Clinical trial NCT06076174: Effects of 6-week Telerehabilitation Exercise Programme on Chronic Non-specific Neck Pain
Official title: Effects of 6-week Telerehabilitation Exercise Programme on Chronic Non-specific Neck Pain: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-specific Neck Pain
Lead sponsor: University of Sharjah
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* residents of UAE, both males and females
* aged between 18 45
* have normal BMI
* referred to physiotherapy for chronic non-specific neck pain
* minimum pain score of 3cm on the VAS
* pain onset at least 3 weeks ago
* have given informed consent for voluntary participation.

Exclusion Criteria:

* diagnosed by a physician with any pathological condition as cause of chronic neck pain
* presently undergoing any physical treatment or taking any medication for said pain
* has comorbidities, such as diabetes and hypertension
* has conditions like migraine and cervicogenic headache
* has vertigo and/or vertebrobasilar insufficiency,
* physically disabled or has recent immobilizing injury
* orthopaedic conditions, such as spondylosis, spondylolisthesis, wryneck
* history of neurological conditions.

Primary outcomes:
measure: Adherence
timeFrame: pre and immediately post intervention, 6 weeks
measure: Adherence
timeFrame: pre and immediately post intervention, 6 weeks
Secondary outcomes:
measure: Visual Analogue Scale for Pain
timeFrame: pre and immediately post intervention, 6 weeks
measure: Neck Disability Index questionnaire
timeFrame: pre and immediately post intervention, 6 weeks
measure: CROM instrument
timeFrame: pre and immediately post intervention, 6 weeks
measure: Cranio-cervical Flexion Test
timeFrame: pre and immediately post intervention, 6 weeks
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: Univeristy of Sharjah
Study officials:
References: