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

NCT07403500 | Not Yet Recruiting

• 1 other identifier: RESPIR/2022/AD-01
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Back Pain Lower Back Chronic

Keywords

Back; Pain; Chronic; Spinal manipulation

Outcome Measures

Primary Outcomes (6)

• 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

  Day 0

• 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

  Day 7

• 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

  Day 10

• 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

  Day 0

• 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

  Day 7

• 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

  Day 10

Secondary Outcomes (54)

• Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)

  Day 1 to 2

• Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)

  Day 1 to 2

• Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)

  Day 7 - 10

• Evolution of lower back pain and lower limb pain (above the knee) in the control group (PM)

  Day 7 - 10

• Evolution of lower back pain and lower limb pain (above the knee) in the experimental group (SM)

  Week 3

Study Arms (2)

SPINE MANIPULATION (SM)

EXPERIMENTAL

The physician determines the level(s) with segmental dysfunction(s), checks the conditions for performing MV (free directions of trunk movement, absence of red flags), which consists of a dynamic push at high speed and low amplitude, a lateral rotation push in flexion performed on one or more vertebral segments where minor intervertebral disturbances are located (patient lying on their side). The rationale behind this approach is to treat minor intervertebral disturbances causing lumbar pain by activating a reflex mechanism that allows muscle relaxation.

Other: Spinal or peripheral manipulation of the lower back to treat lower back pain

PERIPHERAL MANIPULATION (PM)

ACTIVE COMPARATOR

The doctor determines the level(s) with segmental dysfunction(s), then performs peripheral treatment using osteopathic techniques, offering comprehensive treatment for the patient. Mobilization and palpation are localized in the lower limbs (knee and ankle), the abdomen with massage of the psoas muscles, the upper limbs (shoulder and elbow), and the cervical spine with high-amplitude, low-speed mobilization without thrusting. The rationale behind this approach is the treatment of an overall imbalance causing back pain and requiring rebalancing.

Other: Spinal or peripheral manipulation of the lower back to treat lower back pain

Interventions

Spinal or peripheral manipulation of the lower back to treat lower back pain OTHER

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

Also known as: Physiotherapy

PERIPHERAL MANIPULATION (PM); SPINE MANIPULATION (SM)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

Nimes University Hospital

Nîmes, Gard, 30029, France

Location

MeSH Terms

Conditions

Pain; Bronchiolitis Obliterans Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Arnaud DUPEYRON, Professor

CONTACT

+33 4.66.68.34.59; arnaud.dupeyron@umontpellier.fr

Anissa MEGZARI

CONTACT

+33466684236; drc@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: As it is not possible to conduct this trial blinded or even with a blinded evaluator, in order to limit the detrimental effect of subjectivity, the word "placebo" will not be mentioned in the information given to patients (verbal information provided by investigators and written information sheet) and the meaning of the hypothesis will not be mentioned either. The aim will be to compare two types of manipulation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 11, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Locations

FR (1)