NCT05277259

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

14 days

First QC Date

March 3, 2022

Last Update Submit

May 25, 2022

Conditions

Trapezius Muscle Strain

Outcome Measures

Primary Outcomes (6)

  • Visual Analogue Scale (VAS)

    patient's self-assessment of pain, in the range of 0 to 10, higher scores mean a worse outcome.

    at baseline (before the treatment)

  • Visual Analogue Scale (VAS)

    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)

    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)

    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).

    at baseline (before the treatment)

  • Neck Disability Index (NDI)

    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)

    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 Outcomes (3)

  • Measurement of Cervical range of motion (Cervikal ROM)

    at baseline (before the treatment)

  • Measurement of Cervical range of motion (Cervikal ROM)

    2 weeks after baseline (at the end of treatment).

  • Measurement of Cervical range of motion (Cervikal ROM)

    6 weeks after baseline (one month after the end of treatment)

Study Arms (3)

Extracorporeal Shock Wave Therapy

ACTIVE COMPARATOR

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.

Device: Extracorporeal Shock Wave Therapy

Kinesiotaping

ACTIVE COMPARATOR

The Kinesiotaping method is a therapeutic taping technique which alleviates pain.

Other: Kinesiotaping

Conventional Physical Therapy

ACTIVE COMPARATOR

Hotpack, therapeutic ultrasound and tens applications.

Other: Conventional Physical Therapy

Interventions

Extracorporeal Shock Wave TherapyDEVICE

Device named 'Elettronica Pagani,Italy' and will be used with radial probe.

Extracorporeal Shock Wave Therapy
KinesiotapingOTHER

Elastic band to be used to stretch the upper trapezius muscle in the desired direction.

Kinesiotaping
Conventional Physical TherapyOTHER

Conventional physical therapy will be consisted of hotpack, therapeutic ultrasound and tens applications.

Conventional Physical Therapy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University

Van, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy

Intervention Hierarchy (Ancestors)

Ultrasonic TherapyDiathermyHyperthermia, InducedTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Volkan Şah

    Yüzüncü Yıl Üniversitesi Tıp Fakültesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 3, 2022

First Posted

March 14, 2022

Study Start

April 4, 2022

Primary Completion

April 18, 2022

Study Completion

May 2, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)