Pelvic Girdle PainNCT04873778
Comparing Effects of Kinesio and Dynamic Tapings in Postpartum Women With Pelvic Girdle Pain
A study testing Kinesio taping and Dynamic taping in people with Pelvic Girdle Pain, run by National Cheng Kung University at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pelvic Girdle Pain
- What is being tested?
- Kinesio taping and Dynamic taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteTaiwan
- Study dates
- 5 Oct 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- BMI ≥ 30
- lumbar or pelvic surgery
- History of fracture
- Radiculopathy or myopathy
- Gynaecological disorders
- Serious cardiovascular disease
Show all 10Show fewer
- Tumors
- Diagnosed psychiatric disease
- Ongoing pregnancy
- Allergy to acrylic
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pelvic Girdle Pain
- Being tested
- Kinesio taping, Dynamic taping
- Keywords
- Kinesio taping, Dynamic taping, Postpartum
- Medical subject headings
- Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kinesio tapingDevice
Kinesio taping: Invented by Japan Dr.Kase, increase circulation by creating lifts skin,release pain and inflammation, stabilize joints
Dynamic tapingDevice
Dynamic taping: Invented by Kendrick,elasticised with multi-directional rebound and with strong elastic resistance and recoil than KT
| Study group | Role | What they receive |
|---|---|---|
| Dynamic taping group | Experimental | stabilize the Sacroiliac joints and stimulate muscle contraction Receives: Device: Dynamic taping |
| kinesio taping group | Experimental | stabilize the Sacroiliac joints and stimulate muscle contraction Receives: Device: Kinesio taping |
| control group | Placebo comparator | use Kinesio taping for placebo effect Receives: Device: Kinesio taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
for pain
Measured: Change from baseline pain intensity up to 4 weeks
Pelvic Girdle Questionnaire
for disability
Measured: Change from disability baseline up to 4 weeks
Oswestry Disability Index
for disability
Measured: Change from baseline disability up to 4 weeks
Patient specific functional scale measures
for disability
Measured: Change from baseline disability up to 4 weeks
Global rating of change score
for disability
Measured: Change from baseline disability up to 4 weeks
36-item Short-Form Survey
for quality of life
Measured: Change from baseline quality of life up to 4 weeks
Active Straight Leg Raise Fatigue task
for Physical functions
Measured: Change from baseline Physical functions up to 4 weeks
Time up and go test
for Physical functions
Measured: Change from baseline Physical functions up to 4 weeks
10-meter walk test
for Physical functions
Measured: Change from baseline Physical functions up to 4 weeks
Modified Oxford grading scale
for PFM functions
Measured: Change from baseline PFM functions up to 4 weeks
Perineometer
for PFM functions
Measured: Change from baseline PFM functions up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start5 Oct 2020
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Girdle PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng Kung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YI-JU TSAI, National Cheng Kung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873778
- Sponsor's protocol ID
- NCKU-Taping
- Status last verified
- Mar 2024
- First submitted
- 27 Apr 2021
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Effects of Kinesio and Dynamic Tapings in Postpartum Women With Pelvic Girdle Pain
- ClinicalTrials.gov ID
- NCT04873778
- Acronym / sponsor ID
- NCKU-Taping
- Conditions
- Pelvic Girdle Pain
- Keywords
- Kinesio taping, Dynamic taping, Postpartum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- National Cheng Kung UniversityUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 5 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Dynamic taping group | Experimental | Device: Dynamic tapingstabilize the Sacroiliac joints and stimulate muscle contraction |
| kinesio taping group | Experimental | Device: Kinesio tapingstabilize the Sacroiliac joints and stimulate muscle contraction |
| control group | Placebo comparator | Device: Kinesio tapinguse Kinesio taping for placebo effect |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 :
Key exclusion criteria (10 listed)
- BMI ≥ 30
- lumbar or pelvic surgery
- History of fracture
- Radiculopathy or myopathy
- Gynaecological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kinesio tapingKinesio taping: Invented by Japan Dr.Kase, increase circulation by creating lifts skin,release pain and inflammation, stabilize joints | Device | control group, kinesio taping group |
| Dynamic tapingDynamic taping: Invented by Kendrick,elasticised with multi-directional rebound and with strong elastic resistance and recoil than KT | Device | Dynamic taping group |
Primary outcome
Visual Analog Scale
Time frame: Change from baseline pain intensity up to 4 weeks
for pain
Pelvic Girdle Questionnaire
Time frame: Change from disability baseline up to 4 weeks
for disability
Oswestry Disability Index
Time frame: Change from baseline disability up to 4 weeks
for disability
Patient specific functional scale measures
Time frame: Change from baseline disability up to 4 weeks
for disability
Global rating of change score
Time frame: Change from baseline disability up to 4 weeks
for disability
36-item Short-Form Survey
Time frame: Change from baseline quality of life up to 4 weeks
for quality of life
Active Straight Leg Raise Fatigue task
Time frame: Change from baseline Physical functions up to 4 weeks
for Physical functions
Time up and go test
Time frame: Change from baseline Physical functions up to 4 weeks
for Physical functions
10-meter walk test
Time frame: Change from baseline Physical functions up to 4 weeks
for Physical functions
Modified Oxford grading scale
Time frame: Change from baseline PFM functions up to 4 weeks
for PFM functions
Perineometer
Time frame: Change from baseline PFM functions up to 4 weeks
for PFM functions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
Related trials for Pelvic Girdle Pain
Active, not recruiting
Hypopressive-Core Stabilization With and Without Whole-Body Vibration in Postpartum Pelvic Girdle Pain
Postpartum Pelvic Girdle Pain
Recruiting
Effects of Pelvic Floor Muscle Training and a Modified Lumbopelvic Belt on Pain, Kinesiophobia, and Functional Status in Pregnant Women With Symphysis Pubis Pain
Symphysis Pubis Dysfunction, Pregnancy
Recruiting
Effects of Rehabilitation on Cesarean Scar Symptoms and Physical Recovery
Cesarean Birth, Massage
Recruiting
Effects of MET With and Without Lumbopelvic Manipulation
Anterior Pelvic Tilt
Active, not recruiting
Osteopathy in Postpartum Lumbopelvic Pain
Postpartum Lumbopelvic Pain, Postpartum Pelvic Girdle Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesio taping and Dynamic taping in people with Pelvic Girdle Pain, run by National Cheng Kung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Change from baseline pain intensity up to 4 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024.