- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04261647
Kinesio-taping Versus Pelvic Floor Exercise for Post Colonoscopy Coccydynia
February 7, 2020 updated by: Hadaya Mosaad
The Effect of Adding Kinesio-taping Versus Pelvic Floor Exercise to Conventional Therapy in the Management of Post-colonoscopy Coccydynia
Forty-two patients, with coccydynia following colonoscopy were selected from Kasr El-Aini teaching Hospital, with age ranged from 25-45 years.
Patients were randomly assigned to the control or experimental groups.
The patients in the three groups completed 3-weeks 3 sessions per week for traditional physical therapy treatment consisting of stretching exercise for the piriformis and iliopsoas muscles, clamshell exercise, seat cushioning and seat kitz.
Experimental group I received kinsiotaping techniques in addition to the traditional physical therapy.
While experimental group II received pelvic floor exercise in the form of reverse kegel exercise or pelvic pulges, in addition to conventional therapies.
pain intensity were evaluated by numerical rating scale as a primary out come measure, and Oswestry disability index was used as a secondary out come measure.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients suffering from pain in or around the coccyx, following colonoscopy procedures.
- Age group ranging from 38-58 years old.
Exclusion Criteria:
Cancer.
, - Cysts in pelvic area.
- Pelvic fracture or recent trauma.
- Patient with pain in coccyx region referred from lumbar spine, pelvic floor muscles, degenerative disc, neoplasms, bony spurs, or infections.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental group 1
kinesio- taping technique plus traditional physical therapy program.
|
|
Experimental: Experimental group 2
Pelvic floor exercise plus traditional physical therapy program.
|
|
Active Comparator: Control group
traditional physical therapy program in the form of stretching of piriformis, stretching of iliopsoas and clam shell exercise, seat cushioning and seat kitz.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain intensity measured by numerical rating scale.
Time Frame: after 3 weeks of intervention.
|
a one-dimensional measure of pain intensity in adults, including those with chronic pain.
Numerical pain rating scale consists an 11-point numeric scale with 0 representing "no pain" and 10 representing extreme pain (Worst possible pain)
|
after 3 weeks of intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2017
Primary Completion (Actual)
December 30, 2017
Study Completion (Actual)
December 30, 2017
Study Registration Dates
First Submitted
February 6, 2020
First Submitted That Met QC Criteria
February 6, 2020
First Posted (Actual)
February 10, 2020
Study Record Updates
Last Update Posted (Actual)
February 11, 2020
Last Update Submitted That Met QC Criteria
February 7, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012002613
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Study protocol statistical analusis.
IPD Sharing Time Frame
We will share the results after 6 months from publication.
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.
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