Clinical trial NCT05162924: Mechanisms of Chiropractic Spinal Manipulation for Chronic Low Back Pain
Official title: Efficacy of Chiropractic Spinal Manipulative Therapy in Patients With Primary Chronic Low Back Pain: a Mechanistic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Chronic low back pain
Spinal manipulation
Central sensitization
Pressure pain thresholds
Cytokines
Chiropractic
Lead sponsor: Real Centro Universitario Maria Cristina
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
name: Université du Québec à Trois-Rivières
name: University of Alcala
First posted: 2021-12-17
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized placebo-controlled trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Pain intensity
timeFrame: 4 weeks
measure: Oswestry Low Back Pain Disability Index
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain Catastrophizing Scale
timeFrame: 4 weeks
measure: Central Sensitization Inventory
timeFrame: 4 weeks
measure: Pressure pain thresholds
timeFrame: 4 weeks
measure: Urinary levels of cytokine Tumor Necrosis Factor alpha
timeFrame: 4 weeks
measure: Beck Depression Inventory II
timeFrame: 4 weeks
measure: Generalized Anxiety Disorder scale
timeFrame: 4 weeks
measure: Expectations of pain relief
timeFrame: 4 weeks
Other outcomes:
measure: Pain frequency
timeFrame: Baseline measurement for exploratory purposes
measure: Pain duration
timeFrame: Baseline measurement for exploratory purposes
measure: Pain widespreadness
timeFrame: Baseline measurement for exploratory purposes
measure: Pain in lower extremity
timeFrame: Baseline measurement and changes post-treatment for exploratory purposes
measure: Pain medication use
timeFrame: Baseline measurement and changes post-treatment for exploratory purposes
measure: Clinical criteria 1 for diagnosing central sensitization type of pain
timeFrame: Baseline measurement for exploratory purposes
measure: Clinical criteria 2 for diagnosing central sensitization type of pain
timeFrame: Baseline measurement for exploratory purposes
measure: Sex
timeFrame: Baseline measurement for exploratory purposes
measure: Age
timeFrame: Baseline measurement for exploratory purposes
measure: Level of education
timeFrame: Baseline measurement for exploratory purposes
measure: Chronic disease comorbidities
timeFrame: Baseline measurement for exploratory purposes
measure: Adverse reactions (type)
timeFrame: Will be collected at the beginning of every treatment session, except the first one
measure: Adverse reactions (onset)
timeFrame: Will be collected at the beginning of every treatment session, except the first one
measure: Adverse reactions (duration)
timeFrame: Will be collected at the beginning of every treatment session, except the first one
measure: Adverse reactions (severity)
timeFrame: Will be collected at the beginning of every treatment session, except the first one
Locations:
city: San Lorenzo De El Escorial
country: Spain
facility: Real Centro Universitario María Cristina
state: Madrid
Study officials:
affiliation: Real Centro Universitario María Cristina
name: Arantxa Ortega-De Mues, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université du Québec à Trois-Rivières
name: Mathieu Piché, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smart KM, Blake C, Staines A, Thacker M, Doody C. Mechanisms-based classifications of musculoskeletal pain: part 1 of 3: symptoms and signs of central sensitisation in patients with low back (+/- leg) pain. Man Ther. 2012 Aug;17(4):336-44. doi: 10.1016/j.math.2012.03.013. Epub 2012 Apr 23.
citation: Nijs J, Apeldoorn A, Hallegraeff H, Clark J, Smeets R, Malfliet A, Girbes EL, De Kooning M, Ickmans K. Low back pain: guidelines for the clinical classification of predominant neuropathic, nociceptive, or central sensitization pain. Pain Physician. 2015 May-Jun;18(3):E333-46.
citation: Shraim MA, Masse-Alarie H, Hodges PW. Methods to discriminate between mechanism-based categories of pain experienced in the musculoskeletal system: a systematic review. Pain. 2021 Apr 1;162(4):1007-1037. doi: 10.1097/j.pain.0000000000002113.