Trial registered on ANZCTR


Trial ID
ACTRN12615001270505
Ethics application status
Approved
Date submitted
13/11/2015
Date registered
20/11/2015
Date last updated
25/10/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising conservative management of chronic low back pain
Scientific title
In patients with low back pain, does general spine and body conditioning, compared to manual therapy, improve intervertebral disc characteristics?
Secondary ID [1] 287885 0
Nil known
Universal Trial Number (UTN)
U1111-1176-5023
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low back pain 296770 0
Condition category
Condition code
Musculoskeletal 297005 297005 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 297021 297021 0 0
Physiotherapy
Physical Medicine / Rehabilitation 297022 297022 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One group will receive spine and general physical conditioning exercise (including muscle strengthening, improving endurance, improving posture control and balance) over the course of 6 months.
Brief description of each component of the intervention:
a) what it involves
This protocol includes:
1) progressive resistance training
2) proprioceptive training
3) imagery/visualisations of pain provoking activities and/or movements
4) stretching exercises

b) how it is administered
Individual and/or small group sessions with clinical exercise physiologist and/or student

c) the frequency and duration of sessions
Week 1-12: Two supervised sessions per week, 1 hour duration
Week 13-26: One to two supervised sessions per week, 1 hour duration

d) any strategies used to monitor adherence to the intervention if applicable
Exercise diary for home exercises

e) home exercise program
In the first two weeks of the program, the Exercise Physiologist will determine the appropriate intensity of the home exercise protocol. From the third week onwards up until the end of the 6 month intervention period, the home exercise program will consist of:
1) aerobic exercise for 20 minutes, progressing to 40 minutes at 65-85% HRmax by the end of the program. Up to three occasions per week.
2) imagery rehearsal of tasks practiced with the trainer during the supervised exercise training sessions. The participant will be expected to do this once daily.
Intervention code [1] 293251 0
Rehabilitation
Intervention code [2] 293266 0
Treatment: Other
Comparator / control treatment
One group will receive manual therapy (physiotherapists do this to reduce pain and muscle spasm) and muscle control treatment (training of the stomach and back muscles) at a physiotherapy centre over the course of 6 months.
a) what it involves
Manual therapy and motor control training.

The motor control program will include a number of components. Specific muscle activation of transverses abdominis, lumbar multifidus and the pelvic floor will aim to facilitate maintenance of a tonic and automatic contraction at less than 30% of maximum voluntary contraction in daily activities. In most cases, this will require initial training in non-weight bearing positions (e.g. side lying) progressing to functional activities (e.g. walking, lifting). In addition there will be strength training of the global muscles of the spine integrated with specific muscle activation. Functional retraining of normal lumbo-pelvic kinematics will also be used during functional exercise.

Manual therapy will utilise a clinical reasoning process summarised as generation of preliminary hypotheses regarding the nature of the low back problem, provision of manual therapy individualised to this problem, reassessment of key assessment findings following manual therapy and re-evaluation of hypotheses. Manual therapy techniques will include posterior-anterior, transverse and rotation mobilisation as well as rotation manipulation.

b) how it is administered
Individual sessions with a physiotherapist

c) the frequency and duration of sessions
12 half hour treatment sessions over 6 months with a home exercise program

d) any strategies used to monitor adherence if applicable.
Exercise diary for home exercises

Home exercise program: All exercise will be conducted outside of the clinic and checked by the treating physiotherapist for compliance and technique at each treatment sessions. A range of specific muscle activation strategies will be used including lower abdominal drawing in manoeuvre, lifting of the pelvic floor muscles or swelling of lumbar multifidus. Specific muscle activation will commence in non-weight bearing positions with a dosage of 4/day, 5 x 5 seconds (depending on level of specific muscle activation control) progressing to 5 x 10 seconds. This dosage will be continued from non-weight bearing into standing. The first functional progression will be to walking 4/day for 2 minutes with 10 seconds on/off of specific muscle activation progressing to tonic activation. Functional exercise will then progress dependent on the functional goals of of the patient.
Control group
Active

Outcomes
Primary outcome [1] 296600 0
average lumbar spine intervertebral disc T2 relaxation time on MRI
Timepoint [1] 296600 0
0,3,6 months
Primary outcome [2] 296601 0
change in thickness of transversus abdominis muscle on a leg lift in MRI
Timepoint [2] 296601 0
0,3,6 months
Secondary outcome [1] 318857 0
MRI: intervertebral disc water signal on DIXON scanning
Timepoint [1] 318857 0
0,3,6 months
Secondary outcome [2] 318858 0
MRI: trunk muscle size on MRI
Timepoint [2] 318858 0
0,3,6 months
Secondary outcome [3] 318859 0
MRI: lumbar muscle fat content
Timepoint [3] 318859 0
0,3,6 months
Secondary outcome [4] 318860 0
MRI: vertebral body fat content
Timepoint [4] 318860 0
0,3,6 months
Secondary outcome [5] 318861 0
Revised Oswestry disability questionnaire. Outcome = total disability index
Timepoint [5] 318861 0
0,3,6 months
Secondary outcome [6] 318862 0
DXA BMC lumbar spine
Timepoint [6] 318862 0
0,3,6 months
Secondary outcome [7] 318863 0
trunk extensor endurance time.
Trunk extensor endurance test: the subject lies on their stomach (prone position) and the Hart Sport cushion is placed under their lower stomach such that the belly button is below the top border of the cushion. The subject should be able to balance on the cushion with their legs and trunk off the ground. Arms on the side (not touching ground). The subject then raises their chest (sternum) and legs off the floor. Subject to lift their chest as high off the ground as possible. The subject is to keep their neck bent forward (flexion). Every 30 seconds feedback is given on how long the position has been held for. Every 30 seconds also, the operator checks subject body alignment and asks the subject to reposition if necessary. The time to fatigue (in seconds) is recorded.
Timepoint [7] 318863 0
0,3,6 months
Secondary outcome [8] 318864 0
trunk flexor endurance time
Trunk flexor endurance test: the subject is asked to lie on their back and to raise their legs to 90-degrees of hip and knee flexion. .Forearms cross on chest. The subject then lifts their shoulders off the floor such that the lowest border of their shoulder-blade is not touching the floor. The subject maintains this position until exhaustion. Every 30 seconds feedback is given on how long the position has been held for. Every 30 seconds also, the operator checks subject body alignment and asks the subject to reposition if necessary. The time to fatigue (in seconds) is recorded.
Timepoint [8] 318864 0
0,3,6 months
Secondary outcome [9] 318865 0
VO2 max.
Protocol: Peak aerobic power will be assessed using a symptom limited graded exercise test on a motorised treadmill. Participants warm-up at a comfortable walking pace at 0% gradient and speed adjusted gradually until Ratings of Perceived Exertion (6-20 Borg point scale; RPE) of 8 / 20 is achieved. The gradient will be increased by 2% per minute until the participant subjectively reports a 17/20 (very hard) on the Borg rating of perceived exertion scale (RPEpeak = 17). Expired respiratory gases will be collected through a breath by breath pneumotach system. Pulse oximetry will be recorded each minute. Pre exercise and post exercise blood pressure will be taken.
Timepoint [9] 318865 0
0,3,6 months
Secondary outcome [10] 318866 0
Questionnaires: low back pain intensity on visual analogue scale
Timepoint [10] 318866 0
0,2,4,6,8,10,12 weeks
Secondary outcome [11] 318867 0
Questionnaires: Depressive symptoms as measured by the Centre for Epidemiologic Studies Short Depression Scale (CES-D 10)
Timepoint [11] 318867 0
0,2,4,6,8,10,12 weeks
Secondary outcome [12] 318868 0
DXA body composition fat mass
Timepoint [12] 318868 0
0,3,6 months
Secondary outcome [13] 318869 0
MRI: Intervertebral disc volume
Timepoint [13] 318869 0
0,3,6 months
Secondary outcome [14] 318870 0
MRI: Intervertebral disc height
Timepoint [14] 318870 0
0,3,6 months
Secondary outcome [15] 318871 0
MRI: Intervertebral disc signal variation
Timepoint [15] 318871 0
0,3,6 months
Secondary outcome [16] 318872 0
MRI: Vertebral body cortex form
Timepoint [16] 318872 0
0,3,6 months
Secondary outcome [17] 318873 0
anthropometry: Body mass measured on digital scales
Timepoint [17] 318873 0
0,3,6 months
Secondary outcome [18] 318874 0
anthropometry: waist circumference measured with tape measure
Timepoint [18] 318874 0
0,3,6 months
Secondary outcome [19] 318875 0
anthropometry: hip circumference measured with tape measure
Timepoint [19] 318875 0
0,3,6 months
Secondary outcome [20] 318876 0
Transcranial magnetic stimulation (TMS): Motor threshold
Timepoint [20] 318876 0
0,3,6 months
Secondary outcome [21] 318877 0
TMS: Recruitment curve
Timepoint [21] 318877 0
0,3,6 months
Secondary outcome [22] 318878 0
TMS: MEP latency
Timepoint [22] 318878 0
0,3,6 months
Secondary outcome [23] 318879 0
TMS: Silent period
Timepoint [23] 318879 0
0,3,6 months
Secondary outcome [24] 318880 0
TMS:intracortical inhibition
Timepoint [24] 318880 0
0,3,6 months
Secondary outcome [25] 318881 0
TMS: Cortical Mapping
Timepoint [25] 318881 0
0,3,6 months
Secondary outcome [26] 318882 0
Questionnaires: PANAS. Outcome = mood.
Timepoint [26] 318882 0
0,2,4,6,8,10,12 weeks
Secondary outcome [27] 318883 0
Questionnaires: Barriers to Adherence to Rehabilitation
Timepoint [27] 318883 0
0,3,6 months
Secondary outcome [28] 318884 0
Questionnaires: IPAQ. Outcome = physical activity
Timepoint [28] 318884 0
0,3,6 months
Secondary outcome [29] 318885 0
Questionnaires: Medication Usage
Participant is request to "Please write down any medications you took for your back or leg condition in the last 24-hours. (Include medication prescribed by your doctor as well as any other medication)." And to then provide the name of the medication, the number of tablets taken in the last 24 hours and the dosage per tablet. Questionnaire designed specifically for this study.
Timepoint [29] 318885 0
0,3,6 months
Secondary outcome [30] 318886 0
Questionnaires: MOS SF-36. Outcome = quality of life.

http://www.rand.org/health/surveys_tools/mos/mos_core_36item.html
Timepoint [30] 318886 0
0,3,6 months
Secondary outcome [31] 318888 0
Questionnaires: Pittsburgh Sleep Quality Index
Timepoint [31] 318888 0
0,3,6 months
Secondary outcome [32] 318889 0
Questionnaires: Tampa Kinesiophobia Scale
Timepoint [32] 318889 0
0,3,6 months
Secondary outcome [33] 318890 0
Questionnaires: Endicott Work Productivity Scale
Timepoint [33] 318890 0
0,3,6 months
Secondary outcome [34] 318891 0
MRI: lumbar intervertebral disc expansion in lying
Timepoint [34] 318891 0
0,3,6 months
Secondary outcome [35] 318954 0
Questionnaires: Sports Injury Rehabilitation Beliefs Scale (SIRBS)
Timepoint [35] 318954 0
0,3,6 months
Secondary outcome [36] 318965 0
Does change in thickness of transversus abdominis (on MRI) mediate treatment-group specific changes in Oswestry Disability Index?
Timepoint [36] 318965 0
0,3,6 months
Secondary outcome [37] 318966 0
Does change in thickness of transversus abdominis (on MRI) mediate treatment-group specific changes in Pain (0-10 numerical rating scale)?
Timepoint [37] 318966 0
0,3,6 months

Eligibility
Key inclusion criteria
Key inclusion criteria:
* Low back pain of at least 3 months duration. Can be recurrent intermittent low back pain.
* NRS scale (via telephone): minimum of 2 and maximum of 8
* Aged 25-45
* Sedentary: Less than 150 minutes moderate to vigorous physical activity per week. Moderate = make you breathe somewhat harder than normal
* Available to attend up to 3d/week to a facility at either Deakin University or Boronia
* Able to attend during work hours
* Able to attend a 3 hour testing sessions at baseline, 3 and 6 months at Deakin with an additional MRI scan on a different day
Minimum age
25 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Unable to attend of up to 2 sessions per week of 1 hours over a 6 month period.

2. Formal organised sport

3. Gym exercise more than one day a week

4. Any current parallel treatment

5. Unable to complete the testing protocol

6. Spinal pain/treatment exclusions:
* Any other current interventional treatment (aside from seeing GP and/or taking medication)
* Plans at the time of enrolment to undergo invasive treatment (injections or surgery) in the subsequent 6 months
* History of spinal surgery
* Is on a waiting list for spinal surgery
* Have a compensable claim for their back injury
* History of traumatic injury to the spine (e.g. fractures, car accident)
* Known scoliosis for which prior medical consultation has been sought.
* Have cauda equina syndrome based on imaging and bladder or bowel disturbance
* Neurological symptoms: radicular pain (symptoms on clinical subjective examination), pins/needles/numbness
* Non-musculoskeletal causes of low back pain (as defined upon review of baseline MRIs)

7. Current smoker

8. Known anaemia

9. Unable to communicate easily in English

10. Females:
* Pregnancy
* Possible pregnancy
* Breastfeeding
* Plans to become pregnant in next 6 months
* If during the course of the study a female subject thinks there is even a chance she may have become pregnant, she will be excluded from the study. The female subjects will be asked this before each testing session (0,3,6 months).
* Given birth in the last 9 months

11. Further DXA specific criteria:
* Had nuclear medicine done within 3 months (radioactive contrast agent)
* Metal or other implants in the spine
* Unable to fit onto the DXA table: weighs more than 130kg
* Possible pregnancy

12. MR specific criteria:
* Claustrophobia
* Any metal implants or fragments
* Any electronic implants (e.g. pacemaker)
* Piercings that cannot be removed
* Body weight above 120kg

13. TMS specific criteria:
* Epilepsy
* Chronic migraine
* History of seizures
* Family history of seizures
* Stroke
* Serious head injury (including neurosurgery) : a one off incident of concussion is OK, but repeated incidents or anything more serious is an exclusion
* Any illness that caused brain injury
* Any other brain-related condition
* Head implants or pacemakers
* Medication for mental health or neurological diseases (pain killers are ok)

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Anticipated
Actual
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 292380 0
University
Name [1] 292380 0
Deakin University
Address [1] 292380 0
Centre for Physical Activity and Nutrition Research
School of Exercise and Nutrition Sciences
Deakin University Burwood Campus
221 Burwood Highway
Burwood VIC 3125
Country [1] 292380 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Centre for Physical Activity and Nutrition Research
School of Exercise and Nutrition Sciences
Deakin University Burwood Campus
221 Burwood Highway
Burwood VIC 3125
Country
Australia
Secondary sponsor category [1] 291067 0
Commercial sector/Industry
Name [1] 291067 0
Advance Healthcare Boronia
Address [1] 291067 0
1/157 Scoresby Rd
Boronia VIC 3155
Country [1] 291067 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293850 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 293850 0
Deakin Research Integrity
Burwood Campus
221 Burwood Highway
Burwood Victoria 3125
Ethics committee country [1] 293850 0
Australia
Date submitted for ethics approval [1] 293850 0
03/06/2015
Approval date [1] 293850 0
12/10/2015
Ethics approval number [1] 293850 0
2015-191

Summary
Brief summary
This is a pilot study to gain initial data for understanding how treatments of chronic pain in the lower back work. Subjects will be randomised to one of two treatment groups. One group will receive manual therapy (physiotherapists do this to reduce pain and muscle spasm) and muscle control treatment (training of the stomach and back muscles to activate when they should) at a physiotherapy centre (Advance Healthcare) over the course of 6 months. Another group will receive spine and general physical conditioning exercise (including muscle strengthening, improving endurance, improving posture control and balance) at Deakin University over the course of 6 months. To assess the response to the different treatment protocols, magnetic resonance imaging scanning, tests of muscle strength, performance and endurance, dual x-ray absorptiometry scan of the lumbar spine and whole body composition, a series of questionnaires, and the assessment of how muscle activation occurs in the brain will be performed. Each of these tests will be done three times: at the start of the study before randomisation, then after 3 months and then at the end of the study at 6 months. Subjects will also complete a short questionnaire every two weeks to monitor their progress.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 61518 0
A/Prof Daniel Belavy
Address 61518 0
Centre for Physical Activity and Nutrition Research
School of Exercise and Nutrition Sciences
Deakin University Burwood Campus
221 Burwood Highway
Burwood VIC 3125
Country 61518 0
Australia
Phone 61518 0
+61, 3, 9244 6606
Fax 61518 0
Email 61518 0
d.belavy@deakin.edu.au
Contact person for public queries
Name 61519 0
A/Prof Daniel Belavy
Address 61519 0
Centre for Physical Activity and Nutrition Research
School of Exercise and Nutrition Sciences
Deakin University Burwood Campus
221 Burwood Highway
Burwood VIC 3125
Country 61519 0
Australia
Phone 61519 0
+61, 3, 9244 6606
Fax 61519 0
Email 61519 0
d.belavy@deakin.edu.au
Contact person for scientific queries
Name 61520 0
A/Prof Daniel Belavy
Address 61520 0
Centre for Physical Activity and Nutrition Research
School of Exercise and Nutrition Sciences
Deakin University Burwood Campus
221 Burwood Highway
Burwood VIC 3125
Country 61520 0
Australia
Phone 61520 0
+61, 3, 9244 6606
Fax 61520 0
Email 61520 0
d.belavy@deakin.edu.au