Effects of MET on PPDH, Neck Pain and Disability After Cesarean Section

April 18, 2023 updated by: Riphah International University

Effects of Muscle Energy Technique on Post-Dural Puncture Headache, Neck Pain and Disability After Cesarean Section

The goal of this clinical trial is to determine the effect of Muscle Energy Techniques on post dural puncture headache, neck pain and disability after Cesarean Section.

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Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Caesarean section (CS) is the worldwide process of pregnancy termination that delivers live or dead fetuses with an incision on the abdominal wall and uterine wall.

It is performed under neuraxial anesthesia (spinal and epidural anesthesia). Post- dural puncture headache (PDPH) is a major complication of neuraxial anesthesia which presents as a dull throbbing pain in a frontal-occipital distribution, aggravates on sitting or standing, and is reduced by lying down.

This study will be a randomized clinical trial. Subjects with PPDH meeting the predetermined inclusion and exclusion criteria will be divided into two groups: i.e. treatment and control group. Both groups will receive baseline treatments i.e. (heating pads & TENS). In addition, treatment group will receive post-isometric relaxation of METs. Each subject will receive a total of 4 treatment sessions, with 2 treatment sessions per day

Pre-treatment will be done at day 1 and post-treatment will be done at day 2, using Headache Disability Index (HDI), Numeric Pain Rating Scale (NPRS) and Neck Disability Index (NDI) as subjective measurements. Recorded values will be analysed for any change using SPSs

Study Type

Interventional

Enrollment (Anticipated)

30

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 Locations

  • Pakistan
    • Punjab
      • Faisalabad, Punjab, Pakistan, 38000

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:

  • Age between 18 to 40 years
  • Both Primiparous and multiparous
  • Both elective and emergency Lower Section Cesarean Section
  • Headache occurring within 24-72 hours post C-section
  • Headache aggravates on getting in upright position

Exclusion Criteria:

  • History of Trauma/fracture of head and neck region
  • History of cervical spine surgery
  • Had previous diagnostic Lumbar Puncture (LP)
  • Any kind of infection, malignancy, inflammation and structural deformity present in head and neck region.
  • Other serious forms of headaches including Migraine, Cluster, thunderclap, hypnic etc.
  • Cervical Radiculopathies and spondylolisthesis

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Traditional physical therapy
TENS and Heating pads
Other: Traditional Physical Therapy

TENS (transcutaneous electrical nerve stimulation) on continuous mode at 80-120 Hz for 15-20 min and Heating pads for 10-15 min

Total 4 sessions will be given in 2 days
Experimental: Muscle Energy Technique
Muscle Energy Technique protocol in along with TENS and Heating pads
Other: Muscle Energy Technique

Muscle energy technique (Post Isometric relaxation) along with TENS and Heating pads.

  • MET of the scaleni
  • MET of Sternocleidomastoid
  • MET of Levator Scapulae
  • MET of Upper fibers of Trapezius

Total 4 sessions will be given in 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: 2nd day
Numeric pain rating scale (NPRS) is an outcome measure that is a segmented numeric version of visual analogue scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of patient's pain. The common format is horizontal bar or line and NPRS is anchored by terms describing pain and severity extremes
2nd day
Neck Disability Index
Time Frame: 2nd day
The NDI is a 10-item scaled self-administered questionnaire covering pain, concentration, and activities of daily living. Each of the ten items is scored from 0 to 5, and the total is calculated and multiplied by two to produce a percentage score of the maximal score; higher score indicates greater disability. Vernon and Mior defined 0-8 as none, 10-28 as mild, 30-48 as moderate, 50-68 as severe, and over 68 as complete disability
2nd day
Headache Disability Index
Time Frame: 2nd day
The Henry Ford Hospital Headache Disability Questionnaire (HDI) is a 25-item questionnaire that examines the effects of headache on daily life. This questionnaire has a two-factor structure emotionally and functionally. Scoring (No: 0, Sometimes:2, Yes:4) varies between 0 and 100. The higher the score, the more headache disability
2nd day

Collaborators and Investigators

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

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Hafiza Neelam Muneeb, MPhil, 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)

January 1, 2023

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

April 18, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0510

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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