An Over-the-Counter Central Sensitization Therapy: A Chronic Back Pain Registry Study of Pain Relief, Medication Use and Their Adverse Effects

Figures & data

Figure 1. Ratings of pain relief by subjects indicate that only 7.5% get good pain relief, with 60.4% experiencing less than adequate pain relief.

Figure 2. Visual analog scale scores at baseline and after device use shows a mean pain reduction of 39.9% across all the chronic back pain subjects in the study.

Figure 3. The percent of subjects who made changes in medication use during the 7-day trial: no change (49%), increased (0.6%), decreased (36%), eliminated (14%) and started a new medication (0.3%).

Figure 4. Types of adverse effects and the number who reported these effects for the 66% (n = 658) who reported having side effects.

The mean number of adverse effects was 4.6 per subject.

Table 1. Gender distribution.

Gender	n = 1394 (%)
Male	25
Female	75
Age (years)
18–24	1.4
25–34	3.4
35–44	14.9
45–54	29.4
55–64	27.6
65 or more	22.4

Table 2. Duration of pain.

Pain duration	n = 1394 (%)
6 months to 1 year	7.6
1–2 years	21.9
2–5 years	24
5–10 years	21.2
10–20 years	18.4
20 years +	16

Table 3. The reported etiologies show a heterogeneous pain population.

Etiology	%
Not sure what causes my pain	11.5
Accident	7.0
Ankylosing spondylitis	4.2
Cervical issues	2.3
Complex regional pain syndrome	1.1
Disc issues	18.0
Fibromyalgia	11.8
Frozen shoulder	0.9
Ligament damage	1.4
Multiple sclerosis	0.6
Neuropathy	2.4
Osteoarthritis	13.7
Osteoporosis	2.5
Rheumatoid arthritis	6.1
Sciatica	11.8
Sports injury	1.3
Surgery	3.0
Tendinitis	0.9
Tennis elbow	1.1
Trapped nerve	4.4
Other	5.9

Table 4. Medication use of the subjects in the study.

Analgesic	%
Paracetamol (acetaminophen)	52
NSAIDs	46
Weak opioids (codeine, tramadol)	30
Strong opioids	13
Cox-2 inhibitors	1
Pregabalin (e.g., Lyrica)	13
Amitriptyline	29
Topical opioid (e.g., morphine)	10
Topical NSAIDs (e.g., Voltarol)	17
Gabapentin	16
Duloxetine (e.g., Cymbalta)	1
Steroids (e.g., prednisone)	2
Epidural	2
Other	7
No analgesics	3.7
Other modalities
TENS	24
Heat wraps	30
Physical therapy	20

TENS: Transcutaneous electrical nerve stimulation.

Table 5. The percent of individuals who reported a 40% or greater visual analog scale scores reduction was 726/1394 or 52%.

Pain measure	All n = 1394	Effective ≥40% pain reduction n = 726 (52%)
Baseline VAS	8.04 ± 1.46	8.16 ± 1.41
Post-trial VAS	4.83 ± 2.68	2.76 ± 1.40
VAS difference	3.21	5.40
Percent reduction (%)	39.9	66.2
p-value	p < 0.001	p < 0.001

These individuals had a mean pain reduction of 66%.

VAS: Visual analog scale.

Table 6. The intent to continue therapy.

Intent	Percent	Baseline VAS	Trial VAS	VAS difference
Definitely	40.6	8.34 ± 1.40	3.09 ± 1.93	5.25
Probably	13.4	7.92 ± 1.39	4.02 ± 1.96	3.90
Possibly	14.8	7.80 ± 1.58	5.25 ± 2.16	2.55
Probably not	16.3	7.67 ± 1.38	6.70 ± 1.99	0.97
Definitely not	14.9	8.00 ± 1.49	7.87 ± 1.75	0.13

VAS: Visual analog scale.

Table 7. Pain duration, analgesic use, percent subjects reporting adverse effects, mean adverse effects and their impact on patients’ quality of life.

Pain duration	Mean number of meds used	Mean number of prescription meds	Percent of subjects with adverse effects	Mean number of adverse effects (per subject)	Impact on QoL
6 months to 1 year	2.29	1.19	48.2	4.3	4.2
1–2 years	2.23	1.07	50	3.9	5.5
2–5 years	2.48	1.45	68.3	4.1	5.6
5–10 years	2.72	1.74	70.0	5.3	5.9
10–20 years	2.63	1.64	76	4.8	5.8
20 years +	2.61	1.56	72	4.9	6.1

QoL: Quality of life.

Table 8. Subject age group, analgesic use, percent of subjects reporting adverse effects, mean adverse effects and their impact on patients’ quality of life.

Age (years)	Mean number of meds used	Mean number of prescription meds	Percent of subjects with adverse effects	Mean number of adverse effects (per subject)	Impact on QoL
25–34	3.25	2.03	72.7	7.0	6.2
35–44	2.92	1.84	76.7	5.3	6.1
45–55	2.62	1.58	69.6	4.9	5.8
56–64	2.51	1.39	66.2	4.5	5.9
65 +	2.08	1.18	55.6	3.2	5.0

QoL: Quality of life.