Efficacy of Chiropractic Spinal Manipulative Therapy in Patients With Primary Chronic Low Back Pain: a Mechanistic Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Low-back Pain
- Sponsor
- Real Centro Universitario Maria Cristina
- Enrollment
- 147
- Locations
- 1
- Primary Endpoint
- Pain intensity
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Pain intensity
Time Frame: 4 weeks
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
Time Frame: 4 weeks
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 Outcomes
- Pain Catastrophizing Scale(4 weeks)
- Central Sensitization Inventory(4 weeks)
- Urinary levels of cytokine Tumor Necrosis Factor alpha(4 weeks)
- Generalized Anxiety Disorder scale(4 weeks)
- Expectations of pain relief(4 weeks)
- Pressure pain thresholds(4 weeks)
- Beck Depression Inventory II(4 weeks)