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

Sponsor
National Cheng Kung University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04873778
Collaborator
(none)
63
1
3
37.8
1.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Kinesio taping
  • Device: Dynamic taping
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
63 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomized controlled trialrandomized controlled trial
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Comparing Effects of Kinesio and Dynamic Tapings in Postpartum Women With Pelvic Girdle Pain
Actual Study Start Date :
Oct 5, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dynamic taping group

stabilize the Sacroiliac joints and stimulate muscle contraction

Device: Dynamic taping
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

Device: Kinesio taping
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

Device: Kinesio taping
Kinesio taping: Invented by Japan Dr.Kase, increase circulation by creating lifts skin,release pain and inflammation, stabilize joints

Outcome Measures

Primary Outcome Measures

  1. Visual Analog Scale [Change from baseline pain intensity up to 4 weeks]

    for pain

  2. Pelvic Girdle Questionnaire [Change from disability baseline up to 4 weeks]

    for disability

  3. Oswestry Disability Index [Change from baseline disability up to 4 weeks]

    for disability

  4. Patient specific functional scale measures [Change from baseline disability up to 4 weeks]

    for disability

  5. Global rating of change score [Change from baseline disability up to 4 weeks]

    for disability

  6. 36-item Short-Form Survey [Change from baseline quality of life up to 4 weeks]

    for quality of life

  7. Active Straight Leg Raise Fatigue task [Change from baseline Physical functions up to 4 weeks]

    for Physical functions

  8. Time up and go test [Change from baseline Physical functions up to 4 weeks]

    for Physical functions

  9. 10-meter walk test [Change from baseline Physical functions up to 4 weeks]

    for Physical functions

  10. Modified Oxford grading scale [Change from baseline PFM functions up to 4 weeks]

    for PFM functions

  11. Perineometer [Change from baseline PFM functions up to 4 weeks]

    for PFM functions

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Cheng Kung University Tainan Taiwan 701

Sponsors and Collaborators

  • National Cheng Kung University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
YI-JU TSAI, associate professor, National Cheng Kung University
ClinicalTrials.gov Identifier:
NCT04873778
Other Study ID Numbers:
  • NCKU-Taping
First Posted:
May 5, 2021
Last Update Posted:
May 5, 2021
Last Verified:
Oct 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by YI-JU TSAI, associate professor, National Cheng Kung University
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2021