None listed
Conditions
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.
Interventions
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 sm
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.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
25 Years to 45 Years
Healthy volunteers
No
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
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)
Outcome results
None listed