Podal Reflex Laserpuncture as a treatment for Chronic Adenoiditis - Phase III

• Register: RPCEC
• Last refreshed on: 29 April 2013
• Main ID: RPCEC00000129
• Date of registration: 25/05/2012
• Primary sponsor: Center for Aplication and Development of Nuclear Technologies (CEADEN)
• Public title: Podal Reflex Laserpuncture as a treatment for Chronic Adenoiditis - Phase III
• Scientific title: Podal Reflex Laserpuncture as a treatment for Chronic Adenoiditis
• Date of first enrolment: 03/01/2012
• Target sample size: 114
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000129-En
• Study type: Observational
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Treatment

Countries of recruitment

Cuba

Contacts

• Name: Amalia Nieves Alvarez
• Affiliation: Centro Habana Pediatric Hospital

• Name: Alain Riquelme Rodriguez
• Affiliation: Policlinic "Rampa"

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients male and female, 1 to 18 years old. 2. Patients showing at least 3 clinical symptoms of chronic adenoiditis sush as: snoring, mucus secretion on the pharinge wall and infection of the aerial ways. 3. Written approval of informed consent by the legal representative of the patient to participate in the trial 4. Presence of chronic adenoiditis confirmed by means of nosopharinge tact, back rinoscopy, nasofibroscopy or Xrays of the cavum.
Exclusion criteria: 1. Small babies feed by the mother. 2. Hemophiliac patients. 3. Patients with malignant tumors. 4. Hipertrofic adenoiditis asociated to a complete obstruction of the breathing ways. 5. Medium otitis. 6. Patients with fever.

Age minimum: 1 years
Age maximum: 18 years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Adenoiditis

Intervention(s)

Podal Reflex Laserpuncture, with a semiconductor laser AsGa with 780 mm wavelength (infrared), 40mW power output, in a continuos work regime. The dosage to use is: energy density (DE) 35 J/cm2 or an energy dosage of 2.4 J on each application with 3 application on the reflex zone of each foot corresponding to the nose holes, resulting in a density of total energy per sesion of 210 J/cm2 or an energy dosage de 14.4 J in 6 application in a treatment cycle consisting in a sesion each day Monday through Friday, to complete 15 sesions.

Primary Outcome(s)

Clinical response (Interrogation and Physical exam). Measurement Time: 15 days and 3 months after finishing the treatmnet. - Interrogation. Presence or absence of mucopurulent secretion on the pharynge wall. Infections of aerial ways and snoring at nigth. - Physical Exam. Presence of Cronic Adenoiditis. It will include: 1. Nasopharyngeal tac in children 4 years old or younger. 2. Back rynoscopy using larynge mirror or nasofibroscopy in children older than 4 years old. 3. Cavum X Rays for children who don't cooperate on the tests 1 and 2

Secondary Outcome(s)

Need of surgery (Yes, No). Measurement Time: 16 days and 3 month after finishing the treatment. - Adverse Event (AE). Measurement Time: 16 days and 3 month after finishing the treatment. Type of AE (name of the adverse event) Intensity of the AE (Mild, moderate, severe) Severity of the AE (Grave/Serious, Not Grave/Not serious) Causal Relationship of the AE (Remote cause, Possible Cause, Probable cause or Very Probable cause/sure) Treatment indicated (treatment received by each patient for the AE occurred).

Secondary ID(s)

Not applicable

Source(s) of Monetary Support

Center for Aplication and Development of Nuclear Technologies (CEADEN)

Secondary Sponsor(s)

Policlinic "Rampa"