Low Back Pain
Conditions
Keywords
Spinal Manipulation
Brief summary
The purpose of this study is to compare the clinical effectiveness of two types of chiropractic spinal manipulation to conservative medical care for patients at least 55 years old with sub-acute or chronic LBP.
Detailed description
Despite the high prevalence of LBP and the associated economic costs, disability, and lost productivity, and despite the development of several treatment guidelines, one of which recommends chiropractic spinal manipulation for some subgroups of patients with back pain, the management of LBP remains controversial and highly variable across professions and geographic regions. Although one recent publication describes the design of chiropractic and exercise for seniors with low back or neck pain, no published studies, to our knowledge, have assessed the effectiveness of chiropractic manipulation compared to medical care for older adults with sub-acute or chronic low back pain.
Interventions
OTHERHVLA-SM
HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
OTHERLVVA-SM
LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
OTHERUsual Medical Care
Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen)
Sponsors
Department of Health and Human Services
Palmer College of Chiropractic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 21 to 55 * Idiopathic mechanical low back pain (LBP) matching classification 1-4 of the Quebec Task Force. * LBP classified as subacute (onset 4-12 weeks previous) or chronic (onset more than 12 weeks previous), with the current episode occurring at least four weeks prior to the date of contact with the clinic: In order to exclude the greatest proportion of LBP patients that have a favorable natural history of improvement. * Written Informed Consent * A minimum baseline score on the Roland Morris Disability Questionnaire (RMQ) of 6 points.
Exclusion criteria
* LBP from other somatic tissues as determined by history, examination, and course (e.g. pain referred from visceral conditions). * LBP diagnosis not meeting Classifications 1 through 4 of the Quebec Task Force, especially the following: low back pain associated with frank radiculopathy defined as typical shooting leg pain; positive straight leg-raising test; an altered lower extremity reflex; a dermatomal sensory deficit; at least one of the following: progressive unilateral muscle weakness or motor loss, or symptoms of cauda equina compression; and CT or MRI evidence of related anatomical pathology (e.g. abnormal disc, stenosis). * Co-morbid pathology or poor health conditions in patients; Co-morbid conditions and general poor health significantly complicate the prognosis of LBP, and inject a variety of uncontrollable factors in case-management, not to mention experimental analysis and interpretation. Patients who have case histories and physical examination findings indicating other that average good health will be excluded from the study. * Bone and joint pathology contraindicating patient for SM of the lumbar spine and pelvis: Patients with spinal fractures, tumors, infections, arthropathies, and significant osteoporosis will be referred to appropriate health care. * Other contraindications for SM of the lumbar spine and pelvis (e.g. bleeding disorders or anticoagulant therapy, extreme obesity). * Retention of legal advice related to this or a previous LBP episode: Patients with occupational or personal injuries will not be automatically excluded from the study unless they answer yes to a specific question about the retention of legal advice with respect to their LBP episode at the baseline interview. * Pregnancy: Pregnancy is a contraindication for exposing a patient to ionizing radiation and is a confounding factor in the usual course of LBP. * Inability to read or verbally comprehend English. * Clear evidence of narcotic or other drug abuse as determined by history and examination: injects significant confounding factors with respect to internal validity and feasibility. * Major clinical depression: Patients with scores greater than 17 on the Beck Depression Inventory will be excluded from the study. Patients with evidence of other psychiatric disorders as determined by history and exam will also be excluded. * Use of manipulative care for any reason within the past 3 months as determined by history: to exclude the possibility of carryover effects. * Unwillingness to postpone use of all other types of manual treatment for LBP except those provided in the study (including chiropractic and osteopathic SM, physical therapy, and massage) for the duration of the study period: to eliminate confounding effects.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Roland Morris Low Back Pain Disability Questionnaire (RMDQ) | Mean change from baseline to week 3 | The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. This outcome displays the mean change in RMDQ from baseline to week 3. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited primarily through direct mail and local media services.
Participants by arm
| Arm | Count |
|---|---|
| HVLA-SM HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation
HVLA-SM: HVLA-SM, Experimental, high-velocity low amplitude spinal manipulation | 72 |
| LVVA-SM LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation
LVVA-SM: LVVA-SM, Experimental, low velocity variable amplitude spinal manipulation | 72 |
| Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications
Usual Medical Care: Arm: Active Comparator: Usual Medical Care Usual Medical Care, Active Comparator, advice, exercises and medications (Celebrex, Aleve, Bextra, Naptoxen) | 48 |
| Total | 192 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 2 |
Baseline characteristics
| Characteristic | HVLA-SM | LVVA-SM | Usual Medical Care | Total |
|---|---|---|---|---|
| Age, Continuous | 40.5 years STANDARD_DEVIATION 10 | 39.3 years STANDARD_DEVIATION 8.8 | 40.3 years STANDARD_DEVIATION 9.5 | 40.0 years STANDARD_DEVIATION 9.4 |
| Race/Ethnicity, Customized Participant Race Other | 9 Participants | 9 Participants | 5 Participants | 23 Participants |
| Race/Ethnicity, Customized Participant Race White | 63 Participants | 63 Participants | 43 Participants | 169 Participants |
| Roland-Morris Disability Questionnaire (RMDQ) | 9.8 units on a scale STANDARD_DEVIATION 3.6 | 9.5 units on a scale STANDARD_DEVIATION 3 | 9.7 units on a scale STANDARD_DEVIATION 3 | 9.7 units on a scale STANDARD_DEVIATION 3.2 |
| Sex: Female, Male Female | 34 Participants | 33 Participants | 22 Participants | 89 Participants |
| Sex: Female, Male Male | 38 Participants | 39 Participants | 26 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 72 | 0 / 48 |
| other Total, other adverse events | 3 / 72 | 4 / 72 | 5 / 48 |
| serious Total, serious adverse events | 0 / 72 | 0 / 72 | 0 / 48 |
Outcome results
Primary
Roland Morris Low Back Pain Disability Questionnaire (RMDQ)
The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. This outcome displays the mean change in RMDQ from baseline to week 3.
Time frame: Mean change from baseline to week 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HVLA-SM | Roland Morris Low Back Pain Disability Questionnaire (RMDQ) | 4.0 units on a scale | Standard Deviation 4.2 |
| LVVA-SM | Roland Morris Low Back Pain Disability Questionnaire (RMDQ) | 3.8 units on a scale | Standard Deviation 4.1 |
| Usual Medical Care | Roland Morris Low Back Pain Disability Questionnaire (RMDQ) | 1.0 units on a scale | Standard Deviation 3 |