Pilot Study of the Efficacy and Safety of Lidoderm Patch in the Treatment of Low Back Pain

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Patients with moderate to severe chronic Low Back Pain (LBP) despite current analgesic treatment participated in a Phase IV clinical trial to evaluate the analgesic efficacy of the lidocaine patch 5% compared to placebo in treating moderate to severe chronic LBP.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endo Pharmaceuticals
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

1. Were currently experiencing moderate/severe pain despite current analgesic treatment

2. Had daily moderate-to-severe LBP for at least 3 months duration

3. Had a mean daily pain intensity score of >6 on a 0 to 10 scale, with 0 being no pain and 10 being pain as bad as the patients have ever imagined (Question 5 of BPI) during the baseline week; patients had to complete daily diary assessments at least 5 of 7 days during the baseline week

Exclusion Criteria:

1. Had a history of greater than one back surgery, or one back surgery within 3 months of study entry

2. Had severe spinal stenosis

3. Had chronic back pain of >12 months duration with an undefined spinal diagnosis

4. Had radicular symptoms with radiation into the thigh or below (i.e., knee, calf, foot, etc.)

5. Had received an epidural steroid/local anesthetic injection within 2 weeks prior to study entry

6. Had received trigger point injections within 2 weeks prior to study entry

7. Had received Botulinum Toxin Injections for LBP within 3 months prior to study entry

8. Were taking a lidocaine-containing product that could not be discontinued while receiving study medication

9. Were taking class 1 anti-arrhythmic drugs (e.g., mexiletine, tocainide)

10. Had received Lidoderm for LBP in the past