NCT05879016

Brief Summary

Myofascial pain syndrome is a musculoskeletal pain condition that originates from localized, tight areas of skeletal muscle and fascia, called trigger points. Myofascial pain syndrome is the most common cause of musculoskeletal pain and its prevalence in the community is reported to be 12-55%. Patients with myofascial pain syndrome have pain, stiffness, tenderness, burning, and squeezing sensations in the muscles. In treating myofascial pain syndrome, trigger points should be inactivated and normal body mechanics should be corrected as much as possible. Treatment of the trigger point may be the main goal of a physiotherapy rehabilitation program as it can rapidly reduce acute pain. The goal is to control pain, restore limited ROM, and return the muscle to its optimal length and position. One of the treatment methods applied in MAS is kinesio taping. Kinesio Taping is a non-invasive, painless and less time-consuming method with fewer side effects, widely used as a therapeutic tool in various prevention and rehabilitation protocols. It differs from other rigid tapes because it can stretch significantly (130-140% of its original length), reducing mechanical movement limitations and mimicking skin thickness and elasticity. It has been found to be effective in reducing pain and muscle spasm, increasing range of motion, improving local blood and lymph circulation, reducing edema, strengthening weakened muscles, and controlling joint instability and postural alignment. Kinesiological tapes can be applied with different shapes and techniques according to the shape and size of the application area and the purpose of the application. Application techniques can be listed as muscle techniques, functional correlation techniques, fascia correlation techniques, star techniques (circulation / lymphatic correction technique), ligament/tendon correction (ligament) technique, mechanical correction techniques, and neural techniques. Functional correlation technique, which is one of the techniques the investigators will prefer in our study, is just above the area of pain, it lifts the skin, fascia, and soft tissue thanks to the elastic properties of the band, thereby reducing the pressure under the application area, reducing the irritation in the chemical receptors and nociceptors, reducing the lymphatic circulation. It is claimed that it increases blood circulation and helps to remove exudate more effectively, and as a result, it helps to reduce pain. The fascia correlation technique, which is the other technique the investigators would prefer to use in our study, is used to bring the fascial tissue to the desired position. The main goal is to reduce tension and adhesions by making vibration (oscillation) movement between the fascia layers. Another technique the investigators will use in our study is the star technique. This technique is aimed at reducing the pressure on the lymphatic vessels and creating a gap that allows circulation in the tissue. Fan-cut tape is often used. Our study aims to compare the effects of 3 different taping techniques (correction, fascia correction, and star technique) in individuals with Myofascial Pain Syndrome with a trigger point in the trapezius muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

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

May 18, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 30, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 30, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2023

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

2 months

First QC Date

May 18, 2023

Last Update Submit

August 8, 2023

Conditions

Outcome Measures

Primary Outcomes (6)

  • Visual Analogue Scale

    The Visual Analogue Scale is a simple, sensitive and reproducible tool that is often used to assess pain severity. Due to its easy application, it has become the most frequently used self-assessment scale in studies on neck pain. It consists of a ten cm long horizontal or vertical line. The starting point of the line represents no pain, and the end represents the most severe pain imaginable. It is stated that the severity of pain increases when the patient goes from the beginning of the line to the end, and the patient is asked to mark the severity of his pain on the line, the point marked by the patient is recorded in cm.

    1 week

  • Muscle Strength

    With myometer, cervical region flexion, extension, lateral flexion and rotation movements, upper extremity shoulder flexion, abduction, internal and external rotation and elbow flexion angles will be measured bilaterally. Measurements will be repeated 3 times and the average value will be recorded as Newton(N).

    1 week

  • Joint Range of Motion

    With the universal goniometer, cervical region flexion, extension, lateral flexion and rotation movements, upper extremity shoulder flexion, extension, abduction, adduction, internal and external rotation and elbow flexion and extension angles will be measured bilaterally. Measurements will be repeated 3 times and the average value will be recorded in degrees.

    1 week

  • Hand Grip Strength

    The maximum isometric contraction strength of the hand and forearm muscles will be measured bilaterally with the hand dynamometer.

    1 week

  • Pressure Pain Threshold

    The pressure pain threshold that individuals feel will be measured with the Algometer. Algometry is used in many musculoskeletal diseases to evaluate pain and determine therapeutic effects

    1 week

  • Number of Active Trigger Points

    Trapezius fibers will be evaluated for the number of trigger points by manual palpation.

    1 week

Secondary Outcomes (2)

  • Nottingham Health Profile

    1 week

  • Neck Disability Index

    1 week

Study Arms (4)

Group 1

EXPERIMENTAL

Functional Correction Technique

Other: Functional Correction Technique

Group 2

EXPERIMENTAL

Fascia Correction Technique

Other: Fascia Correction Technique

Group 3

EXPERIMENTAL

Star Taping Technique

Other: Star Taping Technique

Group 4

SHAM COMPARATOR

I taping technique without tension

Other: Sham Comparator

Interventions

A single I strip will be used for this technique. Taping will be done by applying moderate (25-35%) degree of stretching to the middle 1/3 of the tape, with the stretched area centered on the trigger point. The ends of the tape will be adhered without stretching.

Group 1

Y tape will be applied to prevent fascia adhesions. In the Y tape application, first the tail strips of the Y will be adhered with maximum tension so that the muscle fiber is transverse. Then it will be glued so that its base is in front of the pain point. No tension will be applied to the ends of the tape. The application will be applied when the patient is in a resting position and his joints are in a tense position.

Group 2

4 I tapes of the same length between 15 cm and 20 cm will be glued on top of each other. After the first I tape is adhered, the 2nd I tape will be adhered at 90 degrees, then the 3rd and 4th I tapes will be adhered at 45 degrees to obtain a star appearance. There will be no tension at the ends of the tapes

Group 3

I shape tape will be adhered for sham purpose without applying any tension.

Group 4

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Be between the ages of 18-30
  • Being diagnosed with myofascial pain syndrome
  • Pain in the upper trapezius area
  • Detection of a taut band in the upper trapezius region on examination
  • Presence of at least one active trigger point within the taut band in the upper trapezius -region on examination
  • The pain caused by the compression of the trigger point is the pain that the patient complains about
  • Having signed the informed consent form

You may not qualify if:

  • Those who have had major surgery or trauma related to the musculoskeletal system, especially the spine and upper extremities
  • Those who have a history of any operation related to the head, neck and shoulder region
  • Those with neuromuscular disease
  • Those with rheumatic disease in the active period
  • Those with systemic diseases (Diabetes, hypothyroidism, infection, malignancy...)
  • Those with any pathology related to musculoskeletal disease, especially in the cervical region (cervical discopathy, cervical spondylosis, pathologies related to the shoulder joint and surrounding soft tissues, scoliosis, kyphosis, leg length difference, polio sequelae, developmental hip dysplasia...)
  • Those with serious psychological problems (BDI score of 30 and above)
  • Those with obesity (BMI≥30 kg/m2)
  • Those with tape allergies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

May 18, 2023

First Posted

May 30, 2023

Study Start

May 30, 2023

Primary Completion

July 30, 2023

Study Completion

August 8, 2023

Last Updated

August 9, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations