NCT05834140

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. .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

April 18, 2023

Last Update Submit

April 18, 2023

Conditions

Post-Dural Puncture HeadacheCesarean Section Complications

Keywords

post dural puncture headacheneck painCesarean Section

Outcome Measures

Primary Outcomes (3)

  • 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

    2nd day

  • 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

    2nd day

  • 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

    2nd day

Study Arms (2)

Traditional physical therapy

ACTIVE COMPARATOR

TENS and Heating pads

Other: Traditional Physical Therapy

Muscle Energy Technique

EXPERIMENTAL

Muscle Energy Technique protocol in along with TENS and Heating pads

Other: Muscle Energy Technique

Interventions

Traditional Physical TherapyOTHER

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

Traditional physical therapy
Muscle Energy TechniqueOTHER

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

Muscle Energy Technique

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Madinah Teaching Hospital

Faisalabad, Punjab Province, 38000, Pakistan

RECRUITING

Related Publications (6)

  • 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.

    PMID: 28367283BACKGROUND

  • 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.

    PMID: 35291537BACKGROUND

  • 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.

    PMID: 32323013BACKGROUND

  • 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.

    PMID: 28681107BACKGROUND

  • 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.

    PMID: 33713410BACKGROUND

  • 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.

    PMID: 22895822BACKGROUND

MeSH Terms

Conditions

Post-Dural Puncture HeadacheNeck Pain

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hafiza Neelam Muneeb, MPhil

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, Phd

CONTACT

03324390125imran.amjad@riphah.edu.pk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

April 28, 2023

Study Start

January 1, 2023

Primary Completion

August 1, 2023

Study Completion

August 1, 2023

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)