- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05614830
Effectiveness Taif University P. O. Box 11099 Taif 21944 Effectiveness of Dry Needling in Management of Myofacial Trigger Point
November 6, 2022 updated by: Slwa Sami Alattar, Taif University
Effectiveness of Dry Needling in Management of Myofacial Trigger Point In Trapezius Muscle
myofascial pain syndrome is considered to be a chronic condition due to sensitive pressure points within the muscle recognized as trigger points
Generally the aim of this study will be :
- To investigate the effectiveness of dry needling on trigger point in trapezius muscle
- Evaluate the pain level before and after the applications of dry needling on trigger points
- compare between the effects of dry needling and physical therapy exercise program
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
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
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinically active trigger point and expression of symptoms of neck pain in trapezius which had lasted for at least 3 months.
- Having a pain level higher than 4 and lower than 8 on Visual Analogue Scale ( VAS )
- Did not receive any other form of neck treatment during the previous month.
Exclusion Criteria:
- Presence of cardiopulmonary disease , the application process requires the subject to be in prone position to expose the area of treatment, this position is un-preferable for cardiopulmonary patients
- History of neck surgery
- Trigger point treatment in the last 30 days
- Any contraindications for dry needling such as local infection, skin disease ,severe postural disorder , tumor , rheumatoid arthritis, cervical spine stenosis and bilateral upper extremity symptoms
- pregnancy
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: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
|
The intervention group will receive sessions of dry needling to relief myofacial pain on trapezius
|
Active Comparator: Control group
Usual physical therapy protocol 4 sessions, two sessions per week each session will include a group of therapeutic exercises
|
Therapeutic exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain level
Time Frame: 6 weeks
|
Will be determined using the visuals analogue scale (VAS)
|
6 weeks
|
Neck disability index
Time Frame: 6 weeks
|
questionnaire contains 10 items aiming to evaluate the limitation because of neck pain
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: 6 weeks
|
Will be determined using the Beck's Depression Inventory ( BDI)
|
6 weeks
|
Neck Range of motion
Time Frame: 6 weeks
|
Will be measured using CROM
|
6 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 (Anticipated)
January 1, 2023
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
November 6, 2022
First Submitted That Met QC Criteria
November 6, 2022
First Posted (Actual)
November 14, 2022
Study Record Updates
Last Update Posted (Actual)
November 14, 2022
Last Update Submitted That Met QC Criteria
November 6, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 44-004
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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