Mechanisms of Chiropractic Spinal Manipulation for Chronic Low Back Pain

Real Centro Universitario Maria Cristina

Status: Completed

Conditions: Chronic Low-back Pain

Treatments: Other: Spinal Manipulation; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05162924

SMTCLBP

Details and patient eligibility

About

This is a mechanistic randomized controlled trial on the effects of chiropractic spinal manipulative therapy on patients with chronic low back pain. It is designed as a mechanistic trial, in which the main objective is to identify which variables related to central sensitization can help predict the response to spinal manipulation, and the evolution of which of these variables can help explain clinical changes in chronic low back pain patients receiving spinal manipulative therapy.

Full description

The study is a mechanistic randomized controlled trials on the effects of chiropractic spinal manipulative therapy on patients with chronic low back pain. 100 chronic low back pain patients will be randomly allocated to receive 12 sessions over 4 weeks of spinal manipulative therapy or placebo spinal manipulation. The main objective is to identify variables related to a central sensitization or nociplastic pain phenotype can help predict the response to spinal manipulation. Additionally, changes in these variables during the treatment period will be used to identify potential pain mechanisms involved in pain relief by spinal manipulation. An additional group of 50 healthy volunteers will be used to measure the same variables and their evolution during 4 weeks in a healthy control population. Response to treatment will be measured according to changes in pain intensity and disability.

Enrollment: 147 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Healthy volunteers will be accepted for that specific comparison group. Those volunteers must demonstrate no evidence of any systemic pathology, inflammatory, psychiatric, neurological or pain condition.

Inclusion Criteria:

• diagnosis of primary chronic low back pain (performed in the initial evaluation or previously received by a healthcare professional), with or without leg pain
• minimum of three months of duration

Exclusion Criteria:

• diagnosis of neuropathic pain in the lower extremity
• evidence of specific pathology affecting the lumbar spine
• diagnosis of psychiatric disorder or pain disorder affecting the hand/thumb or in the vicinity of the lumbar area
• intake corticosteroids, opioids or anticytokine medications
• pregnancy
• having been treated with spinal manipulation in the previous 12 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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147 participants in 3 patient groups, including a placebo group

Spinal manipulation

Experimental group

Description:

Group receiving 12 sessions of spinal manipulative therapy in the lumbar area

Treatment:

Other: Spinal Manipulation

Placebo

Placebo Comparator group

Description:

Group receiving 12 sessions of placebo spinal manipulative therapy in the lumbar area

Treatment:

Other: Placebo

Healthy controls

No Intervention group

Description:

A healthy control population will receive no treatment during the same time period (4 weeks) to measure the same physiological variables and their evolution.