- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05920564
Upper Trapezius Stretching in Patients With Cervical Spondylosis
June 17, 2023 updated by: Mohamed Magdy ElMeligie, Ahram Canadian University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed M ElMeligie, Ph.d
- Phone Number: +201064442032
- Email: mohamed.elmeligie@acu.edu.eg
Study Locations
-
-
Giza
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Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
- Recruiting
- Outpatient clinic of faculty of physical therapy, Ahram Canadian University
-
Contact:
- Mohamed M ElMeligie, Ph.d
- Phone Number: 01064442032
- Email: mohamed.elmeligie@acu.edu.eg
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group
|
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.
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.
|
|
Active Comparator: Control group
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 pain intensity at baseline and after 4 weeks of intervention and 3 months
|
|
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.
|
Changes in neck range of motion at baseline and after 4 weeks of intervention and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in Neck Disability Index
Time Frame: Changes in Neck Disability Index at baseline and after 4 weeks of intervention and 3 months
|
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.
|
Changes in Neck Disability Index at baseline and after 4 weeks of intervention and 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
June 28, 2023
Primary Completion (Estimated)
March 1, 2024
Study Completion (Estimated)
March 1, 2024
Study Registration Dates
First Submitted
June 17, 2023
First Submitted That Met QC Criteria
June 17, 2023
First Posted (Actual)
June 27, 2023
Study Record Updates
Last Update Posted (Actual)
June 27, 2023
Last Update Submitted That Met QC Criteria
June 17, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 012/7780002023
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cervical Spondylosis
-
Wang YuchengUnknownCervical Spondylosis of Cervical TypeChina
-
Cairo UniversityNot yet recruiting
-
Shady Abdelsattar RefaatNot yet recruiting
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Xuanwu Hospital, BeijingRecruitingCervical SpondylosisChina
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Delta University for Science and TechnologyNot yet recruitingCervical Spondylosis
-
Shanghai University of Traditional Chinese MedicineRecruitingCervical SpondylosisChina
-
Shanghai University of Traditional Chinese MedicineCompletedCervical SpondylosisChina
-
Eastern Mediterranean UniversityCompletedCervical SpondylosisCyprus
-
Riphah International UniversityCompletedCervical SpondylosisPakistan
Clinical Trials on Upper fibers of trapezius stretching
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Riphah International UniversityCompleted
-
Sivas State HospitalRecruitingMyofascial Pain of Upper Trapezius MuscleTurkey (Türkiye)
-
University of AlcalaRecruiting
-
The Hong Kong Polytechnic UniversityNot yet recruitingChronic Neck Pain | Neck Pain Treatment | Neck Pain ChronicHong Kong
-
MTI UniversityCompleted
-
Universidad de MurciaEnrolling by invitationMyofascial Pain Syndromes | Massage | StretchingSpain
-
Universidade Federal de Sao CarlosCompleted
-
Universidad Francisco de VitoriaUnknownTrigger Point Pain, Myofascial | Muscle DisorderSpain
-
University of Nevada, Las VegasCompletedNeurophysiological Mechanisms ManipulationUnited States