Pain Related Variables

Association Between Pain Related Variables in Patients With Chronic Neck Pain

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.

Study Overview

• Status: Completed
• Conditions: Musculoskeletal Pain; Chronic Neck Pain; Pain Modulation; Cortical Plasticity; Conditioned Pain Modulation; Temporal Summation
• Intervention / Treatment: Other: pain related variables assessment

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • HACETTEPE UNIVERSİTY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with neck pain; conditioned pain modulation, temporal summation and two-point discrimination will be evaluated in all included participants. Average pain intensity will be asked	Other: pain related variables assessment; Pressure pain threshold, conditioned pain modulation, temporal summation, and two-point discrimination will be evaluated on the upper trapezius muscle. Average pain intensity will be asked.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	'baseline'

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	'baseline'
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.	'baseline'
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.	'baseline'

Collaborators and Investigators

• Sponsor: Hacettepe University

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2023
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): November 25, 2023

Study Registration Dates

• First Submitted: July 4, 2023
• First Submitted That Met QC Criteria: August 22, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 26, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neck Pain; Musculoskeletal Pain
• Other Study ID Numbers: CPM-TS-2PD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No