Clinical Studies for Spinal Decompression System DRX9000™ - Manufactured by Axiom Worldwide, USA

G.N. Minukov, E.V. Vorobiev. Clinical Studies for Spinal Decompression System DRX9000™ - Manufactured by Axiom Worldwide, USA. Conducted in the Neurology Unit of Municipal Clinical Hospital, May 13, 2006 - July 24, 2006. Clinical trial report (act), English version.

The English version was published by the manufacturer of the DRX9000 at the time, Axiom Worldwide (Tampa, Florida, USA), as an undated brochure; the text below is reproduced from that brochure as redistributed by Excite Medical (PDF, 2011). No journal publication, DOI, or PubMed record of the report was found.

G.N. Minukov, Manager of Neurology Unit; E.V. Vorobiev, Doctor of Neurology Unit.

No copyright or licence notice is printed on the document.

Reproduced as published in English. The Russian and Ukrainian versions on this site are translations of this English text, because the Russian original is not available.

Introduction: Clinical studies for spinal decompression system DRX9000™, manufactured by Axiom Worldwide, were conducted in the neurology unit of Municipal Clinical Hospital № 40 between May 13, 2006 and July, 24 2006.

Contests of the ACT: The DRX9000™ was utilized for the treatment of patients with herniated discs L5-S1 (15 patients), L4-L5 (4 patients) and L3-L4 (2 patients).

Conclusion: The DRX9000™ due to its functionality does not have domestic analogues and considerably exceeds all other devices developed for spinal decompression. The expressed positive clinical effects and tomographic images were demonstrated during treatment of the majority of patients diagnosed with disc herniations at the L5-S1 spinal level. The DRX9000™ spinal decompression system, manufactured by Axiom Worldwide, USA, has sustained clinical trials. We have no negative remarks on the DRX9000™.

Recommendations: Based on the results of clinical trials, the DRX9000™, manufactured by Axiom Worldwide, USA, can be recommended for use in medical practice in the Russian Federation.

• Clinical studies for spinal decompression system DRX9000™, manufactured by Axiom Worldwide, were conducted in the neurology unit of Municipal Clinical Hospital № 40 between May 13, 2006 and July, 24 2006.
• Objective – evaluate possibilities of using spinal decompression system DRX9000™, manufactured by Axiom Worldwide, USA in medical institutions in Russian Federation.
• Ground for clinical studies:
  • Assignment № 294-05/652Ф-06 dated 04/13/06 from Department of registration of foreign medical devices.
  • Protocol of studies № 574p/37.1 dated 05/03/06 from Testing Center of medical devices ФГУ “ВНИИИМТ”.
• The following were present to conduct clinical studies:
  • Spinal Decompression System DRX9000, manufactured by Axiom Worldwide, USA.
  • Complete package of the technical documentation and user manual.

• DRX9000™ was utilized for the treatment of patients with herniated discs L5-S1 (15 patients), L4-L5 (4 patients) and L3-L4 (2 patients).
• There were a total of twenty-one patients, fourteen males and seven females.
• Patients ranged in age from twenty-nine to seventy-five years.
• Sixteen of the cases were conducted following the standard six week course of treatment, which was recommended in the user’s manual.
• Five cases were conducted following an individual four week course of treatment due to health improvement and subsequent discharge from the hospital.
• The standard six week course of therapy consisted of five treatments per week for two weeks, three treatments per week for two weeks and two treatments per week for two weeks.
• Twenty treatments were rendered.
• The individual four week course of therapy consisted of five treatments per week for two weeks, three treatments per week for one week and two treatments per week for one week.
• Treatment duration is 35-40 minutes.
• The majority of patients on the first day received an initial decompression treatment set at four kilograms less than half body weight.
• Intensity on the second day of treatment equaled half body weight.
• Increases of two to four kilograms were introduced at each subsequent visit ultimately resulting in an intensity of half body weight plus four to eight kilograms.
• After each treatment, the patient received physiotherapeutic procedures in the form of cold packs and sinusoidal modulated current (80-120 Hz) therapy using system “Amplipulse” (“Амплипульс”).
• Patients demonstrating positive outcomes after ten treatments were assigned physical therapy as well.

The DRX9000™ due to its functionality does not have domestic analogues and considerably exceeds all other devices developed for spinal decompression.

The expressed positive clinical effects and tomographic images were demonstrated during treatment of the majority of patients diagnosed with disc herniations at the L5-S1 spinal level. Thirteen of the twenty-one patients suffered from significant herniations (more that 6 mm) with severe pain syndromes. Only one patient treated on the DRX9000™ was referred for surgical correction. Patients reported a reduction and/or disappearance of both low back and extremity pain, restored sensibility, an increase in physical activity, improved sleep and overall health. There were no complications reported during or after spinal decompression sessions on the DRX9000™. Standard inclusion and exclusion criteria were followed.

Technical advantages of the DRX9000™ include the ability to target the affected spinal segment and a computer monitoring system that ensures the accuracy and efficacy of treatment. Functionality of the system is good. The system is simply installed and connected and is comfortable for the patient. The DRX performed consistently during all tests without any mechanical faults or cosmetic damage. The external surface of the system is tolerant to detergents.

Operating principles and procedures for DRX9000™ are in detail and fully described in the user’s manual, as well as technical characteristics, standard treatment protocol and safety precautions. The DRX9000™ complies with modern requirements of medical equipment for neurology and physiotherapeutic units. The DRX9000™ spinal decompression system, manufactured by Axiom Worldwide, USA, has sustained clinical trials. We have no negative remarks on the DRX9000™.

• Based on the results of clinical trials, the DRX9000™, manufactured by Axiom Worldwide, USA, can be recommended for use in medical practice in the Russian Federation.