Low Back Pain
Conditions
Keywords
Manipulation, Chiropractic, Low Back Pain
Brief summary
The investigators will be comparing the effectiveness of two types of chiropractic manipulation and standard medical care for patients with a recent onset of low back pain. The two types of chiropractic treatments being compared will be hands-on (manual) manipulation and mechanical-assisted (Activator) manipulation. The standard medical care will consist of a medical examination and prescription for over-the-counter anti-inflammatory medication.
Interventions
PROCEDUREManual Manipulation
Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
DEVICEMechanically-assisted manipulation
Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.
OTHERStandard Medical Care
Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: ≥ 18 years of age * Ability to read and write English * Experiencing a new episode of low back pain (LBP) with onset in the past 3 months * Oswestry Disability Index score between 20-70 points (0-100 scale) * Numeric pain rating score between 3-8 points (0-10 scale)
Exclusion criteria
* Prior history of lumbar spine surgery * History of unstable spondylolisthesis, spinal stenosis, or scoliosis \> 20° * Signs or symptoms suggestive of nerve root tension and/or neurological deficit in the lower extremity * History of metastatic cancer, osteoporosis, long-term corticosteroid use, or any other red flags of serious illness including the following: unexplained weight loss of \>10% of body weight, spinal pain associated with fever, and severe night pain unrelieved by medication * Receiving any physical therapy, chiropractic therapy, or any other manual therapy for this episode of LBP (within the past 3 months) * Receiving any on-going medical care for this episode of low back pain * Current use of opiate or other prescription medications for low back pain
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Low Back Pain Disability Index | 4 weeks (post treatment) | The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Score. | 4 weeks (post treatment) | Self-reported level of low back pain. We used the mean of 3 numeric pain rating scales: 1) current pain; 2) worst pain in the past 24 hours; and 3) average pain over the past week. Three individual 0 to 10 Likert scales were anchored by 0 indicating no pain and 10 indicating unbearable pain. Our primary statistical analysis looked at the change in pain scores from baseline to 4 weeks (post treatment). |
Countries
United States
Participant flow
Recruitment details
We recruited 112 patients with a new episode of low back pain from the general population of the Greater Pittsburgh Metropolitan region. Recruitment took place during the period of time between November 2010 and April 2013.
Pre-assignment details
197 patients were screened for potential eligibility. We excluded 85 patients for not meeting the inclusion criteria. Of the 40 patients randomized to Standard Medical Care, 3 never showed up for their first visit and 2 were withdrawn by the PI before receiving any treatments; leaving only 35 in that arm.
Participants by arm
| Arm | Count |
|---|---|
| Manual Manipulation Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants. | 37 |
| Mechanical Manipulation Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.
Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants. | 35 |
| Standard Medical Care Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated. | 35 |
| Total | 107 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Manual Manipulation | Total | Standard Medical Care | Mechanical Manipulation |
|---|---|---|---|---|
| Age, Continuous | 41.4 years STANDARD_DEVIATION 15.3 | 41.1 years STANDARD_DEVIATION 28.8 | 41.3 years STANDARD_DEVIATION 27.4 | 40.4 years STANDARD_DEVIATION 28.8 |
| Gender Female | 25 Participants | 67 Participants | 21 Participants | 21 Participants |
| Gender Male | 12 Participants | 40 Participants | 14 Participants | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 4 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 29 Participants | 11 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 7 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 67 Participants | 22 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 37 | 0 / 35 | 0 / 35 |
| serious Total, serious adverse events | 0 / 37 | 0 / 35 | 0 / 35 |
Outcome results
Primary
Oswestry Low Back Pain Disability Index
The Oswestry (OSW) Questionnaire provides the level of self-reported impairment of activity of daily living (ADLs) due to low back pain. There are 10 items in the OSW, each rated on a Likert scale from 0-5. The total range of possible scores is from 0 -50, which is converted to a percentage ranging from 0-100. The percentage of self-reported disability ranges from 0='no impairment' to 100='complete impairment'. Our statistical analysis looked at the change in OSW score (in percentage points) from baseline to 4 weeks (post treatment).
Time frame: 4 weeks (post treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Manipulation | Oswestry Low Back Pain Disability Index | -16.0 units on a scale | Standard Deviation 14.1 |
| Mechanical Manipulation | Oswestry Low Back Pain Disability Index | -8.9 units on a scale | Standard Deviation 11.9 |
| Standard Medical Care | Oswestry Low Back Pain Disability Index | -9.5 units on a scale | Standard Deviation 14.4 |
p-value: 0.009Regression, Linear
Secondary
Numeric Pain Rating Score.
Self-reported level of low back pain. We used the mean of 3 numeric pain rating scales: 1) current pain; 2) worst pain in the past 24 hours; and 3) average pain over the past week. Three individual 0 to 10 Likert scales were anchored by 0 indicating no pain and 10 indicating unbearable pain. Our primary statistical analysis looked at the change in pain scores from baseline to 4 weeks (post treatment).
Time frame: 4 weeks (post treatment)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Manual Manipulation | Numeric Pain Rating Score. | -3.7 units on a scale | Standard Deviation 1.5 |
| Mechanical Manipulation | Numeric Pain Rating Score. | -2.6 units on a scale | Standard Deviation 1.6 |
| Standard Medical Care | Numeric Pain Rating Score. | -1.9 units on a scale | Standard Deviation 2.2 |
p-value: 0.002Regression, Linear