A Single Blinded Randomized Controlled Clinical Trial on the Efficacy of Ozone Therapy on Breast Cancer-Related Lymphedema

Ozone therapy Application Using the Rectal Insufflation Method: Before starting the first treatment session, each patient in the study group was instructed carefully about the ozone therapy procedure as well as, its safety, values and effects to gain her confidence and cooperation during the treatment sessions. Furthermore, each patient was advised and instructed to evacuate her bladder and rectum before starting each ozone therapy session. Each patient assumed a relaxed modified side lying position, then the catheter was held and lubricated with a neutral lubricant (KY gel), and closed by the clamp before inserting it into the rectum through the anus. After that, the syringe was introduced into the free end of the catheter, and the clamp was removed, and the ozone was injected into the catheter, after that, the catheter was closed with the clamp again, to change the syringe. Then each patient received ozone in form of rectal insufflations with ozone concentration of 20 µg/ml, increased gradually up to 40 µg/ml and the volume was ranged from150-300ml. Three syringes of 50 ml were filled with ozone from the portable generator (Ozomed, Kastner Praxisbedarf- D-76437 Rastatt), with total ozone dose of 150 ml, with the appropriate concentration was delivered the ozone into the rectum via the catheter in the first session, then the dose and concentration of the ozone were increased gradually in the subsequent sessions to reach the maximum range (ozone dose of 300 ml, concentration of 40 µg/ml by using 6 syringes). This procedure was repeated from three to six times according to the ozone dose which was used. Finally, the catheter was removed from the patient's rectum, when all the syringes were used. Then each patient was instructed to clean her anus by using sterile dressing and instructed to rest for 5 minutes. The procedure was repeated three times weekly for the first two months and two times for the last month (Knoch, Roschke, & Klug, 1987; Carpendale, Freeberg, Meleod, 1993; Bocci, Borrelli ,Corradeschi, & Valacchi, 2000). The total duration of intervention was 3-month. "In additional to the Ozone therapy, patients were also advised to perform daily limb exercises which included (1) Arm elevation to 180 degrees with elbows straight (2) Internal rotation with the hand on the back trying to reach as high as possible (3) Abduction with the fingertips on the shoulders (4) Elbows together and apart with the hands behind the neck. Patients were also required to do the following exercises in the standing position: (1) Arm extension with a stick held horizontally behind the back (2) Shoulders forward, backwards, upwards, and downwards (3) Shoulder circles with the fingertips on the shoulder (4) Arm elevation standing in a corner with the back of the hand gliding along the wall. Patients were told to perform each exercise five times in every set on a daily basis. Patients were also instructed to in the skin care to maintain the affected area clean and dry to decrease the risk of infection. All women were instructed to wear pressure garment that provides pressure of (40 to 60 mmHg), and for 20 h daily during the period of the study as reported. All patients were given a diary logbook to complete on a daily basis during the intervention period. They were asked to maintain a daily self-report of their daily exercise activities and duration of wearing garment. The total duration of the intervention was 3 months.".