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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04136197
Other study ID # Istanbul University-Cerrahpasa
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 18, 2020
Est. completion date July 1, 2021

Study information

Verified date August 2021
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date July 1, 2021
Est. primary completion date February 1, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
Manual palpation for incidence determination
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.

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Istanbul University-Cerrahpasa Bahçesehir University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Kadi F, Waling K, Ahlgren C, Sundelin G, Holmner S, Butler-Browne GS, Thornell LE. Pathological mechanisms implicated in localized female trapezius myalgia. Pain. 1998 Dec;78(3):191-196. doi: 10.1016/S0304-3959(98)00126-2. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Manual Palpation 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
Primary Visual Analog Scale 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
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