Comparative Effects of Levator Ani Release and Post Isometric Relaxation Among Patients With Coccydynia

October 25, 2023 updated by: Riphah International University

Comparative Effects of Levator Ani Release and Post Isometric Relaxation on Pain, Disability, and Quality of Life Among Patients With Coccydynia

To compare the effects of levator ani release and post isometric relaxation on pain, disability and quality of life among patients with coccydynia

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Coccygodynia, also known as coccalgia, coccygeal neuralgia, or tailbone pain, is the word used to describe the pain symptoms that develop in the coccyx region. The discomfort is typically brought on while the person is sitting down, but it can also start when the person stands up. The majority of instances get well within a few weeks to months, but for certain people, the pain might last longer and have an adverse effect on quality of life. Due to the complexity of coccygeal pain in these people, management can be challenging.

The aim of the study is to compare effects of levator ani release exercises and post isometric in patients with coccydynia. A randomized control trial will be conducted at Jinnah hospital Lahore through convenience sampling technique on 46 patients which will be allocated through simple random sampling through sealed opaque enveloped into group A and group B. Group A will be treated with levator ani release exercises and Group B will be treated with post isometric relaxation techniques. Outcome measure will be conducted through pain and disability questionnaire at baseline and after 4 weeks. Data will be analyzed using SPSS software version 21. After assessing normality of data by Shapiro - wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Study Type

Interventional

Enrollment (Estimated)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54700
        • Recruiting
        • Ittefaq
        • Contact:
        • Principal Investigator:
          • Hafiz Muhammad Amir Hanif, MS(OMPT)

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:•

  • Both gender
  • Age between 20-40 years
  • Drivers
  • Office workers
  • Computer users
  • Both gender
  • Age between 20-40 years
  • Drivers
  • Office workers
  • Computer users

Exclusion Criteria:

  • Neurological disorders,
  • Bone deficits,
  • Vascular abnormalities,
  • Rheumatoid arthritis
  • Ankylosing spondylitis
  • Fracture
  • Tumor

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levator ani release
Participants will receive levator ani release exercise
Other: Levator ani release
Patients will be treated with levator ani release exercises for pain (3 sets with 10 repetitions 3 times per week for 6 weeks).
Experimental: Post isometric relaxion
Participants will receive post isometric relaxion exercise
Other: Post isometric relaxion
Patients will be treated with Post isometric relaxation exercise and hold contractions for 10 seconds over 5 to 12 repetitions, 3 times per week for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain (NPRS)
Time Frame: 4th week
The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10) that best reflects the intensity of his/her pain 11-point numeric scale ranges from '0' representing no pain to 10 representing the worst imaginable pain.
4th week
Dallas pain questionnaire (DPQ)
Time Frame: 4th week
A condition-specific impairment questionnaire as well as pain and satisfaction indicators such self-assessment pain ratings are needed for the evaluation of low back pain (LBP). The 16-item Dallas Pain Questionnaire (DPQ) was created to assess patients' perceptions of the extent to which four parts of their lives are affected by chronic pain. It is simple to comprehend, can be answered in 3 to 5 minutes, and can be scored in under a minute.
4th week
Oswestry disability index (ODI)
Time Frame: 4th week
The ODI comprises of ten items that examine several activities of daily life (such as lifting, walking, and travelling) and measures the limitations of a patient's performance in comparison to that of a fit individual. On a six-point scale, from 0 to 5, each item is scored. By adding together the values of each individual item, dividing that total by the range of potential scores, and multiplying that result by 100, one can approximate the overall ODI score. Higher scores imply greater levels of disability on the scale of 0 to 100%.
4th week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Humera Mubashar, MS, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 8, 2023

Primary Completion (Estimated)

December 8, 2023

Study Completion (Estimated)

January 8, 2024

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • REC/RCR & AHS/23/0143

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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