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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
147
Manual therapy technique applied by a chiropractor in the form of a high-velocity low-amplitude force to the lumbopelvic spine
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
Real Centro Universitario María Cristina
El Escorial, Madrid, Spain
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.
Time frame: 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.
Time frame: 4 weeks
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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 4 weeks