ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of LTP-like Pain Amplification in Chronic Low Back 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: NCT03362827
Recruitment Status : Not yet recruiting
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Liu Chenjun, Peking University People's Hospital

November 25, 2017
December 5, 2017
December 5, 2017
March 1, 2018
December 31, 2018   (Final data collection date for primary outcome measure)
Change of pain intensity to pinprick stimuli [ Time Frame: The pinprick sensation will be measured three times before and six times after the conditioning electrical stimulation with 10 minutes interval throughout the experiment (90 minutes). ]
Mechanical pinprick-evoked perception was assessed by three weighted pinprick stimulators which were randomly applied in the area adjacent to the conditioned site. The subjects indicated the perceived intensity on the same visual analogue scale(VAS).
Same as current
No Changes Posted
  • Perception Features of conditioning electrical stimulation (CES) [ Time Frame: All subjects will rate the pain ratings during the 50 seconds stimulation. ]
    The subjects were asked to rate continuously the magnitude of pain induced by the 100 Hz CES using a hand-held visual analogue scale (VAS) device. These VAS ratings were sampled by a computer. The VAS ranges from "0"(no sensation") to "100" (most imaginable pain) where "30" means pain threshold.
  • Change of pain intensity to light-stroking stimuli [ Time Frame: The light-touch sensation will be measured three times before and six times after the conditioning electrical stimulation with 10 minutes interval throughout the experiment (90 minutes). ]
    A cotton swab was used for light stroking stimuli (~100mN) for assessing the tactile perception around the conditioned site.
  • Change of pain intensity to single electrical stimulation (SES) [ Time Frame: The pain ratings to SES will be measured three times before and six times after the conditioning electrical stimulation with 10 minutes interval throughout the experiment (90 minutes). ]
    A single rectangular 1 ms constant-current electrical stimulation was applied as a homotopic electrical test stimulus using the same conditioning electrode placed at the conditioned site.
Same as current
Not Provided
Not Provided
 
Assessment of LTP-like Pain Amplification in Chronic Low Back Pain Patients
Assessment of Long-term Potentiation (LTP)-Like Pain Amplification in Chronic Low Back Pain Patients
The present study is aimed to assess the LTP-like pain amplification in chronic low back pain patients to explore the central and peripheral effect for pain LTP.
This study is a cross-sectional study. Two groups, including low back pain group and healthy subjects group will be arranged in this study. 50 subjects will be recruited in each group, The healthy subjects were matched for sex and age in relation to the low back pain group. Conditioning electrical stimulation (100 Hz, repeated 5 times with 10 s intervals, 500 impulses) using circular pin electrodes will be used in both groups to induce LTP-like pain amplification. The pain intensity changes to pinprick and light touch stimuli will be compared between two groups.
Observational
Observational Model: Other
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample
  1. Chronic low back pain patients Age 21-80 years old.People must have experienced low back 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, such as fractures, tumors or inflammatory diseases. Those who were pregnant, patients with cancer and those with a cardiac pacemaker were also excluded.
  2. 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.
Low Back Pain
  • Other: Chronic low back pain patients
    People must have experienced low back 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: Subjects without chronic low back pain
    These participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.
  • Chronic low back pain patients
    People must have experienced low back 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.
    Intervention: Other: Chronic low back pain patients
  • Subjects without chronic low back pain
    Participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.
    Intervention: Other: Subjects without chronic low back pain

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
Same as current
December 31, 2018
December 31, 2018   (Final data collection date for primary outcome measure)
  1. Chronic low back pain patients

    Inclusion Criteria:

    • Age 21-80 years old.
    • People must have experienced low back 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 below 21 or over 80 years old.
    • 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.
Sexes Eligible for Study: All
20 Years to 60 Years   (Adult)
Yes
Contact: Weiwei Xia, Ph.D. 008613260001978 523526767@qq.com
Not Provided
 
 
NCT03362827
BackpainLTP
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Liu Chenjun, Peking University People's Hospital
Peking University People's Hospital
Not Provided
Principal Investigator: Chenjun Liu, Ph.D. Peking University People's Hospital
Peking University People's Hospital
November 2017