- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06530329
Short-Term Effects of Ischemic Compression Applied in Addition to Classical Massage in the Treatment of Trigger Points
July 28, 2024 updated by: Duygu Şahin Altaç, Halic University
Investigation of the Short-Term Effects of Ischemic Compression Applied in Addition to Classical Massage on Pain, Functionality and Quality of Life in the Treatment of Myofascial Trigger Points on the Upper Trapezius Muscle in Women
The aim of our study was to investigate the short-term effects of ischemic compression applied in addition to classical massage for the treatment of myofascial trigger points on the upper trapezius muscle in women on pain, functionality and quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The aim of our study was to investigate the short-term effects of ischemic compression applied in addition to classical massage in the treatment of myofascial trigger points on the upper trapezius muscle in women on pain, functionality and quality of life.
"Visual Analog Scale (VAS)" was used for pain assessment of individuals who accepted to participate in the study; universal goniometer was used to measure active neck active range of motions (AROM) for functionality; and "Short Form-36 (SF-36)" was used for quality of life.
Then, the participants were randomly divided into two groups [Group 1: classical massage group; Group 2: classical massage + ischemic compression group].
Classical massage was applied to both groups three times a week for two weeks, and ischemic compression was applied to Group 2 in addition to classical massage.
At the end of the treatment period, the participants were re-evaluated in terms of VAS, neck AROM and SF-36 scores.Statistical analysis will be performed with SPSS 24.0 program.
If the data is parametric, paired sample t-test will be used for within-group evaluation; independent sample t-test will be used for between-group evaluation.
If the data is non-parametric, Wilson test will be used for within-group evaluation and Mann Whitney U test will be used for between-group evaluation.
Study Type
Interventional
Enrollment (Actual)
22
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 Locations
-
-
-
Istanbul, Turkey
- Haliç University
-
-
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
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being between the ages of 20-50
- Having a myofascial trigger point detected in the upper trapezius muscle for at least two weeks
- Being a student or staff of Halic University
- Being literate
Exclusion Criteria:
- Having a history of cervical surgery
- Having a malignant disease
- Pregnancy
- Menopause
- Having cooperation problems
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1
Classical massage group
|
Classical massage was started by general stroking 3 times.
Then, it was continued by kneading 3 times.
After the kneading movement, fibrocytic nodules on the muscle were searched and friction was applied to the found nodules one by one.
The massage of the muscle was completed by applying stroking 3 times.
The application was carried out 3 times a week for 2 weeks to evaluate the short-term effect.
|
|
Experimental: Group 2
Classical massage + ischemic compression group
|
Classical massage was started by general stroking 3 times.
Then, it was continued by kneading 3 times.
After the kneading movement, fibrocytic nodules on the muscle were searched and friction was applied to the found nodules one by one.
The massage of the muscle was completed by applying stroking 3 times.
The application was carried out 3 times a week for 2 weeks to evaluate the short-term effect.
Ischemic compression was applied to the trigger points in the upper trapezius muscle using an average pressure of 1 kg at a right angle, and after compression, passive stretching was applied to the upper trapezius muscle 3 times in 20-second periods.
The application was performed 3 times a week for 2 weeks to evaluate the short-term effect.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analog Scale
Time Frame: at baseline and at week 2.
|
Pain assessment was made with Visual Analog Scale (VAS).
The subjects were informed that the number '0' on a 10 cm horizontal line indicated 'no pain' and the number '10' indicated 'unbearable pain'.
The subjects were asked to mark the pain they felt on the VAS scale for 3 different areas, namely trapezius pain, neck pain and headache, and the points they marked were recorded as the severity of pain in cm.
VAS measurements were performed twice in total, before and after treatment.
|
at baseline and at week 2.
|
|
Active Range of Motion
Time Frame: at baseline and at week 2.
|
Active Range of Motion (AROM) measurement was evaluated using a universal goniometer.
While the patient was in a sitting position, the pivot point, fixed arm and movable arm of the goniometer were placed in the specified reference areas.
The patient was asked to actively perform neck flexion, extension, right-left lateral flexion and right-left rotation movements and the values at the end of the movements were recorded in degrees.
AROM measurements were performed twice in total, before and after treatment.
|
at baseline and at week 2.
|
|
Short-Form 36
Time Frame: at baseline and at week 2.
|
The Short Form-36 (SF-36) scale was used to assess quality of life.
The lowest score represents the worst health status.
SF-36 measurement was performed twice, before and after treatment.
|
at baseline and at week 2.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Duygu Şahin Altaç, PT, MSc., Haliç University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Physician. 2002 Feb 15;65(4):653-60.
- Sahin D, Kaya Mutlu E, Sakar O, Ates G, Inan S, Taskiran H. The effect of the ischaemic compression technique on pain and functionality in temporomandibular disorders: A randomised clinical trial. J Oral Rehabil. 2021 May;48(5):531-541. doi: 10.1111/joor.13145. Epub 2021 Jan 21.
- Cagnie B, Castelein B, Pollie F, Steelant L, Verhoeyen H, Cools A. Evidence for the Use of Ischemic Compression and Dry Needling in the Management of Trigger Points of the Upper Trapezius in Patients with Neck Pain: A Systematic Review. Am J Phys Med Rehabil. 2015 Jul;94(7):573-83. doi: 10.1097/PHM.0000000000000266.
- Bethers AH, Swanson DC, Sponbeck JK, Mitchell UH, Draper DO, Feland JB, Johnson AW. Positional release therapy and therapeutic massage reduce muscle trigger and tender points. J Bodyw Mov Ther. 2021 Oct;28:264-270. doi: 10.1016/j.jbmt.2021.07.005. Epub 2021 Jul 14.
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 (Actual)
March 15, 2024
Primary Completion (Actual)
May 15, 2024
Study Completion (Actual)
June 15, 2024
Study Registration Dates
First Submitted
July 28, 2024
First Submitted That Met QC Criteria
July 28, 2024
First Posted (Actual)
July 31, 2024
Study Record Updates
Last Update Posted (Actual)
July 31, 2024
Last Update Submitted That Met QC Criteria
July 28, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 28.07.2024-EDP&DA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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