- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05187468
The Effectiveness of Radial ESWT on Upper Trapezius Mtrps
The Effectiveness of Radial Extracorporeal Shockwave on Upper Trapezius Myofascial Trigger Points
Study Overview
Status
Detailed Description
This study was a randomized controlled trial consisted of three intervention groups. Two of them recieved ESWT with different parameters in each group, while the third one was standard care recieving Ultrasound therapy, Therapeutic massage and Heat packs Participants were divided randomly into the three groups. Participants were blind to the group allocated and also the therapist and outcome investigator were blind.
The participants recieved three weekly sessions. The evaluation took place before therapy, after each session and one month after last session.
The outcome measures was the pain intensity with VAS, the pain tolerance to pressure by an algometer device, the range of motion of neck measured by electronic goniometer and and functionality of neck measured by the Northwick Park Neck Pain
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nicosia, Cyprus, 2404
- European University Cyprus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pain between shoulder and neck on upper trapezius muscle
- Three out of five of Travel and Simons criteria for myofascial trigger points
Exclusion Criteria:
- Fibromyalgia diagnosis
- Systemic diseases diagnosis,
- Pacemaker, under 18,
- Any kind of cervical disorder or surgery,
- Mental disorders
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ESWT 1
Extracorporeal Shockwave Therapy 1000 pulses, 60 mJ, 10 Hz
|
1000 pulses at 60 mj, 10 Hz
Other Names:
2000 pulses at 60 mj, 10 Hz
|
Experimental: ESWT 2
Extracorporeal Shockwave Therapy 2000 pulses, 60 mJ, 10 Hz
|
1000 pulses at 60 mj, 10 Hz
Other Names:
2000 pulses at 60 mj, 10 Hz
|
Active Comparator: Ultrasound therapy, Massage, Heat Pack
10 Min massage 5 min US therapy 10 min Heat pack
|
Ultrasound therapy 5 min, 1,2W/cm2, 10 min Massage, 10 min heat pack
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain intensity on myofascial trigger points
Time Frame: baseline
|
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
|
baseline
|
Pain intensity on myofascial trigger points
Time Frame: one week
|
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
|
one week
|
Pain intensity on myofascial trigger points
Time Frame: two weeks
|
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
|
two weeks
|
Pain intensity on myofascial trigger points
Time Frame: three weeks
|
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
|
three weeks
|
Pain intensity on myofascial trigger points
Time Frame: 1 month after
|
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
|
1 month after
|
Pressure Pain Threshold
Time Frame: baseline
|
Pain tolerance to compression.
Measured in kilos
|
baseline
|
Pressure Pain Threshold
Time Frame: one week
|
Pain tolerance to compression.
Measured in kilos
|
one week
|
Pressure Pain Threshold
Time Frame: two weeks
|
Pain tolerance to compression.
Measured in kilos
|
two weeks
|
Pressure Pain Threshold
Time Frame: three weeks
|
Pain tolerance to compression.
Measured in kilos
|
three weeks
|
Pressure Pain Threshold
Time Frame: one month after
|
Pain tolerance to compression.
Measured in kilos
|
one month after
|
cervical range of motion
Time Frame: baseline
|
Goniometer (measured in degrees)
|
baseline
|
cervical range of motion
Time Frame: one week
|
Goniometer (measured in degrees)
|
one week
|
cervical range of motion
Time Frame: two weeks
|
Goniometer (measured in degrees)
|
two weeks
|
cervical range of motion
Time Frame: three weeks
|
Goniometer (measured in degrees)
|
three weeks
|
cervical range of motion
Time Frame: one month after
|
Goniometer (measured in degrees)
|
one month after
|
Northwick Park Neck Pain questionnaire
Time Frame: baseline
|
functionality of Neck related to pain for daily activities.
measured in % (36 questions).
Higher the %, greater the disability
|
baseline
|
Northwick Park Neck Pain questionnaire
Time Frame: one week
|
functionality of Neck related to pain for daily activities.
measured in % (36 questions).
Higher the %, greater the disability
|
one week
|
Northwick Park Neck Pain questionnaire
Time Frame: two weeks
|
functionality of Neck related to pain for daily activities.
measured in % (36 questions).
Higher the %, greater the disability
|
two weeks
|
Northwick Park Neck Pain questionnaire
Time Frame: three weeks
|
functionality of Neck related to pain for daily activities.
measured in % (36 questions).
Higher the %, greater the disability
|
three weeks
|
Northwick Park Neck Pain questionnaire
Time Frame: one month after
|
functionality of Neck related to pain for daily activities.
measured in % (36 questions).
Higher the %, greater the disability
|
one month after
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EuropeanUC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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