NCT04968769

Brief Summary

Objective: The purpose of this study was to compare the effects of ischemic compression (IC) and kinesio taping (KT) treatments on blood flow, tissue stiffness and thickness, pain, and joint range of motion on the upper trapezius muscle of individuals with chronic neck pain. Methods: In this study 22 individuals between the ages of 20-35 were randomly assigned to 3 groups: Group1, which received IC; Group2, received KT; Group3 (control) received exercise, for 2 days and 4 weeks. Pain was measured with VAS, pain threshold with J-Tech Algometer, range of motion with BASELINE Digital Inclinometer, ultrasonographic measurements for blood flow, tissue stiffness and tissue thickness using Acuson S3000. All measurements were performed twice; before and after treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

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

May 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

July 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
Last Updated

July 20, 2021

Status Verified

July 1, 2021

Enrollment Period

2 months

First QC Date

July 9, 2021

Last Update Submit

July 9, 2021

Conditions

Keywords

Trapezius muscletrigger pointultrasonographic imagingblood flowchronic pain

Outcome Measures

Primary Outcomes (4)

  • pain intensity

    Visual Analogue Scale: Individuals were asked to mark the intensity of neck pain on the scale, defining the visual analog scale as 0 "absence of pain-no pain" and 10 "unbearable-worst pain". The distance between the sign of the individual and the 0 point was measured and recorded

    4 weeks

  • pain threshold

    Individuals were asked to sit in a comfortable position in a chair with back support. Before starting the measurement, a statement was made to the individual that "when the pressure sensation turns into pain, give a stop warning". The measurement was repeated 3 times and the average value was recorded. A 30-second interval was taken between measurements to prevent temporal summation. Measurements were taken over the UT muscle of the dominant extremity with the J-TECH USA Commander Algometer device

    4 weeks

  • range of motion

    For ROM measurements individuals were asked to sit on a chair with back support with hands on thighs, shoulders free, hips and knees 90 flexed. For neck flexion and extension movements, the inclinometer was placed on the head of the individual in the sagittal plane, and for the right and left lateral flexion movements, the inclinometer was placed in the frontal plane. For neck rotation measurements, the individual was placed in a supine and relaxed position. The inclinometer was placed on the forehead of the head in the transverse plane. For each measurement, the individual was asked to actively perform the movement to be measured, and the average value was recorded for each parameter by repeating it 3 times. Before each measurement, the inclinometer was restarted after it was positioned over the individual's head. Measurements were made with the BASELİNE Digital Inclinometer device

    4 weeks

  • Ultrasonographic Measurements

    Ultrasonographic measurements Using a 9L4 MHz (Megahertz) linear transducer (Acuson S2000, Siemens Healthcare, Erlangen, Germany) with sufficient amount of gel, the upper fibers of the dominant tar trapezius muscle were aligned longitudinally to the muscle fibers inside the transducer UT muscle with a dorsal approach at the mid-clavicular line level. The thickness of the UT muscle, B mode, peak systolic velocity (PV-cm/s) data from the transverse cervical artery, color Doppler ultrasound (RDUS) and the UT muscle fibers of the muscle again in quantitative ARFI mode (Virtual Touch Quantification®, VTq) for tissue stiffness assessment. Mean VTq values were calculated by taking VTq (m/sec) measurements 10 times.

    4 weeks

Study Arms (3)

ischemic compression and exercise

EXPERIMENTAL

Individuals were positioned in a comfortable position in a chair with back support. By palpating the UT muscle, first the taut band and then the active TP on the muscle were determined. Before starting the treatment, , a statement was made to the individual that "you will soon feel a high level of pain with pressure, and at the same time, you may feel pain, tingling, pricking in additional areas (head-neck-shoulder-arm), after a while the pain will decrease and disappear. In this process, try to stay as steady as possible and breathe regularly and calmly.'' The highest level of pressure that the patient could tolerate was applied to the determined TP with the thumb. Pressure time will be in the range of at least 10-20 seconds and at most 60 seconds; It was terminated after the therapist felt complete relaxation in the tissue under his thumb or after the patient received the return of "pain completely disappeared"

Other: ischemic compressionOther: exercise

kinesio taping and exercise

EXPERIMENTAL

While performing KT, the individual was seated in a comfortable and upright position in a chair with back support. The subject was asked to bring his hand to his back in internal rotation of the shoulder of the taped side and to bring his head to the contralateral lateral flexion and contralateral rotation so that the UT muscle was in a tense position. KT was applied using 'muscle inhibition technique' to ensure correct contraction of the muscle with muscle length/tension optimization, to target the reduction of excessive muscle tension, and to increase circulation with the effects of the tape on the skin. In this technique, to inhibit the muscle, the tape direction is from the muscle insertion to the origin. KT was performed 5 cm below the acromion to the protuberantia occipitalis with 10% tension

Other: kinesio tapingOther: exercise

exercise

ACTIVE COMPARATOR

In order for all the exercises to be done correctly and not to cause any pain, the individuals were asked to perform the movements in front of the mirror. Posture exercises given the individuals for scapular retraction. During the posture exercises individual was positioned in a chair without back support. By counting 5 it was requested to do 10 repetitions of each exercise. For the UT muscle stretching, individuals were asked to hold their right ear with their left hand over their head while sitting on a back-supported chair with their hips and back fully resting on the chair, and to bring their left ear closer to their left shoulder with the help of their hand and count to 20 from the outside.

Other: exercise

Interventions

manual therapy

ischemic compression and exercise

elastic therapeutic taping

kinesio taping and exercise

posture exercises

exerciseischemic compression and exercisekinesio taping and exercise

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • A score ar least 3 and above 3 on the Visual analogue scale
  • Presence of palpable taut band and at least one trigger point on the taut band
  • Presence of referred pain with palpation of the trigger point

You may not qualify if:

  • Analgesic use within the previous 24hours
  • History of cervical surgery
  • Receiving myofascial pain treatment within the previous month of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University

Ankara, 06810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainChronic Pain

Interventions

AcupressureExercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Proffesor

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 20, 2021

Study Start

May 1, 2021

Primary Completion

July 8, 2021

Study Completion

July 8, 2021

Last Updated

July 20, 2021

Record last verified: 2021-07

Locations