Tennis Elbow Treatment
Shock Waves for Pain Relief of Tennis Elbow

“Tennis elbow” or lateral epicondylitis is a painful disorder caused by overstress of muscle tendon attachments to the bone (epicondyle). It produces symptoms of pain with wrist and finger extension and with gripping at the outside of the elbow or forearm.

Treatment requires medical attention as soon as the symptoms appear. Early attention usually prevents the development of a serious disorder.

Early treatment options include:

• Rest from excessive or abusive activity.
• Heat or cold applications.
• Braces or splints.
• Physical conditioning exercises.
• Physical/occupational therapy including ultrasound.
• Over-the-counter pain reliever.
• Prescription pain relievers.
• Non-steroidal anti-inflammatory medications.
• Physiotherapy, rehabilitation.

Chronic cases of tennis elbow are treated with:

• Steroid injections.
• Sonocur® Basic Treatment.
• Surgery (rarely needed).

Sonorex Inc. - ESWT
Sonorex Inc. has a medical device, Sonocur® Basic, to treat and relieve pain associated with tendonitis. This innovative, low energy shock wave treatment has provided pain relief to thousands of patients treated in Europe and Canada and now has FDA approval in the United States for treating lateral epicondylitis. The Sonocur® Basic device is an ESWT system. Extracorporeal Shock Wave Therapy uses low energy shock waves that are applied to the outside of the body.

How it Works. 
The Sonocur Device is a sophisticated Extracorporeal Shockwave Therapy device in which a shock wave is generated at the base of the shock tube by an electromagnetic acoustic source. When a voltage pulse from a capacitor reaches an aluminum membrane, the membrane is repelled causing a shock wave to course through a water filled generator. The shock wave moves through the water into an acoustic lens. The lens then focuses the energy of the shockwave on a concentrated point a fixed distance from the lens.

Interaction
The Sonocur® administers a wide range of low energy shock waves , which allow for anesthesia free treatment. The articulating head of the Sonocur® machine is placed onto the area where the patient feels pain and fine adjustment are made to the area of therapeutic focus (point of maximal focus).

The treatment consists of initiating a preset number of pulses or shock waves. As the treatment progresses, a trained technician will graduate the energy level to therapeutic levels. By gradually increasing the intensity of the shock waves instead of immediately establishing the best level for therapy, the patient can experience the hyperstimluation analgesia effect.  This effect allows the patient to experience minimal increase in pain during the procedure.

Effects
Even though shockwaves have been clinically employed for 20 years, their effects are not precisely known. Generally, the following phases of tissue effects have been postulated:

• Physical Phase. Extracellular cavitations, ionized molecules and an increase of membrane permeability are direct effects of the shock waves.
• Subsequent Physical / Chemical Phase. Diffusible radicals and interactions with biomolecules (in both phases, mitochondrial lesions have been observed with electronmicroscopy).
• Chemical Phase: Intracellular reactions and molecular changes.
• Biological Phase: What occurs in tissues when these changes persist.

Result
The effective result of this graduated program of Extracorporeal Shockwave Therapy (extracorporeal shock wave therapy) is a change in the physical, chemical and biological composition of the soft tissue. Researchers have hypothesized that the treatment causes the following changes:

• Extracorporeal Shockwave Therapy causes physical changes in the cell membrane of nerves inhibiting the sensation of pain.
• Shock waves cause chemical alteration and/or formation of chemical compounds in the affected area resulting in a reduction of painful stimuli.
• Hyperstimulation analgesia occurs when low energy shock waves stimulate nerves through a complicated pathway eventually inhibiting pain transmission. This effect allow the patient to experience minimal increase in pain during the procedure.
• Neovascularization: Shock waves focused by the Extracorporeal Shockwave Therapy therapy device induce increased blood supply in the treated area.

Who should have Sonocur® Basic Lateral Treatment?

• Anyone with 6 months of lateral elbow pain that has been resistant to conservative treatment.
• No relief after 4 weeks of physical/ occupational therapy.
• No relief after 4 weeks of non-steroidial anti-inflammatory medications.
• No relief from steroid injections.

Who should not have Sonocur® Basic Treatment?

• No known contraindications or reasons not to perform this treatment have been identified.

What else should I consider about Sonocur® Basic Treatment?

• Patients with tennis elbow affecting both arms at the same time or who have had previous surgeries have not been studied.

The safety and effectiveness of the Sonocur® Basic Treatment has not been established for several conditions:

• Pregnant women.
• Patients younger than 18 years old.
• Patients with:
  • Coagulation abnormalities.
  • Thrombopathy.
  • Infection.
  • Tumor.
  • Cervical Compression Syndrome.
  • Cervical or upper extremity arthritis.
  • Local arthrosis.
  • Neurological Abnormalities.
  • Radial nerve entrapment.
• Previous tennis elbow surgery.
• Patients who suffer from severe systemic diseases.
• Patients with a cardiac pacemaker.
• Patients who received physical or occupational therapy less than 4 weeks prior to Sonocur® Basic Treatment.
• Patients who received a local steroid injection less than 6 weeks prior to Sonocur® Basic Treatment.
• Patients with tennis elbow affecting both elbows or who have had previous elbow surgery.

What happens during the Sonocur® Basic Treatment?

1. No aspirin and/or anti-inflammatory medications are to be taken one week before your scheduled treatment.
2. You may eat and drink normally.
3. You will be treated sitting in a chair or lying down with your arm supported.
4. The elbow will be examined to locate the exact point that is the most painful.
5. A gel, which helps with the transmission of the shock waves, will be applied to the located painful site.
6. The Sonocur® Basic treatment head will be placed on the area to which the gel was applied.
7. Shock wave application will begin at very low energy levels with small increases in the energy. You will be repeatedly asked if this is the location of your maximum pain. The Sonocur® Basic treatment head will be adjusted accordingly.
8. At this point you may feel mild stinging sensation and pressure from the Sonocur® Basic treatment head applied to your painful area.
9. A single session usually takes about 10-15 minutes. Treatment is usually given over three sessions approximately one week apart.
10. After the treatment, the technician will remove the gel and you are free to go. Usually you may return to normal activities. You will be informed of any restrictions.
11. You may feel some aching after the treatment for a short period of time.
12. You will be able to drive yourself home.
13. You may notice a reddened skin at the treatment site. Some patients will have a few small pinpoint bleeding or bruises on the skin. These should resolve within a few days after the final treatment.

What are the Post Treatment Instructions?
Sonocur® Basic ESWT is designed to give you optimal treatment for your painful elbow. Medical studies have found that for most conditions, a majority of those treated will have significant relief of their pain. Many will find they are much better immediately after the treatment while others may not get the maximum benefit until 12 weeks after their last session. In order to maximize the possibility of successful treatment, you should do the following:

• Complete all prescribed treatments.
• Continue any medications, therapy, stretching, home exercises, etc..
• Although there are no specific limitations on your activities, you should avoid activities that make the pain worse for 30-60 days. The time before resuming full activities will vary with your particular situation, your speed of rehabilitation and the level of conditioning.
• Return to Dr. Rogerson’s office as scheduled.

Sonocur® Basic ESWT has minimal side effects or complications. You may notice a reddened area or superficial discoloration of the skin of the treated area. Some may have mild tingling or a dull ache for a short period of time. If pain is troublesome Dr. Rogerson may instruct you to do the following:

• Ice, 15-20 minutes, twice daily.
• Take an over-the-counter anti-inflammatory medication.

Other than indicated above, treatment imposes no limitations on your activities. You may eat, drink, drive, work or go about any of the normal activities that you performed prior to your treatment.

What adverse effects could happen with Sonocur® Basic Treatment?
The following effects were observed during the clinical trials:

• Pain during and immediately after treatment.
• Nausea was the second most commonly reported side effect.
• May cause sweating, dizziness, tremor, paleness and temporarily widen blood vessels. Most reported events were mild and subsided within 24 hours without any further treatment.
• May cause skin reddening or bruising.
• May cause muscle pain and/or muscle tension. The reported side effects included muscle, forearm and wrist soreness, cramps and spasms. Most of these side effects were mild and disappeared within 48 hours of the treatment, without any further treatment.
• May cause joint stiffness that disappeared within 48 hours requiring no further treatment.
• Some patients reported numbness and tingling sensations, most of which radiated down from the elbow to the wrist. The majority of these sensations subsided without treatment.
• Potential adverse events not seen during the study include problems with the nervous system, tendon tearing, bruising, and/or misdirection energy.

What are the advantages to Sonocur® Basic Treatment?

• 75-90% success rate.
• Significantly reduced pain.
• Improved functional activity.
• Improved specific daily activity functions.
• Is covered by most insurance companies.
• Does not require a hospital visit.
• No incisions in the skin.
• No anesthesia or other medications.
• A cost effective outpatient procedure.

If you have chronic elbow pain that is disrupting your life, please contact us for help. Our goal in treating your elbow pain is getting you back to your level of activity as quickly as possible!

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3/1/2006

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