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IRCT20180728040618N2 IRCT 2019-09-18 Iran University of Medical Sciences The Effect of Recreational Physical Activity On Functional Ability and Quality of Life in Patient with Chronic Non-Specific Low Back Pain The Effect of Recreational Physical Activity Combined with Routine Physical Therapy in Comparison with Routine Physical Therapy Alone on Functional Ability and Quality of Life in Patients with Chronic Non-Specific Low Back Pain 2018-10-22 anticipated 34 Complete https://irct.ir/trial/40650 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Randomization method is "Balanced Block Randomization" which include 4 letters and made from letter A and B. Then, randomization list in the shape of A and B are placed in numbered pockets. "A" is for the control treatment ( routine physiotherapy ) and "B" is for the subject treatment ( routine physiotherapy combined with recreational activities). The randomization process is done before starting the study and by someone who is not in the research team. After the primitive assessment by the researcher, the numbered pockets are given to the subjects with the match numbers. Finally, after entering to the treatment sections the researcher choose the treatment plane due to the numbers in the pockets, Blinding description: Each patient does not know anything the other patient's type of treatment. N/A . Intervention 1: Control group: For people in this group, the "TENS" treatment is done using the Germany-based 5820SL BTL device and exercise therapy. The sessions are held every other day between 13 and 17 . in each session,Therapy is used for 30 minutes of TENS (fifteen minutes of current with {high frequency; 100 Hz and pulse duration of 40 μs}, and fifteen minutes of low frequency{ 5 Hz and pulse duration of 300μs }). There is no specific sequencing for the use of high and low frequencies for patients. The device used is the same for all people and uses a 60x80mm electrodes in this study. The location of the electrodes for patients can be variable, but their best position is on the site of pain. Therapeutic exercises in this study includes stretching exercises and core stability exercises. Stretching exercises include stretching of the lower limbs hamstrings, stretching of the quadratos lumbar muscle in both sides, knee extension to the chest with one leg and two legs. Each tensile exercise is repeated 10 times and kept for 10 seconds. The number of stretching training sets is set to 3. The core stability exercises include posterior hip tilt in supine position, cat and camel training in quadriceps and hands and feet lifting exercises in the four-legged position. The parameters of core stability exercises are the same with stretching exercises. People are also asked to repeat the exercises 2 or 3 times a day at intervals between therapeutic sessions. Intervention 2: Intervention group: For groups of recreational activities, previous interventions are exactly the same as the routine treatment group, and after that, 30 minutes of fixed cycling activity is added to the program. Tolerable intensity cycling is done in the way that the patient will perform 50 to 80 cycles per minute on the bike. The fixed bike seat is adjusted so that the knee joint does not reach its full extension and remains at 10 ° F. The fixed bike used in this study was manufactured by Horizon USA. 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 the researcher of this study Mahan Sahahrooie by email. Email address: mahansh70@yahoo.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 Mahan Shahrooie
Rehabilitation Facualty of Iran University of Medical Science,Madadkaran alley, Shahnazari street, Madar Square , Mirdamad Boulevard
Tehran Iran (Islamic Republic of) 4391-15875 +98 21 2222 2059 mahansh70@yahoo.com Iran University of Medical Sciences scientific Mohamadreza Pourahmadi
Rehabilitation Facualty of Iran University of Medical Science,Madadkaran alley, Shahnazari street, Madar Square , Mirdamad Boulevard
Tehran Iran (Islamic Republic of) 4391-15875 +98 21 2222 2059 pourahmadipt@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Patient Without any Precaution or Contraindication to Do Exercise Therapy Pain Between Twelfth Rib and Inferior Gluteal Fold in More Than Three Months and Without any Specific Reason Pain Intensity Between 30-60 in Rest Position for the 0-100 Pain Scale Normal Body Mass Index 20 years 55 years Both Acute Low Back Pain (Less Than 3 Months) Bone Anomalies in Lumbar and Hip Region (Such as Scoliosis Pregnancy Central or Peripheral Nerve Diseases Self Immune and Systemic Diseases Lumbar Discopathy with Radicular Pain in Lower Limb New Trum Rehabilitation Rehabilitation Control group: For people in this group, the "TENS" treatment is done using the Germany-based 5820SL BTL device and exercise therapy. The sessions are held every other day between 13 and 17 . in each session,Therapy is used for 30 minutes of TENS (fifteen minutes of current with {high frequency; 100 Hz and pulse duration of 40 μs}, and fifteen minutes of low frequency{ 5 Hz and pulse duration of 300μs }). There is no specific sequencing for the use of high and low frequencies for patients. The device used is the same for all people and uses a 60x80mm electrodes in this study. The location of the electrodes for patients can be variable, but their best position is on the site of pain. Therapeutic exercises in this study includes stretching exercises and core stability exercises. Stretching exercises include stretching of the lower limbs hamstrings, stretching of the quadratos lumbar muscle in both sides, knee extension to the chest with one leg and two legs. Each tensile exercise is repeated 10 times and kept for 10 seconds. The number of stretching training sets is set to 3. The core stability exercises include posterior hip tilt in supine position, cat and camel training in quadriceps and hands and feet lifting exercises in the four-legged position. The parameters of core stability exercises are the same with stretching exercises. People are also asked to repeat the exercises 2 or 3 times a day at intervals between therapeutic sessions. Intervention group: For groups of recreational activities, previous interventions are exactly the same as the routine treatment group, and after that, 30 minutes of fixed cycling activity is added to the program. Tolerable intensity cycling is done in the way that the patient will perform 50 to 80 cycles per minute on the bike. The fixed bike seat is adjusted so that the knee joint does not reach its full extension and remains at 10 ° F. The fixed bike used in this study was manufactured by Horizon USA. Functional Ability. Timepoint: Before the Start of the Treatment Period and After it is Completed (Within 4 Weeks). Method of measurement: Roland Morris Questionnaire Star Excursion Test Side hop test Single hop test. Pain. Timepoint: Before the Start of the Treatment Period and After it is Completed (Within 4 Weeks). Method of measurement: Linear Pain Measurement Score. Iran University of Medical Sciences Approved 2019-07-01 National Ethics Committee for Biomedical Research Thirteenth floor, block A, Central Headquarters of the Ministry of Health and Medical Education, Between South Falamak and Zarafshan ,Simaye Iran Street, Ghods(West) Town,Tehran , Iran Tehran Tehran Iran (Islamic Republic of)