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Trial registered on ANZCTR


Registration number
ACTRN12612000068864
Ethics application status
Approved
Date submitted
9/01/2012
Date registered
13/01/2012
Date last updated
21/06/2021
Date data sharing statement initially provided
21/06/2021
Date results information initially provided
21/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectivity of the treatment of tonsillitis with osteopathic manipulation of the vertebrae T9-T10: randomized clinical trial.
Scientific title
Effectivity of the treatment of tonsillitis with osteopathic manipulation of the vertebrae T9-T10: randomized clinical trial, with patients and assessor blinded.
Secondary ID [1] 279676 0
Nill
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tonsillitis 285498 0
Condition category
Condition code
Infection 285690 285690 0 0
Other infectious diseases
Physical Medicine / Rehabilitation 285691 285691 0 0
Other physical medicine / rehabilitation
Alternative and Complementary Medicine 285692 285692 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
METHODOLOGY: Experimental, longitudinal and mixed (prospective-retrospective) design (retrospective information on the number of episodes last year, obtained by patient questionnaire). Convenience sampling. All the cases that come for manipulative treatment of diagnosed tonsillitis are included, once the criteria of inclusion and exclusion have been applied. Independiently, they also receive pharmacological treatment prescribed by your blinded doctor. After filling in the questionnaire (age, sex, number of episodes the previous year, etc)
and signing the informed agreement, they are randomized in two groups: Experimental Group (receive one osteopathic manipulation of the vertebrae T9-T10, thrust with sitting patient's arms across chest, by a trained physiotherapist-osteopath, professor of Osteopathic Methodology) or Control Group (receive one very soft streching in the same position, by the same trained physiotherapist-osteopath, to the Placebo Group). In both groups, only one manipulation or stretching in a single session (of one minute of duration). All the changes in the symptomatology of tonsillitis are recorded in the first week and each month in the following year, recording also the recurrences (by phone call of blinded collaborator).
Intervention code [1] 283965 0
Rehabilitation
Intervention code [2] 283966 0
Treatment: Other
Intervention code [3] 283967 0
Prevention
Comparator / control treatment
"Placebo" manipulation: receive one very soft passive streching in the same position (standing) as the Experimental Group, but without thrust.
Control group
Placebo

Outcomes
Primary outcome [1] 286222 0
Number 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.
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.
Timepoint [1] 286222 0
A week (seven days) after our intervention commencement.
Primary outcome [2] 286223 0
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).
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.
Timepoint [2] 286223 0
Each month during the next year after our intervention commencement.
Secondary outcome [1] 295409 0
Association between results (in the short and long term) and the controlled variables (age, sex, number of episodes the previous year, etc ...)

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.

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.

The controlled variables are measured by the initial questionnaire to the patient and the initial clinical examination.
Timepoint [1] 295409 0
A year after our intervention commencement.

Eligibility
Key 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)
Minimum age
3 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were randomly allocated to the control (n= 40) and experimental (n = 81) groups using a computer-generated table of sequence of numbers (2:1 randomization), using Microsoft Excel 2010, performed by an independent blinded collaborator. This randomization was stratified according to antibiotics consumption. A second collaborator assigned an intervention group to each number. To implement the random allocation sequence, sequentially numbered opaque sealed envelopes was used. Participants were recruited by a different researcher who was blinded to the number sequence and intervention assignment. The researcher who had to apply the manual treatment was the first that opened the opaque sealed envelope.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated table of sequence of numbers (2:1 randomization), using Microsoft Excel 2010, performed by an independent blinded collaborator. This randomization was stratified according to antibiotics consumption. A second collaborator assigned an intervention group to each number.

Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The statistical analysis was carried out using SPSS version 22. The descriptive studied of each variable was carried out in tables with the mean, the standard deviation, IC 95% for the continuous variables and in percentages for the qualitative variables. Before doing the statistic analysis, the conditions of its application were taken in consideration; the Shapiro-Wilk test was used to verify normality. The Mann-Whitney U test was used to determine the homogeneous distribution between groups, when they did not meet normality criteria; on the contrary, the T test was used. Chi-square test was used for qualitative variables. A least squares estimation was carried out to quantify the difference interval between groups. The same drag observation was used. The repeated measures variance analysis (ANOVA) test with linear models with Bonferroni adjustment was used to prove the change profile of the outcome of the number of episodes in those two years, as in the previous one and the following one in the two study groups, and the peer comparison by time and group. The global clinical effects for the analysis of repeated measures were calculated using the eta-squared value (?2), categorized as small = 0.01, medium = 0.06, large = 0.14 [1]. The Mann-Whitney U test was used to analyze the number of days required to solve the episode. Pearson's chi-square test was used for the analysis according to the group of resolution above 48 hours, the initial result and after 12 months. The bivariate correlations of the quantitative variables were analyzed using Pearson’s coefficient. It was established a level of significance p<0,05 and a confidence level of 95%.

[1] Field A. Discovering statistics using IBM SPSS statistics. London: Sage; 2013. p. 473–4. 

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/01/2012
Actual
21/02/2014
Date of last participant enrolment
Anticipated
Actual
30/06/2017
Date of last data collection
Anticipated
Actual
30/06/2018
Sample size
Target
100
Accrual to date
Final
121
Recruitment outside Australia
Country [1] 4042 0
Spain
State/province [1] 4042 0
Cáceres

Funding & Sponsors
Funding source category [1] 284461 0
University
Name [1] 284461 0
University of Cadiz
Country [1] 284461 0
Spain
Primary sponsor type
Individual
Name
Agustin Luceno Mardones
Address
C/ Londres. 14, 5 I
10.005-CACERES
Country
Spain
Secondary sponsor category [1] 283387 0
University
Name [1] 283387 0
University of Cadiz. Manuel Rosety Plaza.
Address [1] 283387 0
Plaza Falla, 9. (Facultad de Medicina)
11.003-CADIZ
Country [1] 283387 0
Spain
Other collaborator category [1] 260426 0
University
Name [1] 260426 0
University of Seville. Angel Oliva Pascual-Vaca
Address [1] 260426 0
C/ Sevilla.1-Izq.
41.740-LEBRIJA (SEVILLE)
Country [1] 260426 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286438 0
"Comite Etico de Experimentacion de la Universidad de Sevilla"
Ethics committee address [1] 286438 0
Universidad de Sevilla
Ethics committee country [1] 286438 0
Spain
Date submitted for ethics approval [1] 286438 0
Approval date [1] 286438 0
17/12/2011
Ethics approval number [1] 286438 0

Summary
Brief summary
OBJECTIVES OF THE DOCTORAL THESIS:
1) To determine whether osteopathic manipulation (G. Experimental) of the vertebrae T9-T10, during an episode of tonsillitis, corresponds to the total disappearance of symptoms in a significantly lower number of days that the manipulation patients with placebo (G. Control).
2) To determine whether osteopathic manipulation (G. Experimental) of the vertebrae T9-T10, during an episode of tonsillitis, corresponds to a decrease in the number of recurrences during the following year, significantly higher than in patients with placebo manipulation (G . Control).3) 3) To determine if there is any association between the treatment results and any of the variables controlled in this study (sex, age, number of previous episodes in last year).

HYPOTHESIS:
1 st) The osteopathic manipulation (G. Experimental) of the vertebrae T9-T10, during an episode of tonsillitis, corresponds to the total disappearance of symptoms in a significantly lower number of days that patients with placebo manipulation (G . Control).
2nd) The osteopathic manipulation (G. Experimental) of the vertebrae T9-T10, during an episode of tonsillitis, corresponds to a decrease in the number of recurrences during the following year, significantly higher than in patients with placebo manipulation (G. Control ).
3 rd) relationship exists between the results of osteopathic treatment of tonsillitis and some of the additional variables considered in this study.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33593 0
Prof Agustín Luceño
Address 33593 0
Centro Sanitario de Fisioterapia Osteopatía Agustín Luceño
C/ Londres. 14, 5º I
10005-Cáceres (SPAIN)
Country 33593 0
Spain
Phone 33593 0
+34 927 233198
Fax 33593 0
Email 33593 0
[email protected]
Contact person for public queries
Name 16840 0
Prof Agustín Luceño
Address 16840 0
Centro Sanitario de Fisioterapia Osteopatía Agustín Luceño
C/ Londres. 14, 5º I
10005-Cáceres (SPAIN)
Country 16840 0
Spain
Phone 16840 0
+34 927 233198
Fax 16840 0
Not
Email 16840 0
[email protected]
Contact person for scientific queries
Name 7768 0
Prof Agustín Luceño
Address 7768 0
Centro Sanitario de Fisioterapia Osteopatía Agustín Luceño
C/ Londres. 14, 5º I
10005-Cáceres (SPAIN)
Country 7768 0
Spain
Phone 7768 0
+34 927 233198
Fax 7768 0
Not
Email 7768 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12172Ethical approval    347915-(Uploaded-25-10-2020-21-02-35)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually

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