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Clinical Trial Summary

This study will be a pilot randomized controlled trial, comparing the effectiveness of two modes of delivery of the same 6-week exercise program for chronic non-specific neck pain. The first group will be monitored via the software that records each session so the therapist can review, and the second will have written instructions on paper to follow through by them themselves. Pre-test and post-test measurements (pain score, disability index, cervical ROM, cervical muscle endurance) will be taken, before and after completion of the exercise programme.


Clinical Trial Description

Following ethical approval from UOS Research Ethics Committee, data collection will begin. E-posters will be sent out as recruitment announcement and those who willingly volunteer and fit the inclusion criteria will be selected. Once they sign the digital informed consent form, which will be created via Microsoft Forms, they will be randomized into either telerehabilitation group or conventional group. Randomization will be done using permuted block method, with treatment allocation concealed. Baseline measurements from all participants will be obtained, by physiotherapist, prior to start of the exercise programme: VAS pain socre, NDI score, CROM (flexion, extension, lateral flexion, rotation) and cervical muscle endurance. All participants will have an in-person session with the physiotherapist for exercise demonstration before beginning the programme. They will carry out the exercises independently at home over a period of six weeks, thrice a week, giving a total of 18 sessions, each lasting 30 minutes. The software group will do each session via the CareSpace software that will record and store the entirety of the session on cloud giving the therapist access to review it. The conventional group will be given a flyer with written instructions. After two weeks, the physiotherapist will hold the first review session with each participant, held online face-to-face for those in the software group (via ConnectToMyDoctor application) and over the telephone for those in the conventional group. Similarly, after four weeks, the second review session will be held. Progressions for exercises will be given to the participants at both review sessions. On completion of all 6 weeks of the exercise programme, post-test measurements will be carried out. For data analysis, The distribution of the data will be analyzed with Shapiro-Wilks's test. Descriptive analyses will be used for the calculation of frequencies, means, and standard deviations. For baseline differences between groups, independent samples t- test will be used. Repeated measures ANOVA will be used for within-group and between-group analyses at three different time points (0 week, 3 weeks, 6 weeks). A p value below 0.05 will be considered significant. Statistical analyses will done using SPSS version 26.0 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06076174
Study type Interventional
Source University of Sharjah
Contact
Status Completed
Phase N/A
Start date September 11, 2023
Completion date April 4, 2024