Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigation of the Effectiveness of Muscle Inhibition and Space Correction Techniques of Kinesiotaping Method in Female Patients With Myofascial Pain Syndrome Related to Upper Trapezius Active Trigger Points

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949010
Recruitment Status : Completed
First Posted : May 14, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Dilşad Sindel, Istanbul University

Brief Summary:
To investigate the effectiveness of muscle inhibition and space correction techniques of kinesiotaping (KT) method; on pain, functional status and quality of life in female patients with myofascial pain syndrome (MPS) related to upper trapezius active trigger points (TP) in comparison to control group and to determine the advantage of each technique over another.

Condition or disease Intervention/treatment Phase
Female Patients With Myofascial Pain Syndrome (MPS) Related to Upper Trapezius Active Trigger Points (TP) Other: Kinesiotaping with space correction technique Other: Kinesiotaping with muscle inhibition technique Other: Home exercise program Not Applicable

Detailed Description:
The investigators conducted a prospective, randomized, controlled trial involving 93 female patients with MPS related to upper trapezius TPs and randomized the patients to KT treatment group with space correction technique and home exercise program (KSCT, n=20), KT treatment group with muscle inhibition technique and home exercise program (KMIT, n=24) and control group (CG, n=27) which received home exercise program only. Patients were evaluated by numerical rating scale (NRS) for their average and maximum pain intensity, Turkish version of neck disability index (NDI), and short form-36 (SF-36) scales. Statistical tests were conducted at the 0.05 significance level for all outcome measures.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : December 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Experimental: Kinesiotaping with space correction technique Other: Kinesiotaping with space correction technique
Kinesiotaping with space correction technique twice per week for two weeks along with home exercise program

Other: Home exercise program
Home exercise program which consists of stretching exercises towards neck area

Experimental: Kinesiotaping with muscle inhibition technique Other: Kinesiotaping with muscle inhibition technique
Kinesiotaping with muscle inhibition technique twice per week for two weeks along with home exercise program

Other: Home exercise program
Home exercise program which consists of stretching exercises towards neck area

Active Comparator: Home exercise program Other: Home exercise program
Home exercise program which consists of stretching exercises towards neck area




Primary Outcome Measures :
  1. Change in pain related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to first, second and six weeks [ Time Frame: Initial assessment, First week, second week, sixth week ]
    Pain intensity mesaurement via Numerical Rating Scale, range between 0 to 10, higher scores indicating more pain intensity

  2. Change in disability related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to second and six weeks [ Time Frame: Initial assessment, second week, sixth week ]
    Functional status measurement via Neck Disability Index

  3. Change in quality of life affected by myofascial pain syndrome due to upper trapezius active trigger points from baseline to second and six weeks [ Time Frame: Initial assessment, second week, sixth week ]
    Quality of life measurement via Short Form-36



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • being female
  • being aged between 18 and 45 years old
  • not being in menopausal period
  • having pain in upper trapezius region
  • determining a taut band in examination
  • having at least one active TP in this taut band
  • the pain produced by palpation of this TP is the pain that the patient complains
  • painfull restriction of cervical lateral flexion
  • having pain score 4 or more according to NRS
  • signing informed consent.

Exclusion Criteria:

  • having major surgery or trauma related to the musculoskeletal system (primarily including the spine and upper extremity)
  • having any operative history including the head and neck region
  • having a neuromuscular disease
  • having an active rheumatic disease
  • having a systemic disease (diabetes, hypothyroidism, infection, malignancy...)
  • having any pathology related to musculoskeletal diseases -especially including the cervical region- (cervical discopathy, cervical spondylosis, pathologies related to shoulder joint and surrounding soft tissues, scoliosis, kyphosis, limb length discrepancy, polio sequelae, developmental hip dysplasia...)
  • having serious psychological problems (having score of 30 or more from Beck Depression Inventory)
  • being obese (Body Mass Index≥30 kg/m2)
  • having allergy to kinesiotapes
Layout table for additonal information
Responsible Party: Dilşad Sindel, Professor, MD, Istanbul University
ClinicalTrials.gov Identifier: NCT03949010    
Other Study ID Numbers: KSCT&KMIT
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dilşad Sindel, Istanbul University:
Myofascial pain syndrome, kinesiotaping, upper trapezius, home exercise program
Additional relevant MeSH terms:
Layout table for MeSH terms
Myofascial Pain Syndromes
Fibromyalgia
Syndrome
Disease
Pathologic Processes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases