Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
112 participants
INTERVENTIONAL
2023-10-25
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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lumbar spinal manipulative therapy
Participants will receive spinal manipulative therapy (SMT) exclusively at dysfunctional lumbar segments. Participants will receive 36 SMT sessions over 12 weeks, 3 times per week, each session lasting ≈15 min. Spinal manipulation will be performed using the diversified technique. For each treatment, the SMT provider will perform two spinal manipulations, one on each side of the most painful lumbar vertebra. During spinal manipulations, participants will lay on their side and they will be instructed to inhale and exhale fully before each thrust.
lumbar spinal manipulative therapy
Spinal manipulative therapy involves the application of spinal manipulation over several sessions. Spinal manipulation is defined as a high-velocity, low-amplitude thrust performed by a clinician to move a segment of the spine in a specific direction. This type of intervention often generates cavitation sounds (audible pops).
full spine spinal manipulative therapy
Participants will receive spinal manipulative therapy (SMT) at dysfunctional spinal segments in the lumbar AND other spine regions. Participants will receive 36 spinal manipulative therapy (SMT) sessions over 12 weeks, 3 times per week, each session lasting ≈15 min. Spinal manipulation will be performed using the diversified technique. For each treatment, the SMT provider will perform a minimum of two spinal manipulations, one on each side of the most painful lumbar vertebra. Spinal manipulation will also be delivered at other dysfunctional spinal segments, based on clinical examination. During spinal manipulations, participants will lay prone, supine or on their side and they will be instructed to inhale and exhale fully before each thrust.
full spine spinal manipulative therapy
Spinal manipulative therapy involves the application of spinal manipulation over several sessions. Spinal manipulation is defined as a high-velocity, low-amplitude thrust performed by a clinician to move a segment of the spine in a specific direction. This type of intervention often generates cavitation sounds (audible pops).
sham spinal manipulative therapy
Participants will receive 36 sham SMT sessions (3x/week for 12 weeks, each session ≈15 min). This will target dysfunctional segments in the lumbar and other spine regions. Three maneuvers will be used:
* Ventral decubitus: 1 to 5 light and brief manual contacts (≈ 20 N and 5 s) will be applied and quickly released over the spinous process of dysfunctional vertebrae identified during clinical examination.
* Dorsal decubitus: sections of the treatment table will be slightly raised or lowered (≈ 5 cm) and their lower limbs' position changed once or twice e.g., knees bent, hips internally or externally rotated. Each position maintained during ≈ 30 s.
* Lateral decubitus: 1 to 5 impulses at the lowest setting of the Activator V instrument (Activator Methods Int. Ltd., Phoenix, Arizona, USA) will be applied on their gluteus and quadratus lumborum muscles. The position of the instrument will change after each impulse.
sham spinal manipulative therapy
Sham spinal manipulative therapy (sham SMT), was designed to be structurally equivalent to SMT, i.e., to attend to the same body regions with the same amount of contact as well as to have the same number, frequency and length of sessions. SMT and sham SMT will be provided by the same treatment provider and will appear to be similarly tailored to the participants' condition. Sham SMT does not share the component of interest of SMT, i.e., the activation of deep high-threshold mechanoreceptors via high-velocity, low-amplitude thrusts applied to the spine. Yet, it shares all the other components not of interest in this study that may contribute to the placebo response, such as therapeutic alliance, contextual factors, physical touch, and expectations. Furthermore, deception will be used to balance expectations and enhance blinding.
no intervention
This fourth arm will comprise healthy volunteers (age/sex-matched to the participants in the test intervention - lumbar group) who will not receive any intervention. The main purpose of this fourth group is to provide reference values to interpret some results obtained in participants with chronic primary low back pain.
No interventions assigned to this group
Interventions
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lumbar spinal manipulative therapy
Spinal manipulative therapy involves the application of spinal manipulation over several sessions. Spinal manipulation is defined as a high-velocity, low-amplitude thrust performed by a clinician to move a segment of the spine in a specific direction. This type of intervention often generates cavitation sounds (audible pops).
sham spinal manipulative therapy
Sham spinal manipulative therapy (sham SMT), was designed to be structurally equivalent to SMT, i.e., to attend to the same body regions with the same amount of contact as well as to have the same number, frequency and length of sessions. SMT and sham SMT will be provided by the same treatment provider and will appear to be similarly tailored to the participants' condition. Sham SMT does not share the component of interest of SMT, i.e., the activation of deep high-threshold mechanoreceptors via high-velocity, low-amplitude thrusts applied to the spine. Yet, it shares all the other components not of interest in this study that may contribute to the placebo response, such as therapeutic alliance, contextual factors, physical touch, and expectations. Furthermore, deception will be used to balance expectations and enhance blinding.
full spine spinal manipulative therapy
Spinal manipulative therapy involves the application of spinal manipulation over several sessions. Spinal manipulation is defined as a high-velocity, low-amplitude thrust performed by a clinician to move a segment of the spine in a specific direction. This type of intervention often generates cavitation sounds (audible pops).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Average LBP intensity during the last 7 days ≥ 3/10;
* (For healthy volunteers only) To be of the same sex and age (± 1 year) as a participant with low back pain.
Exclusion Criteria
* Presence of pain in another body location that is more severe than the pain in the lower back;
* Presence of a neurological deficit i.e., sensation loss, muscle weakness, decreased deep tendon reflexes;
* Presence of contraindications to spinal manipulative therapy e.g., recent fracture, history of spinal surgery, cauda equina syndrome, inflammatory arthritis, taking anticoagulant medication, active cancer, moderate to severe osteoporosis, abdominal aortic aneurysm;
* Underwent surgery in the last 3 months;
* Pregnancy, ≤ 3 months post-partum or planning to get pregnant in the next 12 months;
* History of spinal manipulative therapy in the past 12 months;
* Scoliosis ≥ 20°;
* BMI ≥ 40;
* Insufficient language skills in French to complete the questionnaires;
* Open or pending litigation for LBP or seeking/receiving disability compensation;
* Diagnosis of an illness affecting the sensorimotor functions e.g., diabetes, multiple sclerosis, amyotrophic lateral sclerosis;
* Diagnosis of mental health disorders (with the exception of anxiety and depression);
* Current drug or alcohol dependence;
* Skin of type I on the Fitzpatrick scale;
* (For healthy volunteers only) Regular use of pain medication or usage in the 48 h prior to data collection;
* (For healthy volunteers only) History of chronic pain;
* (For healthy volunteers only) Acute pain on the days of data collection.
18 Years
60 Years
ALL
Yes
Sponsors
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Université du Québec à Trois-Rivières
OTHER
Responsible Party
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Mathieu Piché
Professor
Principal Investigators
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Mathieu Piché
Role: PRINCIPAL_INVESTIGATOR
Université du Québec à Trois-Rivières
Locations
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Université du Québec à Trois-Rivières
Trois-Rivières, Quebec, Canada
Countries
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Central Contacts
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Facility Contacts
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Benjamin Provencher, D.C., M.Sc.
Role: primary
References
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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METRIC
Identifier Type: -
Identifier Source: org_study_id