NCT03362203

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

December 5, 2017

Status Verified

November 1, 2017

Enrollment Period

7 months

First QC Date

November 26, 2017

Last Update Submit

November 29, 2017

Conditions

Keywords

Conditioned pain modulation, neck pain

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.

Other: Patients with chronic neck pain

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.

Other: Subjects without chronic neck pain

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.

Patients with 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.

Subjects without chronic neck pain

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Location

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: 23900134BACKGROUND
  • 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.

    PMID: 27766711BACKGROUND
  • 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.

    PMID: 22100357BACKGROUND

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Chen Guo, Master

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiwei Xia, Ph.D.

CONTACT

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

Locations