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Assessment of LTP-like Pain Amplification in Chronic Low Back Pain Patients

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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):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Low Back Pain Other: Chronic low back pain patients Other: Subjects without chronic low back pain

Detailed Description:
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.

Study Design

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Assessment of Long-term Potentiation (LTP)-Like Pain Amplification in Chronic Low Back Pain Patients
Anticipated Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
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: 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.
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.
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.


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  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.
Criteria
  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.
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): NCT03362827


Contacts
Contact: Weiwei Xia, Ph.D. 008613260001978 523526767@qq.com

Sponsors and Collaborators
Peking University People's Hospital
Investigators
Principal Investigator: Chenjun Liu, Ph.D. Peking University People's Hospital
More Information

Publications:
Responsible Party: Liu Chenjun, Department of Spine Surgery, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT03362827     History of Changes
Other Study ID Numbers: BackpainLTP
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 Liu Chenjun, Peking University People's Hospital:
Low back pain
Long-term potentiation
Hyperalgesia
Allodynia

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