Low Back PainPhase 3NCT00101387
Effects of Lumbar PENS and Exercise in Older Adults With Chronic Low Back Pain
A Phase 3 study testing Lumbar PENS + General Conditioning and Aerobic Exercise and Lumbar PENS in people with Low Back Pain, run by University of Pittsburgh.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Lumbar PENS + General Conditioning and Aerobic Exercise and Lumbar PENS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2003to Jan 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Low back pain for at least 3 months
- Able to walk without an assistive device (e.g., cane or walker)
Who cannot join
- Serious underlying illness causing back pain
- Nerve root compression
- History of back surgery
- Has pacemaker
- Current use of blood thinners
- Major psychiatric disorder
- Chest pains or heart problems that interfere with daily activity
- Fibromyalgia
About this study
Official title: Functional Impact of PENS for 65+ Chronic Low Back Pain
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.
Read the detailed description
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.
- Conditions
- Low Back Pain
- Being tested
- Lumbar PENS + General Conditioning and Aerobic Exercise, Lumbar PENS, Control Lumbar PENS, Control PENS + exercise
- Keywords
- Aged, Acupuncture
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar PENS + General Conditioning and Aerobic ExerciseOther
As above
Lumbar PENSOther
As above
Control Lumbar PENSOther
Identical needle placement as with PENS procedure, but only control needles stimulated for 5 minutes.
Control PENS + exerciseOther
as above
| Study group | Role | What they receive |
|---|---|---|
| Lumbar PENS + exercise | Experimental | Lumbar PENS twice a week for six weeks combined with general conditioning and aerobic exercise Receives: Other: Lumbar PENS + General Conditioning and Aerobic Exercise |
| Lumbar PENS | Active comparator | Lumbar PENS twice a week for 6 weeks Receives: Other: Lumbar PENS |
| Control PENS | Placebo comparator | Control lumbar PENS twice a week for 6 weeks Receives: Other: Control Lumbar PENS |
| Control PENS + exercise | Active comparator | Control PENS twice a week for 6 weeks along with general conditioning and aerobic exercise Receives: Other: Control PENS + exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland and Morris questionnaire
Measured: Baseline, post-intervention, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2005 (estimated)
- Study startSep 2003
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA)
- Investigators
- Debra K. Weiner, MD, Principal investigator, Pain Evaluation and Treatment Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00101387
- Sponsor's protocol ID
- R01AT000985-01A2
- Other IDs
- R01AT000985-01A2
- Status last verified
- Feb 2011
- First submitted
- 10 Jan 2005
- Last updated
- 18 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Impact of PENS for 65+ Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT00101387
- Acronym / sponsor ID
- R01AT000985-01A2
- Conditions
- Low Back Pain
- Keywords
- Aged, Acupuncture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), National Institute on Aging (NIA)
- Study start
- Sep 2003
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 11 Jan 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lumbar PENS + exercise | Experimental | Other: Lumbar PENS + General Conditioning and Aerobic ExerciseLumbar PENS twice a week for six weeks combined with general conditioning and aerobic exercise |
| Lumbar PENS | Active comparator | Other: Lumbar PENSLumbar PENS twice a week for 6 weeks |
| Control PENS | Placebo comparator | Other: Control Lumbar PENSControl lumbar PENS twice a week for 6 weeks |
| Control PENS + exercise | Active comparator | Other: Control PENS + exerciseControl PENS twice a week for 6 weeks along with general conditioning and aerobic exercise |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Low back pain for at least 3 months
- Able to walk without an assistive device (e.g., cane or walker)
Key exclusion criteria (8 listed)
- Serious underlying illness causing back pain
- Nerve root compression
- History of back surgery
- Has pacemaker
- Current use of blood thinners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumbar PENS + General Conditioning and Aerobic ExerciseAs above | Other | Lumbar PENS + exercise |
| Lumbar PENSAs above | Other | Lumbar PENS |
| Control Lumbar PENSIdentical needle placement as with PENS procedure, but only control needles stimulated for 5 minutes. | Other | Control PENS |
| Control PENS + exerciseas above | Other | Control PENS + exercise |
Primary outcome
Roland and Morris questionnaire
Time frame: Baseline, post-intervention, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Debra K. Weiner, MD principal investigator
Pain Evaluation and Treatment Institute
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lumbar PENS + General Conditioning and Aerobic Exercise and Lumbar PENS in people with Low Back Pain, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland and Morris questionnaire (time frame: Baseline, post-intervention, 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2011.