- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06267755
Efficacy of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain (MTP)
February 12, 2024 updated by: Nabil Mahmoud Ismail Abdel-Aal, Cairo University
this study will be conducted to investigate the effect of Extracorporeal Shockwave Therapy on Ultrasonography Changes of Upper Trapezius Myofascial Trigger Points in Patients With Non Specific Neck Pain
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Neck pain is one of the most commonly reported musculoskeletal disorders.
The prevalence for neck pain varies between 16.7% and 75.1% in the general population.
Up to 67% of world's population may present chronic non-specific neck pain at least once in their lives.
The upper trapezius is probably the muscle most often beset by trigger points, it is indicated that the upper trapezius is the most sensitive of 8 different muscles (upper trapezius, pectoralis major, levator scapulae, teres major, supraspinatus, gluteus medius, infraspinatus, paraspinal) to the pressure of an algometer.Recently, the extracorporeal shock wave has been widely known to be an effective therapeutic modality in myofascial pain syndrome treatment and a systematic review provided promising insight into the effectiveness of ESWT in Myofascial pain syndrome treatment.
sixty patients with non specific neck pain will be assigned randomly to two groups; first one will receive shock wave therapy and traditional therapy and the second one will receive traditional therapy only for six weeks.
Study Type
Interventional
Enrollment (Estimated)
60
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: Mahmoud Fouad, master
- Phone Number: 01227740639
- Email: mahmoud.adel27392@gmail.com
Study Contact Backup
- Name: Maher El keblawy, professor
- Phone Number: 01001419544
- Email: katyary@yahoo.com
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:
- Sixty patients receiving a diagnosis of non-specific neck pain with upper trapezius myofascial trigger points by an orthopaedist physician.
- Body mass index of participants was normal less than (30 kg/m2)(Al-asadi, 2018).
- Age over 18 years.
- Presence of taught band.
- Presence of hyper irritable spot in a taught band, and reproduction of the typical referred pain pattern of the myofascial trigger point in response to compression
Exclusion Criteria:
- Having signs and symptoms of neurological disorders that cause nerve root compression.
- Headache as a consequence of specific headache diagnosis.
- Having a history of specific signs of malignancy, or infection.
- Having a history of trauma with or without proven structural disorders in the region of the neck, shoulder, and head (e.g. whiplash).
- Having signs and symptoms of cerebrovascular insufficiency.
- Having a severe chronic disease of the locomotor system (e.g. polyarthritis, muscular disease
- Any participant with contraindications to shock wave therapy
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Extracorporeal Shockwave therapy
Thirty patients will receive Extracorporeal Shockwave therapy and Traditional physical therapy three times per week for six consecutive weeks.
|
the patients will receive Extracorporeal Shockwave therapy sessions by 600 impulses with 1.6 bar pressure at a frequency of 8 Hz on site of the upper trapezius
the patients will receive Traditional physical therapy in the form of Integrated neuro-muscular inhibition technique + posture correction and scapular stabilization exercises.
|
|
Active Comparator: Traditional physical therapy
Thirty patients will receive Traditional physical therapy three times per week for six consecutive weeks.
|
the patients will receive Traditional physical therapy in the form of Integrated neuro-muscular inhibition technique + posture correction and scapular stabilization exercises.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
muscle thickness
Time Frame: up to six weeks
|
Ultrasonography device will be used to assess muscle thickness
|
up to six weeks
|
|
hypoechoic area intensity
Time Frame: up to six weeks
|
An ultrasonography device will be used to assess the hypoechoic area intensity
|
up to six weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neck disability
Time Frame: up to six weeks
|
Arabic version of neck disability index will be used to measure neck disability.
It consists of 10 questions: pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleeping, and recreation.
5 Each item is scored from 0 (no disability) to 5 (total disability).
The maximum possible score is 50.
|
up to six weeks
|
|
pressure pain threshold
Time Frame: up to six weeks
|
Digital algometer will be used to measure pressure pain threshold
|
up to six weeks
|
|
cervical range of motion
Time Frame: up to six weeks
|
The cervical range of motion (CROM) device will be used to measure cervical ROM
|
up to six weeks
|
|
pain intensity
Time Frame: up to six weeks
|
The visual analog scale (VAS) will be used to measure pain intensity.
it is a10 cm line, oriented vertically or horizontally, with one end representing "no pain" and the other end representing pain as bad as it can be
|
up to six weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
February 20, 2024
Primary Completion (Estimated)
August 30, 2024
Study Completion (Estimated)
August 30, 2024
Study Registration Dates
First Submitted
February 12, 2024
First Submitted That Met QC Criteria
February 12, 2024
First Posted (Actual)
February 20, 2024
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 12, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/004884
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.
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