PainShield MD is an innovative treatment for pelvic and abdominal pain

including pain associated with the:
  • bladder
  • sacroiliac joint
  • genitalia
  • pelvic floor
  • lower gastrointestinal system

and pain associated with conditions such as:

  • Adhesions and Adhesions Related Disorder (ARD)
  • Chronic Pelvic Pain (CPP)
  • Complex Abdomino-Pelvic and Pain Syndrome (CAPPS)
  • Endometriosis
  • Interstitial Cystitis (IC)/ Painful Bladder Syndrome
 
  • Sacroilac joint pain (SI Joint)
  • Pelvic Floor Disorder
  • Pudendal Neuralgia
  • Fibromyalgia
  • Irritable Bowel Syndrome (IBS)
Chronic Pelvic Pain is frequently associated with one or more of the above conditions (1,2) and may be relieved by therapies that help reduce muscle spasm (3-5). PainShield® MD uses this principle.
PainShield MD has also been shown to alleviate the pain of trigeminal neuralgia and other pain conditions described here.

In a clinical study (see below) involving 19 patients with severe chronic pelvic pain, interstitial cystitis or other conditions, PainShield MD significantly (p<0.05) reduced:
  • 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)
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References

1. 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.

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"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)

David Wiseman, BSc, PhD, MRPharmS and Teena Petree, PT.
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.

Objective: To assess the efficacy of Painshield (NanoVibronix Ltd., Nesher, Israel) a wearable device delivering low−frequency, low intensity ultrasound in patients with pelvic and related pain.

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 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.

Summary
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.

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"Strategies for Treating Chronic Pelvic, Urological and GI Pain Using Wearable Therapeutic Ultrasound"

(presented at the Annual Meeting of the International Pelvic Pain Society Meeting, Chicago, Oct. 23-26, 2014, Poster 6)

David Wiseman, BSc, PhD, MRPharmS, KevMed LLC, Addison, TX


Click on the thumbnail above to view the poster with latest clinical data.

Summary
PainShield® MD, a wearable ultrasound device, has now been used for over four years to treat chronic pelvic, urological, neurological and GI pain. Several treatment strategies have emerged to optimize clinical outcome.

Objective
To describe strategies for treating chronic pelvic, urological, neurological and GI pain using wearable therapeutic ultrasound.

Methods
Patients:   Patients undergoing treatment with PainShield MD for chronic pelvic, urological, neurological and GI pain.
Diagnoses:  Adhesions, bowel obstruction, endometriosis, IBS, interstitial cystitis/ bladder pain, chronic pelvic pain,  pudendal or other neuralgia, sacroiliac joint pain.
Treatment:  Treatment consists of wearing a patch-mounted ultrasound transducer for 1-2 sessions/day. Each session consists of 13 alternating periods (30 minutes) of active and inactive ultrasound energy delivery. 
Ultrasound: Frequency: Low frequency - 90kHz; Power: Low intensity - 0.4W (70mW/cm2) ;Wave type: Surface acoustic wave
Energy Transfer: < 4 cm below the surface with radius of ~ 10 cm
Strategy Capture: Interviews were conducted with patients using PainShield MD regarding their pattern of use of the device. General descriptive strategic outlines were drafted.

Patient Selection

History of chronic pelvic, urological, GI or related pain with:
- Suspected pelvic floor dysfunction and muscle spasm
- No or little response to other treatment
- Exclusion of other addressable causes from full-work up
- Side effects from opioid use 

Consider especially candidates for:                                              
- Neurostimulator implant
- Nerve block or ablation
- Opioid therapy
- Hysterectomy for pain
- Adhesiolysis only for pain
- Other invasive procedure for pain 

Exclusions and Precautions
- Ultrasound is contraindicated in patients with InterStim® neurostimulators. Consult labelling for similar devices.
- Use with caution near meshes, IUDs and other implants
- Review other contraindications and precautions 

Particularly good candidates may be those who:
- Respond to physical therapy but with relapse between visits
- Respond to non-wearable ultrasound
- Obtain some relief from heating packs or warm baths
- Use the device in the context of multidisciplinary treatment
- Have poor access to specialized physical therapy 

Placement Strategies

                   

1. Place over or close to painful area
2. Place proximal along innervation path (S3, L4, L5, side or central)
3. Place on muscles in spasm (with advice of PT)
4. Place along referral pathway
5. In allodynia, mask adhesive & fix with self adherent bandage

Timing Strategies

1. Aim to keep muscles out of spasm: Start soon after successful PT
2. Begin treatment 1-2 hours before onset of pain if predictable, e.g.
   - pain always/usually occurs around 10 pm 
   - pain always/usually occurs when eating
   - pain always/usually occurs at time of regular bowel movement
   - pain always/usually occurs during car journey  
3. Apply after intercourse or when an “aura” signals a flare-up

Frequency of Use

1. Use for up to two sessions (6.5 hours each) per 24 hour period
2. Once effect occurs, taper frequency & treatment length appropriately
3. Relief usually extends beyond session time

Optimization

1. During optimization period, focus on one area at a time for 2-3 days.
2. Onset of relief: within hours to 14 days for ~90% of responders. Approximately 75-80% patients respond to treatment.

Patient Monitoring

1. Monitor patient progress, preferably using a pain diary – a free diary is available at: www.kevmed.com/PainDiary.html
2. For patients responding to treatment, taper down opioids and other medications under supervision
3. Counsel responsive patients to increase level of physical activity gradually and under medical / PT supervision
4. Advise patients to report unusual symptoms such as swelling, or redness that is more than transient, and to stop using device
5. A few patients, especially those with a neuropathic component, report “burning” or “painful” sensations on first use. If this occurs, reduce the session length or distance the patch from the original site until these sensations do not occur. Gradually increase session time, or patch proximity to the original site.

Conclusion

Using the strategies described, PainShield MD wearable ultrasound can be integrated into almost any program to treat chronic pelvic and related pain.

Disclosure

KevMed, LLC. distributes PainShield MD.

Acknowledgement

We thank the many patients whose experiences have contributed to this work.