- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03362203
Conditioned Pain Modulation in Chronic Neck Pain Patients
November 29, 2017 updated by: guochen, Peking University People's Hospital
The Hypersensitivity and Changes of Conditioned Pain Modulation in Chronic Neck Pain Patients
The aim of this study was to evaluate changes in local and segmental hypersensitivity and endogenous pain inhibition in people with chronic nonspecific neck pain.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Quantitative sensory testing is widely used in human research to investigate the state of the peripheral and central nervous system contributions in pain processing.
It is a valuable tool to help identify central sensitization and may be important in the treatment of chronic neck pain.
This study is a cross-sectional study.
Two groups including chronic neck pain group and healthy volunteers group will be arranged in this study.
The healthy subjects will be matched for sex and age in relation to the neck pain group.
The pressure pain threshold (PPT) will be measured at the neck muscle in both groups.
The cold pressor test will be used in both groups to activate conditioned pain modulation.
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Weiwei Xia, Ph.D.
- Phone Number: 008613260001978
- Email: weiweixia2016@163.com
Study Locations
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Beijing, China, 100044
- Peking University People's Hospital
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Contact:
- Weiwei Xia, Ph.D.
- Phone Number: 008613260001978
- Email: 523526767@qq.com
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Principal Investigator:
- Chen Guo, Master
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- Chronic neck pain subjects People must have experienced neck pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days.Patients were excluded if they had taken pain medications on the day of the assessment or if they had serious spinal pathologies. Those who were pregnant, patients with cancer and those with a cardiac pacemaker were also excluded.
- Healthy volunteers These participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.
Description
Chronic neck pain subjects
Inclusion criteria:
- Age 21-80 years old.
- People must have experienced neck pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days.
Exclusion Criteria:
- Age under 21 or over 80.
- Patients were excluded if they had taken pain medications on the day of the assessment or if they had serious spinal pathologies, such as fractures, tumors or inflammatory diseases, such as ankylosing spondylitis, nerve root compromise confirmed by clinical neurological tests or severe cardiorespiratory diseases.
- Those who were pregnant, patients with cancer and those with a cardiac pacemaker were also excluded.
- Healthy volunteers
Inclusion criteria:
- Age 21-80 years old.
- These participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.
Exclusion Criteria:
- Age below 21 or over 80 years old.
- These participants have presented episodes of low back pain for more than 7 days in the last 12 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients with chronic neck pain
Patients,aged 21-80 years, must have experienced neck pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days.
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Patients,aged 21-80 years, must have experienced neck pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days.
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Subjects without chronic neck pain
Subjects,aged 21-80 years, must not have presented episodes of chronic neck pain for more than 7 days in the last 12 months.
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Subjects,aged 21-80 years, must not have presented episodes of chronic neck pain for more than 7 days in the last 12 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of pressure pain threshold (PPT)
Time Frame: The PPT will be measured before CPT, 30 seconds after the CPT begin, and immediately after CPT.
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A cold pressor test (CPT) was used to induce pain and trigger the conditioned pain modulation (CPM) response.
The conditioned stimulus was immersion of the leg in a bucket of ice water on the side ipsilateral to the most painful neck region.
The neck PPT was recorded beginning 30 s after immersion of the leg with two PPT measures for each point.
The PPT will be also measured again immediately after CPT.
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The PPT will be measured before CPT, 30 seconds after the CPT begin, and immediately after CPT.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numerical rating scale for pain (NRS)
Time Frame: The patients used this scale to rate the pain intensity of the neck pain before the experiment.
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The NRS evaluates levels of pain intensity using an 100-point scale (range 0-100), with 0 being classified as "no sensation", 30 "pain threshold", 100 "pain as bad as could be".
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The patients used this scale to rate the pain intensity of the neck pain before the experiment.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Chen Guo, Master, Peking University People's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dailey DL, Rakel BA, Vance CGT, Liebano RE, Amrit AS, Bush HM, Lee KS, Lee JE, Sluka KA. Transcutaneous electrical nerve stimulation reduces pain, fatigue and hyperalgesia while restoring central inhibition in primary fibromyalgia. Pain. 2013 Nov;154(11):2554-2562. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27.
- Xia W, Morch CD, Matre D, Andersen OK. Exploration of conditioned pain modulation effect on long-term potentiation-like pain amplification in humans. Eur J Pain. 2017 Apr;21(4):645-657. doi: 10.1002/ejp.968. Epub 2016 Oct 20.
- Neziri AY, Dickenmann M, Scaramozzino P, Andersen OK, Arendt-Nielsen L, Dickenson AH, Curatolo M. Effect of intravenous tropisetron on modulation of pain and central hypersensitivity in chronic low back pain patients. Pain. 2012 Feb;153(2):311-318. doi: 10.1016/j.pain.2011.10.008. Epub 2011 Nov 17.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2018
Primary Completion (Anticipated)
August 1, 2018
Study Completion (Anticipated)
August 1, 2018
Study Registration Dates
First Submitted
November 26, 2017
First Submitted That Met QC Criteria
November 29, 2017
First Posted (Actual)
December 5, 2017
Study Record Updates
Last Update Posted (Actual)
December 5, 2017
Last Update Submitted That Met QC Criteria
November 29, 2017
Last Verified
November 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Neckpainspine001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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