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| Name | Class |
|---|---|
| Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | OTHER |
| Université du Québec à Trois-Rivières | OTHER |
| University of Alcala | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal manipulation | Experimental | Group receiving 12 sessions of spinal manipulative therapy in the lumbar area |
|
| Placebo | Placebo Comparator | Group receiving 12 sessions of placebo spinal manipulative therapy in the lumbar area |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Manipulation | Other | Manual therapy technique applied by a chiropractor in the form of a high-velocity low-amplitude force to the lumbopelvic spine |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain frequency | 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) | Baseline measurement for exploratory purposes |
| Pain duration |
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arantxa Ortega-De Mues, PhD | Real Centro Universitario María Cristina | Principal Investigator |
| Mathieu Piché, PhD | Université du Québec à Trois-Rivières | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Real Centro Universitario María Cristina | El Escorial | Madrid | 28200 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22534654 | Background | 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. | |
| 26000680 | Background |
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All IPD that underlie results in a publication will be shared
IPD data will be available in 2022 or immediately after publication
Data will be available upon request via email to the corresponding author of the publication
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 15, 2021 | Dec 15, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 15, 2021 | Dec 15, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020393 | Manipulation, Spinal |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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Randomized placebo-controlled trial
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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.
| 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 |
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| 4 weeks |
| 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. | 4 weeks |
| 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. | 4 weeks |
| 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. | 4 weeks |
| 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. | 4 weeks |
| 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. | 4 weeks |
| 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). | 4 weeks |
Pain duration at baseline since the onset of low back pain, described in months
| Baseline measurement for exploratory purposes |
| Pain widespreadness | Patients will draw in a digital application (Symptom Mapper) the extent of their body affected by pain. | Baseline measurement for exploratory purposes |
| Pain in lower extremity | The presence of pain in the lower extremity concomitant or related to low back pain will be recorded as Yes/No answer. | Baseline measurement and changes post-treatment for exploratory purposes |
| Pain medication use | 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. | Baseline measurement and changes post-treatment for exploratory purposes |
| Clinical criteria 1 for diagnosing central sensitization type of pain | 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. | Baseline measurement for exploratory purposes |
| Clinical criteria 2 for diagnosing central sensitization type of pain | 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. | Baseline measurement for exploratory purposes |
| Sex | Biological sex (Male or Female) | Baseline measurement for exploratory purposes |
| Age | Age (measured in years) | Baseline measurement for exploratory purposes |
| Level of education | Education level (3 categories: basic, high school or university level) | Baseline measurement for exploratory purposes |
| Chronic disease comorbidities | The presence of other chronic disease comorbidities will be assessed as Yes/No answer. | Baseline measurement for exploratory purposes |
| Adverse reactions (type) | Type of adverse reaction to treatment (muscle stiffness, increased pain, radiating discomfort, and others - described by the patient) | Will be collected at the beginning of every treatment session, except the first one |
| Adverse reactions (onset) | Onset of adverse reaction to treatment (immediately, up to 24 hours, or more than 24 hours after the previous session) | Will be collected at the beginning of every treatment session, except the first one |
| Adverse reactions (duration) | Duration of adverse reaction to treatment (minutes, hours (< 24 hours), 24-48 hours, or > 48 hours) | Will be collected at the beginning of every treatment session, except the first one |
| Adverse reactions (severity) | Severity of adverse reaction to treatment (very mild, mild, moderate, severe, very severe) | Will be collected at the beginning of every treatment session, except the first one |
| 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. |
| 33136983 | 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. |
| 36764718 | Derived | 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. |