We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Conditioned Pain Modulation in Chronic Neck Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03362203
Recruitment Status : Not yet recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Neck Pain Other: Patients with chronic neck pain Other: Subjects without chronic 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.

Study Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: The Hypersensitivity and Changes of Conditioned Pain Modulation in Chronic Neck Pain Patients
Anticipated Study Start Date : January 1, 2018
Estimated Primary Completion Date : August 1, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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
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.
Other: 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.


Outcome Measures

Primary Outcome Measures :
  1. 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. ]
    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.


Secondary Outcome Measures :
  1. 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. ]
    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".


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03362203


Contacts
Contact: Weiwei Xia, Ph.D. 008613260001978 weiweixia2016@163.com

Locations
China
Peking University People's Hospital Not yet recruiting
Beijing, China, 100044
Contact: Weiwei Xia, Ph.D.    008613260001978    523526767@qq.com   
Principal Investigator: Chen Guo, Master         
Sponsors and Collaborators
Peking University People's Hospital
Investigators
Principal Investigator: Chen Guo, Master Peking University People's Hospital
More Information

Publications:
Responsible Party: guochen, Department of Spine Surgery, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03362203     History of Changes
Other Study ID Numbers: Neckpainspine001
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by guochen, Peking University People's Hospital:
Conditioned pain modulation, neck pain

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms