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SENSORY RE-TRAINING IN PATIENTS WITH CHRONIC NECK PAIN

Primary Purpose

Neck Pain, Cervical Pain, Neck Muscle Issue

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Proprioceptive Training Exercise
Tactile Acuity Training
Control Group
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring oculomotor exercises, neck pain, cervical pain, sensory re-training

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hacettepe UniverstyRecruiting
  • KübraRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Proprioceptive Training Group

Tactile Acuity Training

Control Group

Arm Description

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

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

pressure pain threshold
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.
temporal summation
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.
conditioned pain modulation
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.
neck disability
A neck disability questionnaire (NDI) will be used

Full Information

First Posted
October 29, 2022
Last Updated
August 23, 2023
Sponsor
Hacettepe University
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1. Study Identification

Unique Protocol Identification Number
NCT05605132
Brief Title
SENSORY RE-TRAINING IN PATIENTS WITH CHRONIC NECK PAIN
Official Title
Comparison of the Effects of Proprioception and Tactile Accuracy Training on Proprioception, Range of Motion, Pain and Disability in Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 18, 2023 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hacettepe University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Cervical Pain, Neck Muscle Issue, Neck Pain, Posterior, Cervical Pain, Posterior
Keywords
oculomotor exercises, neck pain, cervical pain, sensory re-training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
57 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Proprioceptive Training Group
Arm Type
Experimental
Arm Description
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
Arm Title
Tactile Acuity Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
The participants will be evaluated two times at 4-week intervals. No intervention will be applied during the time frame.
Intervention Type
Other
Intervention Name(s)
Proprioceptive Training Exercise
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Tactile Acuity Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
The participants will be evaluated two times at 4-week intervals. No intervention will be applied during the time frame.
Primary Outcome Measure Information:
Title
pain intensity
Description
It will be evaluated using a Numerical Rating Scale (0 indicate no pain, 10 indicate most vulnerable pain)
Time Frame
Change form baseline at 4 weeks
Secondary Outcome Measure Information:
Title
pressure pain threshold
Description
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.
Time Frame
Change form baseline at 4 weeks
Title
temporal summation
Description
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.
Time Frame
Change form baseline at 4 weeks
Title
conditioned pain modulation
Description
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.
Time Frame
Change form baseline at 4 weeks
Title
neck disability
Description
A neck disability questionnaire (NDI) will be used
Time Frame
Change form baseline at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kübra canlı
Phone
90 312 305 25 25
Ext
187
Email
kbrac91@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kübra Canlı
Phone
90 312 305 25 25
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kübra canlı
Organizational Affiliation
Hacettepe University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Filiz Can
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Gökhan Demirkıran
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hacettepe Universty
City
Ankara
State/Province
Sıhhıye
ZIP/Postal Code
06100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kübra Canlı, MD
Facility Name
Kübra
City
Ankara
State/Province
Sıhhıye
ZIP/Postal Code
06230
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kübra
Phone
903123052525
Email
kbrac91@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SENSORY RE-TRAINING IN PATIENTS WITH CHRONIC NECK PAIN

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