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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05206136
Other study ID # GO 20/1034
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 6, 2022
Est. completion date April 16, 2022

Study information

Verified date May 2022
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Back or neck problems often begin with an injury and often include a muscle injury. Injury of muscle fibers can occur due to trauma, disease, myotoxic agents, inflammatory processes, and intense exercise. The level of muscle injury in low back or neck problems is unknown. However, the relationship between muscle injury and pain has been studied intensively. Injury to skeletal muscles occurs when muscle activation begins abruptly and rapidly with muscle lengthening. Muscle pain that occurs with eccentric exercise peaks 24-48 hours after the exercise. Studies on this subject have generally focused on muscle fatigue, changes in the physiological structure of the muscle, and which muscle fiber types are injured more. Experimental studies focused on the results of skeletal muscle injury with early activation of the muscle during eccentric exercises. For example, it has been shown that mechanical changes in the tibialis anterior muscle occur in the first 5-7 minutes of exercise during eccentric exercise. Studies on the back and neck muscles are rare, and it has been stated that fatigue in these muscles plays an active role in the mechanism of injury. It is very difficult to accept this view directly, because there are different types of muscle fibers in the lower back and neck muscles. In terms of low back and neck pain and muscle injury, specific studies on muscle fiber types are required. In addition, muscle strength together with pain can change the load distribution to anatomical structures. However, muscle activity alters spinal stability and kinematics. It has been found that the M. Sternocleideomasteideus (M.SCM) muscle shows 5%-10% elongation tension during muscle activation, along with retraction in whiplash injuries. In deep muscle groups, this rate varies between 10% and 20%. It is not known to what extent the architectural features of the muscle change with these muscle tensions and to what extent the injury occurs when active extension occurs. It is clear that the relationship between muscle pain and injury should be examined in terms of biomechanical modeling, muscle architecture and outcomes. Muscle length, fiber length, pennation angle, and physiological cross-sectional area (PCSA) values of many muscle groups, primarily the M.SCM and M.Transversus Abdominus muscles, were analyzed in healthy individuals. However, it is not known how it changes in individuals with low back or neck pain. For this reason, if the architectural features of the cervical and lumbar region muscles can be determined, since they are the muscles that are most affected by low back and neck problems and then exercised the most by physiotherapists, the relationship between injury and pain can be examined and correct muscle function can be achieved. The emergence of different values from healthy muscle architecture will be valuable in terms of correct exercise planning and proper function in individuals with low back and neck problems. The aim of working with this idea is to evaluate the architectural features of the cervical and lumbar region muscles in individuals with problems characterized by low back and neck pain.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date April 16, 2022
Est. primary completion date March 16, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Patients with neck or low back pain - Healthy Individuals - Between the ages of 18-60, - Being literate, Exclusion Criteria: - Cervical radiculopathy, thoracic outlet syndrome, - Malignant condition, - Having systemic diseases such as neurological, psychological, cardiovascular and loss of function due to these diseases, - A history of surgery in the spine and upper extremity, including the cervical region, in the last 1 year period, - Fracture in the spine and upper extremity, including the cervical region, with a history of inflammation, - Acute infection, - Continuing another rehabilitation program, - Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Ultrasonography
Neck and Low back muscles will be evaluated by ultrasound.

Locations

Country Name City State
Turkey Dilara ONAN Altindag Ankara

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of Neck and Low Back Muscle Thickness or PCSA with Ultrasonography Ultrasonography is used to evaluate the architectural properties of the muscle (thickness or PCSA) in chronic painful musculoskeletal problems such as neck-back pain. Muscle architecture measurements of neck and low back muscles with ultrasound will be evaluated in the resting position by the specialist radiology doctor who is blind to the results of the study using 3.5-10 MHz convex and linear probes (Soundcam Mobile Ultrasound Device). 15 minutes, muscles will be evaluated once.
Secondary Evaluation of pain severity Visual Analogue Scale (VAS) indicates the level of pain that the person is experiencing at the moment, marked with a vertical line on a plane. The pain felt by the person is marked as "0: I feel no pain", "10: I feel very severe pain". Scoring is based on measuring the participant's vertical marking for pain on the plane with a ruler. The validity and reliability study of the scale was conducted by Price et al. 5 minutes, pain intensity will be evaluated once.
Secondary Evaluation of disability Neck Disability Index (NDI) Vernon et al. developed by. The Turkish version study was conducted by Aslan et al. Made by. The NDI includes a total of 10 questions such as pain, personal care, concentration, working, driving, sleeping. Each question is scored between 0-5 points. 0 points means no restrictions, 50 points means complete apology. 0-4 points are evaluated as no disability, 5-14 points as mild disability, 14-24 points as moderate disability, 25-34 serious disability and 35 and above as complete disability.
Oswestry Index (ODI) Fairbank et al. developed by. Questionnaire examines perceived level of disability in 10 everyday activities of daily living. For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, 0-20%: Minimal disability,21-40%: Moderate Disability,41-60%: Severe Disability,61-80%: Crippling back pain,81-100%: Patients are either bed-bound or have an exaggeration of their symptoms.
5 minutes, disability level will be evaluated once.
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