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Trial registered on ANZCTR

Registration number

ACTRN12615001270505

Ethics application status

Approved

Date submitted

13/11/2015

Date registered

20/11/2015

Date last updated

16/10/2017

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]

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

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Physical Medicine / Rehabilitation

Physiotherapy

Physical Medicine / Rehabilitation

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]

Rehabilitation

Intervention code [2]

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]

average lumbar spine intervertebral disc T2 relaxation time on MRI

Timepoint [1]

0,3,6 months

Primary outcome [2]

change in thickness of transversus abdominis muscle on a leg lift in MRI

Timepoint [2]

0,3,6 months

Secondary outcome [1]

MRI: intervertebral disc water signal on DIXON scanning

Timepoint [1]

0,3,6 months

Secondary outcome [2]

MRI: trunk muscle size on MRI

Timepoint [2]

0,3,6 months

Secondary outcome [3]

MRI: lumbar muscle fat content

Timepoint [3]

0,3,6 months

Secondary outcome [4]

MRI: vertebral body fat content

Timepoint [4]

0,3,6 months

Secondary outcome [5]

Revised Oswestry disability questionnaire. Outcome = total disability index

Timepoint [5]

0,3,6 months

Secondary outcome [6]

DXA BMC lumbar spine

Timepoint [6]

0,3,6 months

Secondary outcome [7]

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]

0,3,6 months

Secondary outcome [8]

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]

0,3,6 months

Secondary outcome [9]

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]

0,3,6 months

Secondary outcome [10]

Questionnaires: low back pain intensity on visual analogue scale

Timepoint [10]

0,2,4,6,8,10,12 weeks

Secondary outcome [11]

Questionnaires: Depressive symptoms as measured by the Centre for Epidemiologic Studies Short Depression Scale (CES-D 10)

Timepoint [11]

0,2,4,6,8,10,12 weeks

Secondary outcome [12]

DXA body composition fat mass

Timepoint [12]

0,3,6 months

Secondary outcome [13]

MRI: Intervertebral disc volume

Timepoint [13]

0,3,6 months

Secondary outcome [14]

MRI: Intervertebral disc height

Timepoint [14]

0,3,6 months

Secondary outcome [15]

MRI: Intervertebral disc signal variation

Timepoint [15]

0,3,6 months

Secondary outcome [16]

MRI: Vertebral body cortex form

Timepoint [16]

0,3,6 months

Secondary outcome [17]

anthropometry: Body mass measured on digital scales

Timepoint [17]

0,3,6 months

Secondary outcome [18]

anthropometry: waist circumference measured with tape measure

Timepoint [18]

0,3,6 months

Secondary outcome [19]

anthropometry: hip circumference measured with tape measure

Timepoint [19]

0,3,6 months

Secondary outcome [20]

Transcranial magnetic stimulation (TMS): Motor threshold

Timepoint [20]

0,3,6 months

Secondary outcome [21]

TMS: Recruitment curve

Timepoint [21]

0,3,6 months

Secondary outcome [22]

TMS: MEP latency

Timepoint [22]

0,3,6 months

Secondary outcome [23]

TMS: Silent period

Timepoint [23]

0,3,6 months

Secondary outcome [24]

TMS:intracortical inhibition

Timepoint [24]

0,3,6 months

Secondary outcome [25]

TMS: Cortical Mapping

Timepoint [25]

0,3,6 months

Secondary outcome [26]

Questionnaires: PANAS. Outcome = mood.

Timepoint [26]

0,2,4,6,8,10,12 weeks

Secondary outcome [27]

Questionnaires: Barriers to Adherence to Rehabilitation

Timepoint [27]

0,3,6 months

Secondary outcome [28]

Questionnaires: IPAQ. Outcome = physical activity

Timepoint [28]

0,3,6 months

Secondary outcome [29]

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]

0,3,6 months

Secondary outcome [30]

Questionnaires: MOS SF-36. Outcome = quality of life.

http://www.rand.org/health/surveys_tools/mos/mos_core_36item.html

Timepoint [30]

0,3,6 months

Secondary outcome [31]

Questionnaires: Pittsburgh Sleep Quality Index

Timepoint [31]

0,3,6 months

Secondary outcome [32]

Questionnaires: Tampa Kinesiophobia Scale

Timepoint [32]

0,3,6 months

Secondary outcome [33]

Questionnaires: Endicott Work Productivity Scale

Timepoint [33]

0,3,6 months

Secondary outcome [34]

MRI: lumbar intervertebral disc expansion in lying

Timepoint [34]

0,3,6 months

Secondary outcome [35]

Questionnaires: Sports Injury Rehabilitation Beliefs Scale (SIRBS)

Timepoint [35]

0,3,6 months

Secondary outcome [36]

Does change in thickness of transversus abdominis (on MRI) mediate treatment-group specific changes in Oswestry Disability Index?

Timepoint [36]

0,3,6 months

Secondary outcome [37]

Does change in thickness of transversus abdominis (on MRI) mediate treatment-group specific changes in Pain (0-10 numerical rating scale)?

Timepoint [37]

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

Sex

Both males and females

Can healthy volunteers participate?

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

Completed

Date of first participant enrolment

Anticipated

27/11/2015

Actual

3/12/2015

Date of last participant enrolment

Anticipated

Actual

12/12/2016

Date of last data collection

Anticipated

Actual

15/05/2017

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

University

Name [1]

Deakin University

Address [1]

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]

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]

Commercial sector/Industry

Name [1]

Advance Healthcare Boronia

Address [1]

1/157 Scoresby Rd
Boronia VIC 3155

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Deakin University Human Research Ethics Committee (DUHREC)

Ethics committee address [1]

Deakin Research Integrity
Burwood Campus
221 Burwood Highway
Burwood Victoria 3125

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/06/2015

Approval date [1]

12/10/2015

Ethics approval number [1]

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

A/Prof Daniel Belavy

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

Phone

+61, 3, 9244 6606

Fax

d.belavy@deakin.edu.au

Contact person for public queries

Name

Daniel Belavy

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

Phone

+61, 3, 9244 6606

Fax

d.belavy@deakin.edu.au

Contact person for scientific queries

Name

Daniel Belavy

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

Phone

+61, 3, 9244 6606

Fax

d.belavy@deakin.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

Source	Title	Year of Publication	DOI
Embase	Optimising conservative management of chronic low back pain: Study protocol for a randomised controlled trial.	2017	https://dx.doi.org/10.1186/s13063-017-1913-8
Embase	General strength and conditioning versus motor control with manual therapy for improving depressive symptoms in chronic low back pain: A randomised feasibility trial.	2019	https://dx.doi.org/10.1371/journal.pone.0220442
Embase	Exercise for the intervertebral disc: a 6-month randomised controlled trial in chronic low back pain.	2020	https://dx.doi.org/10.1007/s00586-020-06379-7
Embase	Randomized trial of general strength and conditioning versus motor control and manual therapy for chronic low back pain on physical and self-report outcomes.	2020	https://dx.doi.org/10.3390/jcm9061726
Embase	Exercise may impact on lumbar vertebrae marrow adipose tissue: Randomised controlled trial.	2022	https://dx.doi.org/10.1016/j.bone.2022.116338
Embase	Protection motivation theory screening tool for predicting chronic low back pain rehabilitation adherence: Analysis of a randomised controlled trial.	2022	https://dx.doi.org/10.1136/bmjopen-2021-052644

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically