Upper Trapezius Stretching in Patients With Cervical Spondylosis

NCT05920564 | Unknown

• 1 other identifier: 012/7780002023
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Spondylosis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Changes in Neck Disability Index

  Changes in Neck Disability Index at baseline and after 4 weeks of intervention and 3 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Other: Upper fibers of trapezius stretching; Other: Standard care

Control group

ACTIVE COMPARATOR

Other: Standard care

Interventions

Upper fibers of trapezius stretching OTHER

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 group

Standard care OTHER

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.

Control group; Intervention group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Spondylosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY DIRECTOR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: June 17, 2023
• First Posted: June 27, 2023
• Study Start: June 28, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2024
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)