Mechanisms of Chiropractic Spinal Manipulation for Chronic Low Back Pain

NCT05162924 | Completed

• 1 other identifier: SMTCLBP
• Study Type: interventional
• Target: 147
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain

Keywords

Chronic low back pain; Spinal manipulation; Central sensitization; Pressure pain thresholds; Cytokines; Chiropractic

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Pain intensity will be measured by showing patients a numerical rating scale from 0 (no pain at all) to 100 (maximum possible pain), and patients will rate with a number their current pain, highest, lowest and average during the 7 previous days (baseline) or the days following the previous session.

  4 weeks

• Oswestry Low Back Pain Disability Index

  The Oswestry Disability Index (ODI) questionnaire provides the level of self-reported disability in activities of daily living (ADL) related to low back pain. It includes 10 items rated on a Likert scale from 0-5. The total range of possible scores is from 0-50, where 0 means no disability at all, and 50 is the maximal disability.

  4 weeks

Secondary Outcomes (7)

• Pain Catastrophizing Scale

  4 weeks

• Central Sensitization Inventory

  4 weeks

• Pressure pain thresholds

  4 weeks

• Urinary levels of cytokine Tumor Necrosis Factor alpha

  4 weeks

• Beck Depression Inventory II

  4 weeks

Other Outcomes (15)

• Pain frequency

  Baseline measurement for exploratory purposes

• Pain duration

  Baseline measurement for exploratory purposes

• Pain widespreadness

  Baseline measurement for exploratory purposes

Study Arms (3)

Spinal manipulation

EXPERIMENTAL

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

Other: Spinal Manipulation

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Healthy controls

NO INTERVENTION

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

Interventions

Spinal Manipulation OTHER

Manual therapy technique applied by a chiropractor in the form of a high-velocity low-amplitude force to the lumbopelvic spine

Spinal manipulation

Placebo OTHER

Placebo spinal manipulation consisting in the application by a chiropractor of a lower-velocity lower-amplitude force to gluteal muscles in a non-intentional direction

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Real Centro Universitario Maria Cristina: lead
• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: collaborator
• Université du Québec à Trois-Rivières: collaborator
• University of Alcala: collaborator

Study Sites (1)

Real Centro Universitario María Cristina

El Escorial, Madrid, 28200, Spain

Location

Related Publications (4)

• 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.

  PMID: 22534654 BACKGROUND

• 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.

  PMID: 26000680 BACKGROUND

• 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.

  PMID: 33136983 BACKGROUND

• Gevers-Montoro C, Ortega-De Mues A, Piche M. Mechanisms of chiropractic spinal manipulative therapy for patients with chronic primary low back pain: protocol for a mechanistic randomised placebo-controlled trial. BMJ Open. 2023 Feb 10;13(2):e065999. doi: 10.1136/bmjopen-2022-065999.

  PMID: 36764718 DERIVED

MeSH Terms

Interventions

Manipulation, Spinal

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Arantxa Ortega-De Mues, PhD

  Real Centro Universitario María Cristina

  PRINCIPAL INVESTIGATOR

• Mathieu Piché, PhD

  Université du Québec à Trois-Rivières

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomly allocated to either one of two groups receiving real or sham spinal manipulation. The outcomes assessors will be unaware of the group allocation. The investigator will be unaware of the outcomes measured in patients. Healthy participants in the control group will be unaware of any study hypothesis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized placebo-controlled trial

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 17, 2021
• Study Start: December 17, 2021
• Primary Completion: December 30, 2022
• Study Completion: January 15, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD data will be available in 2022 or immediately after publication
• Access Criteria: Data will be available upon request via email to the corresponding author of the publication

Locations

ES (1)