- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05277259
Comparative Effects of Conventional Physical Therapy, Kinesio Taping and ESWT in Upper Trapezius MPS.
May 25, 2022 updated by: Volkan Şah, Yuzuncu Yıl University
Comparative Effects of Conventional Physical Therapy, Kinesio Taping and Extracorporeal Shock Wave Therapies in Upper Trapezius Myofascial Pain Syndrome.
There is no study in the literature comparing both kinesiotaping and Extracorporeal Shock Wave Therapy (ESWT) with conventional physical therapy in upper trapezius myofascial pain syndrome.
In this study, we aimed to make this comparison.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
99
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
-
-
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Van, Turkey
- Yuzuncu Yil University
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-
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 (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Presence of at least 1 active trigger point in the upper trapezius muscle, exacerbation of pain when this point(s) is pressed, painful limitation of cervical lateral flexion and extension.
Exclusion Criteria:
- Having a history of spine and upper extremity surgery, neuromuscular disease, active rheumatologic disease, active infection, malignancy, having previously applied ESWT or Kinesio Taping to the back and neck region.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Extracorporeal Shock Wave Therapy
Extracorporeal shock wave therapy (ESWT) is a noninvasive treatment that involves delivery of shock waves to injured soft tissue to reduce pain and promote healing.
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Device named 'Elettronica Pagani,Italy' and will be used with radial probe.
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Active Comparator: Kinesiotaping
The Kinesiotaping method is a therapeutic taping technique which alleviates pain.
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Elastic band to be used to stretch the upper trapezius muscle in the desired direction.
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Active Comparator: Conventional Physical Therapy
Hotpack, therapeutic ultrasound and tens applications.
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Conventional physical therapy will be consisted of hotpack, therapeutic ultrasound and tens applications.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale (VAS)
Time Frame: at baseline (before the treatment)
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patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.
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at baseline (before the treatment)
|
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Visual Analogue Scale (VAS)
Time Frame: 2 weeks after baseline (at the end of treatment)
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patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome
|
2 weeks after baseline (at the end of treatment)
|
|
Visual Analogue Scale (VAS)
Time Frame: 6 weeks after baseline (one month after the end of treatment)
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patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome
|
6 weeks after baseline (one month after the end of treatment)
|
|
Neck Disability Index (NDI)
Time Frame: at baseline (before the treatment)
|
a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain.
The total score ranges from 0 (no disability) to 50 (total disability).
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at baseline (before the treatment)
|
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Neck Disability Index (NDI)
Time Frame: 2 weeks after baseline (at the end of treatment)
|
a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain.
The total score ranges from 0 (no disability) to 50 (total disability).
|
2 weeks after baseline (at the end of treatment)
|
|
Neck Disability Index (NDI)
Time Frame: 6 weeks after baseline (one month after the end of treatment)
|
a self-report questionnaire used to determine how neck pain affects a patient's daily life and to assess the self-rated disability of patients with neck pain.
The total score ranges from 0 (no disability) to 50 (total disability).
|
6 weeks after baseline (one month after the end of treatment)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of Cervical range of motion (Cervikal ROM)
Time Frame: at baseline (before the treatment)
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Measuring cervical lateral flexion and cervical extension with a manual goniometer.
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at baseline (before the treatment)
|
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Measurement of Cervical range of motion (Cervikal ROM)
Time Frame: 2 weeks after baseline (at the end of treatment).
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Measuring cervical lateral flexion and cervical extension with a manual goniometer.
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2 weeks after baseline (at the end of treatment).
|
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Measurement of Cervical range of motion (Cervikal ROM)
Time Frame: 6 weeks after baseline (one month after the end of treatment)
|
Measuring cervical lateral flexion and cervical extension with a manual goniometer.
|
6 weeks after baseline (one month after the end of treatment)
|
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 (Actual)
April 4, 2022
Primary Completion (Actual)
April 18, 2022
Study Completion (Actual)
May 2, 2022
Study Registration Dates
First Submitted
March 3, 2022
First Submitted That Met QC Criteria
March 3, 2022
First Posted (Actual)
March 14, 2022
Study Record Updates
Last Update Posted (Actual)
June 1, 2022
Last Update Submitted That Met QC Criteria
May 25, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- van yyü university
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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