Post-Dural Puncture HeadacheNCT05834140
Effects of MET on PPDH, Neck Pain and Disability After Cesarean Section
A study testing Traditional Physical Therapy and Muscle Energy Technique in people with Post-Dural Puncture Headache and Cesarean Section Complications, run by Riphah International University at 1 site in Pakistan.
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. . Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Post-Dural Puncture Headache, Cesarean Section Complications
- What is being tested?
- Traditional Physical Therapy and Muscle Energy Technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2023to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Madinah Teaching Hospital
Faisalabad, Punjab Province, 38000
Hafiza Neelam, MPhil, 0320-4097476, hafiza.neelam@riphah.edu.pk
About this study
Official title: 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.
.
Read the 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
- Being tested
- Traditional Physical Therapy, Muscle Energy Technique
- Keywords
- post dural puncture headache, neck pain, Cesarean Section
- Medical subject headings
- Post-Dural Puncture Headache, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Traditional physical therapy | Active comparator | TENS and Heating pads Receives: Other: Traditional Physical Therapy |
| Muscle Energy Technique | Experimental | Muscle Energy Technique protocol in along with TENS and Heating pads Receives: Other: Muscle Energy Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 2nd day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start1 Jan 2023
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post-Dural Puncture HeadacheStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hafiza Neelam Muneeb, MPhil, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834140
- Sponsor's protocol ID
- REC/RCR & AHS/23/0510
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28367283Halalmeh 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.
PubMed 35291537Patel 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.
PubMed 32323013Yang 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.
PubMed 28681107Segraves 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.
PubMed 33713410Kato 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.
PubMed 22895822
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Muscle Energy Technique on Post-Dural Puncture Headache, Neck Pain and Disability After Cesarean Section
- ClinicalTrials.gov ID
- NCT05834140
- Acronym / sponsor ID
- REC/RCR & AHS/23/0510
- Keywords
- post dural puncture headache, neck pain, Cesarean Section
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional physical therapy | Active comparator | Other: Traditional Physical TherapyTENS and Heating pads |
| Muscle Energy Technique | Experimental | Other: Muscle Energy TechniqueMuscle Energy Technique protocol in along with TENS and Heating pads |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Traditional Physical TherapyTENS (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 | Other | Traditional physical therapy |
| Muscle Energy TechniqueMuscle 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 | Other | Muscle Energy Technique |
Primary outcome
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Background: PubMed 28367283Kwak 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.
- Background: PubMed 35291537Halalmeh 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.
- Background: PubMed 32323013Patel 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.
- Background: PubMed 28681107Yang 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.
- Background: PubMed 33713410Segraves 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.
- Background: PubMed 22895822Kato 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hafiza Neelam Muneeb, MPhil principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Traditional Physical Therapy and Muscle Energy Technique in people with Post-Dural Puncture Headache and Cesarean Section Complications, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: 2nd day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05834140, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.