NCT05821218

Brief Summary

Low back pain is a musculoskeletal problem that we commonly encounter in the clinic,which negatively affects the quality of life, reduces productivity and limits the ability to perform activities of daily living.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 24, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

April 23, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

Same day

First QC Date

March 24, 2023

Last Update Submit

April 23, 2023

Conditions

Keywords

sacroiliac

Outcome Measures

Primary Outcomes (7)

  • Leg Check Test

    When a subject is lying prone or supine, emptying the pelvis, the feet are examined for the presence of a "short leg" or alignment asymmetry, often at the margin (heel-sole interface). Evidence has suggested that for most people, anatomical leg length disparity is not clinically relevant until the size reaches \~20 mm (\~3/4"). It is a clinical test commonly used by chiropractors

    1 day

  • Pressure Pain Threshold Measurement with Algometer

    Pressure algometry is a semi-quantitative method used to localize sensitive areas, trigger points, abnormal sensitivity on muscles and bones, and evaluate pressure pain sensitivity in tissues. The dial is calibrated to 2.5 kg in 25 g divisions. The pressure applied by continuously pressing the disc 35 against the skin is to advance the pointer on the dial clockwise through the metal piston.

    1 day

  • Oswestry Disability Index

    Low back pain is one of the most common disorders that cause activity limitationIt has 16 questions and two subscales: physical activity and work. The physical activity section consists of 5 questions and the labor section consists of 11 questions. The questionnaire was a 7-point Likert type scale. In the answers given to the questionnaire, 0 points are given to the statement of "I don't agree at all" and 6 points to the statement of "I totally agree".

    one day

  • Patrick FABER Test:

    The ipsilateral hip and knee joint of the participant in the supine position was flexed, and the heel was placed on the opposite knee. The test stresses the anterior sacroiliac ligaments and hip joint. It was accepted that the pain was felt in the sacroiliac joint region

    1 day

  • Gaenslen Test

    The participant was in the supine position on the examination table, with the lower extremity close to the evaluator hanging down from the bed, while the hip joint was brought to maximal hyperextension, while the hip and knee joints were passively brought to maximum flexion in the other lower extremity. The

    1 day

  • Compression Test

    The participant was positioned on their side, hips flexed to 45° and knees flexed to 90°. The evaluator applied a compression force from the superior iliac crest to the lower iliac crest behind the patient. This test stretches the posterior sacroiliac ligaments and compresses the anterior portion of the sacroiliac joint. The test was considered positive if there was pain in the sacroiliac joint.

    1 day

  • The straight leg raise test

    The straight leg raise test is known as the sciatic nerve stretch test. It has been reported that mobilization and stretching of the sciatic nerve occur from 30 degrees on.

    1 day

Study Arms (1)

back pain group

back pain group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Bahçeşehir University

You may qualify if:

  • Volunteer
  • Not undergoing surgery related to the lumbar region
  • Cases without lumbar steroid injection in the last 3 months
  • Not having visual and hearing loss
  • Having low back pain
  • Cases without neurological problems
  • Cases without tumor and infection in the lumbar region

You may not qualify if:

  • Not having a musculoskeletal or neuromuscular disease that limits mobility,
  • No upper extremity sequelae,
  • Not volunteering

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HAZAL genç

Istanbul, None Selected, 34353, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

HAZAL genç, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2023

First Posted

April 20, 2023

Study Start

April 23, 2023

Primary Completion

April 23, 2023

Study Completion

July 23, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations