5% Lidocaine-medicated plaster for the treatment of chronic peripheral neuropathic pain: complex regional pain syndrome and other neuropathic conditions

Figures & data

Table 1 Baseline demographic and clinical characteristics of patients

Variable	All patients, n=56	CRPS, n=10	PHN, n=8	DPN, n=7	CPSP, n=16	NES, n=15
Age (years), mean (SD)	58.3 (14.9)	53.0 (15.2)	67.5 (11.6)	68.3 (6.5)	53.1 (15.8)	57.8 (15.0)
Females, n (%)	34 (60.7)	5 (50.0)	5 (62.5)	3 (42.8)	11 (68.8)	10 (66.7)
Months since diagnosis, mean (SD)	8.9 (2.7)	8.9 (2.6)	8.0 (1.7)	12.1 (2.8)	8.7 (3.2)	8.1 (1.6)
Number of concomitant treatments, mean (SD)	2.3 (0.8)	2.1 (0.8)	2.3 (0.5)	2.4 (0.5)	2.5 (1.2)	2.1 (0.6)
Analgesic ladder step, n (%)
Only adjuvants	23 (41)	4 (40.0)	5 (62.5)	3 (42.9)	4 (25.0)	7 (46.6)
Step I	4 (7.1)	1 (10.0)	0 (0)	0 (0)	1 (6.3)	2 (13.3)
Step II	13 (23.2)	3 (30.0)	1 (12.5)	2 (28.6)	3 (18.8)	4 (26.7)
Step III	6 (10.7)	1 (10.0)	1 (12.5)	1 (14.3)	2 (12.5)	1 (6.7)
Step IV	10 (17.8)	1 (10.0)	1 (12.5)	1 (14.3)	6 (37.5)	1 (6.7)
DN4 score, mean (SD)	7.4 (1.2)	8.2 (0.9)	7.8 (1.2)	6.4 (0.8)	7.5 (1.2)	7.1 (1.3)
NRS score, mean (SD)	7.8 (1.1)	7.9 (0.7)	8.8 (1.0)	7.4 (1.3)	7.4 (1.0)	7.7 (1.0)
Oswestry disability index, mean (SD)	24.5 (12.4)	27.7 (15.7)	22.5 (13.9)	17.9 (8.7)	25.8 (13.7)	25.3 (9.1)
HAD-A, mean (SD)	6.3 (3.0)	66.3 (3.6)	6.3 (2.6)	4.4 (1.3)	7.7 (3.2)	5.7 (2.9)
HAD-D, mean (SD)	5.8 (3.8)	4.8 (3.3)	6.4 (2.6)	6.6 (2.6)	6.3 (4.2)	5.4 (4.7)

Abbreviations: CPSP, chronic postsurgery pain; CRPS, complex regional pain syndrome; DN4, Douleur Neuropathique 4 questions; DPN, diabetic polyneuropathy; HAD-A, anxiety subscale of Hospital Anxiety and Depression Scale; HAD-D, depression subscale of Hospital Anxiety and Depression Scale; NES, nerve entrapment syndrome; NRS, numeric rating scale; PHN, postherpetic neuropathy.

Figure 1 Change in average NRS over time by clinical entity.

Abbreviations: CPSP, chronic postsurgery pain; CRPS, complex regional pain syndrome; DPN, diabetic polyneuropathy; NES, nerve entrapment syndrome; NRS, numeric rating scale; PHN, postherpetic neuropathy

Table 2 Treatment outcomes for the overall sample and by clinical entity

Variable	All patients, n=56	CRPS, n=10	PHN, n=8	DPN, n=7	CPSP, n=16	NES, n=15
Change in intrapatient NRS score from baseline, mean (SD)
At 1 month	−3.4 (1.7)	−2.4 (1.7)	−4.3 (1.6)	−3.7 (0.8)	−3.3 (1.5)	−3.7 (2.1)
At 3 months	−4.4 (1.7)	−3.6 (2.0)	−5.9 (1.5)	−4.3 (0.8)	−4.1 (1.2)	−4.5 (2.1)
At 6 months	−4.7 (1.9)	−4.0 (2.3)	−6.3 (1.8)	−4.9 (1.2)	−4.3 (1.4)	−4.7 (2.0)
Oswestry index change from baseline at month 6 among patients, n (%)a
>0%	7 (12.5)	1 (10.0)	0 (0)	3 (42.9)	1 (6.3)	2 (13.3)
0%	14 (25.0)	2 (20.0)	3 (37.5)	1 (14.3)	5 (31.3)	3 (20.0)
−1% to −10%	32 (57.1)	6 (60.0)	4 (50.0)	3 (42.9)	9 (56.3)	10 (66.7)
<−10%	3 (5.4)	1 (10.0)	1 (12.5)	0 (0)	1 (6.3)	0 (0)
HAD-A score reduction from baseline at month 6 among patients, n (%)
0 points	26 (46.4)	6 (60.0)	2 (25.0)	5 (71.4)	7 (43.8)	6 (40.0)
1–2 points	17 (30.4)	1 (10.0)	5 (62.5)	0 (0)	5 (31.3)	6 (40.0)
≥3 points	13 (23.1)	3 (30.0)	1 (12.5)	2 (28.6)	4 (25.1)	3 (20.0)
HAD-D score reduction from baseline at month 6, n (%)b
0 points	42 (75.0)	6 (60.0)	5 (62.5)	7 (100.0)	13 (81.3)	10 (66.7)
1–2 points	8 (14.0)	2 (20.0)	2 (25.0)	0 (0)	2 (12.5)	3 (20.0)
≥3 points	5 (8.7)	1 (10.0)	1 (12.5)	0 (0)	1 (6.3)	2 (13.4)
Patient’s Global Impression of Improvement after 6 months, mean (SD)	37.9% (19.4%)	34.0% (23.7%)	43.1% (24.3%)	35.0% (14.7%)	38.4% (20.7%)	38.7% (15.5%)
Physician’s Global Impression of Improvement after 6 months, mean (SD)	38.6% (18.9%)	35.0% (23.1%)	43.1% (21.9%)	35.0% (14.7%)	40.0% (20.8%)	38.7% (15.5%)
Patients with changes in concomitant analgesic treatments at 6 months, n (%)
No changes from baseline	20 (35.7)	3 (30.0)	4 (50.0)	3 (42.6)	3 (18.8)	7 (46.7)
Dose of 1 or 2 analgesics reduced	29 (51.7)	6 (60.0)	3 (37.5)	4 (57.1)	11 (68.8)	6 (40.0)
Number of analgesic treatments reduced	6 (10.7)	1 (10.0)	1 (12.5)	0 (0)	2 (12.5)	2 (13.3)

Notes:

a Negative change in Oswestry index indicates reduction in disability.

b The HAD-D score increased from baseline at month 6 in one patient in the CRPS group.

Abbreviations: CPSP, chronic postsurgery pain; CRPS, complex regional pain syndrome; DPN, diabetic polyneuropathy; HAD-A, anxiety subscale of Hospital Anxiety and Depression Scale; HAD-D, depression subscale of Hospital Anxiety and Depression Scale; NES, nerve entrapment syndrome; NRS, numeric rating scale; PHN, postherpetic neuropathy.

Figure 2 The percentage of patients reporting at least 50% pain intensity reduction, as measured by NRS score, after 1 month, 3 months, and 6 months of treatment.

Abbreviations: CPSP, chronic postsurgery pain; CRPS, complex regional pain syndrome; DPN, diabetic polyneuropathy; NES, nerve entrapment syndrome; NRS, numeric rating scale; PHN, postherpetic neuropathy.