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Completed

NCT Number: NCT04873778

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

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.

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Key information

Conditions

Pelvic Girdle Pain Musculoskeletal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University

Tainan, 701, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kinesio taping

Device

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

Dynamic taping

Device

Dynamic taping: Invented by Kendrick,elasticised with multi-directional rebound and with strong elastic resistance and recoil than KT

Primary outcomes

  1. Visual Analog Scale

    Time frame: Change from baseline pain intensity up to 4 weeks

    for pain

  2. Pelvic Girdle Questionnaire

    Time frame: Change from disability baseline up to 4 weeks

    for disability

  3. Oswestry Disability Index

    Time frame: Change from baseline disability up to 4 weeks

    for disability

  4. Patient specific functional scale measures

    Time frame: Change from baseline disability up to 4 weeks

    for disability

  5. Global rating of change score

    Time frame: Change from baseline disability up to 4 weeks

    for disability

  6. 36-item Short-Form Survey

    Time frame: Change from baseline quality of life up to 4 weeks

    for quality of life

  7. Active Straight Leg Raise Fatigue task

    Time frame: Change from baseline Physical functions up to 4 weeks

    for Physical functions

  8. Time up and go test

    Time frame: Change from baseline Physical functions up to 4 weeks

    for Physical functions

  9. 10-meter walk test

    Time frame: Change from baseline Physical functions up to 4 weeks

    for Physical functions

  10. Modified Oxford grading scale

    Time frame: Change from baseline PFM functions up to 4 weeks

    for PFM functions

  11. Perineometer

    Time frame: Change from baseline PFM functions up to 4 weeks

    for PFM functions

Sponsors and collaborators

Lead sponsor

National Cheng Kung University

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 5, 2021
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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