Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000165886
Ethics application status
Approved
Date submitted
2/02/2012
Date registered
6/02/2012
Date last updated
7/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A clinical study into the effectiveness of the Mobile Lumbar Traction Unit in the reduction of pain and neurological symptoms in patients with radicular low back pain
Scientific title
A clinical study into the effectiveness of the Mobile Lumbar Traction Unit in the reduction of pain and neurological symptoms in patients with radicular low back pain
Secondary ID [1] 279861 0
Nil
Universal Trial Number (UTN)
U1111-1127-9067
Trial acronym
MLT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Stenosis 285758 0
Low back Pain 285759 0
Condition category
Condition code
Musculoskeletal 285935 285935 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of the Mobile Lumbar Traction unit twice a day, for at least 20mins per session, for a total of 14 sessions per week for 6 weeks; in conjunction with standardised physiotherapy treatment protocol.

The unit is a developmental prototype (provisional patent filed). Briefly, it consists of a upper and lower brace acting as anchors which the participant will wear in standing. Subsequently, the unit has a mechanical wheel crank which the participant will turn to increase the traction force applied on the lumbar region. On initial use, participants will be educated and supervised by the Principal Investigator on the correct use of the device.

For every participant, X-ray of the lumbar spine (standing lateral view) will be taken to analyse for any observable difference in intervertebral space and interforaminal area. One x-ray would be taken of subjects standing with the device worn. Following this, the device will be switched on for 5 minutes, and a second X-ray will be taken of the lumbar spine.
Intervention code [1] 284183 0
Treatment: Devices
Intervention code [2] 284184 0
Rehabilitation
Intervention code [3] 284197 0
Treatment: Devices
Comparator / control treatment
Standardised physiotherapy treatment protocol: once a week for 4 weeks.

Each session of approximately 30-45mins will consist of a review by a qualified physiotherapist and treatment will consists of conventional traction therapy, therapeutic exercise prescription, advice and education as well as any other adjunct therapt such as cryotherapy or electrotherapy as determined under the advice of the qualified physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 286423 0
Visual Analogue Scale for Pain
Timepoint [1] 286423 0
Baseline and 6th week from commencement
Primary outcome [2] 286424 0
Lumbar range of movement - using a digital inclinometer place at T12 and S1 anatomical landmark
Timepoint [2] 286424 0
Baseline and 6th week from commencement
Primary outcome [3] 286425 0
SF-36 questionaire - Physical Health and Mental Health domain: Physical Functioning, Role-Physical, Bodily-Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health scales.
Timepoint [3] 286425 0
Baseline and 6th week from commencement
Secondary outcome [1] 295840 0
EQ5D - single index value of health status based on the 5 domains of Mobility, Self-Care, Activity, Pain, Anxiety/Depression
Timepoint [1] 295840 0
Baseline and 6th week from commencement
Secondary outcome [2] 295841 0
Owestry Disability Index
Timepoint [2] 295841 0
Baseline and 6th week from commencement
Secondary outcome [3] 295842 0
Interspinous and Intervertebral space difference analysed on lateral views of 2 x-rays with mobile lumbar traction unit switched off and switch on.
Timepoint [3] 295842 0
Baseline

Eligibility
Key inclusion criteria
Patients diagnosed with central spinal stenosis, who are referred by senior physiotherapists (who have been managing musculoskeletal patients), and who have been deemed suitable to undergo traction therapy.
Minimum age
45 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of cancer or tumours
Recent spinal injury (less than 3 months from start of participation)
Undergone recent spinal injury (less than 3 months from start of participation)
Have history of physical trauma (eg. Falls, injuries, fractures) less than 3 months from start of participation.
Have undergone recent spinal surgery (less than 3 months from start of participation)
Have osteoporosis, severe scoliosis, or spondylolisthesis

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)
Once participants have been recruited into the study, they will be randomized using a block randomised design into either treatment group (TG) or control group (CG). Study participants will be identified by a unique number. The randomization sequence will be concealed with opaque envelopes. Study participants will be randomly assigned a specifc allocation number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 4101 0
Singapore
State/province [1] 4101 0
Singapore

Funding & Sponsors
Funding source category [1] 284633 0
Hospital
Name [1] 284633 0
Singapore Health Services Pte Ltd
Country [1] 284633 0
Singapore
Primary sponsor type
Individual
Name
Hanniel Han Rong LIM
Address
Singapore General Hospital
Allied Health Division
168 Jalan Bukit Merah
Connection 1, Tower 3 #06-08
Singapore 150168
Country
Singapore
Secondary sponsor category [1] 283546 0
Hospital
Name [1] 283546 0
Singapore General Hospital Pte Ltd
Address [1] 283546 0
Outram Road
Singapore 169608
Country [1] 283546 0
Singapore
Other collaborator category [1] 260495 0
Government body
Name [1] 260495 0
Ngee Ann Polytechnic
Address [1] 260495 0
535 Clementi Rd
Singapore 599489
Country [1] 260495 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286626 0
Singhealth Centralised Institutional Review Board
Ethics committee address [1] 286626 0
Singapore Health Services Pte Ltd
7 Hospital Drive, Block A, #03-01
SingHealth Research Facilities
Singapore 169611
Ethics committee country [1] 286626 0
Singapore
Date submitted for ethics approval [1] 286626 0
17/06/2011
Approval date [1] 286626 0
16/09/2011
Ethics approval number [1] 286626 0
CIRB# 2011/353/D

Summary
Brief summary
The aim of the study is to determine the effect of a mobile lumbar traction unit as an adjunct to standard physiotherapy to reduce pain and improve quality of life in patients with low back pain due to spinal stenosis.
We hypothesize that there will be a difference in pain reduction or an improvement of quality of life in the use of MLT as an adjunct treatment group.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33726 0
Address 33726 0
Country 33726 0
Phone 33726 0
Fax 33726 0
Email 33726 0
Contact person for public queries
Name 16973 0
Hanniel Han Rong LIM
Address 16973 0
Singapore General Hospital
Allied Health Division
168 Jalan Bukit Merah
Connection 1, Tower 3 #06-08
Singapore 150168
Country 16973 0
Singapore
Phone 16973 0
+6563266802
Fax 16973 0
Email 16973 0
[email protected]
Contact person for scientific queries
Name 7901 0
Hanniel Han Rong LIM
Address 7901 0
Singapore General Hospital
Allied Health Division
168 Jalan Bukit Merah
Connection 1, Tower 3 #06-08
Singapore 150168
Country 7901 0
Singapore
Phone 7901 0
+6563266802
Fax 7901 0
Email 7901 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.