Cervical SpondylosisNCT05920564
Upper Trapezius Stretching in Patients With Cervical Spondylosis
A study testing Upper fibers of trapezius stretching in people with Cervical Spondylosis, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
This study aims to investigate the effectiveness of upper trapezius stretching exercises on pain intensity, neck range of motion, and disability in patients with cervical spondylosis. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Cervical Spondylosis
- What is being tested?
- Upper fibers of trapezius stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Jun 2023to 1 Mar 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cervical spondylosis confirmed by orthopedic specialist
- Presence of neck pain for at least 3 months
- willingness to participate in the study and comply with the intervention
Who cannot join
- Recent neck trauma or fractures (within 6 months)
- Previous neck surgery
- Concurrent medical conditions that could affect neck pain and range of motion (e.g. rheumatoid arthritis)
- Concurrent physical therapy or rehabilitation for neck or shoulder
- Use of corticosteroids within past 3 months
- Pregnancy or serious circulatory conditions (due to use of heat pack)
- Known hypersensitivity to heat or cold
- Cognitive impairment that could interfere with ability to understand and complete self-report questionnaires and comply with interventions
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: Efficacy of Upper Trapezius Stretching on Neck Pain, Range of Motion and Disability in Patients With Cervical Spondylosis: A Randomised Controlled Trial
This study aims to investigate the effectiveness of upper trapezius stretching exercises on pain intensity, neck range of motion, and disability in patients with cervical spondylosis. Patients with diagnosed cervical spondylosis will be randomly assigned to either a study group performing upper trapezius stretches or a control group. Both groups will receive heat treatment and strengthening exercises. The study group will additionally perform specific upper trapezius stretching exercises. Outcomes measures will be assessed before and after 4 weeks of intervention and will include neck pain intensity, range of motion, and disability using the Neck Disability Index. The study hypothesizes that the study group will demonstrate greater improvements in pain, range of motion, and disability compared to the control group. The study findings could provide data to guide physical therapy management of cervical spondylosis.
- Conditions
- Cervical Spondylosis
- Being tested
- Upper fibers of trapezius stretching, Standard care
- Medical subject headings
- Spondylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper fibers of trapezius stretchingOther
The Upper fibers of trapezius stretching intervention involves specific stretching exercises designed to target the upper fibers of the trapezius muscle. The stretching exercises will be performed under the guidance of a licensed physical therapist and will involve extending the neck while gently pulling the head downward to stretch the upper fibers of the trapezius muscle. The intervention is designed to improve neck range of motion, reduce pain intensity, and reduce disability in patients with cervical spondylosis. The duration and frequency of the stretching exercises will be standardized across participants, and adherence will be monitored throughout the study period.
Standard careOther
The Control Group in this study will receive standard care, including heat treatment and strengthening exercises, but will not receive the specific Upper fibers of trapezius stretching intervention that is being tested in the Treatment Group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Other: Upper fibers of trapezius stretching; Other: Standard care |
| Control group | Active comparator | Not described Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Neck pain intensity
elf-reported pain intensity in the neck region using a numerical rating scale (NRS).
Measured: Changes in neck pain intensity at baseline and after 4 weeks of intervention and 3 months
Changes in Neck range of motion
Degree of neck flexion, extension, lateral flexion and rotation using a goniometer.
Measured: Changes in neck range of motion at baseline and after 4 weeks of intervention and 3 months
Secondary outcomes (1)
Changes in Neck Disability Index
Self-reported disability due to neck pain based on a 10-item questionnaire covering pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Scored from 0-50, higher scores indicate greater disability.
Measured: Changes in Neck Disability Index at baseline and after 4 weeks of intervention and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start28 Jun 2023 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical SpondylosisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study director, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920564
- Sponsor's protocol ID
- 012/7780002023
- Status last verified
- Jun 2023
- First submitted
- 17 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Upper Trapezius Stretching on Neck Pain, Range of Motion and Disability in Patients With Cervical Spondylosis: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05920564
- Acronym / sponsor ID
- 012/7780002023
- Conditions
- Cervical Spondylosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 28 Jun 2023 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 27 Jun 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 aims to investigate the effectiveness of upper trapezius stretching exercises on pain intensity, neck range of motion, and disability in patients with cervical spondylosis. Patients with diagnosed cervical spondylosis will be randomly assigned to either a study group performing upper trapezius stretches or a control group. Both groups will receive heat treatment and strengthening exercises. The study group will additionally perform specific upper trapezius stretching exercises. Outcomes measures will be assessed before and after 4 weeks of intervention and will include neck pain intensity, range of motion, and disability using the Neck Disability Index. The study hypothesizes that the study group will demonstrate greater improvements in pain, range of motion, and disability compared to the control group. The study findings could provide data to guide physical therapy management of cervical spondylosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Upper fibers of trapezius stretching, Other: Standard care |
| Control group | Active comparator | Other: Standard care |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of cervical spondylosis confirmed by orthopedic specialist
- Presence of neck pain for at least 3 months
- willingness to participate in the study and comply with the intervention
Key exclusion criteria (8 listed)
- Recent neck trauma or fractures (within 6 months)
- Previous neck surgery
- Concurrent medical conditions that could affect neck pain and range of motion (e.g. rheumatoid arthritis)
- Concurrent physical therapy or rehabilitation for neck or shoulder
- Use of corticosteroids within past 3 months
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 |
|---|---|---|
| Upper fibers of trapezius stretchingThe Upper fibers of trapezius stretching intervention involves specific stretching exercises designed to target the upper fibers of the trapezius muscle. The stretching exercises will be performed under the guidance of a licensed physical therapist and will involve extending the neck while gently pulling the head downward to stretch the upper fibers of the trapezius muscle. The intervention is designed to improve neck range of motion, reduce pain intensity, and reduce disability in patients with cervical spondylosis. The duration and frequency of the stretching exercises will be standardized across participants, and adherence will be monitored throughout the study period. | Other | Intervention group |
| Standard careThe Control Group in this study will receive standard care, including heat treatment and strengthening exercises, but will not receive the specific Upper fibers of trapezius stretching intervention that is being tested in the Treatment Group. | Other | Control group, Intervention group |
Primary outcome
Changes in Neck pain intensity
Time frame: Changes in neck pain intensity at baseline and after 4 weeks of intervention and 3 months
elf-reported pain intensity in the neck region using a numerical rating scale (NRS).
Changes in Neck range of motion
Time frame: Changes in neck range of motion at baseline and after 4 weeks of intervention and 3 months
Degree of neck flexion, extension, lateral flexion and rotation using a goniometer.
1 secondary outcome
Changes in Neck Disability Index
Time frame: Changes in Neck Disability Index at baseline and after 4 weeks of intervention and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- 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.
Amal Fawzy, Ph.d study director
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper fibers of trapezius stretching in people with Cervical Spondylosis, run by Ahram Canadian University at 1 site in Egypt.
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 3 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Neck pain intensity (time frame: Changes in neck pain intensity at baseline and after 4 weeks of intervention and 3 months). 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?
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 27 Jun 2023.