Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000369527
Ethics application status
Approved
Date submitted
16/08/2006
Date registered
23/08/2006
Date last updated
9/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Spinal Manipulation on Respiratory Function
Scientific title
The Effect of Spinal Manipulation in the Management of Emphysema & Chronic Bronchitis
Secondary ID [1] 253069 0
Spinal manipulation and lung function
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emphysema & Chronic Bronchitis 1338 0
Condition category
Condition code
Respiratory 1426 1426 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial attempts to measure the effectiveness of Spinal Manipulation in the management of Emphysema and Chronic Bronchitis. Pre -trial, all participants have their Lung Volume measured, undertake a standardized treadmill walking exercise measure, and complete a Chronic Respiratory Questionnaire. Participants are allocated to 3 experimental groups. Group 1 receives Soft Tissue Therapy followed by Spinal Manipulations; Group 2 receives Soft Tissue Therapy followed by Spinal Manipulations followed by a standardized treadmill walking exercise program. The participants receive 8 intervention sessions in total at a rate of 2 per week over a 4 week period.
Intervention code [1] 1314 0
Treatment: Other
Comparator / control treatment
Group 3 receives Soft Tissue Therapy only.
Control group
Active

Outcomes
Primary outcome [1] 1950 0
Spirometry
Timepoint [1] 1950 0
Sessional 1 - 8 sessions
Primary outcome [2] 1951 0
Forced Vital Capacity (FVC) in 1st second (FEV-1)
Timepoint [2] 1951 0
Sessional 1 - 8 sessions
Primary outcome [3] 1952 0
Forced Expiratory Volume in 1st second (FEV-1)
Timepoint [3] 1952 0
Sessional 1 - 8 sessions
Secondary outcome [1] 3418 0
1. Chronic Respiratory Questionnaire: Self -Administered Standardized (CRQ-SAS).
Timepoint [1] 3418 0
Pre-intervention, week 2, week 4.
Secondary outcome [2] 3419 0
2. Walking treadmill assessment.
Timepoint [2] 3419 0
Pre-intervention, week4.

Eligibility
Key inclusion criteria
Non-smoking (minimum 12 months)Current diagnosis of Emphysema or Chronic Bronchitis.
Minimum age
40 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The existence of contra-indications to Spinal Manipulation of the Thoracic and/or Cervical spinesNon-ambulatory status.

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)
Allocation to intervention groups was concealed by using sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation was done by simple randomisation using coin-tossing.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/09/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1558 0
University
Name [1] 1558 0
Macquarie University
Country [1] 1558 0
Australia
Primary sponsor type
Individual
Name
Roger Engel
Address
c/- Macquarie University
Balaclava Road North Ryde NSW 2109
Country
Australia
Secondary sponsor category [1] 1371 0
Individual
Name [1] 1371 0
Subra Vemulpad
Address [1] 1371 0
c/- Macquarie University
Balaclava Road North Ryde NSW 2109
Country [1] 1371 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2990 0
Macquarie University
Ethics committee address [1] 2990 0
Ethics committee country [1] 2990 0
Australia
Date submitted for ethics approval [1] 2990 0
Approval date [1] 2990 0
13/03/2006
Ethics approval number [1] 2990 0
HE26AUG2005-D04264D

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

Contacts
Principal investigator
Name 27921 0
Address 27921 0
Country 27921 0
Phone 27921 0
Fax 27921 0
Email 27921 0
Contact person for public queries
Name 10503 0
Roger Engel
Address 10503 0
Department of Health & Chiropractic
Macquarie University
Sydney
New South Wales 2109
Country 10503 0
Australia
Phone 10503 0
+61 2 98506387
Fax 10503 0
+61 2 98509389
Email 10503 0
[email protected]
Contact person for scientific queries
Name 1431 0
Roger Engel
Address 1431 0
Department of Health & Chiropractic
Macquarie University
Sydney
NSW 2109
Country 1431 0
Australia
Phone 1431 0
+61 2 98506387
Fax 1431 0
+61 2 98509389
Email 1431 0
[email protected]

No information has been provided regarding IPD availability


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.