Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain.

Condition(s) studied

Investigational drug(s) / intervention(s)

Spinal or peripheral manipulation of the lower back to treat lower back pain: The patient will receive treatment for lower back pain (spinal or peripheral manipulation) according to their assignment group.

Study summary

Low back pain is the second most common reason for medical consultation in France and affects 60 to 80% of the working population. Patients with acute episodes of non-specific low back pain recover within 6 to 8 weeks, but recurrence is common and 7 to 10% of patients will experience persistent pain and disability for more than 3 months. Given their low efficacy and the risks associated with nonsteroidal anti-inflammatory drugs or opioids (nearly 60% of all opioids prescribed in the United States), the scientific literature does not support the use of pharmacological treatments. The international recommendations strongly suggest using non-pharmacological therapies, including physical exercise, rehabilitation, and spinal manipulation.Spinal manipulation (SM) is a common choice of therapy in primary care. In the patient's imagination "getting manipulated when in pain leads to heavy use of these manual therapies in a medical (manual medicine and medical osteopathy) or non-medical setting (manual therapy, osteopathy, and chiropractic). However, the evidence of effectiveness is weak in the chronic phase (only in the short term) and contradictory for the acute or subacute phases of low back pain. Pain and function are improved at 6 weeks, but the results are not clinically relevant. There is a lack of evidence regarding efficacy because the trials on spinal manipulations are of poor quality. A meta-analysis has recently reported that SMs are associated with a very limited risk of harm, making them a reasonable treatment option. Therefore, it seems necessary to demonstrate the specific effect of MVs in order to justify their use in primary care, support their wider use around the world, and reinforce recommendations for non-pharmacological treatment of low back pain.

Eligibility

Primary outcome measure(s)

• Short-term effectiveness (7 to 10 days) of spinal manipulation (SM) on pain over the last 24/48 hours in acute and subacute low back pain : experimental group — Day 0
  Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
• Short-term effectiveness (7 to 10 days) of spinal manipulation (SM) on pain over the last 24/48 hours in acute and subacute low back pain : experimental group — Day 7
  Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
• Short-term effectiveness (7 to 10 days) of spinal manipulation (SM) on pain over the last 24/48 hours in acute and subacute low back pain : experimental group — Day 10
  Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
• Short-term effectiveness (7 to 10 days) of peripheral manipulation (PM) on pain over the last 24/48 hours in acute and subacute low back pain : control group — Day 0
  Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
• Short-term effectiveness (7 to 10 days) of peripheral manipulation (PM) on pain over the last 24/48 hours in acute and subacute low back pain : control group — Day 7
  Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
• Short-term effectiveness (7 to 10 days) of peripheral manipulation (PM) on pain over the last 24/48 hours in acute and subacute low back pain : control group — Day 10
  Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours

Trial sites (1)

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