NCT05982964

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

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

July 31, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

July 31, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

Same day

First QC Date

July 31, 2023

Last Update Submit

December 23, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

back pain group

Healthy volunteers

Eligibility Criteria

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

Our study was carried out on healthy and non-specific low back pain individuals who came to Bahçeşehir University.

You may qualify if:

  • 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

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HAZAL genç

Istanbul, None Selected, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

July 31, 2023

First Posted

August 9, 2023

Study Start

July 31, 2023

Primary Completion

July 31, 2023

Study Completion

September 15, 2023

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations