Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001584325
Ethics application status
Approved
Date submitted
19/07/2017
Date registered
27/11/2017
Date last updated
19/11/2019
Date data sharing statement initially provided
19/11/2019
Date results information initially provided
19/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
What effect do different physiotherapy managements of the upper spine have on breathlessness and lung function following exercise in people with COPD?
Scientific title
Does accessory joint mobilisation of the upper spine reduce breathlessness and improve lung function following exercise in people with COPD more than a placebo intervention?
Secondary ID [1] 292466 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 304084 0
Condition category
Condition code
Respiratory 303419 303419 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be asked to attend three sessions within a two-week period with each session separated by >24 hours.

Session 1: Descriptive data will be collected. Participants will undergo a brief passive accessory joint assessment of the thoracic spine in order to select the most ‘stiff’ spinal segment between T2 and T12 at which to perform the placebo and experimental interventions. If more than one spinal level is hypomobile, then the mid-point in the stiff segment will be selected. If no thoracic segments are found to be hypomobile, then a mid-thoracic segment will be selected (between T5 and T7). Participants will then perform the 6MWT and from this 80% of the average speed achieved on the 6MWT will be used to prescribe the intensity of the 6-minute treadmill walking exercise task. This intensity of exercise is consistent with that used for walking training in PRP and a period of 6 minutes is sufficient to evoke breathlessness whilst avoiding a prolonged testing session. Participants will then be familiarised with the treadmill exercise task.

Sessions 2-4: All outcome measures will be taken at baseline, followed by one of the randomly ordered interventions (placebo or experimental). Participants will then undergo the standardised 6-minute exercise task. All outcome measures will then be repeated.

Experimental intervention: Posterior-anterior (PA) thoracic mobilisation (Grade III) will be applied to the selected spinal segment for 3 periods of 1 minutes, each separated by 60 seconds. A grade III mobilisation is defined on the Maitland Joint Mobilization Grading Scale
as large amplitude rhythmic oscillating mobilisation to point of limitation in range of movement.
Intervention code [1] 298650 0
Treatment: Other
Comparator / control treatment
Placebo intervention: The therapist’s hands will be placed as if to complete a posterior anterior mobilisation at the selected thoracic spinal segment for 3 periods of 1 minute each separated by 60 second rest.
Control group
Placebo

Outcomes
Primary outcome [1] 302805 0
Self reported measures of breathlessness- borg dspnoea scale, multidimensional dyspnoea profile
Timepoint [1] 302805 0
This outcome measure will be taken before and immediately after the randomly selected intervention and exercise task.
Primary outcome [2] 302806 0
Lung function will be taken as a composite primary outcome- inspiratory capacity (IC), tidal volume (VT), respiratory rate (RR), FEV1 and forced vital capacity (FVC). Lung function measurements will be taken using an Easyone spirometer.
Timepoint [2] 302806 0
Lung function testing will be measured at three time points (pre-intervention, post-intervention and post-exercise task). This is to determine the effect of the intervention alone and eliminate potential confounding effects of the exercise task. Participants will be given a 10 minute rest period before completing spirometry post-exercise as we expect they will be too breathless to perform effectively. During these 10 minutes remaining measures will be taken.
Secondary outcome [1] 337076 0
Pain sensitisation will be measured with pressure pain threshold (PPT) using a hand-held pressure algometer (Somedic, Sweden) and standard methodology. The participant will be given a hand-held control switch. The 1cm2 rubber-tipped probe will be placed perpendicular to the
marked site. A steadily increasing force (40kPa/sec) will be applied and the participant asked to press the button when the sensation changes from one of pressure to one of uncomfortable or painful pressure. One practice followed by three trials will be measured at each site, with the
average value (kPa) used for analysis.
a. Local sites: PPT will be measured over the left and right facet joints of the selected thoracic segment.
b. Distant site: PPT measured at left and right dorsal forearm, midline approximately 5cms from the wrist crease.
Timepoint [1] 337076 0
This outcome measure will be taken before and immediately after the randomly selected intervention and exercise task.
Secondary outcome [2] 337077 0
Cardiorespiratory function as c composite secondary outcome- SpO2 and heart rate and will be measured using a Masimo Rad-8 oximeter and ear sensor.
Timepoint [2] 337077 0
This outcome measure will be taken before and immediately after the randomly selected intervention and exercise task.

Eligibility
Key inclusion criteria
Diagnosis of COPD confirmed by spirometry; smoking history >10 pack years; breathless on 6-minute walk test (6MWT) or during supervised exercise training (Borg rating = 3 [‘moderate’]); stable clinical state (no exacerbation or change in respiratory medication in previous 4 weeks).
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Aged >80 years; history of thoracic surgery, spinal crush fractures, or osteomyelitis; known severe osteoporosis of spine (T-score =2.5); co-morbid conditions limiting ability or compromising safety to exercise on treadmill; severe exercise limitation (6MWD <300m); long term oxygen therapy; SpO2<80% during 6MWT or exercise training; obese (BMI >35); unable to give informed consent; pain >4/10 during thoracic spine assessment; history of chronic thoracic spinal pain; unable to sustain a supported forward lean sitting position without discomfort for 10 minutes.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation
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
SPSS Version 22, p < 0.05
Data distribution using frequency histograms
Repeated measures/within subjects T-test

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/12/2017
Actual
2/04/2018
Date of last participant enrolment
Anticipated
31/12/2017
Actual
9/07/2018
Date of last data collection
Anticipated
30/04/2018
Actual
23/07/2018
Sample size
Target
12
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 8563 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 16667 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 297034 0
Hospital
Name [1] 297034 0
Sir Charles Gairdner Hospital
Country [1] 297034 0
Australia
Primary sponsor type
Hospital
Name
Sir Charles Gairdner Hospital Physiotherapy department
Address
Hospital Avenue, Nedlands, WA 6009
Country
Australia
Secondary sponsor category [1] 296044 0
None
Name [1] 296044 0
Address [1] 296044 0
Country [1] 296044 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298219 0
Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee
Ethics committee address [1] 298219 0
Sir Charles Gairdner Hospital
Hospital Avenue, Nedlands, WA, 6009
Ethics committee country [1] 298219 0
Australia
Date submitted for ethics approval [1] 298219 0
29/09/2017
Approval date [1] 298219 0
06/02/2018
Ethics approval number [1] 298219 0

Summary
Brief summary
COPD is the fifth greatest contributor to the overall burden of disease in Australia. Breathlessness is the primary symptom that limits exercise in people with COPD. Reduced exercise is associated with higher hospitalisation rates and increased mortality rates. Lung hyperinflation which is characteristic in COPD contributes to spinal rigidity which may further contribute to exertional breathlessness and subsequent reduced exercise capacity. Previous research has shown that manual therapy has immediate effects on reducing breathlessness and improving lung function. There is a known link between joint mobilization and SNS function showing immediate effects on local and centrally mediated pain, muscle and SNS function. It may therefore be hypothesized that improvements in pain and muscle function would be associated with reduced spinal rigidity, potentially improving lung function and reducing breathlessness. Several studies that have pharmacologically inhibited SNS activity have reported reduced breathlessness, so it might also be hypothesised that thoracic mobilisation may have a similar effect on breathlessness. To the best of our knowledge no studies to date have investigated the impact of manual therapy on lung function or breathlessness associated with a functional relevant activity such as walking. This study aims to investigate, in people with stable COPD who experience exertional breathlessness, whether a single treatment involving 6 minutes of Grade III central PA accessory joint mobilisation of the thoracic spine decreases breathlessness and improves lung function more than a placebo intervention. We hypothesis that joint mobilisation of the thoracic spine will decrease breathlessness and improve lung function following a 6 minute walking exercise task. If proven successful, this may permit patients to exercise more frequently and at higher intensities optimizing the benefits of exercise. This along with the potential to increase participation in physical activity may lead to a reduction in exacerbations, hospital admissions and associated cost savings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76382 0
Miss Tamara Hatton
Address 76382 0
Physiotherapy department, Sir Charles Gairdner Hospital, Hospital Avenue, Nedlands, WA 6009
Country 76382 0
Australia
Phone 76382 0
+61466210681
Fax 76382 0
Email 76382 0
[email protected]
Contact person for public queries
Name 76383 0
Miss Tamara Hatton
Address 76383 0
Physiotherapy department, Sir Charles Gairdner Hospital,
Hospital avenue, Nedlands, WA 6009
Country 76383 0
Australia
Phone 76383 0
+61466210681
Fax 76383 0
Email 76383 0
[email protected]
Contact person for scientific queries
Name 76384 0
Dr Sue Jenkins
Address 76384 0
Physiotherapy department, Sir Charles Gairdner Hospital,
Hospital avenue, Nedlands, WA 6009
Country 76384 0
Australia
Phone 76384 0
+61 8 6457 4408
Fax 76384 0
Email 76384 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
5757Ethical approval    373331-(Uploaded-01-11-2019-11-05-57)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference posterNo A poster was presented at the The Thoracis Society... [More Details]

Documents added automatically
No additional documents have been identified.