- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05511805
Examination of Pain in Individuals With Non-Specific Lack Pain
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Sağlık Bilimleri Üniversitesi
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Evaluation of pain
Time Frame: Baseline
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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.
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Baseline
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Evaluation of static stance on one leg
Time Frame: Baseline
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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.
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Baseline
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Evaluation of back extensor strengths
Time Frame: Baseline
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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.
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Baseline
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Evaluation of low back pain thresholds
Time Frame: Baseline
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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.
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Baseline
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Evaluation of the effect of pain on functionality
Time Frame: Baseline
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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.
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Baseline
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Evaluation of the level of functional disability
Time Frame: Baseline
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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.
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Baseline
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Evaluation of the proprioception
Time Frame: Baseline
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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.
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Baseline
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Esra Pehlivan, Assoc. Prof., Saglik Bilimleri University
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12/37
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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