Improvement of Pain and Function After Use of a Topical Pain Relieving Patch: Results of the RELIEF Study

Figures & data

Table 1 Baseline Demographic and Clinical Characteristics of the Control, Treatment and Crossover Groups

Variable	Control Group	Treatment Group	Crossover Group
Number of patients	47	152	34
Age (years)
Mean (SD)  Median  Min, max	48.4 (10.5) 47.8 23.4, 64.8	45.4 (11.8) 46.5 18.1, 64.6	47.3 (11.0) 46.9 23.4, 62.6
Sex, n (%)
Female  Male	27, (57.4) 20, (42.6)	100 (65.8) 52 (34.2)	20 (58.8) 14 (41.2)
Primary pain complaint, n (%)
Arthritis  Neuropathy/radiculopathy  Myofascial/musculoskeletal  Other	9 (19.1) 5 (10.6) 33 (70.2) —	38 (25.0) 15 (9.9) 93 (61.2) 6 (3.9)	3 (8.8) 4 (11.8) 27 (79.4) —
Months with primary pain complaint, n (%)
<1  1–3  3–12  >12	5 (10.6) 4 (8.5) 17 (36.2) 21 (44.7)	3 (2.0) 29 (19.2) 49 (32.5) 70 (46.4)	5 (14.7) 4 (11.8) 6 (17.6) 19 (55.9)
Hours with pain each of last 3 days
Mean (SD)  Median  Min, max	13.4 (6.6) 10.0 6, 24	8.7 (5.5) 8.0 1, 24	15.1 (7.1) 15 6, 24
Patients taking concurrent pain medication/s, n (%)
None  OTC  Prescription NSAID  Opioid or anticonvulsant  Muscle relaxant	— 22 (46.8) 12 (25.5) 7 (14.9) 4 (8.5)	10 (6.6) 92 (60.5) 56 (36.8) 5 (3.3) 5 (3.3)	— 22 (64.7) 12 (35.3) 7 (20.6) 4 (11.8)

Abbreviations: SD, standard deviation; Min, minimum; Max, maximum; OTC, over-the-counter; NSAID, nonsteroidal anti-inflammatory drug.

Table 2 Baseline and Day 14 Brief Pain Inventory Scores for Overall Severity, Severity Questions, Overall Interference, and Interference Questions for the Control, Treatment, and Crossover Groups

Variable	Baseline			Day 14
	CG	TG	CROSSG	CG	TG	CROSSG
Number of patients	47	152	34	47	152	34
Overall pain severity
Mean (SD)  Median  Min, max	5.7 (2.1) 5.8 2.3, 10.0	4.9 (1.5) 4.8 1.0, 9.3	5.4 (1.9) 5.8 1.5, 10.0	5.0 (1.7) 5.0 1.5, 10.0	2.5 (1.5) 2.3 0.0, 6.5	2.8 (1.4) 2.8 0.8, 5.8
Worst pain in last 24 hours
Mean (SD)  Median  Min, max	7.7 (1.7) 8.0 5, 10	7.2 (1.8) 7.0 1, 10	7.0 (1.9) 7.0 3, 10	6.6 (1.8) 6.0 3, 10	4.4 (2.1) 4.0 0, 10	4.0 (1.6) 4.0 1, 7
Least pain in last 24 hours
Mean (SD)  Median  Min, max	3.9 (2.0) 4.0 0, 10	3.1 (1.8) 3.0 0, 10	3.6 (2.0) 3.0 0, 10	3.6 (1.7) 3.0 0, 10	1.3 (1.2) 1.0 0, 5	1.6 (1.1) 1.0 0, 4
Average pain
Mean (SD)  Median  Min, max	5.6 (2.6) 5.0 1, 10	4.7 (1.6) 5.0 1, 10	5.3 (2.2) 6.0 1, 10	4.8 (2.1) 5.0 1, 10	2.5 (1.8) 3.0 0, 7	2.8 (1.4) 3.0 1, 6
Current pain
Mean (SD)  Median  Min, max	5.6 (2.8) 6.0 1, 10	4.5 (2.0) 4.5 0, 10	5.5 (2.2) 6.0 1, 10	5.0 (2.1) 5.0 1, 10	1.9 (1.7) 1.0 0, 7	2.8 (1.6) 3.0 0, 6
Overall pain interference
Mean (SD)  Median  Min, max	5.4 (2.8) 5.9 1.6, 10.0	4.3 (1.8) 4.0 0.7, 9.7	5.5 (2.4) 6.1 1.6, 9.0	4.6 (2.5) 5.1 1.6, 9.0	1.8 (1.6) 1.3 0.0, 8.0	2.5 (1.7) 2.7 0.1, 5.7
Pain interference with general activity
Mean (SD)  Median  Min, max	7.4 (1.9) 7.0 4, 10	6.0 (2.2) 6.0 0, 10	7.2 (1.8) 7.5 4, 10	6.8 (1.8) 6.0 4, 10	3.0 (2.1) 3.0 0, 10	4.1 (2.0) 4.5 1, 8
Pain interference with mood
Mean (SD)  Median  Min, max	4.5 (3.9) 4.0 0, 10	3.4 (2.9) 3.0 0, 10	5.0 (3.5) 6.0 0, 10	3.7 (3.6) 4.0 0, 10	1.4 (2.1) 0.0 0, 10	1.7 (1.4) 2.0 0, 5
Pain interference with ability to walk
Mean (SD)  Median  Min, max	6.6 (2.3) 6.0 3, 10	5.3 (2.6) 6.0 0, 10	6.2 (1.9) 6.0 3, 9	5.7 (1.8) 5.0 3, 9	2.1 (1.9) 2.0 0, 8	2.7 (1.9) 3.0 0, 7
Pain interference with normal work
Mean (SD)  Median  Min, max	6.7 (2.2) 7.0 3, 10	5.6 (2.3) 6.0 0, 10	6.3 (1.8) 6.0 3, 9	5.7 (1.8) 6.0 3, 9	2.2 (1.9) 2.0 0, 10	2.7 (2.0) 3.0 0, 7
Pain interference with social relationships
Mean (SD)  Median  Min, max	3.3 (3.6) 2.0 0, 10	2.1 (2.5) 1.0 0, 10	3.8 (3.0) 4.0 0, 9	2.8 (3.1) 0.0 0, 9	0.8 (1.6) 0.0 0, 9	1.6 (1.4) 2.0 0, 4
Pain interference with sleep
Mean (SD)  Median  Min, max	4.5 (4.5) 3.0 0, 10	3.6 (3.1) 3.0 0, 10	5.0 (3.5) 6.5 0, 9	3.6 (3.8) 3.0 0, 9	1.5 (2.0) 0.0 0, 8	2.5 (2.0) 3.0 0, 6
Pain interference with life enjoyment
Mean (SD)  Median  Min, max	4.7 (3.0) 4.0 1, 10	4.3 (2.4) 4.0 0, 10		3.6 (3.0) 3.0 0, 10	1.3 (1.8) 1.0 0, 10	2.3 (1.9) 2.0 0, 6

Abbreviations: CG, control group; TG, treatment group; CROSSG, crossover group; SD, standard deviation; Min, minimum; Max, maximum.

Figure 1 Baseline and day 14 overall mean (A) severity and (B) interference scores within the control, treatment, and crossover groups. *95% Confidence Interval of the difference, paired t-test. Each difference is statistically significant.

Abbreviations: CG, control group; TG, treatment group; CROSSG, crossover group.

Figure 2 Mean change from baseline to day 14 in overall severity (A) and interference (B) scores within the control, treatment, and crossover groups. *95% Confidence Interval of the difference, unpaired t-test.

Abbreviations: CG, control group; TG, treatment group; CROSSG, crossover group.

Figure 3 Percent using each type of pain medication at baseline and day 14 within the control (A), and treatment (B) groups.

Abbreviations: OTC, over-the-counter; NSAID, nonsteroidal anti-inflammatory drug; OP, opioid; AC, anticonvulsant; MR, muscle relaxant.