Conditioned Pain Modulation in Chronic Neck Pain Patients
The Hypersensitivity and Changes of Conditioned Pain Modulation in Chronic Neck Pain Patients
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2018
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
November 26, 2017
CompletedFirst Posted
Study publicly available on registry
December 5, 2017
CompletedStudy Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedDecember 5, 2017
November 1, 2017
7 months
November 26, 2017
November 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change of pressure pain threshold (PPT)
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.
The PPT will be measured before CPT, 30 seconds after the CPT begin, and immediately after CPT.
Secondary Outcomes (1)
Numerical rating scale for pain (NRS)
The patients used this scale to rate the pain intensity of the neck pain before the experiment.
Study Arms (2)
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.
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.
Interventions
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.
Subjects,aged 21-80 years, must not have presented episodes of chronic neck pain for more than 7 days in the last 12 months.
Eligibility Criteria
1. 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. 2. Healthy volunteers These participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's Hospital
Beijing, 100044, China
Related Publications (3)
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.
PMID: 23900134BACKGROUNDXia 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.
PMID: 27766711BACKGROUNDNeziri 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.
PMID: 22100357BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chen Guo, Master
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Department of Spine Surgery
Study Record Dates
First Submitted
November 26, 2017
First Posted
December 5, 2017
Study Start
January 1, 2018
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
December 5, 2017
Record last verified: 2017-11
Data Sharing
- IPD Sharing
- Will not share