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IRCT20200708048058N1 IRCT 2020-08-02 Tehran University of Medical Sciences Evaluation of the effectiveness of preventive exercise therapy on neck pain Comparison of the effectiveness of preventive exercise therapy delivered by health care providers with the control group on the incidence of neck pain in adults 2020-09-22 anticipated 4000 Complete https://irct.ir/trial/49644 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In order to prevent statistical contamination, randomization will be done in the cluster form at the level of health bases. Eight health bases with equal coverage population will enter simple randomization processes in Excel software and will be divided into two groups of control and exercise intervention. The randomization method is simple randomization, the unit is cluster randomization, and non-stratified randomization is used to better represent the reality of our target community. In this study, Excel statistical software will be used for randomization, Blinding description: In this study, considering the type of intervention (exercise), blinding cannot be carried out on the participants and the health care providers (who are responsible for educating people and collecting data). The data analyst is blinded to the grouping of each individual. N/A Neck pain. Intervention 1: Control group: Without exercise intervention. Participants will be followed by health care providers and relevant data (incidence, prevalence, disability and the costs of treating neck pain) will be collected from them. Intervention 2: Intervention group: Neck exercise group, a sum of 10 simple stretch and strength exercises to strengthen the neck muscles and stabilize the posture which are practicable by the public at home, without any tools, while standing, sitting, and laying down. The training will emphasize on the neck's motion in different directions and also necks stability against force. These exercises, which will be taught to primary health care providers by Sports medicine specialists before the trial begins, will be taught to the Intervention group by primary health care providers in one session interviews, and pamphlets. This study aims to assess the effectiveness of exercises taught by the primary care providers to the study population. Yes - There is a plan to make this available What will be shared: Comparison of the effectiveness of preventive exercise therapy delivered by health care providers with the control group on the incidence of neck pain in adults When: Starting in January 2022 for 5 years To whom: Researchers and policymakers in the field of public health and sports medicine Conditions: Systematic review/Meta-analysis Where to obtain: Tehran University of Medical Sciences (TUMS) Sports Medicine Research Center (SMRC) How to obtain: Contacting the author for correspondence with reasonable request Comments:
public Ramin Kordi
District 6, Jalal-e-Al-e-Ahmad Hwy, No. 7
Tehran` Iran (Islamic Republic of) 14395578 +98 21 8863 0227 ramin_kordi@tums.ac.ir Tehran University of Medical Sciences scientific Ramin Kordi
District 6, Jalal-e-Al-e-Ahmad Hwy, No. 7
Tehran Iran (Islamic Republic of) 14395578 +98 21 8863 0227 ramin_kordi@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Participants under the coverage of rural health network of Tehran University of Medical Sciences 18 to 60 year-old participants 18 years 60 years Both Diagnosed neoplasm Diagnosed remarkable psychiatric disorders Diagnosed cognitive impairment Unwillingness to participate/continue with participation M54.2 Cervicalgia (Neck pain) N/A Prevention Control group: Without exercise intervention. Participants will be followed by health care providers and relevant data (incidence, prevalence, disability and the costs of treating neck pain) will be collected from them. Intervention group: Neck exercise group, a sum of 10 simple stretch and strength exercises to strengthen the neck muscles and stabilize the posture which are practicable by the public at home, without any tools, while standing, sitting, and laying down. The training will emphasize on the neck's motion in different directions and also necks stability against force. These exercises, which will be taught to primary health care providers by Sports medicine specialists before the trial begins, will be taught to the Intervention group by primary health care providers in one session interviews, and pamphlets. This study aims to assess the effectiveness of exercises taught by the primary care providers to the study population. Neck pain incidence. Timepoint: after 12 months since first visit. Method of measurement: Translated Neck pain and disability score (NPDS) questionnaires and participants' electronic health records (SIB). Disability caused by neck pain. Timepoint: after 3, 6, and12 months since first visit. Method of measurement: NPDS questionnaire. Treatment cost. Timepoint: after 12 months since first visit. Method of measurement: Participants' electronic health records (SIB). Prevalence of neck pain. Timepoint: after 3, 6, and12 months since first visit. Method of measurement: NPDS questionnaire. Tehran University of Medical Sciences Approved 2018-05-22 Vice-chancellor in research affairs- Tehran University of Medical Sciences Keshavarz Blv. Tehran, Iran Tehran Tehran Iran (Islamic Republic of)