Non-specific Neck PainNCT06076174
Effects of 6-week Telerehabilitation Exercise Programme on Chronic Non-specific Neck Pain
A study testing 6-week home-based exercise programme in people with Non-specific Neck Pain, run by University of Sharjah at 1 site in United Arab Emirates.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-specific Neck Pain
- What is being tested?
- 6-week home-based exercise programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 11 Sep 2023to 4 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Non-specific Neck Pain
- Being tested
- 6-week home-based exercise programme
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-week home-based exercise programmeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Tele-rehab | Experimental | 6-week home-based exercise programme, will be monitored via the software that records each session so the therapist can review Receives: 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 Receives: Other: 6-week home-based exercise programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: pre and immediately post intervention, 6 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: pre and immediately post intervention, 6 weeks
CROM instrument
Cervical range of motion
Measured: pre and immediately post intervention, 6 weeks
Cranio-cervical Flexion Test
Cervical muscle endurance assessed by therapist
Measured: pre and immediately post intervention, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start11 Sep 2023
- Primary completion14 Mar 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-specific Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sharjah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaina Ahmed, University of Sharjah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06076174
- Sponsor's protocol ID
- REC-23-02-27-01-PG
- Status last verified
- Apr 2024
- First submitted
- 21 Sep 2023
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38420117
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 6-week Telerehabilitation Exercise Programme on Chronic Non-specific Neck Pain: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06076174
- Acronym / sponsor ID
- REC-23-02-27-01-PG
- Conditions
- Non-specific Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SharjahUniversity, hospital or other
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 10 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-rehab | Experimental | Other: 6-week home-based exercise programme6-week home-based exercise programme, will be monitored via the software that records each session so the therapist can review |
| Conventional | Active comparator | Other: 6-week home-based exercise programme6-week home-based exercise programme, will have written instructions on paper to follow through by participant themselves |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-week home-based exercise programmeAll 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. | Other | Conventional, Tele-rehab |
Primary outcome
Adherence
Time frame: pre and immediately post intervention, 6 weeks
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
Time frame: pre and immediately post intervention, 6 weeks
Duration of each session will be noted through exercise diary fro conventional group, and recordings on cloud for tele rehab group.
4 secondary outcomes
Visual Analogue Scale for Pain
Time frame: pre and immediately post intervention, 6 weeks
Neck Disability Index questionnaire
Time frame: pre and immediately post intervention, 6 weeks
CROM instrument
Time frame: pre and immediately post intervention, 6 weeks
Cranio-cervical Flexion Test
Time frame: pre and immediately post intervention, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Derived from this study: PubMed 38420117Ahmed 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-week home-based exercise programme in people with Non-specific Neck Pain, run by University of Sharjah at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence (time frame: pre and immediately post intervention, 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06076174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.