аппликатор

CLINICAL TRIALS

Central Clinical Military Hospital of the Federal Security Service of the Russian Federation.
Ministry of Health of the Russian Federation.
Committee on new medical equipment.
Russian Academy of Medical Sciences. Scientific Center for Children's Health MMSI named after N.A. Semashko, Department of Physiotherapy RSMU named after Pirogov.
Department of Neurology and Neurosurgery SCIENTIFIC CENTER FOR CHILDREN'S HEALTH RAMN: SURFACE REFLECTOR THERAPY OF CEPHALGIA TENSION IN CHILDREN (Manual for doctors). Central Clinical Military Hospital of the Federal Security Service of the Russian Federation.
APPROVE: Head of the Central Committee of the Federal Security Service of the Russian Federation, Major General of the Medical Service Kruglov A.G. Protocol of clinical trials of the applicator for surface reflector therapy manufactured by UIISR "Signum" CJSC "MAP Ltd".

Reason: Recommendation of the expert specialized commission on instruments and devices used for express diagnostics of the functional state of the body according to the physiological parameters of reflexogenic zones and biologically active points and reflexotherapy on zones and BAP of the Committee on New Medical Technology of the Ministry of Health of the Russian Federation on conducting clinical trials.
Medical tests of the application for superficial reflex therapy were carried out in the reflexology room of the physiotherapy department of the Central Committee of the Federal Security Service of the Russian Federation.

  1. Products:
    • Applicators for superficial reflex therapy "Prickly healer" for individual use in the amount of 20 pieces.
  2. Documentation:
    • Protocol of toxicological, sanitary-chemical tests, tests for sterility, pyrogenicity of medical devices (materials) establishing their chemical and biological safety No. 3547 dated 19.04.1999. Test laboratory "Toxicologist" VNIIIMT.
    • Manual.

The applicator for surface reflex therapy is a flexible dielectric plate with metal needles fixed on it with a pitch of 5 mm, made in the form of U-shaped brackets, the transverse base of which is pressed into the plate. The applicator is designed to influence the reflex zones of the human skin surface. The choice of reflex zones for treatment is carried out taking into account the symptoms and techniques used in reflexology. Medical tests were carried out in hospital. 15 patients (10 women and 5 men) aged 37 to 69 years (average age 50 years) with spinal pain syndrome of various localization, spinal osteochondrosis (6 patients), cerebrovascular disease (3 patients), pneumonia (1 patient), vegetative vascular dystonia (3 patients), facial neuropathy (1 patient), coronary heart disease (1 patient) were selected for treatment. Therapeutic applications areas and exposure time were chosen by the doctor in accordance with symptoms and methods of reflexology. All patients underwent therapeutic applications under the supervision of medical personnel in the amount of 5 to 18 times (average 9 applications). For each patient the applicator was individual and disinfected by soaking in a 3% hydrogen peroxide solution with detergent. The swabs taken after disinfection did not reveal the presence of the bacteria group of Escherichia coli and Staphylococcus aureus. All patients tolerated therapeutic applications well, no injuries or inflammatory changes on the skin were noted. The therapeutic effect of the application consisted in analgesic, sedative and expectorant effects.

Conclusion: The applicator for surface reflexology produced by CJSC UIISR "Signum" can be recommended by the commission on devices used for express diagnostics of the functional state of the body according to the physiological parameters of reflexogenic zones and biologically active points and reflexotherapy on zones and BAT of the Committee on New Medical Equipment of the Ministry of Health of the Russian Federation to solve the issue of serial production. The tests were conducted by the candidate of medical sciences Petrova N.N. Ministry of Health of the Russian Federation.

Committee on New Medical Technology.

Extract from the protocol of the Commission on devices used in physiotherapy. The Commission recommends for industrial production and for use in medical practice an applicator "Prickly Healer" made of metal needles for superficial reflex therapy.

Chairman of the Commission, Professor Efanov O.I.

Russian Academy of Medical Sciences.

Scientific Center for Children's Health.

APPROVE: Deputy Director for Science Research Institute of Pediatrics.

Extract from the medical test report

Scientific Center for Children's Health of the Russian Academy of Medical Sciences, Professor MD Smirnov A.E.

Extract from the medical test report of samples of needle applicators KV-100, KV-200 for rehabilitation in diseases of the musculoskeletal system.

1. In the Department of Physical Therapy and Sports Medicine and the Arthrological Department of the Research Institute of Pediatrics, SCCH RAMS, medical tests were carried out on sets of needle applicators KV-100, KV-200 for the rehabilitation of patients with diseases of the musculoskeletal system, developed by UI and SR "Signum" CJSC "MAP".

2. A set of needle applicators was tested in accordance with the instructions for use and the acceptance test report.

3. Clinical trials were conducted in children with posture disorders and patients with severe pain syndrome. The applicators are easy to use, well treated with disinfectants, do not change their shape. 145 procedures were performed in the indicated group of patients. Clinical improvement in the form of reduction or disappearance of pain, increase in the volume of movement in the spine, in the developed joints, reduction of muscle hypertone was noted after 3-5 procedures. The recommended course is 8-10 procedures.

4. A set of needle applicators KV-100, KV-200 facilitates the work of exercise therapy methodologists and can be recommended for home use. Head of the Department of Physical Therapy and Sports Medicine of the Research Institute of Pediatrics, SCCH RAMS, Doctor of Medical Sciences Polyakov S.D.

Extract from the Protocol of medical tests

MMSI named after N.A. Semashko, Department of Physiotherapy.
APPROVED: Vice-Rector of MMSI Dzugaev K.G.

Extract from the medical test report of a prototype applicator for surface reflexology "Prickly Healer".

1. At the Department of Physiotherapy MMSI named after N.A. Semashko tests of experimental samples were conducted. For testing submitted: prototypes, technical documentation.

2. Medical tests were conducted in accordance with the program and methodology of medical tests. The number of patients was 129, the number of procedures per course of treatment was 5-12, lasting 5-30 minutes.

3. Applicators meet the requirements specified in the specification. They were used for acute and chronic cataracts of the upper respiratory tract, trigeminal neuralgia, stomatology, prosopalgia, chronic joints arthritis, hypertension. The positive effect was obtained in 85% of cases in the form of elimination or reduction of pain, inflammation, removed from the respiratory tract, improved joint mobility, and lowering blood pressure.

4. Applicators meet the requirements of medical practice in terms of functional and operational qualities, are easy to use, meet design requirements. Designed for individual use. Can be recommended for serial production. Head Department of Physiotherapy MMSI, Professor Efanov O.I. RSMU named after Pirogov.

Department of Neurology and Neurosurgery.

Extract from the protocol of medical device

Extract from the protocol of the medical device applicator for surface reflexology
"Prickly healer".

The impact of the applicator has a beneficial effect on the body, normalizes blood, increases resistance to diseases, promotes the treatment and prevention of diseases. The applicator can be recommended for serial production.

Professor of the Department of Neurology and Neurosurgery, Russian State Medical University named after Pirogov, doctor of medical sciences Avakyan G.N. MINISTRY OF HEALTH OF THE RUSSIAN FEDERATION SCIENTIFIC CENTER FOR CHILDREN'S HEALTH OF THE RUSSIAN ACADEMY OF MEDICAL SCIENCES.

Protocol No. 1 dated 18.01.2001

APPROVE: Chairman of the Pediatrics Section of the Academic Council of the Ministry of Health of the Russian Federation Professor Baleva L.S.

REFLEX SURFACE THERAPY OF CEPHALGIA TENSION IN CHILDREN
Manual for doctors

The methodological recommendations were made by the staff of the Department of Physical Therapy and Sports Medicine of the Research Institute of Pediatrics SCCH RAMS: Doctor of Medical Sciences, Professor L.A. Shcheplyagina: Doctor of Medical Sciences, Professor S.D. Polyakov, Candidate of Medical Sciences I.T. Korneeva.

The guidelines present schemes for surface reflex therapy with the “Prickly Healer” applicator in children with cephalgia tension. The results of the presented studies are recommended to be used in the practical work of pediatric, rehabilitation departments, physiotherapy and reflexology rooms. Methodical recommendations are intended for pediatricians, reflexologists, physical therapy physicians.

General recommendations for use

The “Prickly Healer” applicator in terms of its surface-reflex effect on the human body is a safe means of over-the-counter treatment and disease prevention, which allows it to be combined with drug therapy, homeopathic agents, physiotherapy, etc.

Expected outcome of the implementation

The proposed method of surface reflex therapy will increase the effectiveness of the treatment of cephalgia tension in children. The effectiveness of the method in complex treatment of cephalgia tension is the use of needle applicators “KV-100-S”, “KV-200-S”, developed by UI and SR “SIGNUM” CJSC “MAP” (patent BY 1256 C1), manifested in the reduction of pain syndrome, improvement of cerebral hemodynamics, as well as normalization of the functional state of the vegetative nervous system. This method can be used in hospital and at home, treatment course is 10-15 procedures.