Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001636842
Ethics application status
Approved
Date submitted
30/03/2021
Date registered
29/11/2021
Date last updated
4/11/2022
Date data sharing statement initially provided
29/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of thoracic spine manipulation on pulmonary function in swimmers with asthma – a study protocol of a randomized controlled crossover trial.
Scientific title
Effect of thoracic spine manipulation on pulmonary function in swimmers with asthma – a study protocol of a randomized controlled crossover trial.
Secondary ID [1] 302291 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 319034 0
Condition category
Condition code
Physical Medicine / Rehabilitation 316988 316988 0 0
Other physical medicine / rehabilitation
Alternative and Complementary Medicine 316992 316992 0 0
Other alternative and complementary medicine
Respiratory 316993 316993 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a protocol study that will serve as a basis for conducting a randomized controlled crossover trial.

This protocol study defines as objectives the analysis of the applicability of thoracic spine manipulation (TSM) and its effects on lung function in swimmers with asthma. Elite level athletes constantly seek methods to improve performance and these techniques can play a very important role in the treatment, recovery, and improvement of the functional capacity of the respiratory system.

Twenty-six (26) participants will be randomly allocated into 2 groups, 13 participants in the intervention group (IG) and 13 participants in the control group, in which there will be 3 treatment sessions per week, totaling 6 treatments in 2 weeks, after which the groups will be crossed and the protocol will be repeated. The study will be carried out in the facilities of four swimming clubs where the participants will be recruited in the Lisbon region, Portugal. The intervention in both groups will be performed by the same osteopath with 13 years of experience in the TSM technique. Participants will be screened for eligibility inclusion and exclusion criteria, and where they must sign an informed consent and a questionnaire relating to personal, health, and nutritional data (or their legal representative).
Participants in the IG will receive high velocity low amplitude (HVLA) technique or manipulation grade V applied to the thoracic spine where the following outcomes will be obtained: forced vital capacity (FVC), forced expiratory volume in one second (FEV1), peak expiratory flow (PEF) at baseline and 1 minute after TSM, and cirtometry and pulse oximetry 4 minutes after FVC, FEV1 and PEF.
The HVLA technique is applied as follows:
The subject will lay supine with the arms crossed over the chest and hands passed around the shoulder. The thoracic spine will be in a neutral position. The hand of the osteopath will contact in a neutral hand position, first over the spinous process of T1-T3, and then over T4-T6. The other hand will stabilize the head, neck, and upper thoracic spine of the participant. Gently, flexion of the thoracic spine will be introduced until slight tension will be palpated in the tissues at the osteopath contact point. Then, an HVLA technique downward toward the couch and in a cephalad direction will be applied. A cracking or popping should accompany accompanied all manipulations. If no popping sound is heard on the first attempt, the osteopath will reposition the participant and perform a second HVLA thrust manipulation. A maximum of 2 attempts will be performed on each participant. The time spends to apply the protocol will be approximately 10 minutes.
Subsequently, there will be a 2-week washout period, after which there will be the crossover of the groups and the protocol will be performed again in the same way.
Intervention code [1] 318575 0
Treatment: Other
Intervention code [2] 318576 0
Rehabilitation
Comparator / control treatment
The control group will receive only the positioning of the osteopath's hands on the participant's body in the same position with an only light touch without performing any maneuver, without reduction, or push or joint noise.
Control group
Active

Outcomes
Primary outcome [1] 325102 0
Lung function known as forced vital capacity will be measured by spirometry with a portable spirometer.
Timepoint [1] 325102 0
Measurement made immediately before (baseline) and 1 minute after each session of the thoracic spine manipulation.
Primary outcome [2] 325103 0
Lung function known as forced expiratory volume in one second will be measured by spirometry with a portable spirometer.
Timepoint [2] 325103 0
Measurement made immediately before (baseline) and 1 minute after each session of the thoracic spine manipulation.
Primary outcome [3] 325104 0
Lung function known as peak expiratory flow will be measured by spirometry with a portable spirometer.
Timepoint [3] 325104 0
Measurement made immediately before (baseline) and 1 minute after each session of the thoracic spine manipulation.
Secondary outcome [1] 386849 0
This is a composite secondary outcome.
Assessment of thoracic expandability will be made by cirtometry.
The participants will be positioned in a bipedal position and using a conventional 1.50 m tape measure, the circumference measurements of the axillary (just below the armpits), xiphoid (at the end of the xiphoid appendix), and basal (passing over the 12th ribs) regions will be obtained.. Each measure will be obtained after asking the participant to perform a maximum inspiration followed by a maximum expiration. The differences between the two measurements will provide information on the degree of the thoracic expandability.
Timepoint [1] 386849 0
Measurement made immediately before (baseline) and 4 minutes after each session of the thoracic spine manipulation.
Secondary outcome [2] 386850 0
Pulse oximetry will be measured using the Geratherm oxy control (GT-300C203, Pulse Oximeter, Germany). The index finger of the right hand will be used for recording or if it is not possible for any reason, the index finger of the left hand will be used.
Timepoint [2] 386850 0
Measurement made immediately before (baseline) and 4 minutes after each session of the thoracic spine manipulation.

Eligibility
Key inclusion criteria
Previously diagnosed with asthma.
Without contraindications to TSM or to co-interventions used in the study.
Aged between 16 and 30 years.
Who have a body mass index (BMI) between 18.5 and 24.9 kg/m2 (inclusive).
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with cognitive or physical disabilities
Osteopathic/chiropractor treatment in the 4-week prior to the start of the study.
Thoracic scoliosis greater than 25º.
Previous sternum/clavicle/rib/vertebra fracture in the last twelve months.
Those who do not meet the general considerations for lung testing requirements according to the “General considerations for lung function testing”.

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)
By centralized randomization using a computerized program. The random number allocation procedure will occur prior to the commencement of the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The principal investigator will conduct the randomization procedure by a computer-generated method software (www.randomizer.org) that will include opaque and sealed envelopes with an assigned number.
The 26 participants will be randomly assigned to either the experimental or control group with a 1:1 allocation.
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Determination of study sample size will be made based on previous literature: for forced vital capacity (FVC) and forced expiratory volume in one second, 12% is estimated to be the minimum level of clinically important change. To calculate the sample size, we will use G*Power software (version 3.1.9.2, Heinrich-Heine-University, Düsseldorf, Germany). Based on previous research, we assume the baseline mean (standard deviation) FVC value would be 6.0 (± 0.9) liters with a correlation between measures of 0.3. Considering an alpha level of 0.05, recruiting 21 participants would provide 90% power to detect a 12% change in FVC. Assuming a 20% dropout rate, the study sample size will be set to at least 26 participants.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/03/2023
Actual
Date of last participant enrolment
Anticipated
26/06/2023
Actual
Date of last data collection
Anticipated
7/08/2023
Actual
Sample size
Target
26
Accrual to date
Final
Recruitment outside Australia
Country [1] 22984 0
Portugal
State/province [1] 22984 0
Lisbon

Funding & Sponsors
Funding source category [1] 306717 0
University
Name [1] 306717 0
Ipluso - Escola Superior de Saúde Ribeiro Sanches
Country [1] 306717 0
Portugal
Primary sponsor type
University
Name
Ipluso - Escola Superior de Saúde Ribeiro Sanches
Address
Rua do Telhal aos Olivais, n8 – 8a, 1950-396 Lisboa, Portugal.
Country
Portugal
Secondary sponsor category [1] 307265 0
None
Name [1] 307265 0
Address [1] 307265 0
Country [1] 307265 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306887 0
Comissão de Ética da Faculdade de Educação Física e Desporto - ULHT
Ethics committee address [1] 306887 0
Ethics committee country [1] 306887 0
Portugal
Date submitted for ethics approval [1] 306887 0
06/10/2020
Approval date [1] 306887 0
20/01/2021
Ethics approval number [1] 306887 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105350 0
Dr Alexandre Miguel Guerra Cordeiro
Address 105350 0
Ipluso - Escola Superior de Saúde Ribeiro Sanches, Rua do Telhal aos Olivais, n8 – 8a, 1950-396 Lisboa, Portugal.
Country 105350 0
Portugal
Phone 105350 0
+351926185688
Fax 105350 0
Email 105350 0
[email protected]
Contact person for public queries
Name 105351 0
Alexandre Miguel Guerra Cordeiro
Address 105351 0
Ipluso - Escola Superior de Saúde Ribeiro Sanches, Rua do Telhal aos Olivais, n8 – 8a, 1950-396 Lisboa, Portugal.
Country 105351 0
Portugal
Phone 105351 0
+351926185688
Fax 105351 0
Email 105351 0
[email protected]
Contact person for scientific queries
Name 105352 0
Alexandre Miguel Guerra Cordeiro
Address 105352 0
Ipluso - Escola Superior de Saúde Ribeiro Sanches, Rua do Telhal aos Olivais, n8 – 8a, 1950-396 Lisboa, Portugal.
Country 105352 0
Portugal
Phone 105352 0
+351926185688
Fax 105352 0
Email 105352 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?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.