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Comparing Effects of Kinesio and Dynamic Tapings in Postpartum Women With Pelvic Girdle Pain

Primary Purpose

Pelvic Girdle Pain

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Kinesio taping
Dynamic taping
Sponsored by
National Cheng Kung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Girdle Pain focused on measuring Kinesio taping, Dynamic taping, Postpartum

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age: > 20 year
  2. Postpartum:≥ 3 months
  3. Pain onset during pregnancy
  4. Pain location is located between costal margin and gluteal fold with or without radiation to lower limb or symphysis pubic
  5. Clinical screening test for pelvic pain :

Active Straight Leg Raising : positive

  • 2 (+) posterior pelvic pain provocation tests (+ symphysis ≥ 1)

Exclusion Criteria:

  1. BMI ≥ 30
  2. lumbar or pelvic surgery
  3. History of fracture
  4. Radiculopathy or myopathy
  5. Gynaecological disorders
  6. Serious cardiovascular disease
  7. Tumors
  8. Diagnosed psychiatric disease
  9. Ongoing pregnancy
  10. Allergy to acrylic

Sites / Locations

  • National Cheng Kung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Dynamic taping group

kinesio taping group

control group

Arm Description

stabilize the Sacroiliac joints and stimulate muscle contraction

stabilize the Sacroiliac joints and stimulate muscle contraction

use Kinesio taping for placebo effect

Outcomes

Primary Outcome Measures

Visual Analog Scale
for pain
Pelvic Girdle Questionnaire
for disability
Oswestry Disability Index
for disability
Patient specific functional scale measures
for disability
Global rating of change score
for disability
36-item Short-Form Survey
for quality of life
Active Straight Leg Raise Fatigue task
for Physical functions
Time up and go test
for Physical functions
10-meter walk test
for Physical functions
Modified Oxford grading scale
for PFM functions
Perineometer
for PFM functions

Secondary Outcome Measures

Full Information

First Posted
April 27, 2021
Last Updated
September 19, 2023
Sponsor
National Cheng Kung University
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1. Study Identification

Unique Protocol Identification Number
NCT04873778
Brief Title
Comparing Effects of Kinesio and Dynamic Tapings in Postpartum Women With Pelvic Girdle Pain
Official Title
Comparing Effects of Kinesio and Dynamic Tapings in Postpartum Women With Pelvic Girdle Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cheng Kung University

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
About 45% of pregnant women and 25% of women postpartum suffer from Pelvic girdle pain. Pain is often reported to be localized between costal margin and gluteal fold with or without radiation to lower limb or symphysis pubic. Kinesio taping (KT) is the application of an elastic tape, for treating musculoskeletal conditions through enhancing muscle strength, relieving spasms, pain and edema, improving blood circulation and lymph reflux, as well as stabilizing joints. However, with limited evidence and a lack of well-designed study, the effects of KT in postpartum women with PGP remains unclear. Compared with KT, the dynamic taping(DT) is recently developed and has stronger elastic resistance and recoil. The DT may have better effects than the KT, although this notion has not been examined. In this study, we make a hypothesis that PGP women in the DT group would have better improvements on pain, disability, quality of life, and PFM functions than that in the KT group and control group.
Detailed Description
The main purpose for this study are to investigate the effects of KT and DT on pain, disability, physical functions, and quality of life, as well as PFM functions in postpartum women with PGP. 60 postpartum women with PGP will be randomized into one of the three groups:(1) kinesio taping group,(2) dynamic taping group (3)control group, and receive 4 weeks intervention. All participants will receive 3 assessments at the baseline, immediately after first taping session, and after 4-week interventions. The outcome measures will include Visual Analog Scale measures of pain intensity, Pelvic Girdle Questionnaire/ Oswestry Disability Index/ Patient specific functional scale measures and Global rating of change score. for disability. The quality of life will be measured by 36-item Short-Form Survey, The Physical functions include Active Straight Leg Raise Fatigue task , Time up and go test,10-meter walk test. The PFM functions will be measured by Modified Oxford grading scale and Perineometer. It is expected that PGP women in both the KT group and DT group will have more improvements than the control group. But the DT group will have even more improvements than the KT groups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Girdle Pain
Keywords
Kinesio taping, Dynamic taping, Postpartum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Participant
Allocation
Randomized
Enrollment
63 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dynamic taping group
Arm Type
Experimental
Arm Description
stabilize the Sacroiliac joints and stimulate muscle contraction
Arm Title
kinesio taping group
Arm Type
Experimental
Arm Description
stabilize the Sacroiliac joints and stimulate muscle contraction
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
use Kinesio taping for placebo effect
Intervention Type
Device
Intervention Name(s)
Kinesio taping
Intervention Description
Kinesio taping: Invented by Japan Dr.Kase, increase circulation by creating lifts skin,release pain and inflammation, stabilize joints
Intervention Type
Device
Intervention Name(s)
Dynamic taping
Intervention Description
Dynamic taping: Invented by Kendrick,elasticised with multi-directional rebound and with strong elastic resistance and recoil than KT
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
for pain
Time Frame
Change from baseline pain intensity up to 4 weeks
Title
Pelvic Girdle Questionnaire
Description
for disability
Time Frame
Change from disability baseline up to 4 weeks
Title
Oswestry Disability Index
Description
for disability
Time Frame
Change from baseline disability up to 4 weeks
Title
Patient specific functional scale measures
Description
for disability
Time Frame
Change from baseline disability up to 4 weeks
Title
Global rating of change score
Description
for disability
Time Frame
Change from baseline disability up to 4 weeks
Title
36-item Short-Form Survey
Description
for quality of life
Time Frame
Change from baseline quality of life up to 4 weeks
Title
Active Straight Leg Raise Fatigue task
Description
for Physical functions
Time Frame
Change from baseline Physical functions up to 4 weeks
Title
Time up and go test
Description
for Physical functions
Time Frame
Change from baseline Physical functions up to 4 weeks
Title
10-meter walk test
Description
for Physical functions
Time Frame
Change from baseline Physical functions up to 4 weeks
Title
Modified Oxford grading scale
Description
for PFM functions
Time Frame
Change from baseline PFM functions up to 4 weeks
Title
Perineometer
Description
for PFM functions
Time Frame
Change from baseline PFM functions up to 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: > 20 year Postpartum:≥ 3 months Pain onset during pregnancy Pain location is located between costal margin and gluteal fold with or without radiation to lower limb or symphysis pubic Clinical screening test for pelvic pain : Active Straight Leg Raising : positive 2 (+) posterior pelvic pain provocation tests (+ symphysis ≥ 1) Exclusion Criteria: BMI ≥ 30 lumbar or pelvic surgery History of fracture Radiculopathy or myopathy Gynaecological disorders Serious cardiovascular disease Tumors Diagnosed psychiatric disease Ongoing pregnancy Allergy to acrylic
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi-Ju Tsai
Phone
06-2353535
Ext
5930
Email
lulilutsai@gmail.com
Facility Information:
Facility Name
National Cheng Kung University
City
Tainan
ZIP/Postal Code
701
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tsai Yi-Ju
Phone
06-2353535
Ext
5930
Email
lulilutsai@gmail.com

12. IPD Sharing Statement

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Comparing Effects of Kinesio and Dynamic Tapings in Postpartum Women With Pelvic Girdle Pain

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