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Neck PainNCT05605132

SENSORY RE-TRAINING IN PATIENTS WITH CHRONIC NECK PAIN

A study testing Proprioceptive Training Exercise and Tactile Acuity Training in people with Neck Pain and Cervical Pain, run by Hacettepe University at 2 sites in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Neck Pain, Cervical Pain, Neck Muscle Issue
What is being tested?
Proprioceptive Training Exercise and Tactile Acuity Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
57 participants
Where
2 sitesTurkey (Türkiye)
Study dates
18 Jan 2023to 30 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • Neurological deficit of disc pathologies
  • Spinal stenosis
  • Spondylolisthesis
  • Pronounced cervical kyphosis
  • Significant scoliosis involving the cervical region

Trial locations and contacts

2 sites in 1 country.

Kübra Canlı contact

90 312 305 25 25

Turkey (Türkiye)2 sites, 2 recruiting
  • Hacettepe Universty

    Ankara, Sıhhıye, 06100

    Kübra Canlı, MD

    Recruiting
  • Kübra

    Ankara, Sıhhıye, 06230

    Kübra, 903123052525, kbrac91@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Being tested
Proprioceptive Training Exercise, Tactile Acuity Training, Control Group
Keywords
oculomotor exercises, neck pain, cervical pain, sensory re-training
Medical subject headings
Neck Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proprioceptive Training ExerciseOther

    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
  • Tactile Acuity TrainingOther

    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.

  • Control GroupOther

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

Study groups in NCT05605132
Study groupRoleWhat they receive
Proprioceptive Training GroupExperimentaloculomotor 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
Receives: Other: Proprioceptive Training Exercise
Tactile Acuity TrainingExperimentalParticipants 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.
Receives: Other: Tactile Acuity Training
Control GroupSham comparatorThe participants will be evaluated two times at 4-week intervals. No intervention will be applied during the time frame.
Receives: Other: Control Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pain intensity

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

    Measured: Change form baseline at 4 weeks

Secondary outcomes (4)
  1. 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.

    Measured: Change form baseline at 4 weeks

  2. 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.

    Measured: Change form baseline at 4 weeks

  3. 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.

    Measured: Change form baseline at 4 weeks

  4. neck disability

    A neck disability questionnaire (NDI) will be used

    Measured: Change form baseline at 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2022
  2. Study start18 Jan 2023
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05605132
Sponsor's protocol ID
Neck Pain
Status last verified
Nov 2022
First submitted
29 Oct 2022
Last updated
25 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 40420069

Questions about this trial

What is this clinical trial studying?

A study testing Proprioceptive Training Exercise and Tactile Acuity Training in people with Neck Pain and Cervical Pain, run by Hacettepe University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kübra canlı (90 312 305 25 25 ext. 187, kbrac91@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pain intensity (time frame: Change form baseline at 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05605132, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.

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