NCT04521127

Brief Summary

The aim of this study is to compare the effectiveness of kinesio tape and dry needling in the treatment of myofascial pain syndrome of the trapezius muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2020

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

August 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

August 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2021

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

August 18, 2020

Last Update Submit

April 18, 2024

Conditions

Keywords

TapingPainTrigger PointDry needling

Outcome Measures

Primary Outcomes (1)

  • Pressure Pain Threshold (PPT) Measurement

    Pain pressure threshold (PPT). was assessed with an analogue algometry (Baseline, FEl Inc. White Plains, NY,USA) with 1 cm2 rubber tip was used to measure the pain pressure threshold. Algometer perpendicularly placed over spinous process of T1 on prone position and pressure progressively increased 1 kg/s until patients verbally reported pain under the tip of algometer or referring pain. Measurement repeated three times and average score recorded.

    two weeks

Secondary Outcomes (3)

  • Visual analog scale

    two weeks

  • Neck Disability Index

    two weeks

  • Global Perceived Effect Scale

    two weeks

Study Arms (3)

Kinesio Taping Group

ACTIVE COMPARATOR

Kinesio taping will be applied to trapezius muscle

Other: Kinesio Taping

Dry needling Group

ACTIVE COMPARATOR

Dry needling will be applied to trigger point on trapezius muscle

Other: Dry needling

Control Group

NO INTERVENTION

Control group will not receive any additional intervention

Interventions

Taping will be performed on sitting position with contralateral lateral flexion and flexion of the neck, using muscle technique with I strip and stretching the head at the maximum level in order to benefit from the muscle release effect. Kinesio tape was applied directly on muscle with 0% stretching.

Kinesio Taping Group

The trigger point on the taut band will be held with the thumb and forefinger from below and above. In the needling technique, a 0.25 \* 25-mm with nickel handle, disposable sterile steel acupuncture needle will be used. The needle tip will be inserted perpendicularly into the subcutaneous tissue and inserted into the muscle until the trigger point in the taut band was found. The same point will be pinned 8-10 times with fast needle movements inside and out. Then the needle tip will pulled back so that it did not come out of the skin, and the bottom, top and sides of the first entered point were also pinned. This procedure was applied to all trigger points in the trapeze muscle.

Dry needling Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being diagnosis with MPS and having active myofascial trigger points on trapezius muscle

You may not qualify if:

  • Fibromyalgia
  • a history of myofascial trigger point injection
  • acute trauma
  • inflammatory joint or muscle disease
  • infection or malignancy on cervical region
  • neurological disorders
  • cervical radiculopathy or myelopathy
  • inadequate cooperation for the treatment
  • a history of neck surgery or spinal degeneration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant Izzet Baysal University

Bolu, Merkez, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Mustafa Fatih Yaşar, MD

    Bolu Abant Izzet Baylsa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Patients will be aware of group distribution due to the nature of the taping and DN procedures. Therefore, the only outcome assessor will be blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three groups with a conventional therapy control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 18, 2020

First Posted

August 20, 2020

Study Start

August 27, 2020

Primary Completion

November 1, 2020

Study Completion

January 15, 2021

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations