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NCT07403500Recruiting

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

Evaluation of the Short-term Effectiveness of Spinal Manipulation to Treat Acute and Subacute Low Back Pain. An Open-label Randomized Controlled Multicenter Trial.

Source: ClinicalTrials.gov · Last updated 23 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
416 (estimated)
First submitted
4 Feb 2026
Start date
28 May 2026
Primary completion date
May 2027
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
NCT number
NCT07403500

What you commit to

  • Study type: Interventional
  • Planned participants: 416
  • From 28 May 2026 to the primary completion date, May 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients participating or having participated in a therapeutic or drug study in the 3 months prior to their inclusion in this protocol.

Other illness

  • 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.

Other

  • Patients who have already undergone spinal manipulation for low back pain with the investigator.
  • 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nîmes University Hospital
Coordinator of this site? Confirm its status
NîmesFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.