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IRCT20181219042055N2 IRCT 2022-07-05 Iran University of Medical Sciences Comparison of the effect of two methods of prescribing exercise on neck pain - A comparative study of the effectiveness of clinically-supervised and internet-based exercise therapy on pain, muscle thickness and endurance and head posture in females with chronic non-specific neck pain 2022-05-22 anticipated 44 Complete https://irct.ir/trial/60711 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: -, Randomization description: Randomization method: Eligible patients were randomized in blocks of four, into the following groups: A: exercise therapy in clinic B: online exercise therapy Randomization tool: Random assignment in groups is done applying the website of "www.randomization.com" (seed 23226) and then in order of entering the study, the participant is allocated to one of the groups of A (supervised exercise therapy) or B (Internet-based exercise therapy) as arranged above. The random sequence has been made online. For allocation concealment the above sequence is only at the disposal of the main researcher and the group assigned to each patient is determined by them after the participant has entered the study. In this study, in order for patients not to be informed about the other group's exercise therapy method, group A patients are treated on even days and group B patients are treated on odd days. It should be noted that the exercise therapy sessions are supervised by a sports medicine resident. Evaluations in hospital, before and after interventions, are performed by another resident who is unaware of the presence of patients in the groups, Blinding description: Of the three main groups involved in researches, including participants, administrators and evaluators, there is only the possibility of blinding for the group of evaluators in this study. As it is not feasible to blind participants to the method of prescribing exercise therapy, the patient is aware of it (in clinic or online). The researcher who is in charge of prescribing and supervising the exercise therapy sessions also knows how people are assigned to different groups, and the researcher prescribes specific exercises to each participant. The third group, i.e. evaluators, including the initial and outcome assessor, data analyzer, as well as the data and safety monitoring board, will not be informed of the method of exercise training in this study; and the data will be provided to them in groups of A and B. N/A Chronic non-specific neck pain. Intervention 1: Intervention group 1: Exercise therapy under the supervision in the sports medicine clinic that includes 18 training sessions, 3 days a week for 6 weeks; and will be done in 3 different phases based on progressive increase of workload . Each phase lasts two weeks and at the end the second week, the exercises of the next phase is added. All sessions start with a warm-up in the form of walking and simultaneously moving the head and neck to the sides, flexion and extension, and rotating the neck to both sides. Step 1 (1-The participant, while sitting, tries to performed the chin tuck without raising her head and maintaining this position for 10 seconds. 2- The participant, while lying down in a supine position, places a towel in the form of a tube in the space between the neck and the table and try to squeeze the towel and maintain this position for 10 seconds). step 2 (1-The participant, lying in supine position, performs the chin tuck position then lifting the head off the table and holding it for 10 seconds. 2- The participant is placed on all fours and flex her head and look at their knees and hold for 10 seconds, then raise the head up to 30 degrees extension and stare at the point between the two hands and hold this position for 10 seconds). step 3 (1- Using an elastic band, while applying a force from back to front, the person moves the head to the extension position and holds for 10 seconds. 2- The person uses an elastic band while applying a force from the front of the head to back, moves the head to the flexion position and holds for 10 seconds) Each set includes 10 repetitions. Intervention 2: Intervention group 2: Internet-based exercise therapy that initially internet and mobile messaging applications access will be checked. For the IET group, exercise therapy guidelines with videos of how to perform exercises are made ready; the first phase of which will be delivered to them after pre-intervention evaluation. Each phase lasts two weeks and at the end of the second week, the exercises of the next phase is added. They will be asked to perform their exercise therapy protocol three days a week for six weeks (18 sessions totally) similar to the other group . If the patient has any questions about the exercises, she can ask online. The details and sequence of prescribing exercises are the same as in intervention group 1. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Needs more consultation and scheduling
public Sara Lotfian
Hazrate Rasoole Akram Hospital, Niyayesh Street, Sattarkhan Avenue
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2446 saralotfiyan@yahoo.com Iran University of Medical Sciences scientific Sara Lotfian
Hazrate Rasoole Akram Hospital, Niyayesh Street, Sattarkhan Avenue
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6435 2446 saralotfiyan@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Having non-specific chronic neck pain (persistent neck pain for at least three months and with an intensity of at least 3 according to VAS criteria) female Age 18- 65 years Body mass index equal to or less than 30 Balanced mood Ability to access the Internet and other communication tools Consent to participate in the trial 18 years 65 years Female Existence of acute traumatic injury in the spine approved by a specialist Existence of a history of surgery or previous lesion of the neck and other joints of the upper limbs during a recent year Pregnancy Simultaneous pain in the shoulder joint Existence of new fractures in the upper limbs during a recent year Suffering from malignant tumors Inflammatory diseases such as ankylosing spondylitis, rheumatoid arthritis, fibromyalgia, myelopathy and cervical radiculopathy Participate in exercise therapy, manipulation, acupuncture and physiotherapy programs during the last three months Congenital spinal deformity M54.2 Cervicalgia Treatment - Other Treatment - Other Intervention group 1: Exercise therapy under the supervision in the sports medicine clinic that includes 18 training sessions, 3 days a week for 6 weeks; and will be done in 3 different phases based on progressive increase of workload . Each phase lasts two weeks and at the end the second week, the exercises of the next phase is added. All sessions start with a warm-up in the form of walking and simultaneously moving the head and neck to the sides, flexion and extension, and rotating the neck to both sides. Step 1 (1-The participant, while sitting, tries to performed the chin tuck without raising her head and maintaining this position for 10 seconds. 2- The participant, while lying down in a supine position, places a towel in the form of a tube in the space between the neck and the table and try to squeeze the towel and maintain this position for 10 seconds). step 2 (1-The participant, lying in supine position, performs the chin tuck position then lifting the head off the table and holding it for 10 seconds. 2- The participant is placed on all fours and flex her head and look at their knees and hold for 10 seconds, then raise the head up to 30 degrees extension and stare at the point between the two hands and hold this position for 10 seconds). step 3 (1- Using an elastic band, while applying a force from back to front, the person moves the head to the extension position and holds for 10 seconds. 2- The person uses an elastic band while applying a force from the front of the head to back, moves the head to the flexion position and holds for 10 seconds) Each set includes 10 repetitions. Intervention group 2: Internet-based exercise therapy that initially internet and mobile messaging applications access will be checked. For the IET group, exercise therapy guidelines with videos of how to perform exercises are made ready; the first phase of which will be delivered to them after pre-intervention evaluation. Each phase lasts two weeks and at the end of the second week, the exercises of the next phase is added. They will be asked to perform their exercise therapy protocol three days a week for six weeks (18 sessions totally) similar to the other group . If the patient has any questions about the exercises, she can ask online. The details and sequence of prescribing exercises are the same as in intervention group 1. Neck pain. Timepoint: Before and after the intervention (6 weeks). Method of measurement: Visual analogue scale. Thickness of neck muscles. Timepoint: Before and after the intervention (6 weeks). Method of measurement: Ultrasound device. Neck muscle endurance. Timepoint: Before and after the intervention (6 weeks). Method of measurement: Cervical flexor and extensor muscles endurance tests. Head posture. Timepoint: Before and after the intervention (6 weeks). Method of measurement: measurement of craniovertebral angle. Neck disability. Timepoint: Before and after treatment intervention (6 weeks later). Method of measurement: Neck Disability Index Questionnaire. Iran University of Medical Sciences Approved 2021-11-28 Ethics Committee of School of Medicine of Iran University of Medical Sciences 3th Floor of School of Medicine, Shahid Hemmat Highway (between Sheikh Fazlollah and Shahid Chamran Intersection) Tehran Tehran Iran (Islamic Republic of)