- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06705933
Effect of Kinesiotaping on Postpartum Pelvic Girdle Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Pregnancy-related pain in the SIJ, lumbosacral region, pubic symphysis, or in any combination of these joints has been coined as pelvic girdle pain (PGP) and has been estimated to affect almost half of all pregnant women. Women with PGP have an increased risk of prenatal anxiety, depressive symptoms and postpartum depression compared with healthy pregnant women.
Kinesio Taping is rehabilitative technique used to facilitate the body's natural healing process while providing support and stability to muscles and joints, without restricting their range of motion. Enhanced rehabilitation is thought to be the effect of stimulated reactivation, proprioceptive training, reduced pain, stimulation of correct movement patterns, and reduction of muscle imbalance.
Kinesio Taping (KT) method has been used to decrease and prevent pain in women suffering from pregnancy related low back pain because of increased muscle relaxation while taping is applied. However, there is lack of knowledge regarding the effect of kinesiotaping on PGP in postpartum women.
Therefore, this study will be conducted to provide physiotherapists with a scientific updated knowledge, concerning the effect of kinesiotaping on pain, level of disability and lumbar flexion and extension ROM in pelvic girdle pain in postpartum women, aiming to improve ADLs of postpartum women. This study may expand the role of physiotherapy in women's health
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Mariam Sobhy kamal
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- All post-partum women < 4 months postnatal having pelvic girdle pain.
- They will be diagnosed using Faber test, and active straight leg raising test.
- Their ages will range from 25 to 35 years.
- Their body mass index (BMI) less than 30 kg/ m².
Exclusion Criteria:
- Pregnant women or planning for pregnancy.
- Cardiovascular diseases.
- Previous spinal surgery.
- History of skeletal deformity.
- Participation at any other exercise training program during this study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Core stability exercise and myofascial release group
The participants will receive core stability exercise and myofascial release for 20 min three times per week for 8 weeks.
|
Lumbo-pelvic stabilizing exercises (posterior pelvic tilt, bilateral hip abduction, bilateral knee raise, bridging, hip shrugging) will be performed three times per week for eight weeks.
The participants will receive myofascial release technique for 20 min for 3 times per week for 8 weeks.
|
|
Experimental: Kinesiotaping, in addition to core stability exercise and myofascial release group
The participants will receive kinesiotaping, in addition to core stability exercise and myofascial release for 8 weeks
|
Lumbo-pelvic stabilizing exercises (posterior pelvic tilt, bilateral hip abduction, bilateral knee raise, bridging, hip shrugging) will be performed three times per week for eight weeks.
The participants will receive myofascial release technique for 20 min for 3 times per week for 8 weeks.
The participants will receive Kinesio-Taping over the sacroiliac joint and the hip region.
Following a test trial of a small patch for 24 hours, they will be instructed to keep the tape on for 48 hours (it will be replaced after 48 hours) .
It will be applied for 8 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assessment of pain
Time Frame: 8 weeks
|
Visual analog scale will be used to assess pain level in each woman in both groups before and after the treatment program.
The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.
A higher score indicates greater pain intensity.
The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain (5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm)
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measurement of disability level
Time Frame: 8 weeks
|
The Oswestry disability index will be used to assess function disability.
It is a questionnaire consisting of 10 questions about the impact of low back pain on daily life.
Unlike other outcome measures in which a higher score is typically a better score, a higher score on the ODI indicates a greater level of disability, according to the following scoring criteria:0-4: No disability; 5-14: Mild disability; 15-24: Moderate disability; 25-34: Severe disability; 35-50: Completely disabled
|
8 weeks
|
|
Assessment of lumbar flexion range of motion (ROM)
Time Frame: 8 weeks
|
Lumbar flexion ROM will be tested by using the inclinometer. The T12 spinous process and the sacral midpoint as landmarks for inclinometer placement. These original landmarks will be modified to the spinal interspaces between T12-L1 and L5-S1 as an attempt to isolate the lumbar spine, and because it was thought that these landmarks are more easily palpated. The trial will begin with the patient in a neutral standing position, with the lumbar spine exposed and feet placed shoulder width apart. The subject will be asked to bend forward as far as possible, keeping their legs straight. This point will be entered as a maximum flexion. Normal lumbar flexion (40-60 degrees). |
8 weeks
|
|
Assessment of lumbar extension range of motion (ROM)
Time Frame: 8 weeks
|
Lumbar extension ROM will be tested by using the inclinometer. The T12 spinous process and the sacral midpoint as landmarks for inclinometer placement. These original landmarks will be modified to the spinal interspaces between T12-L1 and L5-S1 as an attempt to isolate the lumbar spine, and because it was thought that these landmarks are more easily palpated. The trial will begin with the patient in a neutral standing position, with the lumbar spine exposed and feet placed shoulder width apart. The patient will then be asked to extend back as far as possible with their hands on their hips. This point will be entered as maximal extension. Normal lumbar extension (20-35 degrees). |
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Elham Hassan, PHD, Cairo University
- Study Chair: Abeer Eldeeb, Professor, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005017
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pelvic Girdle Pain
-
Foundation University IslamabadActive, not recruitingPregnancy Related Pelvic Girdle PainPakistan
-
Kafrelsheikh UniversityNot yet recruitingPostpartum Pelvic Girdle Pain
-
Helse Stavanger HFUniversity of StavangerCompletedPelvic Girdle Pain Post Partum | Low Back Pain Post PartumNorway
-
Muş Alparlan UniversityCompletedPregnancy-Related Pelvic Girdle PainTurkey
-
Haute Ecole de Santé VaudLa Tour HospitalNot yet recruitingPregnancy | Pelvic Girdle Pain | Pelvic Floor Dysfunctions
-
Riphah International UniversityCompletedPelvic Girdle PainPakistan
-
Loyola UniversityCompletedPelvic Girdle PainUnited States
-
Oslo University HospitalCompleted
-
University of CalgaryCompletedPelvic Girdle Pain
-
National Taiwan University Hospital Hsin-Chu BranchNational Taiwan University Hospital; National Taiwan UniversityRecruitingPelvic Girdle PainTaiwan
Clinical Trials on Core stability exercise
-
Ahi Evran University Education and Research HospitalCompleted
-
University of VirginiaCompleted
-
October 6 UniversityCompleted
-
Riphah International UniversityRecruiting
-
Burdur Mehmet Akif Ersoy UniversityNot yet recruitingManual Dexterity | Core Stability | Hand Grip Strength | Dental Students
-
Foundation University IslamabadCompletedMild Intermittent AsthmaPakistan
-
Kyungdong UniversityCompletedCore StabilityKorea, Republic of
-
Riphah International UniversityCompletedSports Physical TherapyPakistan
-
Cairo UniversityNot yet recruitingPatients With Chronic Mechanical LBPSaudi Arabia