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Not yet recruitingNCT07388706Updated Feb 5, 2026

Body Composition and Cervical Outcomes in Non-Specific Neck Pain

An interventional study of Clinical Assessment in Neck Pain, sponsored by Izmir Democracy University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-05.

Sponsored by Izmir Democracy University · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
111
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Neck Pain

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Keywords

  • Non-Specific Neck Pain
  • Body Composition
  • Cervical Range of Motion
  • Posture
03

In context

Neck Pain

1,232 studies on the registry are indexed under Neck Pain; 255 are open to participants now.

This study's planned enrollment of 111 is above the median of 52 across 1,004 interventional studies indexed under Neck Pain.

Browse Neck Pain studies →

Lead sponsor

Izmir Democracy University is the lead sponsor of 73 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Having a neurological and psychiatric problem that may affect evaluation methods
  • Pregnancy and pregnancy suspected
  • To be an elite athlete
  • Having a malignant disease
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
111 participants (estimated)

Study arms

  • Other
    Non-Specific Neck Pain Group

    Participants diagnosed with non-specific neck pain

    Other: Clinical Assessment

Interventions

  • OtherClinical Assessment

    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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline

  4. Lower Extremity Fat Percentage

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

    Time frame: Baseline

  5. Total Body Muscle Percentage

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

    Time frame: Baseline

  6. Lower Extremity Muscle Percentage

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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline

07

Study locations

1 site
  • Betül TAŞPINAR
    Konak, İ̇zmi̇r, Turkey (Türkiye)
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07388706
Lead sponsor
Izmir Democracy University
Responsible party
Betül Taşpınar (Prof.Dr., Izmir Democracy University) — Principal investigator
First posted
Feb 5, 2026
Start date
Mar 15, 2026 (estimated)
Primary completion
Oct 14, 2026 (estimated)
Completion
Jan 15, 2027 (estimated)
Last update
Feb 5, 2026

Study contacts

Betül TAŞPINAR, Prof.Dr.
Contact
betul.taspinar@idu.edu.tr
+905066804426
Ferruh TAŞPINAR, Prof.Dr.
Contact
ferruh.taspinar@idu.edu.tr
+905426853877
Ayşe Sezgi KIZILIRMAK KARATAŞ, asst.prof.
principal investigator · Izmir Democracy University
Onur Engin, asst.prof.
principal investigator · Izmir Democracy University
Öykü Dündar, std.
principal investigator · Izmir Democracy University
Büşra Aydın, Std.
principal investigator · Izmir Democracy University
Turna Sümen, std.
principal investigator · Izmir Democracy University
Nalan Anık, std.
principal investigator · Izmir Democracy University
Kader İliman, std.
principal investigator · Izmir Democracy University
Fadıma Kılıç, std.
principal investigator · Izmir Democracy University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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