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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
Hadaya Mosaad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain focused on measuring pelvic floor exercise, coccydynia

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 6, 2020
    Last Updated
    February 7, 2020
    Sponsor
    Hadaya Mosaad
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    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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