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The Effectiveness of Radial ESWT on Upper Trapezius Mtrps

Primary Purpose

Myofascial Pain Syndrome, Myofascial Trigger Point Pain, Upper Trapezius Trigger Points

Status
Completed
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Extracorporeal Shockwave Therapy
Extracorporeal Shockwave Therapy
Ultrasound therapy, Massage, Heat pack
Sponsored by
European University Cyprus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndrome focused on measuring Myofascial Trigger points, upper trapezius, Myofascial pain syndrome, Mtrps

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • European University Cyprus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

ESWT 1

ESWT 2

Ultrasound therapy, Massage, Heat Pack

Arm Description

Extracorporeal Shockwave Therapy 1000 pulses, 60 mJ, 10 Hz

Extracorporeal Shockwave Therapy 2000 pulses, 60 mJ, 10 Hz

10 Min massage 5 min US therapy 10 min Heat pack

Outcomes

Primary Outcome Measures

Pain intensity on myofascial trigger points
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Pain intensity on myofascial trigger points
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Pain intensity on myofascial trigger points
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Pain intensity on myofascial trigger points
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Pain intensity on myofascial trigger points
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Pressure Pain Threshold
Pain tolerance to compression. Measured in kilos
Pressure Pain Threshold
Pain tolerance to compression. Measured in kilos
Pressure Pain Threshold
Pain tolerance to compression. Measured in kilos
Pressure Pain Threshold
Pain tolerance to compression. Measured in kilos
Pressure Pain Threshold
Pain tolerance to compression. Measured in kilos
cervical range of motion
Goniometer (measured in degrees)
cervical range of motion
Goniometer (measured in degrees)
cervical range of motion
Goniometer (measured in degrees)
cervical range of motion
Goniometer (measured in degrees)
cervical range of motion
Goniometer (measured in degrees)
Northwick Park Neck Pain questionnaire
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Northwick Park Neck Pain questionnaire
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Northwick Park Neck Pain questionnaire
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Northwick Park Neck Pain questionnaire
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Northwick Park Neck Pain questionnaire
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability

Secondary Outcome Measures

Full Information

First Posted
September 19, 2021
Last Updated
January 9, 2022
Sponsor
European University Cyprus
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1. Study Identification

Unique Protocol Identification Number
NCT05187468
Brief Title
The Effectiveness of Radial ESWT on Upper Trapezius Mtrps
Official Title
The Effectiveness of Radial Extracorporeal Shockwave on Upper Trapezius Myofascial Trigger Points
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
European University Cyprus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study looked after the effectiveness of radial ESWT on upper trapezius mtrps. There were three intervention groups which recieved either ESWT or standard care. VAS, PPT, Neck ROM and Cervical functionality were the main outcomes.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndrome, Myofascial Trigger Point Pain, Upper Trapezius Trigger Points
Keywords
Myofascial Trigger points, upper trapezius, Myofascial pain syndrome, Mtrps

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESWT 1
Arm Type
Experimental
Arm Description
Extracorporeal Shockwave Therapy 1000 pulses, 60 mJ, 10 Hz
Arm Title
ESWT 2
Arm Type
Experimental
Arm Description
Extracorporeal Shockwave Therapy 2000 pulses, 60 mJ, 10 Hz
Arm Title
Ultrasound therapy, Massage, Heat Pack
Arm Type
Active Comparator
Arm Description
10 Min massage 5 min US therapy 10 min Heat pack
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shockwave Therapy
Other Intervention Name(s)
ESWT, rSWT
Intervention Description
1000 pulses at 60 mj, 10 Hz
Intervention Type
Device
Intervention Name(s)
Extracorporeal Shockwave Therapy
Intervention Description
2000 pulses at 60 mj, 10 Hz
Intervention Type
Device
Intervention Name(s)
Ultrasound therapy, Massage, Heat pack
Intervention Description
Ultrasound therapy 5 min, 1,2W/cm2, 10 min Massage, 10 min heat pack
Primary Outcome Measure Information:
Title
Pain intensity on myofascial trigger points
Description
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Time Frame
baseline
Title
Pain intensity on myofascial trigger points
Description
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Time Frame
one week
Title
Pain intensity on myofascial trigger points
Description
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Time Frame
two weeks
Title
Pain intensity on myofascial trigger points
Description
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Time Frame
three weeks
Title
Pain intensity on myofascial trigger points
Description
Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)
Time Frame
1 month after
Title
Pressure Pain Threshold
Description
Pain tolerance to compression. Measured in kilos
Time Frame
baseline
Title
Pressure Pain Threshold
Description
Pain tolerance to compression. Measured in kilos
Time Frame
one week
Title
Pressure Pain Threshold
Description
Pain tolerance to compression. Measured in kilos
Time Frame
two weeks
Title
Pressure Pain Threshold
Description
Pain tolerance to compression. Measured in kilos
Time Frame
three weeks
Title
Pressure Pain Threshold
Description
Pain tolerance to compression. Measured in kilos
Time Frame
one month after
Title
cervical range of motion
Description
Goniometer (measured in degrees)
Time Frame
baseline
Title
cervical range of motion
Description
Goniometer (measured in degrees)
Time Frame
one week
Title
cervical range of motion
Description
Goniometer (measured in degrees)
Time Frame
two weeks
Title
cervical range of motion
Description
Goniometer (measured in degrees)
Time Frame
three weeks
Title
cervical range of motion
Description
Goniometer (measured in degrees)
Time Frame
one month after
Title
Northwick Park Neck Pain questionnaire
Description
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Time Frame
baseline
Title
Northwick Park Neck Pain questionnaire
Description
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Time Frame
one week
Title
Northwick Park Neck Pain questionnaire
Description
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Time Frame
two weeks
Title
Northwick Park Neck Pain questionnaire
Description
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Time Frame
three weeks
Title
Northwick Park Neck Pain questionnaire
Description
functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability
Time Frame
one month after

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
European University Cyprus
City
Nicosia
ZIP/Postal Code
2404
Country
Cyprus

12. IPD Sharing Statement

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The Effectiveness of Radial ESWT on Upper Trapezius Mtrps

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