Effects of 6-week Telerehabilitation Exercise Programme on Chronic Non-specific Neck Pain

Effects of 6-week Telerehabilitation Exercise Programme on Chronic Non-specific Neck Pain: a Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Non-specific Neck Pain
• Intervention / Treatment: Other: 6-week home-based 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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Arab Emirates
  • Sharjah, United Arab Emirates
    • Univeristy of Sharjah
    • Contact: Kalyana Reddy; Phone Number: 7519 +97165057519; Email: kreddy@sharjah.ac.ae

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-rehab; 6-week home-based exercise programme, will be monitored via the software that records each session so the therapist can review	Other: 6-week home-based exercise programme; 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.
Active Comparator: Conventional; 6-week home-based exercise programme, will have written instructions on paper to follow through by participant themselves	Other: 6-week home-based exercise programme; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Frequency per week (Number of sessions completed each week) will be noted through exercise diary fro conventional group, and recordings on cloud for tele rehab group.	pre and immediately post intervention, 6 weeks
Adherence	Duration of each session will be noted through exercise diary fro conventional group, and recordings on cloud for tele rehab group.	pre and immediately post intervention, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale for Pain	Visual Analogue Scale for Pain (VAS Pain) is a continuous scale in the form of a 100mm line, marked by "no pain" (score of 0) on one end and "pain as bad as it could be" (score of 100) on the other end.	pre and immediately post intervention, 6 weeks
Neck Disability Index questionnaire	It consists of 10 items, each scored from 0 - 5, giving a total out of 50, where a higher score is indicative of increased disability.	pre and immediately post intervention, 6 weeks
CROM instrument	Cervical range of motion	pre and immediately post intervention, 6 weeks
Cranio-cervical Flexion Test	Cervical muscle endurance assessed by therapist	pre and immediately post intervention, 6 weeks

Collaborators and Investigators

• Sponsor: University of Sharjah

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Actual): March 14, 2024
• Study Completion (Actual): April 4, 2024

Study Registration Dates

• First Submitted: September 21, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: REC-23-02-27-01-PG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No