NCT04136197

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

July 18, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 25, 2021

Status Verified

August 1, 2021

Enrollment Period

7 months

First QC Date

October 21, 2019

Last Update Submit

August 24, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Interventions

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.

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients having lumbar disc herniation surgery

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, 34740, Turkey (Türkiye)

Location

Related 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.

Related Links

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal Diseases

Study Officials

  • Masoud Amir Rashedi Bonab, MSc.

    Bahçeşehir University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Prof. Dr, PhD

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 23, 2019

Study Start

July 18, 2020

Primary Completion

February 1, 2021

Study Completion

July 1, 2021

Last Updated

August 25, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations