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Neck PainNCT07388706

Body Composition and Cervical Outcomes in Non-Specific Neck Pain

A study testing Clinical Assessment in people with Neck Pain, run by Izmir Democracy University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Non-specific neck pain (NSNP) is a common musculoskeletal condition that significantly affects quality of life, daily activities, and work productivity. Although various physical, postural, and psychosocial factors have been associated with NSNP, the role of body composition in pain and functional outcomes remains… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Neck Pain
What is being tested?
Clinical Assessment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Mar 2026to 15 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • To be between 18-65 years old
  • To be diagnosed with non-specific neck pain
  • Not having had any surgery related to the cervical region

Who cannot join

  • Having a neurological and psychiatric problem that may affect evaluation methods
  • Pregnancy and pregnancy suspected
  • To be an elite athlete
  • Having a malignant disease

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Betül TAŞPINAR, Prof.Dr. contact

+905066804426

betul.taspinar@idu.edu.tr

Ferruh TAŞPINAR, Prof.Dr. contact

+905426853877

ferruh.taspinar@idu.edu.tr

Turkey (Türkiye)1 site
  • Betül TAŞPINAR

    Konak, İ̇zmi̇r

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Body Composition on Pain Threshold, Posture, Cervical Range of Motion, Sensation, and Cervical Function in Individuals With Non-Specific Neck Pain

Non-specific neck pain (NSNP) is a common musculoskeletal condition that significantly affects quality of life, daily activities, and work productivity. Although various physical, postural, and psychosocial factors have been associated with NSNP, the role of body composition in pain and functional outcomes remains unclear. Emerging evidence suggests that muscle and fat mass may influence musculoskeletal pain and related dysfunctions; however, studies examining these relationships in individuals with NSNP using objective measurements are limited. The purpose of this study is to investigate the effects of body composition on pain threshold, posture, cervical range of motion, sensation, and cervical function in individuals with non-specific neck pain. Individuals diagnosed with NSNP will be recruited from the Physical Medicine and Rehabilitation outpatient clinic. Participants' body composition, pain threshold, posture, cervical range of motion, sensory function, and cervical disability will be assessed using validated and objective measurement tools. Understanding the relationship between body composition and cervical outcomes in individuals with non-specific neck pain may contribute to early identification of risk factors and support the development of more targeted and effective physical therapy and rehabilitation strategies.

Read the detailed description

Non-specific neck pain (NSNP) is defined as pain located in the posterior and lateral regions of the neck between the superior nuchal line and the first thoracic vertebra, in the absence of neurological or specific pathologies such as fracture, infection, or inflammation. Neck pain is a common and widespread condition with an episodic course that affects a large proportion of the population. It has been reported that at least 80% of individuals experience neck pain and related disorders at some point during their lifetime. Moreover, 30-50% of the general adult population report experiencing neck pain at least once per year. In addition, approximately 25% of outpatient visits to Physical Medicine and Rehabilitation clinics are due to neck pain complaints. For the majority of patients, neck pain is a complex biopsychosocial disorder accompanied by both physical and psychological symptoms. A relationship between the severity of neck pain and disability has been reported, and neck pain has been associated with decreased health-related quality of life, reduced work productivity, limitations in daily activities, and increased utilization of healthcare services. Risk factors for NSNP include prolonged and/or improper computer use, non-ergonomic desk and chair use, physical activity level, poor posture, body mass index (BMI), female sex, longer working hours, fewer hours of sleep, and stress. Body composition refers to the different tissues that make up total body mass, generally expressed as muscle, fat, bone, and residual mass. Analyses of muscle and fat tissues have shown that muscle cells consist of approximately 70% water, 7% fat, and 22% protein. An excess of fat cells in the body exerts an inhibitory effect on muscles, limiting their ability to function effectively and consequently restricting movement. Additionally, in physical fitness assessments, body composition is often evaluated by examining fat mass and fat-free mass. The literature reports that the load applied to the cervical spine is approximately 10-12 lbs when the head is in a neutral position, increasing to 60 lbs when the head is flexed to 60 degrees. Prolonged maintenance of a forward head position results in irritation of the facet joints, ligaments, and soft tissues of the cervical region. This irritation may cause neck pain radiating to the shoulders and upper back. Furthermore, sustained forward head posture may lead to trigger point formation in muscles, joint motion restrictions, disc degeneration, and potential pathologies such as cervical degenerative disc disease, cervical osteoarthritis, or cervical disc herniation. Maintaining proper posture has been identified as an important factor in the management of neck pain.

Chronic neck pain is a multifactorial condition associated not only with various dysfunctions in the cervical region but also with related structures in other parts of the body. In individuals with chronic neck pain, decreased muscle strength and endurance, limitations in joint range of motion, altered muscle activation patterns, forward head posture, impaired proprioception, and psychological dysfunctions have been reported. In chronic neck pain, a reduction in joint position sense and imbalance in the axio-scapular muscles lead to a shift in the body's midline. An anterior shift of the midline results in abnormal postural patterns, primarily forward head posture. This condition contributes to the development of upper crossed syndrome, which encompasses a range of postural impairments including shoulder elevation and protraction, upper thoracic kyphosis (dowager's hump), scapular winging, and reduced thoracic mobility.

Individuals with neck pain may present with movement restrictions, pain, decreased cervical and thoracic segmental mobility, myotomal muscle weakness, postural abnormalities, numbness or paresthesia, reduced muscle flexibility, increased muscle tension accompanied by a predisposition to myofascial trigger point formation, decreased proprioception, reduced endurance of neck muscles, and impaired coordination. Cervical range of motion supports head and neck movement by contributing to head stabilization during activities of daily living and allowing head orientation in various directions. The literature has demonstrated a reduction in cervical range of motion in individuals with chronic neck pain, and this limitation has been reported to be associated with neck pain severity and cervical functional status.

Therefore, elucidating the pathology of such pain and its associated factors in terms of frequency and impact on daily life is of great importance, and several studies have been conducted to date to investigate these aspects. Nevertheless, many factors related to the pathology and associated parameters of this type of pain remain unclear. Recently, the relationship between body composition-including muscle and fat mass-and various health problems has been reported, and increasing evidence has emerged regarding the role of body composition in different health conditions. For example, increased fat mass combined with age-related muscle loss has been associated with a higher risk of disability and mortality. On the other hand, some researchers have reported associations between body composition and musculoskeletal pain, demonstrating that greater fat mass and reduced muscle mass as body composition factors are related to musculoskeletal pain. In light of this information, studies investigating the effects of body composition in individuals with non-specific neck pain appear to be limited, particularly with respect to the inclusion of objective measurements.

Conditions
Neck Pain
Being tested
Clinical Assessment
Keywords
Non-Specific Neck Pain, Body Composition, Cervical Range of Motion, Posture
Medical subject headings
Neck Pain

What participants receive

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

  • Clinical AssessmentOther

    Participants will undergo clinical assessments including body composition, pain threshold, posture, cervical range of motion, sensory function, and cervical disability. No therapeutic intervention will be applied.

Study groups in NCT07388706
Study groupRoleWhat they receive
Non-Specific Neck Pain GroupOtherParticipants diagnosed with non-specific neck pain
Receives: Other: Clinical Assessment

What is being measured

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

  1. Total Body Weight

    Total body weight (kg) will be measured using the Tanita BC-700 (Tanita, Japan) body composition analyzer, which uses single-frequency bioelectrical impedance analysis (BIA) technology.

    Measured: Baseline

  2. Body Mass Index (BMI)

    Body mass index (BMI, kg/m²) will be calculated automatically by the Tanita BC-700 based on measured body weight and participant-reported height entered into the device prior to measurement.

    Measured: Baseline

  3. Total Body Fat Percentage

    Total body fat percentage (%) will be assessed using the Tanita BC-700 body composition analyzer based on bioelectrical impedance analysis.

    Measured: Baseline

  4. Lower Extremity Fat Percentage

    Lower extremity fat percentage (%) will be measured using the Tanita BC-700 body composition analyzer.

    Measured: Baseline

  5. Total Body Muscle Percentage

    Total body muscle percentage (%) will be assessed using the Tanita BC-700 body composition analyzer.

    Measured: Baseline

  6. Lower Extremity Muscle Percentage

    Lower extremity muscle percentage (%) will be measured using the Tanita BC-700 body composition analyzer.

    Measured: Baseline

  7. Assessment of Pain Threshold

    Pressure pain threshold (PPT) will be evaluated to determine participants' pain sensitivity. A Wagner digital algometer (Wagner Instruments) will be used for PPT assessment. Participants will be seated on a height-adjustable chair with their feet flat on the floor and knees flexed at 90 degrees. The algometer will be applied to the measurement sites at a 90-degree perpendicular angle. Measurements will be taken bilaterally at the following locations: lateral aspect of the C5 spinous process, the midpoint of the upper trapezius, and the midpoint of the deltoid muscle. Each site will be measured three times, with at least a 30-second interval between repeated measurements to prevent sensitization. The value at which the participant first perceives pain will be recorded, and the average of the three measurements will be calculated for each site.

    Measured: Baseline

  8. Assessment of Posture

    Posture will be evaluated using the New York Posture Rating Scale (NYPRS). This scale was first published in 1958 and assesses the body in 13 different regions for potential postural deviations. Each region is scored as follows: 5 points for correct posture, 3 points for moderate deviation, and 1 point for severe deviation. The total score ranges from 13 to 65 points, with higher scores indicating better overall posture.

    Measured: Baseline

  9. Assessment of Cervical Range of Motion

    Cervical range of motion (CROM) will be assessed using the Pa Crom Basic - Cervical Range of Motion device. The CROM device is an inclinometer system that relies on gravity and magnetic fields. It consists of two fixed inclinometers for the sagittal and frontal planes, a horizontal-plane inclinometer with a magnetic needle attached to the top of the device, an arm with a ruler for linear measurements, a magnetic cervical collar, and a vertebra-locating arm with a level system. The device is worn like a pair of glasses, resting on the nose, above both ears, and on the forehead. Flexion and extension movements are measured using the inclinometer positioned at the left lateral side of the head, right and left lateral flexion are measured with the inclinometer at the midpoint of the forehead, and right and left rotation movements are measured with the inclinometer on top of the head combined with the magnetic stabilizer.

    Measured: Baseline

  10. Assessment of Sensation

    Sensation will be assessed using the Semmes-Weinstein Monofilament Test, which evaluates light touch and pressure perception. The therapist applies monofilaments of increasing force (0.086-448 g) from the smallest detectable filament. Testing is performed on the first to fifth fingers, distal to proximal, on anterior and posterior surfaces. The pressure at which the patient first perceives the stimulus is recorded. Responses are marked on a hand map and classified using a color-coded system.

    Measured: Baseline

  11. Assessment of Cervical Function

    Cervical function will be evaluated using the Neck Disability Index (NDI). This questionnaire is used to assess pain originating from the neck and the degree of limitation in daily living activities. It was developed by Dr. Howard in 1980 and consists of a total of 10 items. These items cover areas such as pain intensity, personal care, lifting, reading, headaches, concentration, work, driving, sleep, and recreation, with each item having six response options. Items are scored from 0 to 5, where 0 indicates no disability and 5 indicates complete disability. The total score can reach 50 points, which is then converted to a percentage. Higher scores indicate a higher level of disability.

    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 posted5 Feb 2026
  2. Study start15 Mar 2026 (estimated)
  3. Primary completion14 Oct 2026 (estimated)
  4. Study completion15 Jan 2027 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
111 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07388706
Sponsor's protocol ID
Non-Specific Neck Pain-35
Status last verified
Feb 2026
First submitted
13 Jan 2026
Last updated
5 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Clinical Assessment in people with Neck Pain, run by Izmir Democracy 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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Feb 2026. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Betül TAŞPINAR, Prof.Dr. (+905066804426, betul.taspinar@idu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Body Weight (time frame: Baseline). The study lists 11 primary outcomes in all. 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 5 Feb 2026.

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