NCT06076174

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2024

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2024

Completed
Last Updated

April 15, 2024

Status Verified

April 1, 2024

Enrollment Period

6 months

First QC Date

September 21, 2023

Last Update Submit

April 11, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Visual Analogue Scale for Pain

    pre and immediately post intervention, 6 weeks

  • Neck Disability Index questionnaire

    pre and immediately post intervention, 6 weeks

  • CROM instrument

    pre and immediately post intervention, 6 weeks

  • Cranio-cervical Flexion Test

    pre and immediately post intervention, 6 weeks

Study Arms (2)

Tele-rehab

EXPERIMENTAL

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

Conventional

ACTIVE COMPARATOR

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

Interventions

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.

ConventionalTele-rehab

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univeristy of Sharjah

Sharjah city, United Arab Emirates

Location

Related Publications (1)

  • Ahmed ZZ, Khan MN, Bairapareddy KC. Randomised controlled trial assessing the effects of 6-week telerehabilitation exercise programme on chronic non-specific neck pain: a study protocol. BMJ Open Sport Exerc Med. 2024 Feb 26;10(1):e001874. doi: 10.1136/bmjsem-2023-001874. eCollection 2024.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Teaching Assistant

Study Record Dates

First Submitted

September 21, 2023

First Posted

October 10, 2023

Study Start

September 11, 2023

Primary Completion

March 14, 2024

Study Completion

April 4, 2024

Last Updated

April 15, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations