Effectivity of the treatment of tonsillitis with osteopathic manipulation of the vertebrae T9-T10: randomized clinical trial.

Not Applicable

Completed

• Conditions: tonsillitis; Infection - Other infectious diseases; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12612000068864
• Lead Sponsor: Agustin Luceno Mardones

Brief Summary

The main objective of this study was to know if T9-T10 osteopathic manipulation reduces the duration of symptoms, as well as the number of relapses in subjects with tonsillitis. 120 subjects (70 women) aged between 3 and 57 years completed the study, out of 121 tonsillitis patients included and randomized. No between-groups differences were found for any of the baseline characteristics. Through a randomized clinical trial, we have observed that the number of days of resolution of the tonsillitis episode was significantly lower in the Osteopathic Manipulative Group than in the Control Group -sham manipulation-. Likewise, the number of episodes of tonsillitis in the following year decreased significantly in both groups, compared to the previous year, but significantly more in the T9-T10 manipulation group. No patient reported adverse effects in relation to the treatment received.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-13
• Study Completion: 2018-06-30
• Last Update Posted: 28 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

Diagnosed to be suffering from an episode of tonsillitis (acute or recurrent), less than 48 hours of evolution, or being diagnosed with chronic tonsillitis symptomatic phase.

- The signature of informed consent (if an adult patient, or your parent or guardian if the patient is a minor)

Exclusion Criteria

- Age less than 3 years.
- Being treated with antibiotics immediately before the tonsilitis episode, because of the difficulty to attribute any improvement to the effect of osteopathic treatment or drug.
- Have been previously treated with immunomodulators during the past year, as glycophosphopeptical (Inmunoferon) or anapsos.
- Be suffering an episode of pharyngitis or adenoiditis without palate tonsillitis (eg. tonsillectomy).
- In cases diagnosed as chronic tonsillitis asymptomatic.
- Subjects who do not provide a telephone number in the initial questionnaire for the control callings.
- Diseases that prevent osteopathic manipulation of the vertebrae T9-T10.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of days for the total resolution of the symptoms of tonsillitis (fever, sore throat, cough, etc.), to compare Experimental Group and Control Group, after our intervention. <br>The Outcome will be assessed by collaborative nurse blinded by phone call to each patient to know their evolution (as register and sign) and an collaborator physician blinded review each clinical story and sign.[A week (seven days) after our intervention commencement.];Number of recurrences of tonsillitis in the following year (to compare with the number of episodes in the previous year, both in the Control Group as in the Experimental Group).<br>The Outcome will be assessed by collaborative nurse blinded by phone call to each patient to know their evolution (as register and sign) and an collaborator physician blinded review each clinical story and sign.[Each month during the next year after our intervention commencement.]

Secondary Outcome Measures

Name	Time	Method
Association between results (in the short and long term) and the controlled variables (age, sex, number of episodes the previous year, etc ...)<br><br>Results in the short term (number of days for the total resolution of the symptoms of tonsillitis after our intervention) will be assessed by collaborative nurse blinded by phone call to each patient to know their evolution (as register and sign) and an collaborator physician blinded review each clinical story and sign. <br><br>Results in the long term (number of recurrences of tonsillitis in the following year) will be assessed by collaborative nurse blinded by phone call to each patient to know their evolution (as register and sign) and an collaborator physician blinded review each clinical story and sign. <br><br>The controlled variables are measured by the initial questionnaire to the patient and the initial clinical examination.[A year after our intervention commencement.]