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IRCT20220206053950N1 IRCT 2022-05-07 Zanjan University of Medical Sciences Effectiveness of Isometric Exercises on Disability and Pain Effectiveness of Isometric Exercises on Disability and Pain of Cervical Spondylosis 2017-01-04 anticipated 22 Complete https://irct.ir/trial/61748 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Exercise therapy group performs home-based neck isometric strengthening exercises 6 days a week for 4 consecutive weeks as 3 sets/day (morning, afternoon, evening), Each set consists of 6 movements, holding each movement for 10 seconds, and repeating each 5 times with a 5-second rest between each of them, Randomization description: Microsoft Excel program was used to allocate participants randomly to each group using Blocked randomization with randomly varying blocks (block size 4 and 8). Concealed opaque envelopes identifying the assignments to each group were randomly chosen by participants, Blinding description: Initially, the outcome assessor, who is blind to the allocation of the study groups, evaluated all study participants in terms of clinical outcomes. Participants then go to the therapist with an envelope containing their random allocation for intervention. The therapist is an experienced physiotherapist and exercise therapist who is not blind group allocations. The therapist is not involved in other parts of the study. Then, depending on the allocation of the participants, the therapist either teaches them the exercises (intervention group) or does not teach them (control group). After four weeks, the clinical outcomes are re-evaluated by the same clinical outcome assessor and the data are collected and made available to data analysts who are blind to group allocations. It should be noted that, given the nature of the intervention, which is a type of exercise therapy, and the fact that the control group did not receive any intervention, it was naturally not possible to blind the participants and the therapist during the clinical trial. N/A Cervical spondylosis. Intervention 1: Intervention group: received home-based neck isometric strengthening exercises 6 days a week for 4 consecutive weeks as 3 sets/day (morning, afternoon, evening), Each set consisted of 6 movements, holding each movement for 10 seconds, and repeating each 5 times with a 5-second rest between each of them. Intervention 2: Control group: did not receive the intervention during this period. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information.
public Mina Rostami
No. 4511, Helal 1Alley, Avesta Ave., Phase 3, Golshahr Town
Zanjan Iran (Islamic Republic of) 4514151659 +98 991 207 7996 mina.rostami1373@gmail.com Zanjan University of Medical Sciences scientific Mina Rostami
No. 4511, Helal 1Alley, Avesta Ave., Phase 3, Golshahr Town
Zanjan Iran (Islamic Republic of) 4514151659 +98 991 207 7996 mina.rostami1373@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Patients >18 years Clinical findings of cervical spondylosis (mild to moderate) such as stiffness, chronic neck weakness, radicular or non-radicular neck pain Chronic pain (at least 3 months) Without acute cervical nerve root compression Without surgical indications With a physical examination compatible with cervical spondylosis and with signs on cervical magnetic resonance imaging (MRI) compatible with cervical spondylosis Not receiving exercise therapy or physiotherapy during the 6 weeks prior to the study 18 years no limit Both A history of neck surgery over the past year A history of inflammatory diseases involving the neck joints myelopathy A history of fractures or dislocations of the cervical vertebrae Pregnant women Either patients who did not have a good compliance with the intervention or had difficulty following the study A history of myelopathy M47.812 Spondylosis without myelopathy or radiculopathy, cervical region Rehabilitation N/A Intervention group: received home-based neck isometric strengthening exercises 6 days a week for 4 consecutive weeks as 3 sets/day (morning, afternoon, evening), Each set consisted of 6 movements, holding each movement for 10 seconds, and repeating each 5 times with a 5-second rest between each of them. Control group: did not receive the intervention during this period. Cervical disability score on the Neck Disability Index (NDI). Timepoint: At the beginning of the study (before the intervention) and 4 weeks after the initiation of the exercise therapy. Method of measurement: Neck Disability Index (NDI) score. Neck Pain score on the Neck Pain and Disability Scale (NPAD). Timepoint: At the beginning of the study (before the intervention) and 4 weeks after the initiation of the exercise therapy. Method of measurement: The Neck Pain and Disability Scale (NPAD). Zanjan University of Medical Sciences Approved 2016-12-20 Ethics committee of Zanjan University of Medical Sciences Room No. 22, First Floor, Ethics Committee in Biomedical, Vice-Chancellor for Research and Technology, Azadi Blvd., Zanjan Zanjan Zanjan Iran (Islamic Republic of)