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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

Primary Purpose

Female Patients With Myofascial Pain Syndrome (MPS) Related to Upper Trapezius Active Trigger Points (TP)

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Kinesiotaping with space correction technique
Kinesiotaping with muscle inhibition technique
Home exercise program
Sponsored by
Dilşad Sindel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Female Patients With Myofascial Pain Syndrome (MPS) Related to Upper Trapezius Active Trigger Points (TP) focused on measuring Myofascial pain syndrome, kinesiotaping, upper trapezius, home exercise program

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Kinesiotaping with space correction technique

    Kinesiotaping with muscle inhibition technique

    Home exercise program

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in pain related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to first, second and six weeks
    Pain intensity mesaurement via Numerical Rating Scale, range between 0 to 10, higher scores indicating more pain intensity
    Change in disability related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to second and six weeks
    Functional status measurement via Neck Disability Index
    Change in quality of life affected by myofascial pain syndrome due to upper trapezius active trigger points from baseline to second and six weeks
    Quality of life measurement via Short Form-36

    Secondary Outcome Measures

    Full Information

    First Posted
    May 10, 2019
    Last Updated
    May 14, 2019
    Sponsor
    Dilşad Sindel
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03949010
    Brief Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (Actual)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Dilşad Sindel

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Female Patients With Myofascial Pain Syndrome (MPS) Related to Upper Trapezius Active Trigger Points (TP)
    Keywords
    Myofascial pain syndrome, kinesiotaping, upper trapezius, home exercise program

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    93 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Kinesiotaping with space correction technique
    Arm Type
    Experimental
    Arm Title
    Kinesiotaping with muscle inhibition technique
    Arm Type
    Experimental
    Arm Title
    Home exercise program
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    Kinesiotaping with space correction technique
    Intervention Description
    Kinesiotaping with space correction technique twice per week for two weeks along with home exercise program
    Intervention Type
    Other
    Intervention Name(s)
    Kinesiotaping with muscle inhibition technique
    Intervention Description
    Kinesiotaping with muscle inhibition technique twice per week for two weeks along with home exercise program
    Intervention Type
    Other
    Intervention Name(s)
    Home exercise program
    Intervention Description
    Home exercise program which consists of stretching exercises towards neck area
    Primary Outcome Measure Information:
    Title
    Change in pain related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to first, second and six weeks
    Description
    Pain intensity mesaurement via Numerical Rating Scale, range between 0 to 10, higher scores indicating more pain intensity
    Time Frame
    Initial assessment, First week, second week, sixth week
    Title
    Change in disability related to myofascial pain syndrome due to upper trapezius active trigger points from baseline to second and six weeks
    Description
    Functional status measurement via Neck Disability Index
    Time Frame
    Initial assessment, second week, sixth week
    Title
    Change in quality of life affected by myofascial pain syndrome due to upper trapezius active trigger points from baseline to second and six weeks
    Description
    Quality of life measurement via Short Form-36
    Time Frame
    Initial assessment, second week, sixth week

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    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

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