Neck PainNCT05206136
Cervical and Lumbal Region Muscle Architecture in Individuals With Low Back and Neck Pain
An observational study of Neck Pain and Back Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Ultrasonography
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jan 2022to 16 Apr 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with neck or low back pain and healthy individuals will be included in to study.
Who may be able to join
- Patients with neck or low back pain
- Healthy Individuals
- Between the ages of 18-60,
- Being literate,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Cervical and Lumbal Region Muscle Architecture in Individuals With Low Back and Neck Pain
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.
- Being tested
- Ultrasonography
- Keywords
- neck pain, back pain, muscle architecture
- Medical subject headings
- Neck Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
Neck and Low back muscles will be evaluated by ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Neck Pain Group | Patients with neck pain Receives: Device: Ultrasonography | |
| Low Back Pain Group | Patients with low back pain Receives: Device: Ultrasonography | |
| Healthy Individuals | Patients with no pain in neck or low back region Receives: Device: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 15 minutes, muscles will be evaluated once.
Secondary outcomes (2)
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.
Measured: 5 minutes, pain intensity will be evaluated once.
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.
Measured: 5 minutes, disability level will be evaluated once.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start6 Jan 2022
- Primary completion16 Mar 2022
- Study completion16 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Ulger, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05206136
- Sponsor's protocol ID
- GO 20/1034
- Status last verified
- May 2022
- First submitted
- 7 Jan 2022
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cervical and Lumbal Region Muscle Architecture in Individuals With Low Back and Neck Pain
- ClinicalTrials.gov ID
- NCT05206136
- Acronym / sponsor ID
- GO 20/1034
- Keywords
- neck pain, back pain, muscle architecture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Apr 2022 (actual)
- First posted
- 25 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neck Pain Group | – | Device: UltrasonographyPatients with neck pain |
| Low Back Pain Group | – | Device: UltrasonographyPatients with low back pain |
| Healthy Individuals | – | Device: UltrasonographyPatients with no pain in neck or low back region |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with neck or low back pain and healthy individuals will be included in to study.
Key inclusion criteria (4 listed)
- Patients with neck or low back pain
- Healthy Individuals
- Between the ages of 18-60,
- Being literate,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasonographyNeck and Low back muscles will be evaluated by ultrasound. | Device | Healthy Individuals, Low Back Pain Group, Neck Pain Group |
Primary outcome
Evaluation of Neck and Low Back Muscle Thickness or PCSA with Ultrasonography
Time frame: 15 minutes, muscles will be evaluated once.
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).
2 secondary outcomes
Evaluation of pain severity
Time frame: 5 minutes, pain intensity will be evaluated once.
Evaluation of disability
Time frame: 5 minutes, disability level will be evaluated once.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Pain and Back Pain, run by Hacettepe University 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 8 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 18 May 2022. 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 Neck and Low Back Muscle Thickness or PCSA with Ultrasonography (time frame: 15 minutes, muscles will be evaluated once.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2022.