San Diego - NonSurgical Back Pain Treatment DRX9000 Research Report

The outcome of a clinical study evaluating the effect of nonsurgical intervention on symptoms of spine patients with herniated and degenerative disc disease is presented.

Study performed to evaluate the effect of spinal decompression on symptoms of patients with herniated and degenerative disc disease -- Part 1

PART 2
METHODS

The study group included 229 people, randomly chosen from 500 patients who had symptoms associated with herniated and degenerative disc disease that had been ongoing for at least 4 weeks. Inclusion criteria included pain due to herniated and bulging lumbar discs that is more than 4 weeks old, or persistent pain from degenerated discs not responding to 4 weeks of conservative therapy. All patients had to be available for 4 weeks of treatment protocol, be at least 18 years of age, and have an MRI within 6 months. Those patients who had previous back surgery were excluded. Of note, 73 of the patients had experienced one to three epidural injections prior to this episode of back pain and 22 of those patients had epidurals for their current condition. Measurements were taken before the treatments began and again at week two, four, six, and 90 days post treatment. At each testing point a questionnaire and physical examination were performed without prior documentation present in order to avoid bias. Testing included the Oswetry questionnaire, which was utilized to quantify information related to measurement of symptoms and functional status. Ten categories of questions about everyday activities were asked prior to the first session and again after treatment and 30 days following the last treatment.

Testing also consisted of a modified physical examination, including evaluation of reflexes (normal, sluggish, or absent), gait evaluation, the presence of kyphosis, and a straight leg raising test (radiating pain into the lower back and leg was categorized when raising the leg over 30 degrees or less is considered positive, but if pain remained isolated in the lower back, it was considered negative). Lumbar range of motion was measured with an ergonometer. Limitations ranging from normal to over 15 degrees in flexion and over 10 degrees in rotation and extension were positive findings. The investigator used pinprick and soft touch to determine the presence of gross sensory deficit in the lower extremities.

Of the 229 patients selected, only 10 patients did not complete the treatment protocol. Reasons for noncompletion included transportation issues, family emergencies, scheduling conflicts, lack of motivation, and transient discomfort. The patient protocol provided for 20 treatments of spinal decompression over a 6-week course of therapy. Each session consisted of a 45-minute treatment on the equipment followed by 15 minutes of ice and interferential frequency therapy to consolidate the lumbar paravertebral muscles. The patient regimen included 2 weeks of daily spinal decompression treatment (5 days per week), followed by three sessions per week for 2 weeks, concluding with two sessions per week for the remaining 2 weeks of therapy.

On the first day of treatment, the applied pressure was measured as one half of the person’s body weight minus 10 pounds, followed on the second day with one half of the person’s body weight. The pressure placed for the remainder of the 18 sessions was equivalent to one half of the patient’s body weight plus an additional 10 pounds. The angle of treatment was set according to manufacturer’s protocol after identifying a specific lumbar disc correlated with MRI findings. A

>patient being fitted with a customized lower and upper harness to fit their specific body frame. The patient would step onto a platform located at the base of the equipment, which simultaneously calculated body weight and determined proper treatment pressure. The patient was then lowered into the supine position, where the investigator would align the split of table with the top of the patient’s iliac crest. A pneumatic air pump was used to automatically increase lordosis of the lumbar spine for patient comfort. The patient’s chest harness was attached and tightened to the table. An automatic shoulder support system tightened and affixed the patient’s upper body. A knee pillow was placed to maintain slight flexion of the knees. With use of the previously calculated treatment pressures, spinal decompression was then applied. After treatment, the patient received 15 minutes of interferential frequency (80 to 120 Hz) therapy and cold packs to consolidate paravertebral muscles.

During the initial 2 weeks of treatment, the patients were instructed to wear lumbar support belts and limit activities, and were placed on light duty at work. In addition, they were prescribed a nonsteroidal, to be taken 1 hour before therapy and at bedtime during the first 2 weeks of treatment. After the second week of treatment, medication was decreased and moderate activity was permitted.

Data was collected from 219 patients treated during this clinical study. Study demographics consisted of 79 female and 140 male patients. The patients treated ranged from 24 to 74 years of age (see Table 1). The average weight of the females was 146 pounds and the average weight of the men was 195 pounds. According to the Oswestry Pain Scale, patients reported their symptoms ranging from no pain (0) to severe pain (5).

PATIENT GROUPS

The patients were further subdivided into six groups:

single lateral herniation 67 cases
single central herniation 22 cases
single lateral herniation with disc degeneration 32 cases
single central herniation with disc degeneration. 24 cases
more than 1 herniation with disc degeneration 17 cases
more than 1 herniation without disc degeneration 57 cases

RESULTS

According to the self-rated Oswestry Pain Scale, treatment was successful in 188 of the 219 patients included in this study (Table 2). Treatment success was defined by a reduction in pain to 0 or 1 on the pain scale. The perception of pain was none 0 to occasional 1 without any further need for medication or treatment in 188 patients. These patients reported complete resolution of pain, lumbar range of motion was normalized, and there was recovery of any sensory or motor loss. The remaining 31 patients reported significant pain and disability, despite some improvement in their overall pain and disability score.

Diagnosis MRI
Findings No. of CaseS Female Patients Male Patients Positive Result No Result % of Success

Single Herniation Lateral 67 26 41 63 4 94

Single Herniation Central 22 11 11 20 2 90

Single Herniation w/ Degeneration 24 5 19 24 0 100

Single Herniation Lateral w/ Degeneration 32 14 18 29 3 91

Multiple Herniations w/o Degeneration 57 21 36 39 18 68

Multiple Herniations w/ Degeneration 17 2 15 13 4 77

TOTAL 219 79 140 188 31 86

Table 2. Results on self-rated Oswestry Pain Scale after treatment.

In this study, only patients diagnosed with herniated and degenerative discs with at least a 4week onset were eligible. Each patient’s diagnosis was confirmed by MRI findings. All selected patients reported 3 to 5 on the pain scale with radiating neuritis into the lower extremities. By the second week of treatment, 77% of patients had a greater than 50% resolution of low back pain. Subsequent orthopedic examinations demonstrated that an increase in spinal range of motion directly correlated with an improvement in straight leg raises and reflex response. Table 2 shows a summary of the subjective findings obtained during this study by category and total results post treatment. After 90 days, only five patients (2%) were found to have relapsed from the initial treatment program.

Diagnosis MRI Findings Improved Gait Sluggish to Normal Reflexes Improved Sensory Reception Improved Motor Limitation Abnormal to Normal Straight Leg Raise Test Improved Spinal Range of Motion

Single Herniation Lateral 98% 98% 96% 90% 92% 95%

Single Herniation Central 100% 100% 94% 92% 96% 90%

Single Herniation w/ Degeneration 99% 96% 90% 84% 94% 90%

Single Herniation Lateral w/ Degeneration 94% 97% 94% 88% 90% 92%

Multiple Herniations w/o Degeneration 96% 94% 94% 81% 82% 92%

Multiple Herniations w/ Degeneration 92% 94% 88% 82% 80% 82%

AVERAGE IMPROVEMENT 96% 96% 93% 86% 89% 90%

Table 3. Percentage of patients that had improved physical exam findings post treatment.

Ninety-two percent of patients with abnormal physical findings improved post-treatment. Ninety days later only 3% of these patients had abnormal findings. Table 3 summarizes the percentage of patients that showed improvement in physician examination findings testing both motor and sensory system function after treatment. Gait improved in 96% of the individuals who started with an abnormal gait, while 96% of those with sluggish reflexes normalized. Sensory perception improved in 93% of the patients, motor limitation diminished in 86%, 89% had a normal straight leg raise test who initially tested abnormal, and 90% showed improvement in their spinal range of motion.

SUMMARY

In conclusion, nonsurgical spinal decompression provides a method for physicians to properly apply and direct the decompressive force necessary to effectively treat discogenic disease. With the biotechnological advances of spinal decompression, symptoms were restored by subjective report of patients previously thought to be surgical candidates and mechanical function was restored in 92% using objective data. Ninety days after treatment only 2% reported pain and 3% relapsed, by physical examination exhibiting motor limitations and decreased spinal range of motion. Our results indicate that in treating 219 patients with MRI-documented disc herniation and degenerative disc diseases, treatment was successful as defined by: pain reduction; reduction in use of pain medications; normalization of range of motion, reflex, and gait; and recovery of sensory or motor loss. Biotechnological advances of spinal decompression indeed reveal promising results for the future of effective management of patients with disc herniation and degenerative disc diseases. The cost for successful nonsurgical therapy is less than a tenth of that for surgery. Long-term outcome studies are needed to determine if nonsurgical treatment prevents later surgery or merely delays it.

Thomas A. Gionis, MD, JD, MBA, MHA, FICS, FRCS, is chairman of the American Board of Healthcare Law and Medicine, Chicago; a diplomate professor of surgery, American Academy of Neurological and Orthopaedic Surgeons; and a fellow of the International College of Surgeons and the Royal College of Surgeons.

Eric Groteke, DC, CCIC, is a chiropractor and is certified in manipulation under anesthesia. He is also a chiropractic insurance consultant, a certified independent chiropractic examiner, and a certified chiropractic insurance consultant. Groteke maintains chiropractic centers in northeastern Pennsylvania, in Stroudsburg, Scranton, and Wilkes-Barre.

REFERENCES

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Spinal Decompression Report - Part 2

By Thomas A. Gionis, MD, JD, MBA, MHA, FICS, FRCS, and Eric Groteke, DC, CCIC

METHODS

PATIENT GROUPS

RESULTS

SUMMARY

REFERENCES