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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05920564
Other study ID # 012/7780002023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 28, 2023
Est. completion date March 1, 2024

Study information

Verified date June 2023
Source Ahram Canadian University
Contact Mohamed M ElMeligie, Ph.d
Phone +201064442032
Email mohamed.elmeligie@acu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 64
Est. completion date March 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 40 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Upper fibers of trapezius stretching
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 care
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.

Locations

Country Name City State
Egypt Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al ?ayy Ath Thamin Giza

Sponsors (1)

Lead Sponsor Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Neck pain intensity 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
Primary Changes in Neck range of motion 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 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. Changes in Neck Disability Index at baseline and after 4 weeks of intervention and 3 months
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