NCT05206136

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

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

Study Start

First participant enrolled

January 6, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 7, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2022

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

2 months

First QC Date

January 7, 2022

Last Update Submit

May 17, 2022

Conditions

Keywords

neck painback painmuscle architecture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Evaluation of pain severity

    5 minutes, pain intensity will be evaluated once.

  • Evaluation of disability

    5 minutes, disability level will be evaluated once.

Study Arms (3)

Neck Pain Group

Patients with neck pain

Device: Ultrasonography

Low Back Pain Group

Patients with low back pain

Device: Ultrasonography

Healthy Individuals

Patients with no pain in neck or low back region

Device: Ultrasonography

Interventions

Neck and Low back muscles will be evaluated by ultrasound.

Healthy IndividualsLow Back Pain GroupNeck Pain Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with neck or low back pain and healthy individuals will be included in to study.

You may qualify if:

  • Patients with neck or low back pain
  • Healthy Individuals
  • Between the ages of 18-60,
  • Being literate,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dilara ONAN

Altındağ, Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainBack Pain

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 7, 2022

First Posted

January 25, 2022

Study Start

January 6, 2022

Primary Completion

March 16, 2022

Study Completion

April 16, 2022

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations