Chronic Neck PainNCT06007443
Pain Related Variables
A study testing pain related variables assessment in people with Chronic Neck Pain and Musculoskeletal Pain, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Chronic Neck Pain, Musculoskeletal Pain, Pain Modulation
- What is being tested?
- pain related variables assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jan 2023to 25 Nov 2023
- 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
- pain in the back of the neck region
- pain longer than 3 months
- pain intensity at least 3 based on the visual analog scale
Who cannot join
- vertebra fracture
- fibromyalgia
- chronic fatigue syndrome
- surgery to the neck or shoulder
- radicular pain
- neurologic deficit due to disk hernia
- spinal stenosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Neck Pain, Musculoskeletal Pain, Pain Modulation, Cortical Plasticity, Conditioned Pain Modulation, Temporal Summation
- Being tested
- pain related variables assessment
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pain related variables assessmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: pain related variables assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 'baseline'
Secondary outcomes (3)
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
Measured: '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.
Measured: '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.
Measured: 'baseline'
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start28 Jan 2023
- Primary completion28 Sep 2023
- Study completion25 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Canli, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06007443
- Sponsor's protocol ID
- CPM-TS-2PD
- Status last verified
- Aug 2023
- First submitted
- 4 Jul 2023
- Last updated
- 29 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Pain Related Variables in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT06007443
- Acronym / sponsor ID
- CPM-TS-2PD
- Conditions
- Chronic Neck Pain, Musculoskeletal Pain, Pain Modulation, Cortical Plasticity, Conditioned Pain Modulation, Temporal Summation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 28 Jan 2023 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 25 Nov 2023 (actual)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with neck pain | Experimental | Other: pain related variables assessmentconditioned pain modulation, temporal summation and two-point discrimination will be evaluated in all included participants. Average pain intensity will be asked |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- pain in the back of the neck region
- pain longer than 3 months
- pain intensity at least 3 based on the visual analog scale
Key exclusion criteria (7 listed)
- vertebra fracture
- fibromyalgia
- chronic fatigue syndrome
- surgery to the neck or shoulder
- radicular pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pain related variables assessmentPressure 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. | Other | patients with neck pain |
Primary outcome
pressure pain threshold
Time frame: 'baseline'
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.
3 secondary outcomes
temporal summation
Time frame: 'baseline'
conditioned pain modulation
Time frame: 'baseline'
tactile acuity
Time frame: 'baseline'
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pain related variables assessment in people with Chronic Neck Pain and Musculoskeletal Pain, run by Hacettepe University at 1 site 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pressure pain threshold (time frame: 'baseline'). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2023.