Low Back PainPhase 1NCT00502619
Assessment of Acupuncture to Improve Function, Exercise Capacity, and Pain
A Phase 1 study testing Acupuncture and Treadmill Exercise in people with Low Back Pain, run by VA Maryland Health Care System at 1 site in United States.
Trial summary
The purpose of this research proposal is to conduct a feasibility study to determine the viability a larger efficacy study of combined acupuncture treatments plus treadmill exercise to decrease pain, facilitate exercise, and improve function in Veterans with chronic low back pain (CLBP). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Acupuncture and Treadmill Exercise
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Jan 2010
- Phase
- Phase 1
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veterans eligible for this study are men or women between 25 and 65 years old with non-malignant low back pain greater than 6 months duration and pain scores greater than 4 (on a Numeric Pain Scale of 0 = No Pain and 10 = Worst Imaginable Pain) on most days out of the preceding month.
- Eligible subjects will also need to be able to tolerate 3 minutes walking at a rate of 0.5 miles per hour on a horizontal surface.
Who cannot join
- Inability to provide informed consent
- Diagnosis of dementia
- Severe depression (Beck Depression Inventory score > 30), suicidality, or untreated mental illness
- Severe anxiety (Beck Anxiety Inventory score > 30)
- Evidence of current substance abuse or alcoholism on the TICS
- Ongoing litigation related to the low back pain complaint
Show all 15Show fewer
- Pregnancy or intent to become pregnant during time of study
- Ambulation requiring an assistive device
- Neurological, orthopedic, or other conditions impairing ambulation that would affect exercise safety
- Progressive neurological changes, altered sensation, or a history of cauda equina syndrome
- Pain below the knee that limits ambulation
- Lower extremity amputation proximal to the toes
- Low back pain problem requiring surgical intervention or impending surgery
- A history of lumbar vertebral fracture; and
- A history of prior lumbar surgery. Additional exclusion criteria include medical conditions that would affect an exercise program, such as rheumatologic, infectious, cardiac, peripheral vascular and pulmonary conditions, or ongoing cancer treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study to Determine the Efficacy and Feasibility of a Structured Acupuncture and Treadmill Program to Treat Chronic Low Back Pain Patients to Improve Function, Exercise Capacity, and Pain Control.
The purpose of this research proposal is to conduct a feasibility study to determine the viability a larger efficacy study of combined acupuncture treatments plus treadmill exercise to decrease pain, facilitate exercise, and improve function in Veterans with chronic low back pain (CLBP). To test this novel approach, subjects enrolled from a Veteran population at the Veteran Affairs Maryland Health Care System (VAMHCS) will undergo acupuncture plus low intensity treadmill walking exercise. Preliminary data regarding subject compliance, self-report of function, pain control, ambulatory activity, and exercise capacity will be collected to assess the response to this combined acupuncture/treadmill exercise protocol. Additionally, this study will determine the viability of this combined treatment paradigm for a larger study that will examine efficacy.
Read the detailed description
Chronic non-malignant low back pain (CLBP) is very common. It is treated with diverse pharmacological and non-pharmacological therapies, including complementary and alternative pain treatments. Acupuncture has gained increasing acceptance among patients in the United States; however, the efficacy and duration of benefit of acupuncture treatments is often unknown, and prolonged utilization of these treatments is expensive. Successful acupuncture may provide an alternative to pain medications. Randomized studies have shown that exercise can produce long term benefits for individuals experiencing CLBP. Studies have also shown that acupuncture may be useful for the treatment of CLBP.
The purpose of the proposed research is to conduct a study to determine the feasibility of a larger efficacy study of acupuncture to decrease pain and facilitate exercise and function in Veterans with chronic low back pain (CLBP), in a Veteran population at the Veteran Affairs Maryland Health Care System (VAMHCS). To test this novel approach, subjects will undergo 16 weeks of treatment, consisting of acupuncture for 4 weeks followed by an overlapping period of 12 weeks of acupuncture plus low intensity treadmill walking exercise. Preliminary data will be collected to assess the improvement, if any, of: a) self-report of function, b) pain control, c) ambulatory activity, and d) exercise capacity. Additionally, this study will determine the viability of this combined treatment paradigm for a larger study that will examine efficacy.
Major objectives are to determine the rates of compliance for participation in this therapy of acupuncture plus low-intensity treadmill walking program, the completion rate of all treatment sessions and associated health assessment forms, as well as the challenges of recruitment. In addition, preliminary data to support the application for the larger pilot study will be obtained. The investigators' long-term research goal is to study this novel paradigm and its ability to reduce chronic low back pain.
The specific aims of the study are as follows:
Specific Objective 1. To determine whether individuals with CLBP receiving acupuncture plus treadmill exercise will exhibit superior improvement in function measured by Oswestry Disability Index II.
Specific Objective 2. To determine whether CLBP patients receiving acupuncture plus treadmill exercise will exhibit reduced pain scores measured by the Numeric Pain Intensity Rating Scale.
Specific Objective 3. To determine whether CLBP patients receiving acupuncture plus treadmill exercise will have improved home and community based ambulatory activity levels quantified by Step Activity Monitors (SAM).
Specific Objective 4. CLBP patients receiving acupuncture plus exercise will have greater gains in cardiovascular fitness levels measured by exercise testing with open circuit spirometry (V02 Max).
- Conditions
- Low Back Pain
- Being tested
- Acupuncture, Treadmill Exercise
- Keywords
- Low back pain, acupuncture, treadmill exercise
- 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.
AcupunctureProcedure or surgery
A specific regimen of acupuncture sites will be needled twice weekly for eight weeks and once weekly for a subsequent eight weeks.
Treadmill ExerciseOther
After the first four weeks of acupuncture treatments, subjects will initiate a three times per week treadmill program, which will continue for a total of 12 weeks in conjunction with the acupuncture treatments.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture plus Treadmill Exercise | Experimental | Acupuncture plus Treadmill Exercise Receives: Procedure: Acupuncture; Other: Treadmill Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measures are: (1) Numeric Pain Scale, (2) Oswestry Disability Index II, (3) fitness level determined by treadmill exercise, and (4) free-range ambulatory activity using step activity monitors.
Measured: 16 weeks
Secondary outcomes (1)
Self-reports, including function, depression, anxiety, and sleep; a physical performance test battery.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2010
- Study completionJan 2010
Why it stopped: Inadequate recruitment of study subjects and inadequate retention.
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Maryland Health Care System
- Sponsor type
- US federal agency
- Collaborators
- Samueli Institute for Information Biology
- Investigators
- Robert A Lavin, M.D., Principal investigator, VA Maryland Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00502619
- Sponsor's protocol ID
- H-27101
- Other IDs
- Samueli Institute:, Dept. of Defense IRB:
- Status last verified
- Jul 2011
- First submitted
- 16 Jul 2007
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Determine the Efficacy and Feasibility of a Structured Acupuncture and Treadmill Program to Treat Chronic Low Back Pain Patients to Improve Function, Exercise Capacity, and Pain Control.
- ClinicalTrials.gov ID
- NCT00502619
- Acronym / sponsor ID
- H-27101
- Conditions
- Low Back Pain
- Keywords
- Low back pain, acupuncture, treadmill exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment of study subjects and inadequate retention.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- VA Maryland Health Care SystemUS federal agency
- Collaborators
- Samueli Institute for Information Biology
- Study start
- Sep 2007
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 17 Jul 2007 (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 research proposal is to conduct a feasibility study to determine the viability a larger efficacy study of combined acupuncture treatments plus treadmill exercise to decrease pain, facilitate exercise, and improve function in Veterans with chronic low back pain (CLBP). To test this novel approach, subjects enrolled from a Veteran population at the Veteran Affairs Maryland Health Care System (VAMHCS) will undergo acupuncture plus low intensity treadmill walking exercise. Preliminary data regarding subject compliance, self-report of function, pain control, ambulatory activity, and exercise capacity will be collected to assess the response to this combined acupuncture/treadmill exercise protocol. Additionally, this study will determine the viability of this combined treatment paradigm for a larger study that will examine efficacy.
Detailed description
Chronic non-malignant low back pain (CLBP) is very common. It is treated with diverse pharmacological and non-pharmacological therapies, including complementary and alternative pain treatments. Acupuncture has gained increasing acceptance among patients in the United States; however, the efficacy and duration of benefit of acupuncture treatments is often unknown, and prolonged utilization of these treatments is expensive. Successful acupuncture may provide an alternative to pain medications. Randomized studies have shown that exercise can produce long term benefits for individuals experiencing CLBP. Studies have also shown that acupuncture may be useful for the treatment of CLBP.
The purpose of the proposed research is to conduct a study to determine the feasibility of a larger efficacy study of acupuncture to decrease pain and facilitate exercise and function in Veterans with chronic low back pain (CLBP), in a Veteran population at the Veteran Affairs Maryland Health Care System (VAMHCS). To test this novel approach, subjects will undergo 16 weeks of treatment, consisting of acupuncture for 4 weeks followed by an overlapping period of 12 weeks of acupuncture plus low intensity treadmill walking exercise. Preliminary data will be collected to assess the improvement, if any, of: a) self-report of function, b) pain control, c) ambulatory activity, and d) exercise capacity. Additionally, this study will determine the viability of this combined treatment paradigm for a larger study that will examine efficacy.
Major objectives are to determine the rates of compliance for participation in this therapy of acupuncture plus low-intensity treadmill walking program, the completion rate of all treatment sessions and associated health assessment forms, as well as the challenges of recruitment. In addition, preliminary data to support the application for the larger pilot study will be obtained. The investigators' long-term research goal is to study this novel paradigm and its ability to reduce chronic low back pain.
The specific aims of the study are as follows:
Specific Objective 1. To determine whether individuals with CLBP receiving acupuncture plus treadmill exercise will exhibit superior improvement in function measured by Oswestry Disability Index II.
Specific Objective 2. To determine whether CLBP patients receiving acupuncture plus treadmill exercise will exhibit reduced pain scores measured by the Numeric Pain Intensity Rating Scale.
Specific Objective 3. To determine whether CLBP patients receiving acupuncture plus treadmill exercise will have improved home and community based ambulatory activity levels quantified by Step Activity Monitors (SAM).
Specific Objective 4. CLBP patients receiving acupuncture plus exercise will have greater gains in cardiovascular fitness levels measured by exercise testing with open circuit spirometry (V02 Max).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acupuncture plus Treadmill Exercise | Experimental | Procedure: Acupuncture, Other: Treadmill ExerciseAcupuncture plus Treadmill Exercise |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Veterans eligible for this study are men or women between 25 and 65 years old with non-malignant low back pain greater than 6 months duration and pain scores greater than 4 (on a Numeric Pain Scale of 0 = No Pain and 10 = Worst Imaginable Pain) on most days out of the preceding month.
- Eligible subjects will also need to be able to tolerate 3 minutes walking at a rate of 0.5 miles per hour on a horizontal surface.
Key exclusion criteria (15 listed)
- Inability to provide informed consent
- Diagnosis of dementia
- Severe depression (Beck Depression Inventory score > 30), suicidality, or untreated mental illness
- Severe anxiety (Beck Anxiety Inventory score > 30)
- Evidence of current substance abuse or alcoholism on the TICS
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 |
|---|---|---|
| AcupunctureA specific regimen of acupuncture sites will be needled twice weekly for eight weeks and once weekly for a subsequent eight weeks. | Procedure or surgery | Acupuncture plus Treadmill Exercise |
| Treadmill ExerciseAfter the first four weeks of acupuncture treatments, subjects will initiate a three times per week treadmill program, which will continue for a total of 12 weeks in conjunction with the acupuncture treatments. | Other | Acupuncture plus Treadmill Exercise |
Primary outcome
Primary outcome measures are: (1) Numeric Pain Scale, (2) Oswestry Disability Index II, (3) fitness level determined by treadmill exercise, and (4) free-range ambulatory activity using step activity monitors.
Time frame: 16 weeks
1 secondary outcome
Self-reports, including function, depression, anxiety, and sleep; a physical performance test battery.
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Inadequate recruitment of study subjects and inadequate retention.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2011.
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
Robert A Lavin, M.D. principal investigator
VA Maryland Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Acupuncture and Treadmill Exercise in people with Low Back Pain, run by VA Maryland Health Care System at 1 site in United States.
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 15 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: stopped early, as of the sponsor's last update on 4 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Inadequate recruitment of study subjects and inadequate retention.). Results are not available in the source record.
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?
Primary outcome measures are: (1) Numeric Pain Scale, (2) Oswestry Disability Index II, (3) fitness level determined by treadmill exercise, and (4) free-range ambulatory activity using step activity monitors. (time frame: 16 weeks). 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 4 Aug 2011.