NCT04873778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
Last Updated

March 26, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

April 27, 2021

Last Update Submit

March 24, 2024

Conditions

Keywords

Kinesio tapingDynamic tapingPostpartum

Outcome Measures

Primary Outcomes (11)

  • Visual Analog Scale

    for pain

    Change from baseline pain intensity up to 4 weeks

  • Pelvic Girdle Questionnaire

    for disability

    Change from disability baseline up to 4 weeks

  • Oswestry Disability Index

    for disability

    Change from baseline disability up to 4 weeks

  • Patient specific functional scale measures

    for disability

    Change from baseline disability up to 4 weeks

  • Global rating of change score

    for disability

    Change from baseline disability up to 4 weeks

  • 36-item Short-Form Survey

    for quality of life

    Change from baseline quality of life up to 4 weeks

  • Active Straight Leg Raise Fatigue task

    for Physical functions

    Change from baseline Physical functions up to 4 weeks

  • Time up and go test

    for Physical functions

    Change from baseline Physical functions up to 4 weeks

  • 10-meter walk test

    for Physical functions

    Change from baseline Physical functions up to 4 weeks

  • Modified Oxford grading scale

    for PFM functions

    Change from baseline PFM functions up to 4 weeks

  • Perineometer

    for PFM functions

    Change from baseline PFM functions up to 4 weeks

Study Arms (3)

Dynamic taping group

EXPERIMENTAL

stabilize the Sacroiliac joints and stimulate muscle contraction

Device: Dynamic taping

kinesio taping group

EXPERIMENTAL

stabilize the Sacroiliac joints and stimulate muscle contraction

Device: Kinesio taping

control group

PLACEBO COMPARATOR

use Kinesio taping for placebo effect

Device: Kinesio taping

Interventions

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

control groupkinesio taping group

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

Dynamic taping group

Eligibility Criteria

Age20 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • (+) posterior pelvic pain provocation tests (+ symphysis ≥ 1)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University

Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Pelvic Girdle Pain

Condition Hierarchy (Ancestors)

Musculoskeletal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

April 27, 2021

First Posted

May 5, 2021

Study Start

October 5, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

March 26, 2024

Record last verified: 2024-03

Locations