NCT07005076

Brief Summary

In this study, women with chronic neck pain residing in Afyonkarahisar, Turkey, will participate in an exercise-based intervention. Both the control and experimental groups will engage in conventional exercise programs; however, the experimental group will also receive an additional technology-assisted exercise program. It is anticipated that these interventions will positively impact participants' daily living activities and functional abilities. The study aims to assess whether the inclusion of technology-supported exercises leads to superior outcomes compared to conventional exercises alone. The findings are expected to provide valuable evidence on the effectiveness of integrating technology-assisted exercise programs into physiotherapy and rehabilitation practices for women with chronic neck pain.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 5, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 5, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

May 27, 2025

Last Update Submit

May 27, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Numerical Rating Scale (NRS)

    Patients will be asked to mark the number between 0 and 10 that best corresponds to the intensity of their pain.

    From enrollment to the end of treatment at 4 weeks

  • G-Walk Wireless Movement Analysis System

    G-Walk is a wireless system used to assess gait, balance, and functional mobility through motion sensors placed on the lower back. While wearing the G-Walk device, the participant walks at a normal pace between two markers placed 10 meters apart. Furthermore, static balance will be assessed by having the participant maintain a one-legged stance for 30 seconds.

    From enrollment to the end of treatment at 4 weeks

  • Modified Four Square Step Test

    The Modified Four Square Step Test (mFSST) is used to assess dynamic balance and the ability to step in multiple directions. During the test procedure, four strips, each measuring 90 cm in length, are arranged on the floor to form a square, with each quadrant labeled from 1 to 4. The participant is instructed to step through each quadrant first in a clockwise direction and then in a counterclockwise direction, ensuring continuous forward gaze and avoiding contact with the strips throughout the test.

    From enrollment to the end of treatment at 4 weeks

Study Arms (2)

Control Group

NO INTERVENTION

The treatment process for the control group consisted of hot therapy and TENS application before the exercises, followed by an exercise program including neck range of motion exercises, neck strengthening exercises, stretching exercises, scapular retraction, etc.

Experimental Group

EXPERIMENTAL

The program will be implemented over four weeks, three days a week, with a duration of 40-45 minutes per day. In addition to conventional treatment, an exercise program prepared with a light reaction time measurement and exercise set will be implemented.

Other: Experimental Group

Interventions

Participants in the experimental group will participate in a conventional exercise program similar to the control group, but with the addition of a technology-assisted exercise program. The intervention group will receive training with a reaction time measurement set using lights and an exercise set. The reaction time measurement and exercise set will be used, where light pods are placed in different positions, such as on a table, mirror, and floor, and patients will be instructed to extinguish the lit light as quickly as possible. The difficulty level of the sessions will be progressively increased by adjusting factors such as the duration of light activation, colors, the number of illuminated pods, their placement locations, and the distance between them.

Also known as: Tech-Assisted Training
Experimental Group

Eligibility Criteria

Age18 Years - 59 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Non-specific neck pain diagnosis
  • Having neck pain persisting for at least 3 months
  • Having the ability to speak and comprehend Turkish fluently
  • A pain score of 3 or higher according to the Numerical Rating Scale
  • A score of 5 or higher on the Neck Disability Index

You may not qualify if:

  • Having a history of spinal surgery.
  • Having an additional musculoskeletal disorder affecting the cervical region and upper extremities (e.g., scoliosis, rheumatoid arthritis, fibromyalgia, etc.).
  • Receiving physical therapy and/or other treatments for any reason within the last 6 months.
  • Having a diagnosed psychiatric disorder.
  • Having a vestibular pathology.
  • Having visual problems despite using visual aids.
  • Being pregnant.
  • Having a neurological deficit that may affect balance.
  • Discontinuing or being unable to complete the treatment process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Sciences University

Merkez, Afyonkarahisar, 03030, Turkey (Türkiye)

RECRUITING

Study Officials

  • FATMA EKEN

    Afyonkarahisar Sağlık Bİlimleri Üniversitesi

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research asistant

Study Record Dates

First Submitted

May 27, 2025

First Posted

June 5, 2025

Study Start

May 1, 2025

Primary Completion

November 1, 2025

Study Completion

December 1, 2025

Last Updated

June 5, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations