NCT04261647

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 10, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

12 months

First QC Date

February 6, 2020

Last Update Submit

February 7, 2020

Conditions

Keywords

pelvic floor exercisecoccydynia

Outcome Measures

Primary Outcomes (1)

  • 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)

    after 3 weeks of intervention.

Study Arms (3)

Experimental group 1

EXPERIMENTAL

kinesio- taping technique plus traditional physical therapy program.

Other: kinesio-taping techniques.Other: traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz.

Experimental group 2

EXPERIMENTAL

Pelvic floor exercise plus traditional physical therapy program.

Other: Pelvic floor exerciseOther: traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz.

Control group

ACTIVE COMPARATOR

traditional physical therapy program in the form of stretching of piriformis, stretching of iliopsoas and clam shell exercise, seat cushioning and seat kitz.

Other: traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz.

Interventions

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients suffering from pain in or around the coccyx, following colonoscopy procedures.
  • Age group ranging from 38-58 years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer at physical therapy department for Surgery, Cairo university

Study Record Dates

First Submitted

February 6, 2020

First Posted

February 10, 2020

Study Start

January 1, 2017

Primary Completion

December 30, 2017

Study Completion

December 30, 2017

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Study protocol statistical analusis.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
We will share the results after 6 months from publication.