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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT000985-01A2 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to determine whether a form of electrical acupuncture, called percutaneous electrical nerve stimulation (PENS), can reduce pain and disability in older adults with chronic low back pain (LBP). This study will also determine the effects of general conditioning and aerobic exercise (GCAE) on chronic LBP.
Each year, a significant number of elderly individuals experience at least one episode of LBP. When LBP becomes chronic, it can lead to functional and emotional impairment, increased health care utilization, and decreased quality of life. Standard treatment for LBP typically consists of non-opioid analgesics and physical therapy; however, analgesic-associated morbidity in older adults often limits their utility. This study will determine the efficacy of PENS treatment, a neuroanatomically guided form of electroacupuncture, and exercise in reducing pain in older adults with chronic LBP.
Participants will be randomly assigned to one of four treatment groups: PENS alone, PENS placebo, PENS plus GCAE, or PENS placebo plus GCAE. The treatments will be given twice weekly for 6 weeks. Pain intensity, physical function, health care utilization, and psychosocial function will be assessed with self-report and performance-based measures. These assessments will be conducted at study start, immediately after the last treatment session, and 6 months after study completion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumbar PENS + exercise | Experimental | Lumbar PENS twice a week for six weeks combined with general conditioning and aerobic exercise |
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| Lumbar PENS | Active Comparator | Lumbar PENS twice a week for 6 weeks |
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| Control PENS | Placebo Comparator | Control lumbar PENS twice a week for 6 weeks |
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| Control PENS + exercise | Active Comparator | Control PENS twice a week for 6 weeks along with general conditioning and aerobic exercise |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumbar PENS + General Conditioning and Aerobic Exercise | Other | As above |
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| Measure | Description | Time Frame |
|---|---|---|
| Roland and Morris questionnaire | Baseline, post-intervention, 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra K. Weiner, MD | Pain Evaluation and Treatment Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Lumbar PENS |
| Other |
As above |
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| Control Lumbar PENS | Other | Identical needle placement as with PENS procedure, but only control needles stimulated for 5 minutes. |
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| Control PENS + exercise | Other | as above |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |