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

Primary Purpose

Post-Dural Puncture Headache, Cesarean Section Complications

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Traditional Physical Therapy
Muscle Energy Technique
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Dural Puncture Headache focused on measuring post dural puncture headache, neck pain, Cesarean Section

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Madinah Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Traditional physical therapy

Muscle Energy Technique

Arm Description

TENS and Heating pads

Muscle Energy Technique protocol in along with TENS and Heating pads

Outcomes

Primary Outcome Measures

Numeric Pain Rating Scale (NPRS)
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
Neck Disability Index
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
Headache Disability Index
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

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
April 18, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05834140
Brief Title
Effects of MET on PPDH, Neck Pain and Disability After Cesarean Section
Official Title
Effects of Muscle Energy Technique on Post-Dural Puncture Headache, Neck Pain and Disability After Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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. .
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Dural Puncture Headache, Cesarean Section Complications
Keywords
post dural puncture headache, neck pain, Cesarean Section

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional physical therapy
Arm Type
Active Comparator
Arm Description
TENS and Heating pads
Arm Title
Muscle Energy Technique
Arm Type
Experimental
Arm Description
Muscle Energy Technique protocol in along with TENS and Heating pads
Intervention Type
Other
Intervention Name(s)
Traditional Physical Therapy
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Muscle Energy Technique
Intervention Description
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
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale (NPRS)
Description
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
Time Frame
2nd day
Title
Neck Disability Index
Description
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
Time Frame
2nd day
Title
Headache Disability Index
Description
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
Time Frame
2nd day

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, Phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hafiza Neelam Muneeb, MPhil
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Madinah Teaching Hospital
City
Faisalabad
State/Province
Punjab
ZIP/Postal Code
38000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hafiza Neelam, MPhil
Phone
0320-4097476
Email
hafiza.neelam@riphah.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28367283
Citation
Kwak KH. Postdural puncture headache. Korean J Anesthesiol. 2017 Apr;70(2):136-143. doi: 10.4097/kjae.2017.70.2.136. Epub 2017 Feb 3.
Results Reference
background
PubMed Identifier
35291537
Citation
Halalmeh DR, Sandio A, Adrian M, Moisi MD. Intracranial Subdural Hematoma Versus Postdural Puncture Headache Following Epidural Anesthesia: A Case Report. Cureus. 2022 Feb 1;14(2):e21824. doi: 10.7759/cureus.21824. eCollection 2022 Feb.
Results Reference
background
PubMed Identifier
32323013
Citation
Patel R, Urits I, Orhurhu V, Orhurhu MS, Peck J, Ohuabunwa E, Sikorski A, Mehrabani A, Manchikanti L, Kaye AD, Kaye RJ, Helmstetter JA, Viswanath O. A Comprehensive Update on the Treatment and Management of Postdural Puncture Headache. Curr Pain Headache Rep. 2020 Apr 22;24(6):24. doi: 10.1007/s11916-020-00860-0.
Results Reference
background
PubMed Identifier
28681107
Citation
Yang XJ, Sun SS. Comparison of maternal and fetal complications in elective and emergency cesarean section: a systematic review and meta-analysis. Arch Gynecol Obstet. 2017 Sep;296(3):503-512. doi: 10.1007/s00404-017-4445-2. Epub 2017 Jul 5.
Results Reference
background
PubMed Identifier
33713410
Citation
Segraves RL, Segraves JM. Reducing Maternal Morbidity on the Frontline: Acute Care Physical Therapy After Cesarean Section During and Beyond the COVID-19 Pandemic. Phys Ther. 2021 Jul 1;101(7):pzab093. doi: 10.1093/ptj/pzab093. No abstract available.
Results Reference
background
PubMed Identifier
22895822
Citation
Kato S, Takeshita K, Matsudaira K, Tonosu J, Hara N, Chikuda H. Normative score and cut-off value of the Neck Disability Index. J Orthop Sci. 2012 Nov;17(6):687-93. doi: 10.1007/s00776-012-0276-y. Epub 2012 Aug 16.
Results Reference
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Effects of MET on PPDH, Neck Pain and Disability After Cesarean Section

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