Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000207819
Ethics application status
Approved
Date submitted
8/01/2021
Date registered
26/02/2021
Date last updated
11/08/2024
Date data sharing statement initially provided
26/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title

Does subgroup classification by movement patterns of chronic low back pain patients result in differing effects of a device based progressive strength and movement exercise rehabilitation ( 24 sessions), on measures of strength and range of movement in the spinal musculature and daily function and disability.
Scientific title
Effect of subgroup classification by movement patterns of chronic low back pain patients on strength, range of motion, pain, and disability following a device-based strength and movement exercise rehabilitation program
Secondary ID [1] 303303 0
none
Universal Trial Number (UTN)
U1111-1259-1373
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non specific chronic low back pain 319257 0
Condition category
Condition code
Musculoskeletal 317225 317225 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 317226 317226 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will provide two, 40 minute Device based exercise rehabilitation sessions per week over a 12-week period. All the device based exercise sessions will be supervised by physiotherapists and exercise physiologists who are experienced in prescribing and delivering device based strengthening and movement rehabilitation exercises to people with chronic low back pain. The first 5 sessions will be a one on one with the Exercise Therapist and all subsequent sessions will be on a small group basis of one to 5 participants supervised by the Exercise Therapist. A description of the specific device based rehabilitation exercise follows:

Device Based Isolated, Targeted and Progressive Resistance Strengthening and Movement:
Six specific Exercise Devices will be used in this study. The Devices and the inbuilt software [David Health Solutions Company, Finland] are designed to produce a strengthening training effect by isolating the spinal musculature and provide safe, progressive resistance exercise and permit range of motion (ROM) in flexion, extension, lateral flexion and rotation in the lumbar/thoracic and cervical spine.
These exercise devices are registered with Therapeutic Goods Administration (TGA), Department of Health as "Medical Exercise Rehabilitation Devices with measuring Function" .
The Device based strengthening and movement intervention training (24 sessions ,2 per week for 12 weeks) will have four distinct phases over the intervention:
Coordination phase
Adaptation phase
Strengthening phase
Normalization phase
Regardless of the Classification Pattern every patient will go through the same stages of progression, in the same order, however the timing and magnitude of each stage are very individual.
Using the strength and ROM data collected by each device during the initial assessment the training will commenced at 30% of the initial maximal pain free range of movement and at 25% of the maximal Isometric strength measured on assessment . Strength resistance starting point (Kg) is based off the individual initial isometric maximal torque Newton Meters where 1kg weight resistance equates to 0.98NM of torque.
Each device is fitted with a computer screen providing the patient with movement speed and ROM feedback, guidance and motivation to produce a quality consistent movements . The devices record performance indicators like the compliance graphs speed of movement and ROM) which indicates the patient's ability to co ordinate the specific concentric, eccentric and isometric muscle contractions of the spinal musculature.
Using the Exercise Device terminal, feedback, guidance and motivation will provide for the patients to complete one set of 20 controlled contractions (concentric, Isometric and eccentric) lasting 4.5seconds per repetition. Once Coordination is established ROM is progressed to above 50% ,the speed is adjusted to 6.0 seconds per repetition. under the guidance of the Exercise Therapist (Exercise Physiologist or Physiotherapist) the training/ rehabilitation program will be progressed to meet the following resistance levels for each phase: Orientation phase 2/5, Adaption phase 3/5, exercise phase 4/5 and optimisation phase 4/5 based on initial evaluation test.
Intervention code [1] 318726 0
Treatment: Devices
Intervention code [2] 318727 0
Rehabilitation
Intervention code [3] 319603 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325341 0
Oswestry Disability Index

Questionnaire scored using 10 sections about pain,disability and function. Overall scores are calculated into percentages ranging from 0 to 100%; higher percentages indicate worse disability. The Oswestry Disability Index contains ten items related to limitations in daily life activities, rating each on a 0–5 point scale; the points are added together and converted into a percentage (Fairbank and Pynsent 2000).
Timepoint [1] 325341 0
Baseline, 24 exercise sessions post commencement of intervention (Primary timepoint), and 12 months post the completion of the intervention.
Primary outcome [2] 325342 0
Evaluate changes in Pain VAS
Pain will be recorded by the patients using a 10-cm visual analogue scale, where 0 represented no pain and 10 represented unbearable pain.
Timepoint [2] 325342 0
Baseline, 24 exercise sessions post commencement of intervention (Primary timepoint), and 12 months post the completion of the intervention.
Primary outcome [3] 325343 0
Change in Spinal Muscular Strength Measurement: Maximal Isometric Torque (NM) recorded on the Devices in Lumbar/Thoracic Extension of the Spine. Seated with Hip lock and knees secured.
Timepoint [3] 325343 0
Baseline, 24 exercise sessions post commencement of intervention (Primary timepoint), and 12 months post the completion of the intervention.
Secondary outcome [1] 391143 0
This is a Primary outcome.
Change in Spinal Muscular Strength Measurement: Maximal Isometric Torque (NM) recorded on the Devices in Flexion of the Spine. Seated with Hip lock and knees secured
Timepoint [1] 391143 0
Baseline, 24 exercise sessions post commencement of intervention (Primary timepoint), and 12 months post the completion of the intervention.
Secondary outcome [2] 391145 0
This is a Primary Outcome.
Change in Spinal Muscular Strength Measurement: Maximal Isometric Torque (NM) recorded on the Devices in Lumbar/Thoracic Lateral Flexion. Seated with Hip lock and knees secured
Timepoint [2] 391145 0
Baseline, 24 exercise sessions post commencement of intervention (Primary timepoint), and 12 months post the completion of the intervention.
Secondary outcome [3] 391147 0
This is a Primary outcome
Change in Spinal Muscular Strength Measurements: Maximal Isometric Torque (NM) recorded on the Devices in Lumbar/Thoracic Rotation whilst seated the lower body laterally rotated 30 Degrees
Timepoint [3] 391147 0
Baseline, 24 exercise sessions post commencement of intervention (Primary timepoint), and 12 months post the completion of the intervention.
Secondary outcome [4] 391150 0
This is a primary outcome.
Change in Spinal Muscular Strength Measurements: Maximal Isometric Torque (NM) recorded on the Devices in Cervical Extension .
Timepoint [4] 391150 0
Baseline, 24 exercise sessions post commencement of intervention (Primary timepoint), and 12 months post the completion of the intervention.
Secondary outcome [5] 391152 0
This is a Primary Outcome.
Change in Spinal Muscular Strength Measurements: Maximal Isometric Torque (NM) recorded on the Devices in Cervical Rotation.
Timepoint [5] 391152 0
Baseline, 24 exercise sessions post commencement of intervention (Primary timepoint), and 12 months post the completion of the intervention.
Secondary outcome [6] 391154 0
This is a Primary Outcome
Change in Spinal Muscular Strength Measurements: Maximal Isometric Torque (NM) recorded on the Devices in Cervical Lateral Flexion.
Timepoint [6] 391154 0
Baseline, 24 exercise sessions post commencement of intervention (Primary timepoint), and 12 months post the completion of the intervention.
Secondary outcome [7] 391157 0
Change in Range of Motion (ROM)in the Spine. The Devices measure the degrees of motion possible without pain in extension in the lumbar/thoracic Spine.
Timepoint [7] 391157 0
Baseline, 24 exercise sessions post commencement of intervention , and 12 months post the completion of the intervention.
Secondary outcome [8] 391158 0
Change in Range of Motion (ROM)in the Spine. The Devices measure the degrees of motion possible without pain in flexion in the lumbar/thoracic Spine.
Timepoint [8] 391158 0
Baseline, 24 exercise sessions post commencement of intervention, and 12 months post the completion of the intervention.
Secondary outcome [9] 391159 0
Change in Range of Motion (ROM)in the Spine. The Devices measure the degrees of motion possible without pain in rotation in the lumbar/thoracic Spine.
Timepoint [9] 391159 0
Baseline, 24 exercise sessions post commencement of intervention, and 12 months post the completion of the intervention.

Eligibility
Key inclusion criteria
i) aged over 18 years;
ii) report recurrent low back pain with or without pain radiating into the lower limbs for at least six weeks
iii) demonstrate moderate disability on the Oswestry Disability Index (i.e., 28% or less).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(1) diagnosed as having a tumour, infection, or inflammatory disease affecting the spine;
(2) recent spinal or lower-limb surgery;
(3) had spinal fractures or structural deformities such as spondylolisthesis and spondylolysis;
(4) contraindications to exercise therapy (e.g., uncontrolled hypertension, previous myocardial infarction, cerebrovascular disease, peripheral vascular disease, respiratory disorders);
(5) signs of nerve root compromise, defined as decreased tendon reflexes, sensory loss, and motor deficits;
(6) receiving medications other than analgesics and non steroidal anti-inflammatory drugs.
(7) Oswestry Disability score exceeding 30.
(8) Patient with a Movement Classification 'Leg Dominant always constant pain (Red Flag Sciatica)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Patients presenting with chronic low back pain will be clinically classified into one of six subgroups by their ability to perform movement patterns which aggravate or alleviate their pain (Hall et al. 2013)
Classification Pattern 1: Back Dominant and aggravated by Flexion and relief with extension
Classification Pattern 2: Back Dominant and aggravated by Flexion and extension.
Classification Pattern 3: Back Dominant aggravated by Extension.
Classification Pattern 4: Leg Dominant always constant pain (Red Flag Sciatica)
Classification Pattern 5: Leg Dominant Flexion Aggravated pain is intermittent
Classification Pattern 6: Leg Dominant Flexion Relieved (bending forward).
Classification Pattern 4 makes the exercise intervention inappropriate for this group.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This study aims to evaluate the efficacy of a spinal muscular strengthening rehabilitation treatment for reducing pain and disability in subgroups of patients with chronic back pain. A two sided test of hypothesis will be conducted, at a =0.05, to assess whether there is a statistically significant difference in Oswestry Disability Index scores before and after treatment. Assume that the standard deviation in the difference scores is approximately 20 units this computes an effect size of 0.50. A sample of size n=32 patients for each subgroup with Oswestry Disability Index will ensure that a two-sided test with a =0.05 has 80% power to detect a minimum clinically important difference of 10 points in Oswestry Disability Index before and after treatment.
The statistical analysis will use the Repeated Measures Analysis of Variance (ANOVA-RM). SPSS version 12.0 (SPSS Inc, Chicago, IL) will be used to calculate descriptive and within and between -group inferential statistics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
15/05/2024
Date of last participant enrolment
Anticipated
1/07/2025
Actual
Date of last data collection
Anticipated
1/11/2025
Actual
Sample size
Target
180
Accrual to date
28
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment postcode(s) [1] 31666 0
3206 - Middle Park
Recruitment postcode(s) [2] 31676 0
2300 - Cooks Hill
Recruitment postcode(s) [3] 31677 0
2330 - Singleton
Recruitment postcode(s) [4] 31678 0
3550 - Bendigo
Recruitment postcode(s) [5] 31775 0
2446 - Wauchope

Funding & Sponsors
Funding source category [1] 306865 0
Commercial sector/Industry
Name [1] 306865 0
getback Pty Ltd
Country [1] 306865 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
getback Pty Ltd
Address
50-52 Mills Street
Middle Park
Victoria 3206
Country
Australia
Secondary sponsor category [1] 307506 0
None
Name [1] 307506 0
Address [1] 307506 0
Country [1] 307506 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307023 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 307023 0
Ethics committee country [1] 307023 0
Australia
Date submitted for ethics approval [1] 307023 0
30/01/2024
Approval date [1] 307023 0
25/03/2024
Ethics approval number [1] 307023 0
DUHREC 2024-083

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

Contacts
Principal investigator
Name 105774 0
Prof John Carlson
Address 105774 0
getback Pty ltd
50-52 Mills Street
Middle Park ,3204
Victoria
Country 105774 0
Australia
Phone 105774 0
+61 409213687
Fax 105774 0
Email 105774 0
[email protected]
Contact person for public queries
Name 105775 0
John Carlson
Address 105775 0
getback Pty Ltd
50-52 Mills Street
Middle Park, 3204
Victoria
Country 105775 0
Australia
Phone 105775 0
+61 409213687
Fax 105775 0
Email 105775 0
[email protected]
Contact person for scientific queries
Name 105776 0
John Carlson
Address 105776 0
getback Pty Ltd
50-52 Mills Street
Middle Park, 3204
Victoria
Country 105776 0
Australia
Phone 105776 0
+61 409213687
Fax 105776 0
Email 105776 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After de identification patient reported outcomes, including Oswestry Disability Index, VAS pain, multiple strength and range of motion measures in all Cervical, lumbar/thoracic movement planes.
When will data be available (start and end dates)?
Beginning Six months after publication and ending 36 months after publication in peer reviewed Journal.
Available to whom?
Researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To accomplish the aims of the proposal
How or where can data be obtained?
Access subject to approval of Principal Investigator Professor Emeritus John Carlson
email [email protected]


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.