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

November 29, 2017 updated by: Liu Chenjun, Peking University People's Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
All subjects will rate the pain ratings during the 50 seconds stimulation.
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.
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).
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.
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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Investigators

  • Principal Investigator: Chenjun Liu, Ph.D., Peking University People's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

March 1, 2018

Primary Completion (Anticipated)

December 31, 2018

Study Completion (Anticipated)

December 31, 2018

Study Registration Dates

First Submitted

November 25, 2017

First Submitted That Met QC Criteria

November 29, 2017

First Posted (Actual)

December 5, 2017

Study Record Updates

Last Update Posted (Actual)

December 5, 2017

Last Update Submitted That Met QC Criteria

November 29, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BackpainLTP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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