Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000549426
Ethics application status
Approved
Date submitted
19/04/2016
Date registered
28/04/2016
Date last updated
2/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Does home-based tilt-table inversion traction therapy reduce pain in people with chronic discogenic low back pain (LBP)?
Scientific title
Testing a heuristic protocol for Inversion traction treatment for people with chronic discogenic low back pain (LBP): Randomised Control Trial
Secondary ID [1] 288947 0
Nil Known
Universal Trial Number (UTN)
U1111-1181-6697
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Discogenic Low Back Pain 298311 0
Condition category
Condition code
Musculoskeletal 298433 298433 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 298434 298434 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is investigating whether the use of inversion therapy may reduce pain in chronic LBP patients, where it is thought that the pain is associated with the intervertebral disc (i.e. discogenic pain), According to a heuristic assessment protocol of a prominent Musculoskeletal Pain Specialist with many years experience of using Inversion therapy for LBP.
In this study inversion therapy will be performed using the Teeter tilt-table.
We are looking to test whether four weeks of at-home inversion therapy is beneficial for people who have had LBP for more than six months, either with or without leg symptoms, which is suspected to involve the disc, and which has not settled with conventional therapy.
If participants are randomised into the inversion group (and have tolerated the inversion at the initial appointment and prior to randomisation), a tilt-table inversion machine will be delivered to their home for the four weeks of the trial. They may also continue with their usual care, as directed by the specialist. They will be expected to complete the inversion to 45 degrees, for 3 sets of 2 minutes (with 1 minute rest - in the upright position - between the 3 sets), twice (2 times) a day. So this would require 20 minutes a day. Also to encourage fidelity amongst the inversion group we will be asking them to complete a daily inversion diary.

It is well accepted, with respect to LBP, that the research, the current assessment and management knowledge is lmited, consequently it is difficult to be confident in the definition and diagnosis of LBP. We are basing our assessment of likely discogenic LBP on the work of Waddell (1987, 2005), Chou et al., (2007), and Chanda et al., (2011) concerning the diagnositic triage; as well as the work of Bogduk (2009) on referred pain; and researchers who have undertaken studies to help rule out hip (Brown et al., 2004), and SIJ disorders (Laslett et al., 2003; Szadek et al., 2009).
So the heuristic assessment protocol (detailed within the Inclusion and Exclusion criteria with respect to discogenic LBP) that we are testing (as well as the effect of inversion on this particular presentation of LBP) is based upon these sources. It is not 'newly developed' per se, as it is used in clinical practice but, in itself, has not been previously studied or validated;
Intervention code [1] 294423 0
Treatment: Devices
Comparator / control treatment
If participants are randomised into the usual care group, then they will continue with their usual care, as directed by the specialist. Usual care is to include advice and continuation with usual treatment that the participant is undertaking and in consultation with relevant referers such as GPs, physiotherapy, osteopathy, acupuncture etc. Because the participants have chronic pain on more than 50% of days over at least 6 months duration, and failed conservative treatment, it is expected that their current usual care has been ineffectual.
Control group
Active

Outcomes
Primary outcome [1] 297924 0
Effect of 4 weeks of usual care plus at-home inversion therapy versus usual care only, on pain using the Numercial Pain Rating Scale (NPRS) rated for the BACK.
Timepoint [1] 297924 0
NPRS for the BACK at baseline, after 4 weeks of intervention (usual care plus at-home inversion therapy for the experimental group, and usual care for the control group), and at 12 weeks
Primary outcome [2] 298096 0
Effect of 4 weeks of usual care plus at-home inversion therapy versus usual care only, on pain using the Numercial Pain Rating Scale (NPRS) rated for the LEG.
Timepoint [2] 298096 0
NPRS for the LEG at baseline, after 4 weeks of intervention (usual care plus at-home inversion therapy for the experimental group, and usual care for the control group), and at 12 weeks
Secondary outcome [1] 322642 0
Oswestry Disability Index (ODI); for assessing how well participants manage with their LBP.
Timepoint [1] 322642 0
ODI at baseline, after 4 weeks of intervention (usual care plus at-home inversion therapy for the experimental group, and usual care for the control group), and at 12 weeks
Secondary outcome [2] 322643 0
Patient Reported Outcomes Measurement Information System (PROMIS-29 v2.0); to allow participants to record how LBP affects them.
Timepoint [2] 322643 0
PROMIS-29 at baseline, after 4 weeks of intervention (usual care plus at-home inversion therapy for the experimental group, and usual care for the control group), and at 12 weeks
Secondary outcome [3] 322644 0
Participants will be asked about their Pain Medication Use, specifically what they are taking
0 No analgesic use
1 nonnarcotic analgesics, antidepressants, muscle relaxants < 4 x wk
2 nonnarcotic analgesics, antidepressants, muscle relaxants > 4 x wk
3 morphine or analogues < 4 x wk
4 morphine or analogues > 4 x wk
Timepoint [3] 322644 0
Pain medication use at baseline, after 4 weeks of intervention (usual care plus at-home inversion therapy for the experimental group, and usual care for the control group), and at 12 weeks
Secondary outcome [4] 322645 0
The Global Perceived Effect (GPE), so participants can tell us the effect of the four week study on their LBP.
Timepoint [4] 322645 0
GPE measured after 4 weeks of intervention (usual care plus at-home inversion therapy for the experimental group, and usual care for the control group), and at 12 weeks
Secondary outcome [5] 322646 0
Open Qualitative Question with written response given to the usual care plus inversion (experimental) group only, asking about their experience of inversion therapy in their own words
Timepoint [5] 322646 0
Open Qualitative Question at the end of the intervention at 4 weeks

Eligibility
Key inclusion criteria
Inclusion
Male or Female or Gender Uncertainty
Aged between 18 - 60 years
Height between 147 – 198 cm inclusive (height limits of tilt-table)
Chronic LBP for greater than 6 months duration, and consistent with discogenic LBP, with or without leg pain
LBP present on more than half the days in the past 6 months
At least 4/10 on the NPRS as used by Dr. Kanji
Pain aggravated by bending, lifting, sitting for long periods
Relieved by lying down, walking around
Radiological confirmation of disc derangement
MRI annular tear, dehydration, narrowing (less than or equal to 80%)
X-Ray changes of disc narrowing (less than or equal to 80%), or osteophytes
Experience no adverse effects while undergoing a trial on the tilt-table inversion (including ability to coordinate self-treatment using this device)
Ability (space) to accommodate the inversion table at home
No prior experience of inversion therapy
Proficient in English language
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion
Systemic Inflammatory disorders usually associated with constant pain, or little change with position or lying down, (Rheumatoid arthritis, psoriatic arthritis, SLE, Ankylosing Spondylitis, etc)
Recent fractures
Any hip disorders or hip replacements – hip pain predicted by presence of limp and anterior medial pain hip pain on stressing with flexion / adduction
Pain of sacro-iliac origin - patients with a positive thigh thrust test or compression test are more likely to have SI joint pain (Szadek et al., 2009) or 3 or more SIJ pain provocation tests in absence of centralisation or peripheralisation of pain (Laslett et al., 2003)
Pregnancy
Weight more than 140kg
Spinal surgery
Greater than 80% disc narrowing on X-ray or MRI scan
Uncontrolled arterial hypertension
Cerebrovascular accident
Hiatus hernia
Ventral hernia
Glaucoma
Detachment of retina
Known high intraocular pressure or central retinal artery pressure
Uncontrolled congestive heart failure
Severe vascular disease
Chronic obstructive & restrictive lung disorders
Osteoporosis
Vulnerable areas of stress from recent surgery
History of cancer
Psychological or physical impediment to inversion e.g. disability-wheelchair bound or
ankle pain

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)
Musculoskeletal Specialist - defines if patients are eligible for the trial but is blinded to group allocation

Lead Researcher - Allocation is concealed by sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block Randomisation prepared by the statistician who will be blinded to the group allocation. The randomisation sequence was generated using SAS 9.4 (SAS Institute Inc., Cary, NC, USA) statistical software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
120 participants in total (60 to each group) will be necessary for any statistically significant results to be obtained in our primary outcome measure, the NPRS (an 11-point scale that rates pain from 0 to 10). This is based on the study on inversion by Prasad et al., (2012), using the standard deviation of 2.7 points, with a power of 90%, and looking for a difference of two points or a reduction of approximately 30% to represent a minimal clinical important difference that exceeds the bounds of measurement error in the NPRS (Childs et al., 2005; Farrar et al., 2001; Ostelo et al., 2008). It also allows for around a 10% drop out rate.
We will analyse the results as intention-to-treat and also per-protocol.
The NPRS (analysed separately for back and leg), ODI and PROMIS-29 (T-scores as analysed by the Assessment Center Scoring System as recommended by PROMIS from our inputed raw scores from the seven individual profile domains) will be compared with a mixed model analysis of covariance with terms from group (intervention or control), patient with group, time (4 or 12 weeks), group x time interaction, and baseline pain score as the covariate. Pain Medication will be analysed with a ordinal logistic regression. This does not assume equal spacing but equal odds ratios of going from one level to the next (this assumption can be checked). The method would be a mixed ordinal logistic regression with terms from group (intervention or control), patient with group, time (4 or 12 weeks), group x time interaction, and baseline pain meds score. The GPE will be compared with a mixed model analysis of variance (no baseline - so no covariate). The statistical analysis will utilise the SAS 9.4 (SAS Institute Inc., Cary, NC, USA).
So we will be looking for any statistical significant and clinically significant differences between the inversion and control group in the baseline adjusted values at 4 and 12 weeks.
Also are those differences (4 and 12 week baseline adjusted group differences) statistically significant and clinically significantly different. I.e. is the effect of the inversion different at 4 and 12 weeks.
We are expecting to describe the continuous variables with means and SD and 95%CI for their differences. If the they are not close to a normal distribution then we would use medians.
We are assuming normally distributed data, but may make an alteration if this assumption seem unreasonable.

The Open Qualitative question given to the Inversion group will be analysed utilising the qualitative description (QD) method as it can openly borrow from other qualitative designs (Neergaard, Olesen, Andersen, & Sondergaard, 2009; Sandelowski, 2000), within a descriptive thematic approach framework, to identify the common themes associated with each patient’s experience of inversion.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/05/2016
Actual
15/06/2016
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
40
Final
Recruitment outside Australia
Country [1] 7795 0
New Zealand
State/province [1] 7795 0
Wellington

Funding & Sponsors
Funding source category [1] 293306 0
Charities/Societies/Foundations
Name [1] 293306 0
New Zealand Pain Foundation
Country [1] 293306 0
New Zealand
Funding source category [2] 293395 0
Commercial sector/Industry
Name [2] 293395 0
Teeter International
Country [2] 293395 0
United States of America
Primary sponsor type
Individual
Name
Associate Professor Rachel Page
Address
Director of Research and Education
Director School of Food and Nutrition Wellington
Team Leader Human Physiology and Metabolism
Massey Institute of Food Science and Technology
College of Health
Massey University Wellington
PO Box 756
Wellington 6140
Country
New Zealand
Secondary sponsor category [1] 292114 0
Individual
Name [1] 292114 0
Grant Plumbley (Masters student)
Address [1] 292114 0
Willis Street Physiotherapy Limited
Level 9, Willbank House,
57 Willis Street
PO Box 11351, Manners Street,
Wellington 6142
Country [1] 292114 0
New Zealand
Other collaborator category [1] 278934 0
Individual
Name [1] 278934 0
Dr Giresh Kanji
Address [1] 278934 0
The Sports and Pain Clinic
Level 2, 354 Lambton Quay
Wellington 6011
Country [1] 278934 0
New Zealand
Other collaborator category [2] 278935 0
Individual
Name [2] 278935 0
Dr Danielle Lambrick
Address [2] 278935 0
Lecturer in Life Sciences
Building 67
Faculty of Health Sciences
University of Southampton
University Road
Southampton
Hampshire
SO17 1BJ
Country [2] 278935 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294780 0
Massey University Human Ethics Committee: Human Ethics Southern A Committee
Ethics committee address [1] 294780 0
Ethics committee country [1] 294780 0
New Zealand
Date submitted for ethics approval [1] 294780 0
30/03/2016
Approval date [1] 294780 0
31/03/2016
Ethics approval number [1] 294780 0
Human Ethics Application SOA 16/15

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

Contacts
Principal investigator
Name 65006 0
Mr Grant Plumbley
Address 65006 0
Willis Street Physiotherapy Limited
Level 9, Willbank House,
57 Willis Street
PO Box 11351, Manners Street,
Wellington 6142
Country 65006 0
New Zealand
Phone 65006 0
+64 21 024 96714
Fax 65006 0
Email 65006 0
[email protected]
Contact person for public queries
Name 65007 0
Grant Plumbley
Address 65007 0
Willis Street Physiotherapy Limited
Level 9, Willbank House,
57 Willis Street
PO Box 11351, Manners Street,
Wellington 6142
Country 65007 0
New Zealand
Phone 65007 0
+64 21 024 96714
Fax 65007 0
Email 65007 0
[email protected]
Contact person for scientific queries
Name 65008 0
Grant Plumbley
Address 65008 0
Willis Street Physiotherapy Limited
Level 9, Willbank House,
57 Willis Street
PO Box 11351, Manners Street,
Wellington 6142
Country 65008 0
New Zealand
Phone 65008 0
+64 21 024 96714
Fax 65008 0
Email 65008 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.