SENSORY RE-TRAINING IN PATIENTS WITH CHRONIC NECK PAIN

August 23, 2023 updated by: Kübra Canli, Hacettepe University

Comparison of the Effects of Proprioception and Tactile Accuracy Training on Proprioception, Range of Motion, Pain and Disability in Patients With Chronic Neck Pain

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Kübra Canlı
  • Phone Number: 90 312 305 25 25

Study Locations

  • Turkey
    • Sıhhıye
      • Ankara, Sıhhıye, Turkey, 06100
        • Recruiting
        • Hacettepe Universty
        • Contact:
          • Kübra Canlı, MD
      • Ankara, Sıhhıye, Turkey, 06230
        • Recruiting
        • Kübra
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Proprioceptive Training Group

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

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
Experimental: Tactile Acuity Training
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
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.
Sham Comparator: Control Group
The participants will be evaluated two times at 4-week intervals. No intervention will be applied during the time frame.
Other: Control Group
The participants will be evaluated two times at 4-week intervals. No intervention will be applied during the time frame.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain intensity
Time Frame: Change form baseline at 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
pressure pain threshold
Time Frame: Change form baseline at 4 weeks
It will be evaluated in the middle of the upper trapezius muscle and the dominant side of the tibialis anterior muscle. It will be evaluated two times at 30-second intervals. The average of value will be recorded.
Change form baseline at 4 weeks
temporal summation
Time Frame: Change form baseline at 4 weeks
It will be evaluated in the middle of the upper trapezius muscle. 10 subsequent stimuli with a 1-second application at the level of pressure pain threshold and 1-second rest. Pain intensity at 1, 5 and 10th stimuli will be asked based on the Numerical Rating Scale.
Change form baseline at 4 weeks
conditioned pain modulation
Time Frame: Change form baseline at 4 weeks
The sphygmomanometer will be applied on the arm which is the contralateral side of the upper trapezius. It will be inflated at a rate of 20 mm/Hg and held at this value for 30 seconds. Then, the patient's pain intensity will be questioned according to the numerical pain scale.
Change form baseline at 4 weeks
neck disability
Time Frame: Change form baseline at 4 weeks
A neck disability questionnaire (NDI) will be used
Change form baseline at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hacettepe University

Investigators

  • Study Chair: Kübra canlı, Hacettepe University
  • Study Director: Filiz Can, Hacettepe University
  • Principal Investigator: Gökhan Demirkıran, Hacettepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

October 29, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 4, 2022

Study Record Updates

Last Update Posted (Actual)

August 25, 2023

Last Update Submitted That Met QC Criteria

August 23, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neck Pain

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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