Clinical trial NCT03362203: Conditioned Pain Modulation in Chronic Neck Pain Patients
Official title: The Hypersensitivity and Changes of Conditioned Pain Modulation in Chronic Neck Pain Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neck Pain
Keywords: Conditioned pain modulation, neck pain
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2017-12-05
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility criteria: 1. 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.
2. 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.

Primary outcomes:
measure: Change of pressure pain threshold (PPT)
timeFrame: The PPT will be measured before CPT, 30 seconds after the CPT begin, and immediately after CPT.
Secondary outcomes:
measure: Numerical rating scale for pain (NRS)
timeFrame: The patients used this scale to rate the pain intensity of the neck pain before the experiment.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Chen Guo, Master
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.