NCT05187468

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
Last Updated

January 11, 2022

Status Verified

September 1, 2021

Enrollment Period

3 months

First QC Date

September 19, 2021

Last Update Submit

January 9, 2022

Conditions

Myofascial Pain SyndromeMyofascial Trigger Point PainUpper Trapezius Trigger Points

Keywords

Myofascial Trigger pointsupper trapeziusMyofascial pain syndromeMtrps

Outcome Measures

Primary Outcomes (20)

  • Pain intensity on myofascial trigger points

    Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)

    baseline

  • Pain intensity on myofascial trigger points

    Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)

    one week

  • Pain intensity on myofascial trigger points

    Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)

    two weeks

  • Pain intensity on myofascial trigger points

    Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)

    three weeks

  • Pain intensity on myofascial trigger points

    Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain)

    1 month after

  • Pressure Pain Threshold

    Pain tolerance to compression. Measured in kilos

    baseline

  • Pressure Pain Threshold

    Pain tolerance to compression. Measured in kilos

    one week

  • Pressure Pain Threshold

    Pain tolerance to compression. Measured in kilos

    two weeks

  • Pressure Pain Threshold

    Pain tolerance to compression. Measured in kilos

    three weeks

  • Pressure Pain Threshold

    Pain tolerance to compression. Measured in kilos

    one month after

  • cervical range of motion

    Goniometer (measured in degrees)

    baseline

  • cervical range of motion

    Goniometer (measured in degrees)

    one week

  • cervical range of motion

    Goniometer (measured in degrees)

    two weeks

  • cervical range of motion

    Goniometer (measured in degrees)

    three weeks

  • cervical range of motion

    Goniometer (measured in degrees)

    one month after

  • Northwick Park Neck Pain questionnaire

    functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability

    baseline

  • Northwick Park Neck Pain questionnaire

    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

    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

    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

    functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability

    one month after

Study Arms (3)

ESWT 1

EXPERIMENTAL

Extracorporeal Shockwave Therapy 1000 pulses, 60 mJ, 10 Hz

Device: Extracorporeal Shockwave Therapy

ESWT 2

EXPERIMENTAL

Extracorporeal Shockwave Therapy 2000 pulses, 60 mJ, 10 Hz

Device: Extracorporeal Shockwave Therapy

Ultrasound therapy, Massage, Heat Pack

ACTIVE COMPARATOR

10 Min massage 5 min US therapy 10 min Heat pack

Device: Ultrasound therapy, Massage, Heat pack

Interventions

Extracorporeal Shockwave TherapyDEVICE

1000 pulses at 60 mj, 10 Hz

Also known as: ESWT, rSWT
ESWT 1
Ultrasound therapy, Massage, Heat packDEVICE

Ultrasound therapy 5 min, 1,2W/cm2, 10 min Massage, 10 min heat pack

Ultrasound therapy, Massage, Heat Pack

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pain between shoulder and neck on upper trapezius muscle
  • Three out of five of Travel and Simons criteria for myofascial trigger points

You may not qualify if:

  • Fibromyalgia diagnosis
  • Systemic diseases diagnosis,
  • Pacemaker, under 18,
  • Any kind of cervical disorder or surgery,
  • Mental disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European University Cyprus

Nicosia, 2404, Cyprus

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Interventions

Extracorporeal Shockwave TherapyUltrasonic TherapyMassage

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

DiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitationTherapy, Soft TissueMusculoskeletal ManipulationsComplementary Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 19, 2021

First Posted

January 11, 2022

Study Start

August 1, 2019

Primary Completion

October 30, 2019

Study Completion

February 28, 2020

Last Updated

January 11, 2022

Record last verified: 2021-09

Locations

CY(1)