- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04136197
Trigger Point Incidence After Lumbar Disc Herniation Surgery
August 24, 2021 updated by: Ebru Kaya Mutlu, PT, Istanbul University - Cerrahpasa (IUC)
The Determination of the Trigger Point Incidence After Lumbar Disc Herniation Surgery
Our purpose is to determine the incidence of trigger points in patients who remain in a fixed position for a long time during lumbar disc herniation surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The 110 participants between 30-70 years are chosen from patients who had lumbar disc herniation surgery.
The trigger points are determined by manually palpating quadratus lumborum, iliocostalis lumborum, gluteus Maximus, gluteus minimus, gluteus medius, ve piriformis muscles before and after surgery.
Data will be recorded on the patient assessment file and transferred to the computer and analyzed.
Data analysis will be performed with SPSS.20.
Study Type
Observational
Enrollment (Actual)
110
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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İstanbul, Turkey, 34740
- Istanbul University-Cerrahpasa
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The patients having lumbar disc herniation surgery
Description
Inclusion Criteria:
- To be between 30-70 years
- To have low back pain during minimum 6 weeks
- To be voluntary participation for this study
- To approve the informed consent form
- To have the trigger point causing low back pain on muscles including quadratus lumborum, iliocostalis lumborum, gluteus maximus, gluteus minimus, gluteus medius, ve piriformis muscles.
Exclusion Criteria:
- To be diagnosed with spinal stenosis or spondylolisthesis
- To have any skin problem affecting lower extremity evaluation
- To have tumor on spinal region
- To have rheumatological or any systemic problem that may interfere with trigger point diagnose
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Manual Palpation
Time Frame: Change from baseline (preoperative state) to postoperative first and third day
|
The patients are positioned in a sitting and prone lying posture.Trigger points are discrete, local, hypersensitive spots located in a taut band of muscles.
Palpation of the trigger point will cause elicitation pain over the affected area and radiation of pain toward a zone of reference and a local twitch response.
|
Change from baseline (preoperative state) to postoperative first and third day
|
|
Visual Analog Scale
Time Frame: Change from baseline (preoperative state) to postoperative first and third day
|
Pain will be assessed with Visual Analog Scale (VAS).The VAS is usually a horizontal line, 10 cm in length, anchored by word descriptors at each end with "No Pain" (score of zero) on the left side up to "pain as bad as it could be" or the "worst imaginable pain" (Score of 100 [100-mm scale]) on the right side.The patient was asked to mark the line point that represented his or her current pain.
|
Change from baseline (preoperative state) to postoperative first and third day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Masoud Amir Rashedi Bonab, MSc., Bahcesehir university
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
July 18, 2020
Primary Completion (ACTUAL)
February 1, 2021
Study Completion (ACTUAL)
July 1, 2021
Study Registration Dates
First Submitted
October 21, 2019
First Submitted That Met QC Criteria
October 21, 2019
First Posted (ACTUAL)
October 23, 2019
Study Record Updates
Last Update Posted (ACTUAL)
August 25, 2021
Last Update Submitted That Met QC Criteria
August 24, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Istanbul University-Cerrahpaşa
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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