NCT06455774

Brief Summary

The goal of this clinical trial is to investigate the effects of wearable postural feedback devices added to exercise approach on neck pain and proprioception in office workers with nonspecific chronic neck pain. H0: The effects of wearable postural feedback devices added to exercise and exercise approach on neck pain and proprioception are similar in office workers with nonspecific chronic neck pain. H1: The effects of wearable postural feedback devices added to exercise and exercise approach on neck pain and proprioception are different in office workers with nonspecific chronic neck pain. 58 office workers aged 25-55 years with nonspecific chronic neck pain will be included and divided into 2 groups, physiotherapy programs will be applied for 8 weeks, 3 days a week. All participants will be trained on office ergonomics and proper sitting posture at the beginning of the study. Group 1: Exercise and Postural feedback, Group 2: Exercise. Sociodemographic information will be questioned, pain, neck proprioception, craniovertebral angle, neck muscle strength, endurance and range of motion will be assessed. Neck disability index, physical activity level, stress perception level, fatigue level, work performance and patient satisfaction will also be evaluated at baseline and 8 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

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

First Submitted

Initial submission to the registry

June 7, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 12, 2024

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

1.1 years

First QC Date

June 7, 2024

Last Update Submit

March 28, 2026

Conditions

Keywords

cervical painpostureexercisevibrotactilefeedback

Outcome Measures

Primary Outcomes (2)

  • Neck Pain

    Neck pain will be assessed using the Numeric Pain Rating Scale. The patient is asked to rate the severity of pain out of 10. The patient chooses the appropriate value between 0; no pain and 10; the worst pain felt. The Neck Pain Numeric Pain Rating Scale has been reported as a valid and reliable method in patients with neck pain.

    8 week

  • Proprioception

    Neck proprioception will be assessed with the Cervical Joint Position Error Test. Participants will be asked to sit in a chair placed 90 cm from the wall and hold their head in a relaxed neutral position while facing the wall in front of them. A laser pointer will be attached to his/her head with an elastic strap. The laser light on the wall will be marked as the reference point and the participant will then be asked to perform active neck movements (flexion, extension, rotation) and then align the laser light to the reference point with eyes open. He/she will then be asked to repeat the same process with eyes closed and when he/she brings his/her head to the reference point, the new point on the wall will be marked as the target point. The joint position error will be found by measuring the distance between the target and the reference point in cm. Each procedure will be performed 3 times and average values will be taken.

    8 week

Secondary Outcomes (11)

  • Pressure Pain Threshold

    8 weeks

  • Craniovertebral Angle

    8 weeks

  • Neck Disability Index:

    8 weeks

  • Muscle strength

    8 weeks

  • Range of motion

    8 weeks

  • +6 more secondary outcomes

Study Arms (2)

Group1- Exercise and Wearable Postural Feedback Devices Group

EXPERIMENTAL

Participants will wear the postural feedback device for 8 weeks, 3 days a week during their desk work (6-8 hours) and will be included in an exercise program including 30 minutes of stretching and strengthening exercises for the cervical region. Exercises will be performed 3 days a week for 30 minutes and will be supervised by a physiotherapist one day a week.

Device: Wearable Postural Feedback DeviceOther: Exercise

Group2- Exercise Group

EXPERIMENTAL

Participants will receive an exercise program consisting of stretching and strengthening exercises for the cervical region. Exercises will be performed 3 days a week for 30 minutes and will be supervised by a physiotherapist one day a week. Patients will be followed up with an exercise diary.

Other: Exercise

Interventions

The postural feedback wearable device we will use in the study is programmed to vibrate when hunched postures are detected (based on changes in the curvature and curvature of the spine), alerting users to changes in their body position.

Group1- Exercise and Wearable Postural Feedback Devices Group

Trapezius, Sternocleidomastoid (SCM), Scalene, pectoral muscles will be targeted for stretching exercises and deep neck flexors, Trapezius, Levator Scapula, Rhomboids will be targeted for strengthening exercises. The intensity of the exercises will be increased according to the weeks. Stretching exercises will be performed as a single set at the pain limit, maintaining the position of the muscle groups in the longest tolerable position for 30 seconds. In strengthening exercises, participants will hold the position for 5-10 seconds at the end of the movement. Moderate resistance elastic bands and free weights will be used for resistance exercises. In the following weeks, progression will be made in all exercises according to the patient's condition.

Group1- Exercise and Wearable Postural Feedback Devices GroupGroup2- Exercise Group

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Complained of neck pain during work for at least 3 months,
  • Neck pain severity of 3 and above according to the Numerical Pain Rating Scale,
  • Office worker between the ages of 25-55,
  • Full-time and regular desk worker for the last 3 years,
  • Participants who use a computer at a desk for at least 3 hours a day will be included.

You may not qualify if:

  • Having neurological and rheumatologic chronic diseases,
  • Receiving physical therapy in the last 6 months
  • History of trauma to the upper extremities and spine,
  • Having diagnoses such as thoracic outlet, cervical rib, vertebrobasilar artery insufficiency,
  • History of cervical spine surgery,
  • Having suffered a whiplash injury,
  • Diagnosed cervical disc and spine pathologies (such as radiculopathy, myelopathy, fracture, infection, tumor, inflammatory diseases, osteoporosis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University- Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck PainMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Gökşen Kuran Aslan, Prof

    Istanbul University - Cerrahpasa

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc, PhD Student

Study Record Dates

First Submitted

June 7, 2024

First Posted

June 12, 2024

Study Start

November 1, 2024

Primary Completion

November 30, 2025

Study Completion

November 30, 2025

Last Updated

April 2, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations