NCT06007443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 28, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 23, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2023

Completed
Last Updated

November 29, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

July 4, 2023

Last Update Submit

November 26, 2023

Conditions

Outcome Measures

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.

    'baseline'

Secondary Outcomes (3)

  • temporal summation

    'baseline'

  • conditioned pain modulation

    'baseline'

  • tactile acuity

    'baseline'

Study Arms (1)

patients with neck pain

EXPERIMENTAL

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

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.

patients with neck pain

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • pain in the back of the neck region
  • pain longer than 3 months
  • pain intensity at least 3 based on the visual analog scale

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Musculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 4, 2023

First Posted

August 23, 2023

Study Start

January 28, 2023

Primary Completion

September 28, 2023

Study Completion

November 25, 2023

Last Updated

November 29, 2023

Record last verified: 2023-08

Locations