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Back PainNCT05511805

Examination of Pain in Individuals With Non-Specific Lack Pain

An observational study of Back Pain and Balance, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to examine the relationship between pain, and balance, proprioception sensation in the knee, erector spinae and multifidus muscle strength in individuals with non-specific low back pain. Read more about this study

Who is it for?
Ages 16 to 50 years
Conditions the study is for
Back Pain, Balance, Proprioception
What is being tested?
Visual Analogue Scale (VAS),, Oswestry Low Back Pain and Disability Questionnaire and Functional Low Back Pain Scale
Type of treatment
Medical device
How many people
52 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Aug 2022to 30 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 50 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Study population: Patients with non-specific low back pain.

Who may be able to join

  • Having pain intensity of 3 or more according to VAS.
  • Having a mini mental test score of 24 and above
  • Being able to stand on one leg.
  • Having low back pain for 3 months or more

Who cannot join

  • Osteoporosis
  • Being in the 0%-20% range on the Oswestry scale
  • Pregnancy
  • Being on constant painkillers for one reason or another
  • Having undergone lumbar, hip, knee and ankle surgery.
  • Having severe hearing, vision, speech impairment

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Sağlık Bilimleri Üniversitesi

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: Investigation of the Relationship Between Pain, and Balance, Proprioception in the Knee, the Strength of the Erector Spinae and Multifidus Muscles in Individuals With Non-Specific Low Back Pain

The aim of this study is to examine the relationship between pain, and balance, proprioception sensation in the knee, erector spinae and multifidus muscle strength in individuals with non-specific low back pain.

Read the detailed description

Impaired postural control in people with non-specific low back pain; It can be affected by many factors such as pain, musculoskeletal disorders, proprioception. Postural control is important for the continuation of activities of daily living. Postural control is decreased in patients with non-specific low back pain. According to the proprioception examinations, patients with low back pain are more impaired than healthy individuals. Impaired proprioception can also reduce the ability to maintain posture, balance control and increase the load on the spine. Thus, individuals with low back pain may become more vulnerable to injuries. Weakness of the abdominal muscles and superficial trunk muscles are also risk factors for low back pain.

Weakness and fatigue may occur as a result of structural changes, which are more common in the paraspinal muscles and the multifidus muscle. This can lead to deterioration of lumbar stability. Because these muscles have an important place in providing stability.

Proprioceptive information from the hip, knee and ankle and coordination of the joints are important in maintaining and controlling balance. Regional receptors in muscles, joints, skin and tendons and proprioception in the knee joint provide the necessary joint activity and stabilization. With the decrease in balance and proprioception, pain may occur, and we may encounter a decrease in muscle strength as a result of leading a sedentary life. In this case, since the proper posture, muscle activity and balance required for coordinated movement are negatively affected, the movement is impaired. Because these activities must be performed in the correct order for the movement to occur.

In the literature, there are studies on the relationship of low back pain with muscle strength, balance and proprioception; however, the lack of sufficient studies investigating the relationship between balance and proprioception in the knee in individuals with non-specific low back pain suggests that the study to be conducted will make an important contribution to the literature and reveals the importance of our study.

Being tested
Visual Analogue Scale (VAS),, Oswestry Low Back Pain and Disability Questionnaire, Functional Low Back Pain Scale, Prokin TecnoBody isokinetic balance 2 device, EMG
Keywords
Low back pain, Balance, Proprioception
Medical subject headings
Back Pain, Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visual Analogue Scale (VAS),Other

    The pain levels of the individuals participating in the study will be evaluated with the Visual Analog Scale. According to VAS, in the severity of pain; '0' means no pain, '10' means worst pain imaginable. During the study, the participants will be asked to rate their pain experienced in daily life and pain during evaluation between 0-10 points. Individuals with pain intensity of 3 and above according to VAS will be included in the study.

  • Oswestry Low Back Pain and Disability QuestionnaireOther

    The Oswestry scale will be used to determine the level of functional disability due to low back pain. In this questionnaire, 10 questions are asked about pain intensity, social life, weight lifting, walking, personal care, sitting, sleeping, sexual life, standing and travel. Each question has 6 options and the patient is asked to choose the statement that best describes his or her condition.

  • Functional Low Back Pain ScaleOther

    The Functional Low Back Pain Scale will be used to evaluate how much the low back pain experienced by the people who will be included in the study affects their daily living activities. Evaluated functions; work and school activities, home activities, wearing shoes or socks, leaning forward, lifting an object from the ground, habits, sleeping, walking, sitting, climbing stairs, standing and driving. The questionnaire consists of 12 questions, and each item scores in the range of 0-5 points.

  • Prokin TecnoBody isokinetic balance 2 deviceDevice

    For the one-leg balance test, the subject is positioned on one leg at the origin of the platform. The participant is asked to look at any stationary point or object in front of him. Participants are allowed to experiment on the platform of the meter for approximately 2-3 minutes. The stem sensor apparatus is then attached to coincide with the xiphoid projection. After the torso sensor is attached, the patient is placed in the dominant side position on one foot and the static balance test measurement is started. 30 seconds from the patient in this position. asked to stop.

  • EMGDevice

    In our study, electromyography (EMG) device will be used to evaluate muscle strength. Electromyography is a method by which electrical activity analysis of muscles can be performed. In the study, the erector spina and multifidus muscles will be measured. Measurements are made with electrodes placed on the skin surface.

  • AlgometerDevice

    The pressure perception and pain threshold of pain sensitivity are determined and recorded with an algometer. The details of the application will be explained to the participant and it will be emphasized that the feeling of pressure he feels causes pain and that he should give a 'stop' command. The pressure force is increased until the patient receives the 'stop' command in the area to be applied. It is stopped by the command from the patient and the response on the algometer screen is recorded. These measurements are repeated 3 times. The average of these three recorded measurements is determined.

  • GoniometerDevice

    Using the universal goniometer's measure of knee joint range of motion, sense of proprioception will be evaluated. For measurement, subjects are asked to lie on a stretcher in the prone position. The pivot point of the goniometer is placed in the center of the lateral knee joint condyle. The fixed arm of the goniometer is fixed in parallel at the level of the thoracantary major, and the movable arm is positioned at the level of the head of the fibula and the lateral malleolus. First of all, starting from the 0° extension position to the knee joint, the angle desired by the physiotherapist is made and the value in the goniometer is recorded. Then, the patient is asked to bring the knee joint, which is still in 0° extension, to the angle brought by the physiotherapist. Then the angle brought by the patient to the knee joint is recorded.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of pain

    This was evaluated using the Visual Analogue Scale (VAS). According to VAS, in the severity of pain; Generally, '0' means no pain, and '10' means the worst pain imaginable.

    Measured: Baseline

  2. Evaluation of static stance on one leg

    This was evaluated with Prokin TecnoBody isokinetic balance 2 device. After the torso sensor was attached, the patient was placed in the dominant side position on one foot and the static balance test measurement was started. The patient is expected to stand in this position for 30 seconds.The test was started by pressing the start button on the computer keyboard connected to the device. The test was automatically terminated by the computer when it expired. A computer printout containing the static test evaluation results was obtained.

    Measured: Baseline

  3. Evaluation of back extensor strengths

    These were evaluated with EMG. In the study, measurement of erector spina and multifidus muscles was performed. Measurements were performed with electrodes placed on the skin surface to measure the total activity of the muscles and to determine muscle fatigue non-invasively.

    Measured: Baseline

  4. Evaluation of low back pain thresholds

    This was evaluated with Algometer. Determination of pressure perception and pain threshold of sensitivity to pain was determined and recorded with an algometer. It was standardized to perform the measurements on the determined -region-. The details of the application were explained to the participant, and it was emphasized that the pressure sensation he felt caused pain and that he needed to give a 'stop' command. It was stopped with the command received from the patient and the response on the algometer screen was recorded.

    Measured: Baseline

  5. Evaluation of the effect of pain on functionality

    It is a scale used to evaluate the extent to which low back pain experienced by patients affects their functions in daily life. Evaluated functions; work and school activities, home activities, wearing shoes or socks, bending forward, lifting an object from the ground, habits, sleeping, walking, sitting, climbing stairs, standing and driving. This questionnaire consists of 12 questions. Each item has a score in the range of 0 - 5 points. The minimum possible score is "0", and the maximum possible score is "60". 60 points; states that the activities in the questionnaire were not difficult.

    Measured: Baseline

  6. Evaluation of the level of functional disability

    It is a scale used to determine the level of functional disability due to low back pain. This scale consists of ten questions. Each question has a score between zero and five. In this questionnaire, the severity of pain, social life, lifting, walking, personal care, sitting, sleeping, standing, traveling, the level of pain and the degree of change in pain are questioned.

    Measured: Baseline

  7. Evaluation of the proprioception

    The sense of proprioception was evaluated by using the joint range of motion measurement of the universal goniometer. The subjects were asked to lie on the stretcher in the prone position to measure the range of motion of the knee joint. The pivot point of the goniometer was determined as the lateral knee joint condyle and placed. The fixed arm of the goniometer was fixed in parallel at the level of the trochanter major, and the movable arm was positioned at the level of the head of the fibula and the lateral malleolus. First of all, the knee joint is started from 0° extension position and brought to the angle desired by the physiotherapist and the value in the goniometer is recorded. Then, the patient is asked to bring the knee joint, which is again in 0° extension, to the angle brought by the physiotherapist. By following the knee joint flexion of the movable arm, the angle that the patient brings the knee joint is recorded.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Aug 2022
  2. Study start15 Aug 2022
  3. Primary completion1 Sep 2022
  4. Study completion30 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05511805
Sponsor's protocol ID
12/37
Status last verified
Sep 2022
First submitted
18 Aug 2022
Last updated
10 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nowotny AH, Calderon MG, Alves BMO, de Oliveira MR, Andraus RAC, Aguiar AF, Amorim CF, Leonard G, da Silva RA. Low-Back Pain and Knee Position-Related Differences on Postural Control Measures During a One-Legged Stance in Athletes. J Sport Rehabil. 2020 Nov 25;30(4):631-637. doi: 10.1123/jsr.2020-0095.

    PubMed 33238243
  • Goubert D, Oosterwijck JV, Meeus M, Danneels L. Structural Changes of Lumbar Muscles in Non-specific Low Back Pain: A Systematic Review. Pain Physician. 2016 Sep-Oct;19(7):E985-E1000.

    PubMed 27676689
  • Ruhe A, Fejer R, Walker B. Is there a relationship between pain intensity and postural sway in patients with non-specific low back pain? BMC Musculoskelet Disord. 2011 Jul 15;12:162. doi: 10.1186/1471-2474-12-162.

    PubMed 21762484
  • Hlaing SS, Puntumetakul R, Wanpen S, Boucaut R. Balance Control in Patients with Subacute Non-Specific Low Back Pain, with and without Lumbar Instability: A Cross-Sectional Study. J Pain Res. 2020 Apr 23;13:795-803. doi: 10.2147/JPR.S232080. eCollection 2020.

    PubMed 32425585
  • Hodges P, van den Hoorn W, Dawson A, Cholewicki J. Changes in the mechanical properties of the trunk in low back pain may be associated with recurrence. J Biomech. 2009 Jan 5;42(1):61-6. doi: 10.1016/j.jbiomech.2008.10.001. Epub 2008 Dec 4.

    PubMed 19062020
  • Yuce B, Karaman D, Dalli E, Gumussu G, Yener R, Evkaya-Acar A, Yagci F, Pehlivan E. The relationship between single leg balance and proprioception of the knee joint in individuals with non-specific chronic back pain. J Bodyw Mov Ther. 2024 Oct;40:822-827. doi: 10.1016/j.jbmt.2024.06.004. Epub 2024 Jun 6.

    PubMed 39593682

Questions about this trial

What is this clinical trial studying?

An observational study of Back Pain and Balance, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of pain (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05511805, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023; AzTrials last refreshed its copy on 8 Nov 2026.

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