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

March 24, 2024 updated by: YI-JU TSAI, National Cheng Kung University
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Tainan, Taiwan, 701
        • National Cheng Kung University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dynamic taping group
stabilize the Sacroiliac joints and stimulate muscle contraction
Dynamic taping: Invented by Kendrick,elasticised with multi-directional rebound and with strong elastic resistance and recoil than KT
Experimental: kinesio taping group
stabilize the Sacroiliac joints and stimulate muscle contraction
Kinesio taping: Invented by Japan Dr.Kase, increase circulation by creating lifts skin,release pain and inflammation, stabilize joints
Placebo Comparator: control group
use Kinesio taping for placebo effect
Kinesio taping: Invented by Japan Dr.Kase, increase circulation by creating lifts skin,release pain and inflammation, stabilize joints

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale
Time Frame: Change from baseline pain intensity up to 4 weeks
for pain
Change from baseline pain intensity up to 4 weeks
Pelvic Girdle Questionnaire
Time Frame: Change from disability baseline up to 4 weeks
for disability
Change from disability baseline up to 4 weeks
Oswestry Disability Index
Time Frame: Change from baseline disability up to 4 weeks
for disability
Change from baseline disability up to 4 weeks
Patient specific functional scale measures
Time Frame: Change from baseline disability up to 4 weeks
for disability
Change from baseline disability up to 4 weeks
Global rating of change score
Time Frame: Change from baseline disability up to 4 weeks
for disability
Change from baseline disability up to 4 weeks
36-item Short-Form Survey
Time Frame: Change from baseline quality of life up to 4 weeks
for quality of life
Change from baseline quality of life up to 4 weeks
Active Straight Leg Raise Fatigue task
Time Frame: Change from baseline Physical functions up to 4 weeks
for Physical functions
Change from baseline Physical functions up to 4 weeks
Time up and go test
Time Frame: Change from baseline Physical functions up to 4 weeks
for Physical functions
Change from baseline Physical functions up to 4 weeks
10-meter walk test
Time Frame: Change from baseline Physical functions up to 4 weeks
for Physical functions
Change from baseline Physical functions up to 4 weeks
Modified Oxford grading scale
Time Frame: Change from baseline PFM functions up to 4 weeks
for PFM functions
Change from baseline PFM functions up to 4 weeks
Perineometer
Time Frame: Change from baseline PFM functions up to 4 weeks
for PFM functions
Change from baseline PFM functions up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2020

Primary Completion (Actual)

May 1, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

April 30, 2021

First Posted (Actual)

May 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 24, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • NCKU-Taping

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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