- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04873778
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
Intervention / Treatment
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
- Name: Yi-Ju Tsai
- Phone Number: 5930 06-2353535
- Email: lulilutsai@gmail.com
Study Locations
-
-
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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:
- 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
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
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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