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

N/ANot Yet RecruitingNCT07403500

Centre Hospitalier Universitaire de Nīmes416 enrolled

Overview

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.

Low back pain is a common musculoskeletal condition that affects 60 to 80% of the working population at least once in their lifetime. 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 them will experience persistent pain and disability for more than 3 months. It is the second most common reason for medical consultation in France. The scientific literature does not support the use of pharmacological treatments given their low efficacy and the risks associated with prescribing nonsteroidal anti-inflammatory drugs or opioids (which account for nearly 60% of all opioids prescribed in the United States). It is therefore easy to understand why the international recommendations strongly suggest using non-pharmacological therapies, including physical exercise, rehabilitation, and spinal manipulation. Spinal manipulation (SM) is a very common therapy of choice in primary care, enjoying popularity beliefs rooted in the patient's imagination ("getting manipulated when you're in pain"), leading 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, evidence of effectiveness is considered 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. The main reason for this lack of evidence is that efficacy trials concerning spinal manipulations are, at best, of poor quality for a number of reasons: SMs are very often combined with other strategies (exercises, medication, rehabilitation, etc.), which limits the assessment of a specific effect; manual therapies are very diverse, limiting comparability; the time required to assess the effects is often long (more than 4 weeks), comparable to the usual time required for pain to resolve; comparative trials are of low power, limiting the ability to demonstrate a difference; The use of a placebo comparator to test the effect of MV is not trivial and must be carefully defined, particularly for physicians who do not consider placebo to be an alternative in standard care. As far as we know, there has only been one RTC against placebo, the results of which were negative (n=240). 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. The hypothesis is that patients receiving spinal manipulations will experience greater pain relief in the short term (7 to 10 days after treatment) than patients receiving peripheral manipulations. Patients in the experimental group (spinal manipulation) should also show improvement in their pain in the medium term, their functional abilities, their physical and work avoidance scores, catastrophizing, and the occurrence of lumbar flare-ups up to three months of follow-up.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Patients under legal protection, guardianship, or conservatorship. * Patients unable to give their consent. * Patients for whom it is impossible to provide informed consent. * Pregnant or breastfeeding patients.

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