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

Cesarean Section Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05834140
• Other study ID #: REC/RCR & AHS/23/0510
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: August 2023

Study information

• Verified date: April 2023
• Source: Riphah International University
• Contact: Imran Amjad, Phd
• Phone: 03324390125
• Email: imran.amjad[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Headache
• Neck Pain
• Post-Dural Puncture Headache

Intervention

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
• 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

Locations

Country	Name	City	State
Pakistan	Madinah Teaching Hospital	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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