Intended use:

To help lumbar region mobility, help muscle stretching of the lumbo-sacral area, help to support the lumbar muscle tissue, soothe local pain, pain at rest or caused by movement and bad posture

MD-LUMBAR is a medical device finalized to help movement by limiting a physiological degeneration of joints and tissues as well as by counterbalancing any damage caused by:

• aging
• bad posture
• concomitant chronic diseases
• blows and injuries
• pollutants

MD-LUMBAR is a medical device finalized to help movement, specifically the lumbosacral area of the vertebral spine. Its main therapeutic functions include:

• a barrier effect
• a lubricating activity
• a mechanical support while administering other pharmacological treatments

MD-LUMBAR is a medical device intended to be used by a qualified staff in private or public health facilities.

Direction for use

Periarticular treatment protocol:

2 treatments for the first 2 weeks. 1 treatment until improvement of symptoms (average 8-10 sessions).

Chronic pathologies: go on with 1 treatment weekly for one month until improvement of symptoms, and then with 1 treatment monthly or - according to individual needs - every 45-50 days.

The site of application must be sterile; insert the needle near the lumbar and lumbosacral joints at 3-4 mm depth.

For this purpose the use of the following materials and accessories is recommended;

Materials for aseptic skin preparation: sterile gloves, Iodine solution, Alcohol solution, sterile gauze pads, Ethyl chloride spray for the skin.
Needles: sterile 27 G.
Syringes: 5 or 10 cc size, according to the volume of the solution to inject.

Contraindications / Side effects

There is no history of hypersensitivity to MD-LUMBAR. However, patients with a recognized hypersensitivity to any ingredient or excipient should be tested before use, making a spot into one arm and be monitored for 1 hour.

Performance

MD-LUMBAR may be used as a single treatment or mixed with other medical devices of the same range, in order to make a customized treatment according to clinical evolution. When a supportive treatment is needed for acute pain, MD-LUMBAR can be associated with MD-NEURAL, MD-POLY and MD-MUSCLE (together with one or more than one of these).

Moreover, when a supportive treatment is needed for the connective tissue matrix or when the physiological aging process should be slowed down, MD-LUMBAR can be associated with MD-MATRIX and MD-TISSUE.

It may also be used as a mechanical support while treating the following diseases:

Lumbar pain secondary to cartilage degenerative lumbar spine disorders (lumbar and lumbar-sacral arthrosis)
Lumbar vertebral osteophytosis
Low back pain secondary to musculo-tendinous trigger points (in association with MD-MUSCLE)
Postural low back ache (in association with MD-NEURAL and MD-MUSCLE)
Lumbar and lumbar-sacral mechanical imbalance
Lumbar and lumbar-sacral spinal ligament syndrome
Sacro-iliac syndrome
Spinal lumbar and lumbar-sacral nerve root pain (in association with MD-NEURAL and MD-ISCHIAL).

Instructions in case of damage to the sterile vials / ampoules

Do not use if the seal is open or if the vial/ampoule is not perfectly sealed.

Once open, the vial/ampoule must be immediately injected.

Do not use if the package is damaged.

Warnings and precautions

Spinal pain requires differential diagnosis for herniated disk, primary or secondary cancer pain; reflex or referred pain from internal organs.

A sight reddening at the site may be due to a mechanical effect of the needle or to a skin superficial reaction.

Skin cleansing/disinfection is required before and after application. Saprophytic bacteria may produce site abscesses. KEEP AWAY FROM THE REACH AND THE SIGHT OF CHILDREN.

Do not use after the expiration date. The expiration date refers to the product property stored in an unopened package. Use the product immediately after opening the package.