Low Back PainNCT01360359
Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)
A study testing Core Stabilization and Trunk Motion and Fitness in people with Low Back Pain, run by Drexel University at 2 sites in United States.
Trial summary
The purpose of this randomized clinical trial of low back pain exercise programs is to determine if trunk control can be changed by core stabilization exercises. The proposed mechanism of pain reduction and functional improvement of core stabilization exercises is that it enhances trunk movement and muscle control. 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?
- Core Stabilization and Trunk Motion and Fitness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2011to Mar 2015
- Phase
- Interventional
- 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
- duration of the current episode less than 3 months,
- average pain intensity over past 2 weeks greater than 4 on an 11 point (0 = no pain, 10 = worst pain ever) verbal pain rating scale,
- self-report global function less than 80% (0-100 %, 100% = normal pain free function)
- Oswestry Index > 19%
- no physical therapy or chiropractic treatment for the current episode of low back pain.
- clinical diagnosis of poor trunk control/ clinical lumbar instability needs to be met based upon completion of specific physical therapy examination finding
Who cannot join
- permanent structural spinal deformity (e.g., scoliosis),
- spinal fracture or history of spinal fracture,
- osteoporosis,
- inflammatory joint disease,
- signs of systemic illness or suspected non-mechanical LBP (spinal tumor or infection),
- previous spinal surgery,
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- frank neurological loss, i.e., weakness and sensory loss in a NR distribution,
- pain or paresthesia below the knee,
- leg length discrepancy of greater than 2.5 cm,
- history of neurologic disease that required hospitalization,
- active treatment of another medical illness that would preclude participation in any aspect of the study,
- pregnancy,
- vestibular dysfunction,
- extreme psychosocial involvement
- allergies to medical tape or adhesives
- Body mass index greater than 30 kg/m2
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Drexel University Physical Therapy
Philadelphia, Pennsylvania, 19102
Optimum Physical Therapy Associates
West Chester, Pennsylvania, 19380
About this study
The purpose of this randomized clinical trial of low back pain exercise programs is to determine if trunk control can be changed by core stabilization exercises. The proposed mechanism of pain reduction and functional improvement of core stabilization exercises is that it enhances trunk movement and muscle control. This study will provide preliminary evidence of the link between patient outcomes and treatment mechanisms.
The investigators hypothesize that:
- both treatment groups will demonstrate significant improvements in pain and function;
- only subjects in the core stabilization group will demonstrate significant improvements in trunk movement and muscle control.
- Conditions
- Low Back Pain
- Being tested
- Core Stabilization, Trunk Motion and Fitness
- Keywords
- low back pain, core stabilization, trunk muscle exercises, physical therapy, RCT
- 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.
Core StabilizationOther
3 Stages: Stage 1: emphasis on neutral spine position, co-contraction of stabilizing muscles with performance feedback through observation and palpation for correct muscle activation; patient education
Stage 2: promotes maintenance of co-contraction while performing movements of the arms/legs and trunk progressing to preformance of these exercises on unstable surfaces; trunk muscle conditioning also emphasized; feedback gradually reduced.
Stage 3: emphasis on maintenance of co-contraction while performing functional activities; stable and unstable surfaces; use of perturbation and random practice to enhance motor learning.
Trunk Motion and FitnessOther
3 Stages: Stage 1: reducing pain and restoring spine motion and flexibility; patient education
Stage 2: trunk muscle conditioning exercises
Stage 3: trunk muscle conditioning and cardiovascular conditioning exercises
| Study group | Role | What they receive |
|---|---|---|
| Core Stabilization | Experimental | 8-week core stabilization program in 3 stage that emphasizes use of specific local trunk stabilizing muscles to restore active control and stability to the trunk.
8-week exercise program, 1-2 sessions/ week, 30-60 minute sessions Receives: Other: Core Stabilization |
| Trunk Motion and Fitness | Active comparator | 8-week exercise program in 3 stages emphasizing spine motion, general trunk flexibility and strengthening and cardiovascular fitness.
8-week exercise program, 1-2 sessions/ week, 30-60 minute sessions Receives: Other: Trunk Motion and Fitness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk Neuromuscular Control
Using surface EMG, kinematics and force parameters. Trunk neuromuscular control is characterized and compared between groups and pre/post intervention.
Measured: Baseline, 8 weeks
Secondary outcomes (1)
Clinical Outcomes
Oswestry Disability Index- measure of self-perceived functional limitations NPRS- numeric pain index
Measured: Baseline, 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2011 (estimated)
- Study startMay 2011
- Primary completionMar 2015
- Study completionMar 2015
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sheri Silfies, Drexel University
- Investigators
- Sheri P. Silfies, PT, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01360359
- Sponsor's protocol ID
- K01HD053632
- Other IDs
- K01HD053632
- Status last verified
- Mar 2015
- First submitted
- 24 May 2011
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recurrent Low Back Pain: Linking Mechanism to Outcomes (RCT)
- ClinicalTrials.gov ID
- NCT01360359
- Acronym / sponsor ID
- K01HD053632
- Conditions
- Low Back Pain
- Keywords
- low back pain, core stabilization, trunk muscle exercises, physical therapy, RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2011
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 May 2011 (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 randomized clinical trial of low back pain exercise programs is to determine if trunk control can be changed by core stabilization exercises. The proposed mechanism of pain reduction and functional improvement of core stabilization exercises is that it enhances trunk movement and muscle control. This study will provide preliminary evidence of the link between patient outcomes and treatment mechanisms.
The investigators hypothesize that:
- both treatment groups will demonstrate significant improvements in pain and function;
- only subjects in the core stabilization group will demonstrate significant improvements in trunk movement and muscle control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Stabilization | Experimental | Other: Core Stabilization8-week core stabilization program in 3 stage that emphasizes use of specific local trunk stabilizing muscles to restore active control and stability to the trunk. 8-week exercise program, 1-2 sessions/ week, 30-60 minute sessions |
| Trunk Motion and Fitness | Active comparator | Other: Trunk Motion and Fitness8-week exercise program in 3 stages emphasizing spine motion, general trunk flexibility and strengthening and cardiovascular fitness. 8-week exercise program, 1-2 sessions/ week, 30-60 minute sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- duration of the current episode less than 3 months,
- average pain intensity over past 2 weeks greater than 4 on an 11 point (0 = no pain, 10 = worst pain ever) verbal pain rating scale,
- self-report global function less than 80% (0-100 %, 100% = normal pain free function)
- Oswestry Index > 19%
- no physical therapy or chiropractic treatment for the current episode of low back pain.
Key exclusion criteria (16 listed)
- permanent structural spinal deformity (e.g., scoliosis),
- spinal fracture or history of spinal fracture,
- osteoporosis,
- inflammatory joint disease,
- signs of systemic illness or suspected non-mechanical LBP (spinal tumor or infection),
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 |
|---|---|---|
| Core Stabilization3 Stages: Stage 1: emphasis on neutral spine position, co-contraction of stabilizing muscles with performance feedback through observation and palpation for correct muscle activation; patient education Stage 2: promotes maintenance of co-contraction while performing movements of the arms/legs and trunk progressing to preformance of these exercises on unstable surfaces; trunk muscle conditioning also emphasized; feedback gradually reduced. Stage 3: emphasis on maintenance of co-contraction while performing functional activities; stable and unstable surfaces; use of perturbation and random practice to enhance motor learning. | Other | Core Stabilization |
| Trunk Motion and Fitness3 Stages: Stage 1: reducing pain and restoring spine motion and flexibility; patient education Stage 2: trunk muscle conditioning exercises Stage 3: trunk muscle conditioning and cardiovascular conditioning exercises | Other | Trunk Motion and Fitness |
Primary outcome
Trunk Neuromuscular Control
Time frame: Baseline, 8 weeks
Using surface EMG, kinematics and force parameters. Trunk neuromuscular control is characterized and compared between groups and pre/post intervention.
1 secondary outcome
Clinical Outcomes
Time frame: Baseline, 8-weeks
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 11 Mar 2015.
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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.
Sheri P. Silfies, PT, PhD principal investigator
Drexel University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core Stabilization and Trunk Motion and Fitness in people with Low Back Pain, run by Drexel University at 2 sites 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 6 inclusion and 16 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 11 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
Trunk Neuromuscular Control (time frame: Baseline, 8 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 11 Mar 2015.