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

Low Back Pain Clinical Trial

Official title:

Assessment of Long-term Potentiation (LTP)-Like Pain Amplification in Chronic Low Back Pain Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03362827
• Other study ID #: BackpainLTP
• Status: Not yet recruiting
• Phase: N/A
• First received: November 25, 2017
• Last updated: November 29, 2017
• Start date: March 1, 2018
• Est. completion date: December 31, 2018

Study information

• Verified date: November 2017
• Source: Peking University People's Hospital
• Contact: Weiwei Xia, Ph.D.
• Phone: 008613260001978
• Email: 523526767[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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
These participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

References & Publications (5)

Biurrun Manresa JA, Mørch CD, Andersen OK. Long-term facilitation of nociceptive withdrawal reflexes following low-frequency conditioning electrical stimulation: a new model for central sensitization in humans. Eur J Pain. 2010 Sep;14(8):822-31. doi: 10.1016/j.ejpain.2009.12.008. Epub 2010 Jan 27. — View Citation

Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-7. — View Citation

Mørch CD, Hennings K, Andersen OK. Estimating nerve excitation thresholds to cutaneous electrical stimulation by finite element modeling combined with a stochastic branching nerve fiber model. Med Biol Eng Comput. 2011 Apr;49(4):385-95. doi: 10.1007/s11517-010-0725-8. Epub 2011 Jan 5. — View Citation

Mouraux A, Iannetti GD, Plaghki L. Low intensity intra-epidermal electrical stimulation can activate Ad-nociceptors selectively. Pain. 2010 Jul;150(1):199-207. doi: 10.1016/j.pain.2010.04.026. Epub 2010 May 26. Erratum in: Pain. 2011 May;152(5):1212. — View Citation

Xia W, Mørch CD, Andersen OK. Test-Retest Reliability of 10 Hz Conditioning Electrical Stimulation Inducing Long-Term Potentiation (LTP)-Like Pain Amplification in Humans. PLoS One. 2016 Aug 16;11(8):e0161117. doi: 10.1371/journal.pone.0161117. eCollection 2016. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of pain intensity to pinprick stimuli	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	Perception Features of conditioning electrical stimulation (CES)	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.
Secondary	Change of pain intensity to light-stroking stimuli	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).
Secondary	Change of pain intensity to single electrical stimulation (SES)	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).