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CompletedNCT06007443Updated Nov 29, 2023

Pain Related Variables

An interventional study of pain related variables assessment in Chronic Neck Pain, Musculoskeletal Pain and Pain Modulation, sponsored by Hacettepe University. Completed at 1 site in Turkey. Open to participants aged 20 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-11-29.

Sponsored by Hacettepe University · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2023, registered Jul 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
46
Allocation
Not applicable
Ages
20 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Neck Pain
  • Musculoskeletal Pain
  • Pain Modulation
  • Cortical Plasticity
  • Conditioned Pain Modulation
  • Temporal Summation
03

In context

Musculoskeletal Pain

493 studies on the registry are indexed under Musculoskeletal Pain; 113 are open to participants now.

This study's enrollment of 46 is below the median of 69 across 346 interventional studies indexed under Musculoskeletal Pain.

Browse Musculoskeletal Pain studies →

Lead sponsor

Hacettepe University is the lead sponsor of 983 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • vertebra fracture
  • fibromyalgia
  • chronic fatigue syndrome
  • surgery to the neck or shoulder
  • radicular pain
  • neurologic deficit due to disk hernia
  • spinal stenosis
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
46 participants (actual)

Study arms

  • 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

Interventions

  • Otherpain 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 'baseline'

Secondary outcomes

  1. 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

    Time frame: 'baseline'

  2. 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.

    Time frame: 'baseline'

  3. 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.

    Time frame: 'baseline'

07

Study locations

1 site
  • Hacettepe University
    Ankara, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 29, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06007443
Lead sponsor
Hacettepe University
Responsible party
Kübra Canli (Principal investigator, Hacettepe University) — Principal investigator
First posted
Aug 23, 2023
Start date
Jan 28, 2023
Primary completion
Sep 28, 2023
Completion
Nov 25, 2023
Last update
Nov 29, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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