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

Primary Purpose

Non-specific Neck Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
6-week home-based exercise programme
Sponsored by
University of Sharjah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-specific Neck Pain

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Univeristy of Sharjah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tele-rehab

Conventional

Arm Description

6-week home-based exercise programme, will be monitored via the software that records each session so the therapist can review

6-week home-based exercise programme, will have written instructions on paper to follow through by participant themselves

Outcomes

Primary Outcome Measures

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.
Adherence
Duration of each session will be noted through exercise diary fro conventional group, and recordings on cloud for tele rehab group.

Secondary Outcome Measures

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.
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.
CROM instrument
Cervical range of motion
Cranio-cervical Flexion Test
Cervical muscle endurance assessed by therapist

Full Information

First Posted
September 21, 2023
Last Updated
October 6, 2023
Sponsor
University of Sharjah
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1. Study Identification

Unique Protocol Identification Number
NCT06076174
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sharjah

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele-rehab
Arm Type
Experimental
Arm Description
6-week home-based exercise programme, will be monitored via the software that records each session so the therapist can review
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
6-week home-based exercise programme, will have written instructions on paper to follow through by participant themselves
Intervention Type
Other
Intervention Name(s)
6-week home-based exercise programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adherence
Description
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.
Time Frame
pre and immediately post intervention, 6 weeks
Title
Adherence
Description
Duration of each session will be noted through exercise diary fro conventional group, and recordings on cloud for tele rehab group.
Time Frame
pre and immediately post intervention, 6 weeks
Secondary Outcome Measure Information:
Title
Visual Analogue Scale for Pain
Description
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.
Time Frame
pre and immediately post intervention, 6 weeks
Title
Neck Disability Index questionnaire
Description
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.
Time Frame
pre and immediately post intervention, 6 weeks
Title
CROM instrument
Description
Cervical range of motion
Time Frame
pre and immediately post intervention, 6 weeks
Title
Cranio-cervical Flexion Test
Description
Cervical muscle endurance assessed by therapist
Time Frame
pre and immediately post intervention, 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Univeristy of Sharjah
City
Sharjah
Country
United Arab Emirates
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kalyana Reddy
Phone
+97165057519
Ext
7519
Email
kreddy@sharjah.ac.ae

12. IPD Sharing Statement

Plan to Share IPD
No

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

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