (Cycle ergometer 10 mins), Lumbar Stabilisation exercises (5reps * 3 sets), TENS (20 mins) (Continuous mode).The treatment was provided at hospital/rehabilitation clinic during the 1 hour therapy session, 3 days per week on alternate basis, for 4 weeks (12 sessions). Yes - There is a plan to make this available What will be shared: IPD, study protocol, statistical analysis plan, informed consent form and clinical study report will be shared for primary and secondary outcome measure with interested research after considering the ethics and confidentiality. When: Data will be available after 6 months of publication for 3 consecutive years. To whom: Data will only be shared with individual researcher and academic researchers working in movement disorders. Data will not be shared for any commercial purposes/businesses for any reasons. Conditions: Data can be used under confidentiality and ethics. Where to obtain: Data can be obtained by emailing at haiderullah@live.com. Mobile number 0092 331 4127210 How to obtain: Simple email can do this. But this can take up to 4 weeks. Comments:
public Muhammad Haider Ullah Khan
90-A, Civil Lines, Johar Road, Sheikhupura
Lahore Pakistan 39350 Sheikhupura haiderullah@live.com The University of Lahore scientific Muhammad Abdullah Khan
90-A Civil Lines, Johar Road, Sheikhupura
Sheikhupura Pakistan 39350 +92 56 3785097 abdullahpt94@gmail.com The University of Lahore Pakistan Pakistan Diagnosed patients of chronic low back pain (CLBP) duration 3 months or greater Both adult males and females; 18 - 60 years of age Body mass index (BMI) less than 30 18 years 60 years Both Positive nerve root tension signs, signs of progressive or persistent neurological deficit. Suffered from any spinal tumor or infection, spinal fracture Contraindications to Ergon Technique and neuromuscular electrical stimulation (NMES) (e.g. skin allergy/wound). Have severe cardiovascular or pulmonary problems Fibromyalgia, cauda equina syndrome, previous spine surgery or musculoskeletal injuries of the lower limbs, pregnancy or plans to become pregnant. Systemic disease (autoimmune, infectious, vascular, endocrine, metabolic or neoplasic disease) Previous experience with myofascial therapy or a history of rehabilitation treatment for back pain within the preceding 1 month. M54.5 Low back pain Rehabilitation Rehabilitation Intervention group: ERGON + EMS +RPT. Progression of ERGON Technique from basic to advance using multiple strokes on lower back especially paraspinal muscles, multifidus and transverse abdominis(TrA) for a duration of minimum 20 mins as per patient requirement. The NMES electrodes were placed on multifidus and TrA and parameters were set to produce a pulse frequency of 75 pulses per second, a pulse duration of 250 µs, with a 4-s ramp up and ramp down time, and a 6-s stimulation period at the maximum amplitude, followed by a 50 s rest period to minimize fatigue. Same protocol of exercise and routine physical therapy as in control group except for TENS because of NMES protocol in this group. Control group: Routine physical therapy. Strengthening exercises of lumbar extensors (10 reps * 2 sets), Stretching Hams (5 sec hold 3reps * 3 sets), Hot pack 10 mins, Lumbar mobility exercises (10 reps * 2 sets), Aerobic exercises (Cycle ergometer 10 mins), Lumbar Stabilisation exercises (5reps * 3 sets), TENS (20 mins) (Continuous mode).The treatment was provided at hospital/rehabilitation clinic during the 1 hour therapy session, 3 days per week on alternate basis, for 4 weeks (12 sessions). Pain. Timepoint: At baseline (before intervention), and at end of treatment (4 weeks). Method of measurement: Numeric pain rating scale (NPRS). The NPRS measures pain intensity on an 11-point scale from 0 (no pain) to 10 (maximum pain). We used the ‘‘triple NPRS’’ in which the subject is asked to respond to three questions:(1) the intensity of current pain; (2) the best pain intensity in the past 24 h; and (3) the worst pain intensity in the past 24 h. The mean of these sub-scores was reported as the subject’s NPRS score. Functional mobility. Timepoint: At baseline (before intervention), and at end of treatment (4 weeks). Method of measurement: Modified Oswestry disability questionnaire (MODQ). The MODQ is a self-reported measure of functional disability consisting of 10 questions about various activities related to back pain. Each question has 6 possible responses ranging from 0 to 5, with a total possible maximum score of 50.The total MODQ score is multiplied by 2 to get a percentage score, with higher percentages indicating greater levels of self-reported disability. Fear Avoidance. Timepoint: At baseline (before intervention) and at end of treatment (4 weeks). Method of measurement: The Fear Avoidance-Behavior Questionnaire (FABQ) is a self-reported questionnaire consisting of a total of 16 items, divided into two subscales: physical activity (5 items) and work (11 items). Not all items are calculated toward the final score (i.e. item 1 in the physical activity scale, and items 8, 12, 14 and 16 in the work scale do not count). The total possible maximum FABQ score is 66, with higher scores indicating greater levels of fear avoidance. The University of Lahore Approved 2020-03-06 Institutional Review Board of The University of Lahore 1-KM Defence Road, Off Bhobatian Chowk, Lahore Lahore Punjab Pakistan