Back to resultsMechanisms of Chiropractic Spinal Manipulation for Chronic Low Back Pain
Primary Purpose
Chronic Low-back Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Spinal Manipulation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low-back Pain focused on measuring Chronic low back pain, Spinal manipulation, Central sensitization, Pressure pain thresholds, Cytokines, Chiropractic
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
Sites / Locations
- Real Centro Universitario María Cristina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
Spinal manipulation
Placebo
Healthy controls
Arm Description
Group receiving 12 sessions of spinal manipulative therapy in the lumbar area
Group receiving 12 sessions of placebo spinal manipulative therapy in the lumbar area
A healthy control population will receive no treatment during the same time period (4 weeks) to measure the same physiological variables and their evolution.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Pain Catastrophizing Scale
The Pain Catastrophizing Scale (PCS) provides the level of catastrophizing beliefs and emotions that a person has with regards to his/her own pain experience, in this case, low back pain. It includes 13 items rated on a Likert scale from 0-4. The total range of possible scores is from 0-52, where 0 is the lowest possible level of catastrophizing and 52 the highest. This scale will also be used in healthy participants.
Central Sensitization Inventory
The Central Sensitization Inventory (CSI) identifies key symptoms associated with central sensitization and provides a quantification for the degree of these symptoms, which help to identify a central sensitization phenotype patients with chronic pain. It includes 25 items rated on a Likert scale from 0-4. The total range of possible scores is from 0-100, where 0 is the lowest possible level of central sensitization symptoms and 100 the highest. Additionally, the CSI asks one more question related to the previous diagnosis of either one of 10 conditions that have been related to central sensitization. this part is informative and is not used for scoring purposes. This scale will also be used in healthy participants.
Pressure pain thresholds
Pressure pain thresholds (PPTs) are part of quantitative sensory testing. The aim is to identify the threshold and the sensitivity to suprathreshold pressure stimulation in different areas of the patients' bodies. A digital algometer will be used (Wagner Force Dial FPX, Greenwich, CT, USA) to measure PPTs in the lumbar segment of greatest pain for each patient (2cm lateral to the spinous process or the posterosuperior iliac spine if applicable) locally, in the dermatome of this segment in the lower limbs, at the regional level four segments cranial from the segment of greatest pain, and remotely at the level of the thenar eminences. Measures will always be taken bilaterally two times, and averaged. At that time, the patient will rate in a numerical rating scale from 0 to 100 the intensity of the first painful stimulation (suprathreshold sensitivity). For healthy participants, pressure pain thresholds will be measured at every segment of the lumbar spine and in the thenar eminences.
Urinary levels of cytokine Tumor Necrosis Factor alpha
Tumor Necrosis Factor alpha (TNF-a) is a pro-inflammatory cytokines that have been involved with different stages of low back pain. First morning urine samples will be taken from patients and healthy participants at the beginning and the end of the trial period. Samples will be stored at -20ºC and concentrations will be measured with a sandwich ELISA. TNF-a will be the only cytokine used for before and after changes.
Beck Depression Inventory II
The Beck Depression Inventory (BDI-II) identifies key symptoms associated with clinical depression and provides a quantification for the presence and severity of depressive symptoms. It includes 21 items rated on a Likert scale from 0-3. The total range of possible scores is from 0-63, where 0 is the lowest possible level of depressive symptoms and 63 the highest.This scale will also be used in healthy participants.
Generalized Anxiety Disorder scale
The Generalized Anxiety Disorder (GAD) identifies key symptoms associated with generalized anxiety disorder and provides a quantification for the presence and severity of these symptoms. It includes 7 items rated on a Likert scale from 0-3. The total range of possible scores is from 0-63, where 0 is the lowest possible level of depressive symptoms and 21 the highest. The threshold of 10/21 is used to diagnose generalized anxiety disorder. This scale will also be used in healthy participants.
Expectations of pain relief
Participants will rate in a numerical rating scale their expectations of pain relief at the end of the trial. It will consist on a scale from -100 (maximum reduction in current pain) to 0 (no change) to +100 (maximum imaginable pain increase).
Full Information
NCT ID
NCT05162924
First Posted
December 2, 2021
Last Updated
January 23, 2023
Sponsor
Real Centro Universitario Maria Cristina
Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Université du Québec à Trois-Rivières, University of Alcala
1. Study Identification
Unique Protocol Identification Number
NCT05162924
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 17, 2021 (Actual)
Primary Completion Date
December 30, 2022 (Actual)
Study Completion Date
January 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Real Centro Universitario Maria Cristina
Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz, Université du Québec à Trois-Rivières, University of Alcala
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
Chronic low back pain, Spinal manipulation, Central sensitization, Pressure pain thresholds, Cytokines, Chiropractic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized placebo-controlled trial
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
147 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spinal manipulation
Arm Type
Experimental
Arm Description
Group receiving 12 sessions of spinal manipulative therapy in the lumbar area
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Group receiving 12 sessions of placebo spinal manipulative therapy in the lumbar area
Arm Title
Healthy controls
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Spinal Manipulation
Intervention Description
Manual therapy technique applied by a chiropractor in the form of a high-velocity low-amplitude force to the lumbopelvic spine
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
4 weeks
Title
Oswestry Low Back Pain Disability Index
Description
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.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pain Catastrophizing Scale
Description
The Pain Catastrophizing Scale (PCS) provides the level of catastrophizing beliefs and emotions that a person has with regards to his/her own pain experience, in this case, low back pain. It includes 13 items rated on a Likert scale from 0-4. The total range of possible scores is from 0-52, where 0 is the lowest possible level of catastrophizing and 52 the highest. This scale will also be used in healthy participants.
Time Frame
4 weeks
Title
Central Sensitization Inventory
Description
The Central Sensitization Inventory (CSI) identifies key symptoms associated with central sensitization and provides a quantification for the degree of these symptoms, which help to identify a central sensitization phenotype patients with chronic pain. It includes 25 items rated on a Likert scale from 0-4. The total range of possible scores is from 0-100, where 0 is the lowest possible level of central sensitization symptoms and 100 the highest. Additionally, the CSI asks one more question related to the previous diagnosis of either one of 10 conditions that have been related to central sensitization. this part is informative and is not used for scoring purposes. This scale will also be used in healthy participants.
Time Frame
4 weeks
Title
Pressure pain thresholds
Description
Pressure pain thresholds (PPTs) are part of quantitative sensory testing. The aim is to identify the threshold and the sensitivity to suprathreshold pressure stimulation in different areas of the patients' bodies. A digital algometer will be used (Wagner Force Dial FPX, Greenwich, CT, USA) to measure PPTs in the lumbar segment of greatest pain for each patient (2cm lateral to the spinous process or the posterosuperior iliac spine if applicable) locally, in the dermatome of this segment in the lower limbs, at the regional level four segments cranial from the segment of greatest pain, and remotely at the level of the thenar eminences. Measures will always be taken bilaterally two times, and averaged. At that time, the patient will rate in a numerical rating scale from 0 to 100 the intensity of the first painful stimulation (suprathreshold sensitivity). For healthy participants, pressure pain thresholds will be measured at every segment of the lumbar spine and in the thenar eminences.
Time Frame
4 weeks
Title
Urinary levels of cytokine Tumor Necrosis Factor alpha
Description
Tumor Necrosis Factor alpha (TNF-a) is a pro-inflammatory cytokines that have been involved with different stages of low back pain. First morning urine samples will be taken from patients and healthy participants at the beginning and the end of the trial period. Samples will be stored at -20ºC and concentrations will be measured with a sandwich ELISA. TNF-a will be the only cytokine used for before and after changes.
Time Frame
4 weeks
Title
Beck Depression Inventory II
Description
The Beck Depression Inventory (BDI-II) identifies key symptoms associated with clinical depression and provides a quantification for the presence and severity of depressive symptoms. It includes 21 items rated on a Likert scale from 0-3. The total range of possible scores is from 0-63, where 0 is the lowest possible level of depressive symptoms and 63 the highest.This scale will also be used in healthy participants.
Time Frame
4 weeks
Title
Generalized Anxiety Disorder scale
Description
The Generalized Anxiety Disorder (GAD) identifies key symptoms associated with generalized anxiety disorder and provides a quantification for the presence and severity of these symptoms. It includes 7 items rated on a Likert scale from 0-3. The total range of possible scores is from 0-63, where 0 is the lowest possible level of depressive symptoms and 21 the highest. The threshold of 10/21 is used to diagnose generalized anxiety disorder. This scale will also be used in healthy participants.
Time Frame
4 weeks
Title
Expectations of pain relief
Description
Participants will rate in a numerical rating scale their expectations of pain relief at the end of the trial. It will consist on a scale from -100 (maximum reduction in current pain) to 0 (no change) to +100 (maximum imaginable pain increase).
Time Frame
4 weeks
Other Pre-specified Outcome Measures:
Title
Pain frequency
Description
Chronic pain patients will describe whether their pain is episodic (pain-free periods of at least 4 week duration) or fluctuating (no pain-free periods of at least 4 week duration)
Time Frame
Baseline measurement for exploratory purposes
Title
Pain duration
Description
Pain duration at baseline since the onset of low back pain, described in months
Time Frame
Baseline measurement for exploratory purposes
Title
Pain widespreadness
Description
Patients will draw in a digital application (Symptom Mapper) the extent of their body affected by pain.
Time Frame
Baseline measurement for exploratory purposes
Title
Pain in lower extremity
Description
The presence of pain in the lower extremity concomitant or related to low back pain will be recorded as Yes/No answer.
Time Frame
Baseline measurement and changes post-treatment for exploratory purposes
Title
Pain medication use
Description
The use of pain medication (apart from the ones referred to in the exclusion criteria) will be reported as Yes/No answer, and a description will be noted.
Time Frame
Baseline measurement and changes post-treatment for exploratory purposes
Title
Clinical criteria 1 for diagnosing central sensitization type of pain
Description
A set of clinical criteria (defined by Smart et al., Manual Therapy 2015 and Nijs et al., Pain Physician 2015) will be used to classify patients as having central sensitization pain, this first one will be answered with a "Yes" or "No" regarding whether their pain is disproportionate to damage to lumbar tissues.
Time Frame
Baseline measurement for exploratory purposes
Title
Clinical criteria 2 for diagnosing central sensitization type of pain
Description
A set of clinical criteria will be used to classify patients as having central sensitization pain, this second one will be answered with a "Yes" or "No" regarding whether their pain has a diffuse anatomical distribution.
Time Frame
Baseline measurement for exploratory purposes
Title
Sex
Description
Biological sex (Male or Female)
Time Frame
Baseline measurement for exploratory purposes
Title
Age
Description
Age (measured in years)
Time Frame
Baseline measurement for exploratory purposes
Title
Level of education
Description
Education level (3 categories: basic, high school or university level)
Time Frame
Baseline measurement for exploratory purposes
Title
Chronic disease comorbidities
Description
The presence of other chronic disease comorbidities will be assessed as Yes/No answer.
Time Frame
Baseline measurement for exploratory purposes
Title
Adverse reactions (type)
Description
Type of adverse reaction to treatment (muscle stiffness, increased pain, radiating discomfort, and others - described by the patient)
Time Frame
Will be collected at the beginning of every treatment session, except the first one
Title
Adverse reactions (onset)
Description
Onset of adverse reaction to treatment (immediately, up to 24 hours, or more than 24 hours after the previous session)
Time Frame
Will be collected at the beginning of every treatment session, except the first one
Title
Adverse reactions (duration)
Description
Duration of adverse reaction to treatment (minutes, hours (< 24 hours), 24-48 hours, or > 48 hours)
Time Frame
Will be collected at the beginning of every treatment session, except the first one
Title
Adverse reactions (severity)
Description
Severity of adverse reaction to treatment (very mild, mild, moderate, severe, very severe)
Time Frame
Will be collected at the beginning of every treatment session, except the first one
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arantxa Ortega-De Mues, PhD
Organizational Affiliation
Real Centro Universitario María Cristina
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mathieu Piché, PhD
Organizational Affiliation
Université du Québec à Trois-Rivières
Official's Role
Principal Investigator
Facility Information:
Facility Name
Real Centro Universitario María Cristina
City
San Lorenzo De El Escorial
State/Province
Madrid
ZIP/Postal Code
28200
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All IPD that underlie results in a publication will be shared
IPD Sharing Time Frame
IPD data will be available in 2022 or immediately after publication
IPD Sharing Access Criteria
Data will be available upon request via email to the corresponding author of the publication
Citations:
PubMed Identifier
22534654
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.
Results Reference
background
PubMed Identifier
26000680
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.
Results Reference
background
PubMed Identifier
33136983
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.
Results Reference
background
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Mechanisms of Chiropractic Spinal Manipulation for Chronic Low Back Pain
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