Chronic Low Back PainPhase 1NCT01632618
Trunk Muscle Training and Neuromuscular Electrical Stimulation to Improve Function in Older Adults With Chronic Low Back Pain
A Phase 1 study testing Trunk Muscle Training+NMES in people with Chronic Low Back Pain, run by University of Delaware.
Trial summary
Low back pain (LBP) is the most frequently reported musculoskeletal problem and third most frequently reported symptom of any kind in people over the age of 75. In fact, 17.3% of all visits to physicians for LBP involve individuals over 65. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Trunk Muscle Training+NMES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- May 2007to Apr 2011
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Exclusion Criteria: Subjects will be excluded from the study if any of the following exist:
- Prominent component of radicular pain: CLBP with distal radiation below the knee
- Known spinal pathology other than osteoarthritis: (e.g., a history of back surgery or recent trauma, spinal stenosis, vertebral compression fractures, ankylosing spondylitis, carcinoma metastatic to the spine) In these other cases, LBP may be of non-mechanical origin.
- Non-ambulatory, or severely impaired mobility (i.e., require the use of a walker): Since measurement of physical performance in the proposed study includes gait velocity and standing balance, conditions other than LBP that could negatively impact these measures may confound our study results.
- Folstein Mini-Mental State Examination score of < 24 will exclude subjects because of the uncertain reliability of their answers to the self-reported outcome measures.
- Severe visual or hearing impairment: Since this study will involve questionnaires and telephone evaluations, severe visual and/or hearing impairments may interfere with data collection.
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- Red flags indicative of a serious disorder underlying the LBP: Red flags that would require specialized medical attention include fever, significant unintentional weight loss, a sudden recent change in the character or intensity of pain, trauma that preceded the onset of pain, or signs and symptoms of caudae equinae. These subjects will be promptly referred to their primary practitioners.
- Significant pain in parts of the body other than the back or acute LBP: Since we will be specifically evaluating chronic LBP, we do not want to confound the outcome data with pain from other areas or with acute pain. Thus only subjects with LBP severity that is greater than pain severity elsewhere in the body will be included.
- Acute or terminal illness: To insure weekly participation and a six month follow-up, subjects with an acute or terminal illness will be excluded from the study.
- Presence of a pacemaker: Since electrical stimulation will be used in this study and the effects of that stimulation on pacemakers is unknown, we will be cautious and exclude subjects with this device.
About this study
Low back pain (LBP) is the most frequently reported musculoskeletal problem and third most frequently reported symptom of any kind in people over the age of 75. In fact, 17.3% of all visits to physicians for LBP involve individuals over 65. In older adults, LBP has been associated with a host of negative consequences, including decreased physical function, increased fall risk, increased mood disturbance and increased health care utilization. Surprisingly, little research has focused on LBP in people over 65. But, recent evidence demonstrates that LBP is associated with increased intramuscular fat infiltration in the abdominal and paraspinal muscles and that this altered muscle composition increases the risk of mobility-related functional decline in older adults. While trunk muscle training (TMT) has been used in younger LBP groups, it is unproven in elders and, alone may not be sufficient to substantially improve function and symptoms, given the compromised state of ages muscle. TMT augmented with neuromuscular electrical stimulation (NMES) known to improve strength and function beyond the capacity of volitional exercise alone, may provide greater improvements. Treatment of chronic LBP in older adults using an exercise intervention has been hypothesized as a way to prevent functional decline and frailty progression; however this hypothesis has yet to be experimentally confirmed. In this exploratory study, the investigators will test the hypothesis that TMT plus NMES will result in reduced disability and pain severity compared to usual care in elders with chronic LBP.
- Conditions
- Chronic Low Back Pain
- Being tested
- Trunk Muscle Training+NMES, Passive control intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk Muscle Training+NMESBehavioural
Progressive exercise program for the stabilizing muscles of the trunk, as well as neuromuscular electrical stimulation to the lumbar paraspinals
Passive control interventionBehavioural
Passive physical therapy approach to low back pain
| Study group | Role | What they receive |
|---|---|---|
| Trunk Muscle Training+NMES | Experimental | Progressive exercise program for the stabilizing muscles of the trunk, as well as neuromuscular electrical stimulation to the lumbar paraspinals Receives: Behavioral: Trunk Muscle Training+NMES |
| Passive control intervention | Active comparator | Passive physical therapy interventions, including moist heat, ultrasound, massage and flexibility exercises Receives: Behavioral: Passive control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timed Up and Go
timed performance test
Measured: 6 months
Secondary outcomes (3)
Gait speed
Measured: 6 months
Oswestry Low Back Pain Disability Questionnaire
Measured: 6 months
Global Rating of Functional Improvement
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startMay 2007
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Evan Hicks, University of Delaware
- Investigators
- Gregory E Hicks, PT, PhD, Principal investigator, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632618
- Sponsor's protocol ID
- 160167
- Status last verified
- Sep 2016
- First submitted
- 28 Jun 2012
- Last updated
- 21 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trunk Muscle Training and Neuromuscular Electrical Stimulation to Improve Function in Older Adults With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT01632618
- Acronym / sponsor ID
- 160167
- Conditions
- Chronic Low Back Pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 3 Jul 2012 (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.
Low back pain (LBP) is the most frequently reported musculoskeletal problem and third most frequently reported symptom of any kind in people over the age of 75. In fact, 17.3% of all visits to physicians for LBP involve individuals over 65. In older adults, LBP has been associated with a host of negative consequences, including decreased physical function, increased fall risk, increased mood disturbance and increased health care utilization. Surprisingly, little research has focused on LBP in people over 65. But, recent evidence demonstrates that LBP is associated with increased intramuscular fat infiltration in the abdominal and paraspinal muscles and that this altered muscle composition increases the risk of mobility-related functional decline in older adults. While trunk muscle training (TMT) has been used in younger LBP groups, it is unproven in elders and, alone may not be sufficient to substantially improve function and symptoms, given the compromised state of ages muscle. TMT augmented with neuromuscular electrical stimulation (NMES) known to improve strength and function beyond the capacity of volitional exercise alone, may provide greater improvements. Treatment of chronic LBP in older adults using an exercise intervention has been hypothesized as a way to prevent functional decline and frailty progression; however this hypothesis has yet to be experimentally confirmed. In this exploratory study, the investigators will test the hypothesis that TMT plus NMES will result in reduced disability and pain severity compared to usual care in elders with chronic LBP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trunk Muscle Training+NMES | Experimental | Behavioral: Trunk Muscle Training+NMESProgressive exercise program for the stabilizing muscles of the trunk, as well as neuromuscular electrical stimulation to the lumbar paraspinals |
| Passive control intervention | Active comparator | Behavioral: Passive control interventionPassive physical therapy interventions, including moist heat, ultrasound, massage and flexibility exercises |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Exclusion Criteria: Subjects will be excluded from the study if any of the following exist:
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 |
|---|---|---|
| Trunk Muscle Training+NMESProgressive exercise program for the stabilizing muscles of the trunk, as well as neuromuscular electrical stimulation to the lumbar paraspinals | Behavioural | Trunk Muscle Training+NMES |
| Passive control interventionPassive physical therapy approach to low back pain | Behavioural | Passive control intervention |
Primary outcome
Timed Up and Go
Time frame: 6 months
timed performance test
3 secondary outcomes
Gait speed
Time frame: 6 months
Oswestry Low Back Pain Disability Questionnaire
Time frame: 6 months
Global Rating of Functional Improvement
Time frame: 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 21 Sep 2016.
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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.
Gregory E Hicks, PT, PhD principal investigator
University of Delaware
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trunk Muscle Training+NMES in people with Chronic Low Back Pain, run by University of Delaware.
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 0 inclusion and 10 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 21 Sep 2016. 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. 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 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?
Timed Up and Go (time frame: 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 21 Sep 2016.