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

Pelvic Girdle Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04873778
• Other study ID #: NCKU-Taping
• Status: Completed
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: March 2024
• Source: National Cheng Kung University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Girdle Pain

Intervention

Device:
• Kinesio taping
Kinesio taping: Invented by Japan Dr.Kase, increase circulation by creating lifts skin,release pain and inflammation, stabilize joints
• Dynamic taping
Dynamic taping: Invented by Kendrick,elasticised with multi-directional rebound and with strong elastic resistance and recoil than KT

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng Kung University

Country where clinical trial is conducted

Taiwan, 

Outcome

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