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出境医 / 临床实验 / 慢性颈部疼痛的缺血性加压疗法和肌动片的比较

慢性颈部疼痛的缺血性加压疗法和肌动片的比较

Study Description
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.


Condition or disease Intervention/treatment Phase
Neck Pain Other: ischemic compression Other: kinesio taping Other: exercise Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled study
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Ischemic Compression Therapy and Kinesiotaping on Blood Flow, Tissue Stiffness, Pain and Range of Motion in Chronic Neck Pain
Actual Study Start Date : May 1, 2021
Actual Primary Completion Date : July 8, 2021
Actual Study Completion Date : July 8, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: ischemic compression and exercise
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 compression
manual therapy

Other: exercise
posture exercises

Experimental: kinesio taping and exercise
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 taping
elastic therapeutic taping

Other: exercise
posture exercises

Active Comparator: exercise
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
posture exercises

Outcome Measures
Primary Outcome Measures :
  1. pain intensity [ Time Frame: 4 weeks ]
    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

  2. pain threshold [ Time Frame: 4 weeks ]
    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

  3. range of motion [ Time Frame: 4 weeks ]
    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. Ultrasonographic Measurements [ Time Frame: 4 weeks ]

    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.



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Locations
Layout table for location information
Turkey
Baskent University
Ankara, Turkey, 06810
Sponsors and Collaborators
Baskent University
Tracking Information
First Submitted Date  ICMJE July 9, 2021
First Posted Date  ICMJE July 20, 2021
Last Update Posted Date July 20, 2021
Actual Study Start Date  ICMJE May 1, 2021
Actual Primary Completion Date July 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2021)
  • pain intensity [ Time Frame: 4 weeks ]
    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
  • pain threshold [ Time Frame: 4 weeks ]
    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
  • range of motion [ Time Frame: 4 weeks ]
    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
  • Ultrasonographic Measurements [ Time Frame: 4 weeks ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Ischemic Compression Therapy and Kinesiotaping in Chronic Neck Pain
Official Title  ICMJE Comparison of Ischemic Compression Therapy and Kinesiotaping on Blood Flow, Tissue Stiffness, Pain and Range of Motion in Chronic Neck Pain
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
randomized controlled study
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neck Pain
Intervention  ICMJE
  • Other: ischemic compression
    manual therapy
  • Other: kinesio taping
    elastic therapeutic taping
  • Other: exercise
    posture exercises
Study Arms  ICMJE
  • Experimental: ischemic compression and exercise
    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"
    Interventions:
    • Other: ischemic compression
    • Other: exercise
  • Experimental: kinesio taping and exercise
    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
    Interventions:
    • Other: kinesio taping
    • Other: exercise
  • Active Comparator: exercise
    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.
    Intervention: Other: exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2021)
22
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 8, 2021
Actual Primary Completion Date July 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Analgesic use within the previous 24hours
  • History of cervical surgery
  • Receiving myofascial pain treatment within the previous month of the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04968769
Other Study ID Numbers  ICMJE KA 21/19
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Nihan Ozunlu Pekyavas, Baskent University
Study Sponsor  ICMJE Baskent University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Baskent University
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP