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IRCT20150210021034N6 IRCT 2020-02-06 University of Isfahan Effects of therapeutic game for neck pain The effects of an exergame on the pain and muscle strength in people with neck osteoarthritis 2018-12-22 anticipated 30 Complete https://irct.ir/trial/43067 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The randomization was stratified by severity of the lesion (mild/moderate) to pursue equal distribution of the degrees of severity for both intervention and control groups. Randomization in each stratum was carried out by having a piece of paper that has the phrase "intervention (exergame+physiotherapy)" and "control (hand exercise+physiotherapy)" placed inside an envelope. The outside of the envelops were sequentially numbered. After participants have been enrolled in the study and consented, a sequence number envelope on the stack will be randomly drawn and opened to determine the study group that the participant will enter. N/A People with grade 2 (mild) and grade 3 (moderate) cervical spondylosis. Intervention 1: Intervention group: The conventional physiotherapy modalities were delivered with isometric exercise through the computerized game (exergame). The conventional physiotherapy included heating through a towel at 74 degrees of Celsius, transcutaneous electrical stimulation (pulse duration:100-110 ms; frequency: 70-80 Hz), ultrasound modality (pulse wave with intensity of 1.25-1.5 W/cm2; duration: 5 min), and stretching of the upper trapezius muscle (10-30 seconds; 3-5 repeats). The exergame included software and a glove as a controller of the game. The isometric neck exercises are carried out while the patient was playing the game. The hand pressure against the head was applied in four directions. This pressure was holding 10 seconds to control the motion of the game character in the game's path. Intervention 2: Control group: The conventional physiotherapy protocols for neck pain followed with hand-resisted isometric exercise. The conventional physiotherapy was the same as explained for the exergame group. The participants were instructed to apply pressure by their hand against the head and hold it for 10 s in four directions. Each pressure repeated five times, and two minutes rest was given after each exercise set. People carried out the exercise three times a day and repeated it every other day. Yes - There is a plan to make this available What will be shared: The study data (excluding the personal details) can be shred with other researchers or systematic reviewers. When: No limit was set. To whom: No specific limitation is considered. Conditions: No terms and conditions is considered for sharing the data. Where to obtain: People can sent their request to the correspondence and obtain the data. How to obtain: Request can be sent through an email. Comments:
public Ebrahim Sadeghi
Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 81746-73461 0098 31 7925235 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Ebrahim Sadeghi
Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 914 044 8890 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) People with clinical symptoms of mild and moderate neck osteoarthritis Neck pain (if pain is scored at least 3 on visual analouge scale) Muscle spasm Sensory loss in the arm Shoulder or scapular muscles pain 27 years no limit Both People with severe neck osteoarthritis Canal stenosis A history of vertebral fracture Severe osteoporosis Rheumatoid arthritis Neurological disease Cardiovascular disease Pregnancy Spinal deformities M43.02 Spondylolysis, cervical region Rehabilitation Rehabilitation Intervention group: The conventional physiotherapy modalities were delivered with isometric exercise through the computerized game (exergame). The conventional physiotherapy included heating through a towel at 74 degrees of Celsius, transcutaneous electrical stimulation (pulse duration:100-110 ms; frequency: 70-80 Hz), ultrasound modality (pulse wave with intensity of 1.25-1.5 W/cm2; duration: 5 min), and stretching of the upper trapezius muscle (10-30 seconds; 3-5 repeats). The exergame included software and a glove as a controller of the game. The isometric neck exercises are carried out while the patient was playing the game. The hand pressure against the head was applied in four directions. This pressure was holding 10 seconds to control the motion of the game character in the game's path. Control group: The conventional physiotherapy protocols for neck pain followed with hand-resisted isometric exercise. The conventional physiotherapy was the same as explained for the exergame group. The participants were instructed to apply pressure by their hand against the head and hold it for 10 s in four directions. Each pressure repeated five times, and two minutes rest was given after each exercise set. People carried out the exercise three times a day and repeated it every other day. Neck function. Timepoint: The outcome was measured in three time intervals: before starting the exercise, after the last session of the exercise, and one month after finishing the exercise sessions. Method of measurement: Neck was assessed using the "Neck disability index". Pain intensity. Timepoint: The outcome was measured in three time intervals: before starting the exercise, after the last session of the exercise, and one month after finishing the exercise sessions. Method of measurement: Pain intensity was measured using "visual analogue scale". Isometric strength of neck muscles. Timepoint: The outcome was measured in three time intervals: before starting the exercise, after the last session of the exercise, and one month after finishing the exercise sessions. Method of measurement: The isometric strength of neck muscles were measured using a digital force dynamometer. University of Isfahan Approved 2019-11-06 Ethics committee of University of Esfahan Daneshgah Blvd Isfahan Isfehan Iran (Islamic Republic of)