Clinical trial NCT05834140: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Post-Dural Puncture Headache
Cesarean Section Complications
Keywords: post dural puncture headache
neck pain
Cesarean Section
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-04-28
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 2nd day
measure: Neck Disability Index
timeFrame: 2nd day
measure: Headache Disability Index
timeFrame: 2nd day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Madinah Teaching Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Hafiza Neelam Muneeb, MPhil
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.