Body Composition and Cervical Outcomes in Non-Specific Neck Pain

NCT07388706 | Not Yet Recruiting

• 1 other identifier: Non-Specific Neck Pain-35
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neck Pain

Keywords

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

Outcome Measures

Primary Outcomes (11)

• 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.

  Baseline

• 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.

  Baseline

• Total Body Fat Percentage

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

  Baseline

• Lower Extremity Fat Percentage

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

  Baseline

• Total Body Muscle Percentage

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

  Baseline

• Lower Extremity Muscle Percentage

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

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

Study Arms (1)

Non-Specific Neck Pain Group

OTHER

Participants diagnosed with non-specific neck pain

Other: Clinical Assessment

Interventions

Clinical Assessment OTHER

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.

Non-Specific Neck Pain Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Betül TAŞPINAR

Konak, İ̇zmi̇r, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ayşe Sezgi KIZILIRMAK KARATAŞ, asst.prof.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Onur Engin, asst.prof.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Öykü Dündar, std.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Büşra Aydın, Std.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Turna Sümen, std.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Nalan Anık, std.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Kader İliman, std.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Fadıma Kılıç, std.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Betül TAŞPINAR, Prof.Dr.

CONTACT

+905066804426; betul.taspinar@idu.edu.tr

Ferruh TAŞPINAR, Prof.Dr.

CONTACT

+905426853877; ferruh.taspinar@idu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.Dr.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 5, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

TU (1)