Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000911594
Ethics application status
Approved
Date submitted
28/07/2015
Date registered
2/09/2015
Date last updated
2/09/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of Pilates versus usual care on pain and disability in people with chronic nonspecific low back pain
Scientific title
To evaluate the effectiveness of Pilates exercise versus usual care on pain and disability in people with chronic non specific low back pain
Secondary ID [1] 287250 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Non specific Low back pain 295829 0
Condition category
Condition code
Physical Medicine / Rehabilitation 296086 296086 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pilates exercise is a mind-body exercise that focuses on strengthening, stretching, core stability, breathing, and posture. Participants will undertake an individualised and supervised Pilate’s exercise program based on the recommended principles reported in Wells et al (2014).Participants will be required to participate in 2 supervised exercise sessions per week at the New Acton Pilates studio for 12 weeks. These sessions will be of 60 minutes in duration, and will include mat-based exercises and the use of specialised equipment, such as a Reformer, Cadillac, and Ladder Barrel. Pilate’s exercises will be based on the protocol. Exercise sessions will be supervised by trained Pilate’s instructors. Participants will be supervised individually for 3-4 sessions, and then supervised in small groups (with no more than 4 participants per class). A home exercise program will also be provided to participants which will be of 10 – 15 minutes duration. Participants will be requested to complete these exercises 5 days a week (on the days not undertaking supervised sessions at the studio), and report adherence (in a written diary, and to Pilates instructor).
Intervention code [1] 292441 0
Rehabilitation
Comparator / control treatment
The usual care group will be requested to maintain current physical activity levels and not undertake any new exercise program throughout the trial. They also will be requested to not undertake any heath professional treatment for low back pain, apart from medications. They will be requested to provide a weekly record of any unavoidable change in activity, health professional treatment they sought, and medication usage via an online survey
Control group
Active

Outcomes
Primary outcome [1] 295683 0
1. Oswestry disability questionnaire
Timepoint [1] 295683 0
At baseline and at 6,12 and 26 weeks after intervention
Primary outcome [2] 295761 0
2. Numeric rating score of pain
Timepoint [2] 295761 0
At baseline ,6, 12 and 26 weeks after intervention
Secondary outcome [1] 316223 0
1.Fear avoidance Beliefs questionnaire
Timepoint [1] 316223 0
At baseline ,12 and 26 weeks after intervention
Secondary outcome [2] 316451 0
2. Tampa scale of Kinesiophobia
Timepoint [2] 316451 0
At baseline,12 and 26 weeks after intervention
Secondary outcome [3] 316453 0
Modified Schobers test - To measure the flexion and extension range of motion of lumbar spine.
Timepoint [3] 316453 0
At baseline, 12 and 26 weeks after intervention
Secondary outcome [4] 316522 0
Sorenson's test - To measure the back extensors endurance.
Timepoint [4] 316522 0
At baseline,12 and 26 weeks after intervention
Secondary outcome [5] 316814 0
Active Straight leg raise - To measure motor control impairment
Timepoint [5] 316814 0
At Baseline,12 and 26 weeks after intervention
Secondary outcome [6] 316815 0
Single leg balance- To measure motor control impairment
Timepoint [6] 316815 0
At baseline,12 and 26 weeks after intervention
Secondary outcome [7] 316816 0
Plank /Side plank - To measure motor control impairment
Timepoint [7] 316816 0
At baseline,12 and 26 weeks after intervention
Secondary outcome [8] 316817 0
Prone Hip Extension- To measure motor control impairment
Timepoint [8] 316817 0
At baseline,12 and 26 weeks after intervention

Eligibility
Key inclusion criteria
1.Diagnosed with nonspecific low back pain for more than 12 weeks
2.Aged between 18 and 60 years
3.Willing to participate in the study,including willingness to be randomized to the usual care group
4.Be confident in speaking ,understanding and writing in English
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Previous lumbar spine surgery
2.Previous Pilates exercise experience
3.Physiotherapy in the last 6 months
4.Presence of red flags indicating significant pathology requiring medical assessment such as recent unexplained weight loss,night pain,high levels of resting pain that is non mechanical in nature,cauda equina symptoms,prolonged use of corticosteroids,morning stiffness for more than an hour
5.Neurological involvement indicated by a presence of radiculopathy or spinal canal stenosis demonstrated as change in strength,reflexes and sensation
6.Any other medical condition precluding involvement in an exercise program such as those listed in the Physical Activity Readiness Questionnaire
7.Participants who are mostly (2/10) or wholly( 1/10)inactive according to University of California Los Angelos Activity Scale

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 will be self referred responding to advertising or referred by other professionals.The project will be promoted in advertisements in local newspaper,magazines,radio and notices on buildings of the University of Canberra.Referrals from medical doctors and physiotherapists will also be encouraged by face to face and written communication with the chief investigator. In response to enquiries,the participants information sheets will be posted or emailed to potential participants.The chief investigator will then follow up contact with the potential participant via phone to confirm interest and potential suitability for participant inclusion according to the selection criteria.If potential participants verbally consent to being involved in the project they will be requested to attend the University of Canberra for an initial assessment and to bring their completed written informed consent form. Research staff responsible for assessment will be blind to information consent form.Research staff responsible for assessment will be blind to information about the group allocation.Following recruitment and first assessment,participant will then be randomly allocated to treatment groups.Treatment allocation will be concealed using an opaque envelopes and notify the participant and the intervention group manager
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The treatment allocation will be randomised using a computer generated random number.The randomisation will be permuted block randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Nil
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
A power calculation was computed to determine the appropriate sample size for the study. The primary variable utilized to calculate sample size was Oswestry Disability Index. To detect a moderate effect size with a power of 0.80(80%) and the level of significance at 0.05 we will require 40 participants in each group. To allow for a 15% drop out rate, approximately 92 participants will be recruited.To determine differences in the outcomes between groups over time, a repeated measures ANOVA will be used.To know where the differences occur, a multiple comparison test Post Hoc will be conducted.This analysis may require to be further developed into general linear model with the capacity to control prognostic factors of participants such as age,pain and disability.An intention to treat analysis will be undertaken.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
92
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW

Funding & Sponsors
Funding source category [1] 291734 0
University
Name [1] 291734 0
University of Canberra
Country [1] 291734 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
Locked Bag 1, University of Canberra, ACT 2601 AUSTRALIA

Location-University Drive,Bruce,ACT 2617
Country
Australia
Secondary sponsor category [1] 290408 0
Commercial sector/Industry
Name [1] 290408 0
New Acton Studio- Pilates,Canberra
Address [1] 290408 0
3/21 Marcus Clarke St,(New Acton) ACT 2601
Country [1] 290408 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293256 0
University of Canberra (Human Research Ethics committee)
Ethics committee address [1] 293256 0
Research Ethics & Compliance Officer
University of Canberra Human Research Ethics Committee
Building 1 Level D 83
Kirinari Street, Bruce
University of Canberra, ACT, 2617
Ethics committee country [1] 293256 0
Australia
Date submitted for ethics approval [1] 293256 0
13/07/2015
Approval date [1] 293256 0
12/08/2015
Ethics approval number [1] 293256 0

Summary
Brief summary
The primary purpose of this randomised controlled trial is to investigate the effectiveness of Pilates versus usual care on pain and disability in people with chronic non specific low back pain in short term(6-12 weeks) and long term (26 weeks).The research hypothesis is that the Pilates exercise will show short term and long term effects in decreasing pain and disability in people with chronic non specific low back pain more than usual care.The alternative hypothesis is that there is no difference in pain and disability in participants who undertake Pilates exercise and those that continue usual care.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes
Nil

Contacts
Principal investigator
Name 59126 0
Mrs Roopika Sodhi
Address 59126 0
11 Kirinari St,Building(12 B-12)
Discipline of Physiotherapy,Faculty of Health
University of Canberra
Bruce,2617
Canberra (ACT)
Country 59126 0
Australia
Phone 59126 0
+61452183192
Fax 59126 0
Email 59126 0
Roopika.sodhi@canberra.edu.au
Contact person for public queries
Name 59127 0
Ms Cherie wells
Address 59127 0
11 Kirinari St,Building (12 D-51)
Discipline of Physiotherapy,Faculty of Health
University of Canberra
Bruce,2617
Canberra (ACT)
Country 59127 0
Australia
Phone 59127 0
+61262015955
Fax 59127 0
+61262015727
Email 59127 0
cherie.wells@canberra.edu.au
Contact person for scientific queries
Name 59128 0
A/Prof Jennie Scarvell
Address 59128 0
Head of Physiotherapy
11 Kirinari St,Building (12 D- 51)
Discipline of Physiotherapy,Faculty of Health
University of Canberra
Bruce,2617
Canberra (ACT)
Country 59128 0
Australia
Phone 59128 0
+61262068710
Fax 59128 0
+61262015727
Email 59128 0
jennie.scarvell@canberra.edu.au

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
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