PainShield MD is an innovative treatment for pelvic and abdominal pain
|including pain associated with the:|
| || |
- pelvic pain
- bladder pain
- pain on urination
- pain on defecation
- related muscle or joint pain
Reductions in the frequency of painful urinary episodes, sacro-iliac joint pain, painful intercourse (dyspareunia), rectal pain, and pain resulting from prolonged sitting were also noted. Some patients reported a decrease in pain-associated sleep disturbance as well as reduced expenditures for pain and related medications (e.g. opioids). Patients rated their overall response as:
- Good (10/19)
- Moderate (3/19)
- Mild (4/19)
- Negative (2/19)
References1. Ustinova E et al. Neurourol Urodyn. 2010; 29:77
2. Rodriguez,et al., J Urol. 2009 182:2123
3. FitzGerald, et al. J Urol. 2012: 187:2113
4. Montenegro et al., Int J Clin Pract. 2008 62:263
5. West et al. Gastroenterol Clin North Am. 1992; 21:793
Please note the full prescribing information can be found on our Ordering Page.
"Reduction of chronic abdominal and pelvic pain, urological and GI symptoms using a wearable device delivering low frequency ultrasound"
(presented at the Annual Meeting of the International Pelvic Pain Society Meeting, Chicago, October 18-20, 2012, Abstract 42, Poster 29. see press release here)
International Adhesions Society; Summit Physical Therapy, Dallas, TX
| || |
Click here or on thumbnail for clinical data.
|Click here for a video summary of the clinical data.|
Methods: In this open−label, prospective, experiential study, 16 women and 3 men (age 46, range 33−62) with a history of chronic pelvic, urological or related pain or symptoms (15.3 years, range 1−33 years), received Painshield on prescription. Diagnoses included endometriosis (26%), adhesions (63%), bowel obstruction (42%), IBS (32%), Interstital Cystitis (32%) or other CPP (63%). Patients provided information about their symptoms before treatment and up to 51.4 days (range 1−207) afterwards. Scoring was based on the Brief Pain Inventory, Short−Form McGill Questionnaire, and the International Pelvic Pain Society’s form. Scores from before and after treatment were compared by t test comparison of rankings of levels (0−10) of each type of pain using the maximum score reported.
Results: Often exceeding or approaching statistical significance, improvements in pain or related symptoms were noted (before treatment score v. after treatment score, N, p) for all symptoms which were pain before urination (6.1 v. 4.3, N=12, p=0.021); pain on urination (6.0 v. 2.0, N=7, p=0.001); urinary urgency (% of time) (100% v. 54%, N=6, p=0.06); urination frequency/day (21 v. 14, N=11); difficulty urinating (% of time) (100% vs 60%, N=8, p=0.08); Other chronic pelvic or abdominal pain (8.3 vs 5.9, N=12, p=0.042); dyspareunia (during) (7.8 v. 5.5, N=12); dyspareunia (after) (6.6 v. 4.3, N=8); dyschezia (7.7 v. 3.6; N=10, p=0.001); abdominal bloating (% of time) (83% vs 53%, N=10, p=0.049); rectal pain (9.3 v. 6.0, N=4); sacroiliac joint pain (8.5 v. 6.5, N=6, p=0.081); sitting tolerance (minutes) (36 v. 91 mins, N=12); other muscle/joint pain (7.4 v. 5.2, N=18, p=0.03).
Patients often reported the onset of relief within hours or days after starting treatment and a reduced need for analgesic or other medication. Overall patients rated their response as Negative (2/19), Mild (4/19), Moderate (3/19) or Good (10/19). The two patients responding negatively reported a rapid onset (< 1 day) of pain and/or swelling which subsided from 1 to several days later. One patient responding well experienced some abdominal discomfort after using the device. Two of these patients reported similar reactions to conventional office−based ultrasound.
Conclusion: Further evaluation of the utility of PainShield in this patient population is warranted.
Summary: PainShield, a portable, wearable ultrasound device was found to reduce pelvic, urological pain and related symptoms in 19 patients presenting with long−standing and refractory symptoms.
Keywords; Pain, pelvic, ultrasound, bladder, rectal
We thank Nanovibronix for providing PainShield units at no cost. At the time of the study, neither author had a financial interest. Since concluding the study, the primary author's company has become a distributor for PainShield. ___________________________________
We have now followed up patients using PainShield MD for 17 months, with excellent results as documented in the clinical study below, which was presented at the Annual Meeting of the International Pelvic Pain Society in Orlando, FL Oct. 17-19, 2013.
"Reduction of Chronic Pelvic, Urological and GI Pain Using Wearable Therapeutic Ultrasound in Women with Extended Follow-Up to 17 Months"
see press release here
David Wiseman, BSc, PhD, MRPharmS and Teena Petree, PT
International Adhesions Society; Summit Physical Therapy, Dallas, TX
Click on one of the thumbnails above for latest clinical data.
Objective: To assess the efficacy of a wearable low−frequency, low intensity ultrasound device in treating pelvic and related pain up to 17 months.
Methods: In this open−label, prospective study, 16 women (age 47, 33−62) diagnosed with endometriosis (31%), adhesions (69%), bowel obstruction (44%), IBS (31%), interstitial cystitis (25%) other CPP (63%) or prior hysterectomy (69%) were treated for pain using PainShield®MD (NanoVibronix, Nesher, Israel). These patients were part of a cohort that included 3 male patients previously followed up to 207 days. Worst, Least and Average scores (0-10) from before and up to 190 days (1−541) after treatment were compared by the Wilcoxon Signed Rank test.
Results: Improvements (* p<0.05) were noted in most scores for Worst (W), Least (L) and Average (A) pain (median before/after treatment) for dysuria (n=6), (W=4.5/2.0*; L=0.0/0.0; A=2.5/1.0*); pain on full bladder (n=10), (W=5.0/3.0; L=2.5/0.0*; A=4.5/1.0*); pelvic or abdominal pain (n=10), (W=9.5/6.5*; L=2.0/0.0; A=5.5/3.0*); dypareunia, during (n=11), (W=10.0/5.0*; L=2.0/2.0; A=4.0/3.0); dyspareunia, after (n=8), (W=7.0/2.5*; L=1.0/0.5; A=4.5/1.5*); dyschezia (n=8), (W=7.0/3.5*; L=0.0/0.0; A=3.0/2.0*); rectal pain (n=3), (W=10.0/6.0; L=3.0/0.0; A=6.0/3.0); SI Joint pain (n=10), (W=9.5/7.5*; L=3.0/0.5*; A=6.0/3.0*); sitting pain (n=10), (W=8.5/8.0; L=1.0/1.5; A=4.5/5.0); other musculoskeletal pain (n=13), (W=8.0/5.5*; L=2.0/1.0; A=6.0/5.0).
Reductions in the % of time (before/after) with pain (Student’s t test) were also noted for pain on full bladder (83/38*), dysuria (78/41), pelvic or abdominal pain (84/61**), dyspareunia, during (92/68), dyspareunia, after (100/70*), dyschezia (84/52**), rectal pain (53/18), SI Joint pain (87/48*), other musculoskeletal (77/63).
Onset of relief was reported to within hours or days after starting treatment often with a reduced need for analgesic or other medication. Overall patients rated their response as Negative (1/16), Mild (4/16), Moderate (2/16) or Good (9/16). The one patient responding negatively reported a rapid onset (< 1 day) of pain which rapidly subsided. One patient responding well reported abdominal discomfort. Both patients reported similar reactions to conventional ultrasound.
Conclusions: These findings extend those described previously in this cohort from up to 207, now to 541 days of treatment, confirming the utility of PainShield MD in treating painful pelvic, urological and GI pain in patients with long−standing and refractory disease.
The reduction of pelvic, urological and GI pain by PainShield MD, a wearable ultrasound device, persisted in this follow-up to 541 days in 16 women with long-standing and refractory symptoms.
Key words: Pain, pelvic, ultrasound, bladder, rectal
At the time of the study, neither author had a financial interest. Subsequently, the primary author has established a company (KevMed, LLC) to distribute this device.
This study was also presented at the annual meeting of AAGL, Washington DC, November 13 2013.