Mechanism-based Choice of Therapy for Neuropathic Pain

Pain Clinical Trial

Official title:

Mechanism-based Choice of Therapy for Neuropathic Pain: Can Treatments Success in Neuropathic Post-operative Pain be Coupled to Psychophysical Pain Modulation Profile?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359514
• Other study ID #: PostOperativePain05CTIL
• Status: Completed
• Phase: N/A
• First received: July 10, 2010
• Last updated: October 10, 2017
• Start date: April 2008
• Est. completion date: January 2014

Study information

• Verified date: October 2017
• Source: Rambam Health Care Campus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mechanism-based choice of therapy for neuropathic pain:

Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain modulation profile?

Description:

Neuropathic or idiopathic pain patients will be assessed with the variety of pain tests including the conditioned pain modulation (CPM) and temporal summation (TS). Then, they will be offered on the double-blind design a several weeks treatment with either pregabalin or duloxetine. Patients will be followed-up weekly by phone for their pain relief and will be re-assessed in the lab toward the end of the treatment. The investigators suggest that patients with less-efficient CPM (deficient pain inhibition) will "earn" more pain relief from the treatment with duloxetine, while the patients with the enhanced pain summation will response better to pregabalin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients planned for thoracotomy

Exclusion Criteria:

• age below 18 and above 75 years

• patients with psychiatric or cognitive dysfunction precluding use of psychophysics

• those who cannot communicate in Hebrew

• patients with existing thoracic or other current chronic pain

Related Conditions & MeSH terms

• Neuralgia
• Pain

Intervention

Drug:
• Pregabalin
Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 5 weeks
• Duloxetine
Initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 5 weeks

Locations

Country	Name	City	State
Israel	Rambam Medical center	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pain	The pain relief will be achieved by treatment with duloxetine or pregabalin. We propose that the patients with deficient pain inhibition (As assessed by conditioned pain modulation lab test) will have better drug efficacy of cymbalta which restores the deficient level of serotonin and noradrenalin. In turn, pregabalin will be more effective in patients with enhance central sensitization of pain as measured by temporal summation assessment. In line, CPM and TS will be modulated by the treatment, in parallel with the analgesic effect.	One year