Optimising conservative management of chronic low back pai

Completed

• Conditions: ow back pain; Low back pain; Musculoskeletal - Other muscular and skeletal disorders; Physical Medicine / Rehabilitation - Physiotherapy; Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation

• Registration Number: ACTRN12615001270505
• Lead Sponsor: Deakin University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-20
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
average lumbar spine intervertebral disc T2 relaxation time on MRI[0,3,6 months];change in thickness of transversus abdominis muscle on a leg lift in MRI[0,3,6 months]