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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05982964
Other study ID # E-85646034-604.02.02-62452
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 31, 2023
Est. completion date September 15, 2023

Study information

Verified date September 2023
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the expected recovery time.


Description:

Chronic low back pain is defined as pain that lasts for more than 3 months or exceeds the expected recovery time.


Recruitment information / eligibility

Status Completed
Enrollment 81
Est. completion date September 15, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion criteria: - Individuals between the ages of 18-65 - Individuals with low back pain for at least 3 months for the first group - 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 - Exclusion criteria: - Individuals under the age of 18 - Individuals with low back pain for less than 3 months for the first group - Not having a musculoskeletal or neuromuscular disease that limits mobility,

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Turkey HAZAL genç Istanbul None Selected

Sponsors (1)

Lead Sponsor Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pressure Pain Threshold Algometer The pressure algometer is a tool used to assess the pain threshold. The algometer used in this study is connected to a dial measuring the pressure in kilograms and pounds, and consists of a metal piston with a diameter of 1 centimeter at the tip, the smallest gap of which is 100 gr and 10 kg/cm². 1 day
Primary Examining the Scapular Position The lateral scapular glide test was used to evaluate the scapula position. In the first position, the arms were relaxed at the sides, the shoulder was in the neutral position, in the second position the patient's hands were positioned around the waist and the humerus was brought to medial rotation and abduction of 45 degrees, and in the third position, the humerus was placed in maximal medial rotation and 90-degree abduction. 1 day
Primary Evaluation of Balance The static and dynamic postural stability of all individuals included in the study were evaluated with the Biodex Balance System (BDS).
For dynamic stability measurement, a total of 3 tests were conducted, with the platform in dynamic position, with each period lasting 20 seconds, giving the participant a rest period of 10 seconds in between. Afterwards, the average of these 3 tests was obtained automatically by the device. In the results obtained, it is possible to interpret that as the score approaches 0, the balance is maintained, and as it moves away from 0, the balance is deteriorated.
1 day
Primary Proprioception Evaluation An inclinometer is an instrument that records angular movements with respect to gravity. The inclinometer has many advantages such as precise measurement, digital display, and ease of use.
In our study, inclinometer was used in the evaluation of proprioception. Measurements will be recorded in degrees.
1 day
Primary Evaluation of Functionality The Oswestry Low Back Pain Disability Questionnaire (OBAEA) was used to examine functionality in patients with chronic low back pain. This survey consists of 10 questions in total. Each question has 6 options and ranges from 0 to 5. Participants are asked to mark the option that best fits their individual situation. While 50 is the highest score, it is evaluated as mild functional disability between 1 and 10 points, moderate functional disability between 11 and 30 points, and severe functional disability between 31 and 50 points. 1 day
Primary Waist Awareness Assessment Fremantle Waist Awareness Questionnaire was used to evaluate low back awareness in the study. The Fremantle Waist Awareness Questionnaire is the only one that assesses body awareness about the waist. It consists of 9 questions in total and each question has a score ranging from 0-4. In total, the lowest 0 and the highest 36 points can be obtained. High scores indicate low back awareness. 1 day
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