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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05187468
Other study ID # EuropeanUC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2019
Est. completion date February 28, 2020

Study information

Verified date September 2021
Source European University Cyprus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date February 28, 2020
Est. primary completion date October 30, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Device:
Extracorporeal Shockwave Therapy
1000 pulses at 60 mj, 10 Hz
Extracorporeal Shockwave Therapy
2000 pulses at 60 mj, 10 Hz
Ultrasound therapy, Massage, Heat pack
Ultrasound therapy 5 min, 1,2W/cm2, 10 min Massage, 10 min heat pack

Locations

Country Name City State
Cyprus European University Cyprus Nicosia

Sponsors (1)

Lead Sponsor Collaborator
European University Cyprus

Country where clinical trial is conducted

Cyprus, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain intensity on myofascial trigger points Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain) baseline
Primary Pain intensity on myofascial trigger points Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain) one week
Primary Pain intensity on myofascial trigger points Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain) two weeks
Primary Pain intensity on myofascial trigger points Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain) three weeks
Primary Pain intensity on myofascial trigger points Visual Analogue Scale 1-10 (1 is the least pain, 10 is the worst pain) 1 month after
Primary Pressure Pain Threshold Pain tolerance to compression. Measured in kilos baseline
Primary Pressure Pain Threshold Pain tolerance to compression. Measured in kilos one week
Primary Pressure Pain Threshold Pain tolerance to compression. Measured in kilos two weeks
Primary Pressure Pain Threshold Pain tolerance to compression. Measured in kilos three weeks
Primary Pressure Pain Threshold Pain tolerance to compression. Measured in kilos one month after
Primary cervical range of motion Goniometer (measured in degrees) baseline
Primary cervical range of motion Goniometer (measured in degrees) one week
Primary cervical range of motion Goniometer (measured in degrees) two weeks
Primary cervical range of motion Goniometer (measured in degrees) three weeks
Primary cervical range of motion Goniometer (measured in degrees) one month after
Primary Northwick Park Neck Pain questionnaire functionality of Neck related to pain for daily activities. measured in % (36 questions). Higher the %, greater the disability baseline
Primary 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
Primary 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
Primary 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
Primary 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
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