NCT05718713

Brief Summary

The goal of this observational study is to learn about respiratory muscle strength, respiratory functions, and balance in patients with chronic low back pain.

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
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

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

January 30, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2023

Completed
Last Updated

April 5, 2023

Status Verified

April 1, 2023

Enrollment Period

3 months

First QC Date

January 30, 2023

Last Update Submit

April 3, 2023

Conditions

Chronic Low-back Pain

Keywords

Respiratory musclesRespiratory function testMuscle strength

Outcome Measures

Primary Outcomes (9)

  • FEV1 (liter)

    This is the amount of air with pulmonary function test that the patient can force out of their lungs in one second.

    During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.

  • FEV1 (%-percentage)

    This is the percentage of air with pulmonary function test that the patient can force out of their lungs in one second.

    During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.

  • FVC (liter)

    This is the greatest total amount of air patient can forcefully breathe out after breathing in as deeply as possible.

    During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.

  • FVC (%-percentage)

    This is the percentage of total amount of air patient can forcefully breathe out after breathing in as deeply as possible.

    During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.

  • FEV1/FVC (percentage)

    The FEV1/FVC ratio is a number that represents the percentage of patient lung capacity patient is able to exhale in one second.

    During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.

  • Inspiratory muscle test

    Maximal inspiratory pressure (MIP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).

    During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.

  • Expiratory muscle test

    Maximal expiratory pressure (MEP) is going to measured using a mouth pressure meter (MicroRPM; MicroMedical, UK) according to the guideline of ATS and European Respiratory Society (ERS).

    During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.

  • Star Excursion Balance Test (SEBT)

    Four strips of athletic tape will need to be cut to a length of 6-8 feet each. Two pieces will be used to form a '+', with the other two being placed over top to form an 'x' so that a star shape is formed. It is important that all lines are separated from each other by a 45° angle. The goal of the SEBT is to maintain single leg stance on one leg while reaching as far as possible with the contralateral leg. The person performing the test must maintain a their balance on one leg, while using the other leg to reach as far as possible in 8 different directions. The person (standing on his/her left leg for example) must reach in 8 different positions, once in each of the following directions: anterior, anteromedial, medial, posteromedial, posterior, posterolateral, lateral and anterolateral.

    During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.

  • Berg Balance Scale (BBS)

    The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete.

    During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.

Secondary Outcomes (1)

  • Change in Visual Analog Scale (VAS) Pain Score

    During the 6-month data collection process, pulmonary function measurements is going to made on the same day as the day the participants came to the clinic for examination or control.

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chronic low back pain patients

You may qualify if:

  • being diagnosed with chronic low back pain
  • being age 25-65
  • defining pain with a minimum of 5 out of 10 in Visual Analog Scale (VAS)
  • getting at least 24 points from the Mini Mental Test.

You may not qualify if:

  • Having physical therapy in the last one month
  • Orthopedic, neurological, and vestibular problems that will affect balance
  • Severe discopathy
  • Compression fracture
  • Pregnancy
  • Body Mass Index (BMI) of \> 30kg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haliç University

Istanbul, Turkey (Türkiye)

RECRUITING

Haliç University

Istanbul, Turkey (Türkiye)

RECRUITING

Study Officials

  • Seda Saka

    STUDY DIRECTOR

  • Abdullah Okur

    XXX Clinic

    PRINCIPAL INVESTIGATOR

  • Nagihan Koparan

    PRINCIPAL INVESTIGATOR

  • Berna Calp

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdullah Okur

CONTACT

+90 5349573147fzt.abdullahokur@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 8, 2023

Study Start

January 30, 2023

Primary Completion

April 20, 2023

Study Completion

May 20, 2023

Last Updated

April 5, 2023

Record last verified: 2023-04

Locations

TU(2)