Kinesio-taping Versus Pelvic Floor Exercise for Post Colonoscopy Coccydynia
Primary Purpose
Musculoskeletal Pain
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
kinesio-taping techniques.
Pelvic floor exercise
traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz.
Sponsored by
About this trial
This is an interventional treatment trial for Musculoskeletal Pain focused on measuring pelvic floor exercise, coccydynia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Experimental group 1
Experimental group 2
Control group
Arm Description
kinesio- taping technique plus traditional physical therapy program.
Pelvic floor exercise plus traditional physical therapy program.
traditional physical therapy program in the form of stretching of piriformis, stretching of iliopsoas and clam shell exercise, seat cushioning and seat kitz.
Outcomes
Primary Outcome Measures
pain intensity measured by numerical rating scale.
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)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04261647
Brief Title
Kinesio-taping Versus Pelvic Floor Exercise for Post Colonoscopy Coccydynia
Official Title
The Effect of Adding Kinesio-taping Versus Pelvic Floor Exercise to Conventional Therapy in the Management of Post-colonoscopy Coccydynia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 30, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hadaya Mosaad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain
Keywords
pelvic floor exercise, coccydynia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group 1
Arm Type
Experimental
Arm Description
kinesio- taping technique plus traditional physical therapy program.
Arm Title
Experimental group 2
Arm Type
Experimental
Arm Description
Pelvic floor exercise plus traditional physical therapy program.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
traditional physical therapy program in the form of stretching of piriformis, stretching of iliopsoas and clam shell exercise, seat cushioning and seat kitz.
Intervention Type
Other
Intervention Name(s)
kinesio-taping techniques.
Intervention Type
Other
Intervention Name(s)
Pelvic floor exercise
Intervention Type
Other
Intervention Name(s)
traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz.
Primary Outcome Measure Information:
Title
pain intensity measured by numerical rating scale.
Description
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)
Time Frame
after 3 weeks of intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Study protocol statistical analusis.
IPD Sharing Time Frame
We will share the results after 6 months from publication.
Learn more about this trial
Kinesio-taping Versus Pelvic Floor Exercise for Post Colonoscopy Coccydynia
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