Skip to content

A study to validate a classification algorithm for Chronic low back pain participants using spinal injection as a comparison to measure improvement in symptoms.

A study to validate a classification algorithm for Chronic low back pain participants using spinal injection as a comparison to measure improvement in symptoms.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000267752
Enrollment
200
Registered
2013-03-06
Start date
2013-03-04
Completion date
2015-09-21
Last updated
2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

There are 3 components to this research study.Prior to assessment patients will be asked to completequality of life (QOL) and disability surveys and a visual analogue score (VAS) of their pain. 1. The McKenzie diagnostic classification (MKD) is used during examination of patients with chronic low back pain (CLBP) to determine if a joint or disc is likely to be the source of symptoms. It requires the patient to repeat movements in a number of directions. To determine the validity of this classification system physiotherapists will assess patients attending the Townsville Hospital Pain Clinic using the MKD. A neurosurgeon will also examine the patients and at the discretion of the neurosurgeon an injection of the joint or area surrounding the spinal nerves with anaesthetic and corticosteroid will be performed. The patient will be reassessed using MKD to determine if the injection has altered the pain response and range of motion. Outcome measures will be range of motion (ROM), response to MKD and (VAS) for pain. 2. It is known that the core trunk muscles supporting the spine 'switch-off' when pain is present but it is unknown what direct effect pain relieving injections have on the short term and long term function of the core muscles. Hence, patient core muscle function will also be assessed prior to and after injection using ultrasonography. We hypothesise that the physiotherapy classification pathway will be a valid physiotherapy diagnostic indicator for CLBP patients. We also hypothesise that the deep spinal postural muscles (transversus abdominis and Lumbar Multifidus) do not immediately start to function normally post spinal anaesthetic injection.

Interventions

Physiotherapy diagnostic classification and examination ( modified McKenzie diagnostic classification),measurement of transversus abdominis and lumbar multifidus muscle using real time ultrasound scanning, flouroscopy guided spinal (either facet, foraminal or epidural) injections - conducted by a neurosurgeon, and determined by the neurosurgeon diagnosis. The procedure consists of instillation of less than 30 mls of 0.25% Bupivicaine (Marcaine) or less than 10 mls of 1% Lignocaine, and 40 mg (p

Physiotherapy diagnostic classification and examination ( modified McKenzie diagnostic classification),measurement of transversus abdominis and lumbar multifidus muscle using real time ultrasound scanning, flouroscopy guided spinal (either facet, foraminal or epidural) injections - conducted by a neurosurgeon, and determined by the neurosurgeon diagnosis. The procedure consists of instillation of less than 30 mls of 0.25% Bupivicaine (Marcaine) or less than 10 mls of 1% Lignocaine, and 40 mg (per vial) of Methylprednisolone (Depomedrone) as determined by the attending neurosurgeon, into the predetermined spinal structure Duration of intervention 2hours with two repeat sessions consisting of a 2 week phone interview and 3 month post injection 20minute reexamination. Flouroscopy guided injection as reference standard. This is the usual treatment that would be applied to the study cohort.

Sponsors

Miss Carol Ann Flavell
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Adults presenting with pain of spinal origin and distribution below T12. of duration greater than 12 weeks.

Exclusion criteria

Post spinal surgery previous twelve months, serious medical pathology, systemic inflammatory conditions such as rheumatoid Arthritis or Ankylosing Spondylitis, pregnancy, psychological or physical disorders which would render the participant unable to tolerate the examination/study process. < 18years old

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026