A clinical trial of manipulative therapy and/or NSAIDs for significant acute low back pain

A randomised controlled trial to evaluate the effect of spinal manipulative therapy and/or NSAIDs on time to recovery of pain for patients with acute low back pain who have received general practitioner advice and paracetamol

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000036617

Enrollment

240

Registered

2005-07-22

Start date

2005-06-01

Completion date

2006-06-30

Last updated

2020-01-13

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

Conditions

None listed

Interventions

Study group 1: NSAIDs (Diclofenac 50 mg bd) and spinal manipulative therapy for up to 4 weeks Study group 2: NSAIDs (Diclofenac 50 mg bd) and placebo spinal manipulative therapy for up to 4 weeks Study group 3: Placebo NSAIDs and spinal manipulative therapy for up to 4 weeks

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

1) Primary complaint of pain extending in an area between the 12th rib and buttock crease. This may or may not be accompanied by leg pain. 2) New episode of low back pain. 3) Pain of less than 6 weeks duration (in accordance with the Cochrane Collaboration Back Review Group definition for acute pain). 4) Low back pain severe enough to cause moderate pain and moderate interference with normal work including work outside the home and housework (as measured by adaptations of items 7 and 8 of the SF-36).

Exclusion criteria

1) known or suspected serious spinal pathology (metastatic, inflammatory or infective diseases of the spine, cauda equina syndrome, spinal fracture). 2) nerve root compromise evidenced by at least two of the following (i) myotomal weakness, (ii) dermatomal or widespread sensory loss, (iii) hypo or hyperreflexia of the lower limb reflexes; 3) currently taking NSAIDs. 4) currently receiving SMT. 5) spinal surgery within the preceding 6 months; 6) history of peptic ulcer; 7) allergy to aspirin; 8) currently receiving anticoagulant therapy; 9) serious co-morbidities preventing prescription of NSAIDs or paracetamol eg: cardiac, liver or renal failure

Outcome results