Clinical trial NCT04873778: Comparing Effects of Kinesio and Dynamic Tapings in Postpartum Women With Pelvic Girdle Pain
Official title: Comparing Effects of Kinesio and Dynamic Tapings in Postpartum Women With Pelvic Girdle Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Girdle Pain
Keywords: Kinesio taping
Dynamic taping
Postpartum
Lead sponsor: National Cheng Kung University
Sponsor class: OTHER
First posted: 2021-05-05
Enrollment: 57
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual Analog Scale
timeFrame: Change from baseline pain intensity up to 4 weeks
measure: Pelvic Girdle Questionnaire
timeFrame: Change from disability baseline up to 4 weeks
measure: Oswestry Disability Index
timeFrame: Change from baseline disability up to 4 weeks
measure: Patient specific functional scale measures
timeFrame: Change from baseline disability up to 4 weeks
measure: Global rating of change score
timeFrame: Change from baseline disability up to 4 weeks
measure: 36-item Short-Form Survey
timeFrame: Change from baseline quality of life up to 4 weeks
measure: Active Straight Leg Raise Fatigue task
timeFrame: Change from baseline Physical functions up to 4 weeks
measure: Time up and go test
timeFrame: Change from baseline Physical functions up to 4 weeks
measure: 10-meter walk test
timeFrame: Change from baseline Physical functions up to 4 weeks
measure: Modified Oxford grading scale
timeFrame: Change from baseline PFM functions up to 4 weeks
measure: Perineometer
timeFrame: Change from baseline PFM functions up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
References: