search
Back to results

Tactile Acuity and Pain Modulation

Primary Purpose

Chronic Neck Pain, Musculoskeletal Pain, Pain Modulation

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
pain modulation and cortical somatosensory representation assessment
Sponsored by
Hacettepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Neck Pain

Eligibility Criteria

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

Inclusion Criteria: pain in the back of the neck region pain longer than 3 months pain intensity at least 3 based on the visual analog scale Exclusion Criteria: vertebra fracture fibromyalgia chronic fatigue syndrome surgery to the neck or shoulder radicular pain neurologic deficit due to disk hernia spinal stenosis

Sites / Locations

  • Hacettepe UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

patients with neck pain

Arm Description

conditioned pain modulation, temporal summation and two-point discrimination will be evaluated in all included participants.

Outcomes

Primary Outcome Measures

pressure pain threshold
The pressure pain threshold (PPTs) of the upper trapezius and dominant tibialis anterior muscles will be evaluated. For the upper trapezius muscle, assessment will be made approximately 5 to 8 cm superomedial to the superior angle of the scapula. For the tibialis anterior muscle, the assessment will be made muscle belly, which is approximately 2.5 cm lateral and 5 cm inferior to the tibial tubercle. Palpation during resisted active dorsiflexion ensured that the tibialis anterior muscle belly had been found. Pressure pain thresholds will assessed using a pressure algometer (Algometer) with a stimulation area of 1 cm2. The increment rate of pressure will be kept at approximately 1 kg/cm2/s. The first time the pressure perceived as pain will be recorded as a PPTs. Two PPT assessments with a 30 second will be completed, and the average was used for statistical analysis.

Secondary Outcome Measures

temporal summation
Temporal summation (TS) of pressure pain will be elicited at the upper trapezius muscle by administering 10 consecutive pressure pulses using the algometer. For each pulse of the TS procedure, the pressure will be increased at approximately 2 kg/s until the previously determined PPT will be reached and maintained for one second. Pressure pulses will be presented with an inter-stimulus interval of one second. Participants will be instructed to rate their perceived pain intensity during the first, fifth, and tenth pressure pulse using a verbal numeric rating scale (VNRS). The TS pain score will be obtained by subtracting the first VNRS score from the last VNRS, with increased number indicates higher pain facilitation
conditioned pain modulation
An inflated occlusion cuff placed on the contralateral arm will be used as a conditioned stimulus. The occlusion cuff will be inflated at a rate of 20 mm Hg/s until "the first sensation of pain". At that point, it will be maintained for 30 s. Pain intensity will then be rated on a VNRS. Next, cuff inflation will be increased or decreased until the VNRS will be rated as 3/10. PPTs assessment will be repeated during maintenance of the cuff inflation. CPM will be calculated as the first NRS score during cuff inflation minus the first VNRS score before cuff inflation, with more positive values indicating more pain inhibition and more negative values indicating more pain facilitation.
tactile acuity
It will be assessed by using two-point discrimination threshold on both sides of the neck. A sliding two-point Vernier Calliper with digital measurement will be placed under its own weight on the participant's skin, to provide two simultaneous tactile stimuli. For the spinal measures, the caliper will be aligned vertically 15 mm lateral to the spinous processes of C7. Assessment will be commenced with the two-points at a 20 mm separation, and will be increased by 2 mm increments until the participant reported feeling two points of contact. If two distinct points perceived in three consecutive trials this value will be recorded. A series of three ascending and descending assessments will be performed, with the mean of the six values will be used for analyses.

Full Information

First Posted
July 4, 2023
Last Updated
August 27, 2023
Sponsor
Hacettepe University
search

1. Study Identification

Unique Protocol Identification Number
NCT06007443
Brief Title
Tactile Acuity and Pain Modulation
Official Title
Association Between Tactile Acuity and Pain Modulation in Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2023 (Actual)
Primary Completion Date
September 28, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (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
Chronic neck pain is a common problem among the general population. Patients with chronic neck pain used health care services twice as much as the population on average, mainly due to intense pain intensity. It is well-known that pain intensity depends on the association of pain processing in several levels of central pain processing. Identifying the association between conditioned pain modulation, temporal summation, and somatosensory representation, all represent separate central pain processing, will provide an opportunity to develop treatment strategies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Neck Pain, Musculoskeletal Pain, Pain Modulation, Cortical Plasticity, Conditioned Pain Modulation, Temporal Summation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients with neck pain
Arm Type
Experimental
Arm Description
conditioned pain modulation, temporal summation and two-point discrimination will be evaluated in all included participants.
Intervention Type
Other
Intervention Name(s)
pain modulation and cortical somatosensory representation assessment
Intervention Description
Pressure pain threshold, conditioned pain modulation, temporal summation, and two-point discrimination will be evaluated on the upper trapezius muscle.
Primary Outcome Measure Information:
Title
pressure pain threshold
Description
The pressure pain threshold (PPTs) of the upper trapezius and dominant tibialis anterior muscles will be evaluated. For the upper trapezius muscle, assessment will be made approximately 5 to 8 cm superomedial to the superior angle of the scapula. For the tibialis anterior muscle, the assessment will be made muscle belly, which is approximately 2.5 cm lateral and 5 cm inferior to the tibial tubercle. Palpation during resisted active dorsiflexion ensured that the tibialis anterior muscle belly had been found. Pressure pain thresholds will assessed using a pressure algometer (Algometer) with a stimulation area of 1 cm2. The increment rate of pressure will be kept at approximately 1 kg/cm2/s. The first time the pressure perceived as pain will be recorded as a PPTs. Two PPT assessments with a 30 second will be completed, and the average was used for statistical analysis.
Time Frame
'baseline'
Secondary Outcome Measure Information:
Title
temporal summation
Description
Temporal summation (TS) of pressure pain will be elicited at the upper trapezius muscle by administering 10 consecutive pressure pulses using the algometer. For each pulse of the TS procedure, the pressure will be increased at approximately 2 kg/s until the previously determined PPT will be reached and maintained for one second. Pressure pulses will be presented with an inter-stimulus interval of one second. Participants will be instructed to rate their perceived pain intensity during the first, fifth, and tenth pressure pulse using a verbal numeric rating scale (VNRS). The TS pain score will be obtained by subtracting the first VNRS score from the last VNRS, with increased number indicates higher pain facilitation
Time Frame
'baseline'
Title
conditioned pain modulation
Description
An inflated occlusion cuff placed on the contralateral arm will be used as a conditioned stimulus. The occlusion cuff will be inflated at a rate of 20 mm Hg/s until "the first sensation of pain". At that point, it will be maintained for 30 s. Pain intensity will then be rated on a VNRS. Next, cuff inflation will be increased or decreased until the VNRS will be rated as 3/10. PPTs assessment will be repeated during maintenance of the cuff inflation. CPM will be calculated as the first NRS score during cuff inflation minus the first VNRS score before cuff inflation, with more positive values indicating more pain inhibition and more negative values indicating more pain facilitation.
Time Frame
'baseline'
Title
tactile acuity
Description
It will be assessed by using two-point discrimination threshold on both sides of the neck. A sliding two-point Vernier Calliper with digital measurement will be placed under its own weight on the participant's skin, to provide two simultaneous tactile stimuli. For the spinal measures, the caliper will be aligned vertically 15 mm lateral to the spinous processes of C7. Assessment will be commenced with the two-points at a 20 mm separation, and will be increased by 2 mm increments until the participant reported feeling two points of contact. If two distinct points perceived in three consecutive trials this value will be recorded. A series of three ascending and descending assessments will be performed, with the mean of the six values will be used for analyses.
Time Frame
'baseline'

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: pain in the back of the neck region pain longer than 3 months pain intensity at least 3 based on the visual analog scale Exclusion Criteria: vertebra fracture fibromyalgia chronic fatigue syndrome surgery to the neck or shoulder radicular pain neurologic deficit due to disk hernia spinal stenosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kübra canlı, MSc
Phone
903123052525
Email
kbrac91@gmail.com
Facility Information:
Facility Name
Hacettepe University
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kübra canlı, MSc

12. IPD Sharing Statement

Learn more about this trial

Tactile Acuity and Pain Modulation

We'll reach out to this number within 24 hrs