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Upper Trapezius Stretching in Patients With Cervical Spondylosis

Primary Purpose

Cervical Spondylosis

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Upper fibers of trapezius stretching
Standard care
Sponsored by
Ahram Canadian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Spondylosis

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Control group

Arm Description

Outcomes

Primary Outcome Measures

Changes in Neck pain intensity
elf-reported pain intensity in the neck region using a numerical rating scale (NRS).
Changes in Neck range of motion
Degree of neck flexion, extension, lateral flexion and rotation using a goniometer.

Secondary Outcome Measures

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.

Full Information

First Posted
June 17, 2023
Last Updated
June 17, 2023
Sponsor
Ahram Canadian University
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1. Study Identification

Unique Protocol Identification Number
NCT05920564
Brief Title
Upper Trapezius Stretching in Patients With Cervical Spondylosis
Official Title
Efficacy of Upper Trapezius Stretching on Neck Pain, Range of Motion and Disability in Patients With Cervical Spondylosis: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Anticipated)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Spondylosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Upper fibers of trapezius stretching
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Neck pain intensity
Description
elf-reported pain intensity in the neck region using a numerical rating scale (NRS).
Time Frame
Changes in neck pain intensity at baseline and after 4 weeks of intervention and 3 months
Title
Changes in Neck range of motion
Description
Degree of neck flexion, extension, lateral flexion and rotation using a goniometer.
Time Frame
Changes in neck range of motion at baseline and after 4 weeks of intervention and 3 months
Secondary Outcome Measure Information:
Title
Changes in Neck Disability Index
Description
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.
Time Frame
Changes in Neck Disability Index at baseline and after 4 weeks of intervention and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Faculty of Physical Therapy, Ahram Canadian University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No

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Upper Trapezius Stretching in Patients With Cervical Spondylosis

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