About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Patients seeking treatment for low back pain present for less than 3 months, with an average intensity greater than 50 on a visual analog scale of 0-100 in the previous 48 hours.
Patients able to complete online questionnaires.
Patients who have given their free and informed consent.
Patients who are affiliated with or beneficiaries of a health insurance plan.
Disqualifiers
Patients with a history of back surgery, undergoing corticosteroid or morphine treatment, with acute or chronic inflammatory diseases, with psychiatric illness, or with low back pain lasting more than 3 months.
Patients who have already undergone spinal manipulation for low back pain with the investigator.
Patients participating or having participated in a therapeutic or drug study in the 3 months prior to their inclusion in this protocol.
Patients in a period of exclusion determined by another study.
Trial design
Parallel
Treatments tested in this trial
Spinal or peripheral manipulation of the lower back to treat lower back pain
Other interventionThe patient will receive treatment for lower back pain (spinal or peripheral manipulation) according to their assignment group.
Treatment groups
Trial outcomes
Primary outcomes
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
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
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
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
Pain assessment using a visual analog scale of 0-100 over the last 24/48 hours
Secondary outcomes
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)
Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).
Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)
Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).
Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)
Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).
Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)
Measurement of pain in the back and lower limbs at rest and during activities over the last 24/48 hours at 7/10 days and 3 weeks, then at 1 and 3 months using the visual analog pain scale (0-100).
Sponsors and contacts
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