Conditioned Pain Modulation in Chronic Neck Pain Patients

Neck Pain Clinical Trial

Official title:

The Hypersensitivity and Changes of Conditioned Pain Modulation in Chronic Neck Pain Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03362203
• Other study ID #: Neckpainspine001
• Status: Not yet recruiting
• Phase: N/A
• First received: November 26, 2017
• Last updated: November 29, 2017
• Start date: January 1, 2018
• Est. completion date: August 1, 2018

Study information

• Verified date: November 2017
• Source: Peking University People's Hospital
• Contact: Weiwei Xia, Ph.D.
• Phone: 008613260001978
• Email: weiweixia2016[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Dailey DL, Rakel BA, Vance CG, 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):2554-62. doi: 10.1016/j.pain.2013.07.043. Epub 2013 Jul 27. — View 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):311-8. doi: 10.1016/j.pain.2011.10.008. Epub 2011 Nov 17. — View Citation

Xia W, Mørch 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Numerical rating scale for pain (NRS)	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".	The patients used this scale to rate the pain intensity of the neck pain before the experiment.