NCT05605132

Brief Summary

It is known that tactile acuity and proprioceptive sense decrease in patients with chronic neck pain. However, sensory re-training in patients with chronic neck pain has not been given sufficient importance. The effects of proprioceptive and tactile acuity training on pain intensity in patients with chronic neck pain will be compared in this study. Eligible participants will be divided into three groups as follows: Proprioceptive Training Group (PTG), Tactile Acuity Training Group (TAG), and Control Group (CG). The randomization will be performed using the block randomization method to obtain an equal number of participants in the groups. Each participant will be evaluated two times at a 4-week interval. Participants will be evaluated regarding subjective pain intensity by using a Numerical Rating Scale, temporal summation, and conditioned pain modulation using an algometer (JTECH Medical-Algometer Commander, USA). Neck proprioception exercises will be applied to the patients in the PTG at 3 days a week for 4 weeks. Tactile acuity training will be applied to the patients in the TAG 3 days a week for 4 weeks. Between the two assessments, the Control Group will not receive any treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

October 29, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 18, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 25, 2023

Status Verified

November 1, 2022

Enrollment Period

12 months

First QC Date

October 29, 2022

Last Update Submit

August 23, 2023

Conditions

Keywords

oculomotor exercisesneck paincervical painsensory re-training

Outcome Measures

Primary Outcomes (1)

  • pain intensity

    It will be evaluated using a Numerical Rating Scale (0 indicate no pain, 10 indicate most vulnerable pain)

    Change form baseline at 4 weeks

Secondary Outcomes (4)

  • pressure pain threshold

    Change form baseline at 4 weeks

  • temporal summation

    Change form baseline at 4 weeks

  • conditioned pain modulation

    Change form baseline at 4 weeks

  • neck disability

    Change form baseline at 4 weeks

Study Arms (3)

Proprioceptive Training Group

EXPERIMENTAL

oculomotor exercises will be applied to the participants three times a week for four weeks. oculomotor exercises: head relocation gaze stability eye follow saccadic eye movement head and eye coordination

Other: Proprioceptive Training Exercise

Tactile Acuity Training

EXPERIMENTAL

Participants will be requested to lie face down. Five points will be marked in the painful areas on the right and left sides of the neck. The distance between the points will equal the two-point discrimination value. A photograph of the neck will be taken. The patient will not see his/her own neck during the application but see the photograph of his/her neck. The points will be touched lightly with two different stimuli (a pen with a 2 mm diameter and a mushroom probe with an 11 mm diameter). Participants will be asked about the location and type of the stimuli. The interstimulus interval will be 15 seconds. If more than 90% of correct answers are obtained, the distance between the points will be reduced by 10%. The training will be performed in three separate blocks, a total of 72 stimuli (block duration = 6 minutes, rest time between blocks = 3 minutes, number of stimuli applied in each block = 24 stimuli). The treatment time will be 24 minutes.

Other: Tactile Acuity Training

Control Group

SHAM COMPARATOR

The participants will be evaluated two times at 4-week intervals. No intervention will be applied during the time frame.

Other: Control Group

Interventions

oculomotor exercises will be applied to the participants three times a week for four weeks. oculomotor exercises: * head relocation * gaze stability * eye follow * saccadic eye movement * head and eye coordination

Proprioceptive Training Group

Participants will be requested to lie face down. Five points will be marked in the painful areas on the right and left sides of the neck. The distance between the points will equal the two-point discrimination value. A photograph of the neck will be taken. The patient will not see his/her own neck during the application but see the photograph of his/her neck. The points will be touched lightly with two different stimuli (a pen with a 2 mm diameter and a mushroom probe with an 11 mm diameter). Participants will be asked about the location and type of the stimuli. The interstimulus interval will be 15 seconds. If more than 90% of correct answers are obtained, the distance between the points will be reduced by 10%. The training will be performed in three separate blocks, a total of 72 stimuli (block duration = 6 minutes, rest time between blocks = 3 minutes, number of stimuli applied in each block = 24 stimuli). The treatment time will be 24 minutes.

Tactile Acuity Training

The participants will be evaluated two times at 4-week intervals. No intervention will be applied during the time frame.

Control Group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • to be aged between 20-60 years old
  • Pain limited to the posterior of the cervical region.
  • Pain that lasts longer than 3 months
  • Pain severity of 3 or higher on the Visual Analog Scale

You may not qualify if:

  • Malignant tumor in any part of the body (no screening will be performed for the presence of tumor and patients diagnosed with tumors before the study will not be included).
  • Vertebral fractures
  • Fibromyalgia
  • chronic fatigue syndrome
  • History of surgery in the neck or shoulder area
  • Radicular pain
  • Neurological deficit of disc pathologies
  • Spinal stenosis
  • Spondylolisthesis
  • Pronounced cervical kyphosis
  • Significant scoliosis involving the cervical region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hacettepe Universty

Ankara, Sıhhıye, 06100, Turkey (Türkiye)

RECRUITING

Kübra

Ankara, Sıhhıye, 06230, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Canli K, Demirkiran G, Can F. The efficiency of tactile discrimination training and oculomotor exercises in people with chronic neck pain: a randomized controlled trial. BMC Musculoskelet Disord. 2025 May 27;26(1):519. doi: 10.1186/s12891-025-08755-0.

MeSH Terms

Conditions

Neck Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Kübra canlı

    Hacettepe University

    STUDY CHAIR
  • Filiz Can

    Hacettepe University

    STUDY DIRECTOR
  • Gökhan Demirkıran

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kübra Canlı

CONTACT

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 Assistant

Study Record Dates

First Submitted

October 29, 2022

First Posted

November 4, 2022

Study Start

January 18, 2023

Primary Completion

December 30, 2023

Study Completion

December 30, 2024

Last Updated

August 25, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations