Low Back PainNCT01611792
Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain
A study testing Stabilization exercise protocol and Strength and conditioning exercise protocol in people with Low Back Pain, run by University of Vermont at 1 site in United States.
Trial summary
Low back pain affects 80% of Americans at some time during their lives. Although recovery usually occurs within 6 months, there is a 50% recurrence within one year's time. It has long been thought that poor control of trunk muscle may lead to abnormal forces across the spine, which then damage local spinal structures… Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Stabilization exercise protocol and Strength and conditioning exercise protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jun 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- a history of chronic LBP with or without recurrences for a minimum of 12 months
- between 21 - 55 years of age
- able to stand and walk without assistance
- have an Oswestry Disability Score of 19% or higher
Who cannot join
- any major structural spinal deformity including scoliosis, kyphosis, or stenosis
- spinal fracture or dislocation
- osteoporosis
- ankylosing spondylitis
- rheumatoid arthritis
- disc herniation with corroborating clinical signs and symptoms
Show all 19Show fewer
- serious spinal complications such as tumor or infection
- previous spinal surgery
- frank neurological loss, i.e., weakness and sensory loss
- pain or paresthesia below the knee
- etiology of LBP other than the lumbar spine, e.g., hip joint
- history of neurological disease which required hospitalization
- active treatment for cancer
- history of unresolved cancer
- pregnancy or less than 6 months post-partum or less than 6 months post weaning
- magnified symptom-behavior
- worker's compensation or disability case
- in litigation for the LBP problem
- have a BMI ≥ 30
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Motion Analysis Laboratory
Burlington, Vermont, 05405
About this study
Low back pain affects 80% of Americans at some time during their lives. Although recovery usually occurs within 6 months, there is a 50% recurrence within one year's time. It has long been thought that poor control of trunk muscle may lead to abnormal forces across the spine, which then damage local spinal structures, thus, leading to low back pain. However, the investigators know little about the function of specific trunk muscles in healthy subjects during various activities of daily life. Furthermore, the precise muscle dysfunction associated with low back pain has not been well characterized at all. In addition, the investigators know little about which exercise protocol is most beneficial for particular subgroups of people with low back pain. Thus, the purposes of this study are to learn more about: 1) how trunk muscles are affected by low back pain; 2) which exercises might be most beneficial for people with certain kinds of low back pain; and 3) how these exercises influence trunk muscle function. By having a better understanding of which trunk muscles are affected by low back pain, rehabilitation specialists can design exercise programs and therapeutic interventions that are more specific and more effective.
- Conditions
- Low Back Pain
- Being tested
- Stabilization exercise protocol, Strength and conditioning exercise protocol
- Keywords
- Stabilization exercise, Strength and conditioning exercise, Physical therapy, Rehabilitation
- 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.
Stabilization exercise protocolOther
Also called Trunk stabilization exercises, Segmental stabilization exercises
The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
Strength and conditioning exercise protocolOther
Also called General trunk exercise, General strength training
This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
| Study group | Role | What they receive |
|---|---|---|
| Stabilization | Experimental | Not described Receives: Other: Stabilization exercise protocol |
| Strengthening and Conditioning | Active comparator | Not described Receives: Other: Strength and conditioning exercise protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)
Disability; Scale 0-100% Lower score is considered better/improved Negative value indicates improvement
Measured: Baseline and 11 weeks
Change From Baseline to 6 Months in Oswestry Disability Scale (0-100%)
Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement
Measured: Baseline and 6 Months
Change From 11 Weeks to 6 Months in Oswestry Disability Scale (0-100%)
Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement
Measured: 11 Weeks and 6 Months
Change From Baseline to 11 Weeks in Numeric Pain Rating Scale (0-10 Points)
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
Measured: Baseline and 11 weeks
Change From Baseline to 6 Months in Numeric Pain Rating Scale (0-10 Points)
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
Measured: Baseline and 6 months
Change From 11 Weeks to 6 Months in Numeric Pain Rating Scale (0-10 Points)
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
Measured: 11 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startMar 2003
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Sharon M. Henry, University of Vermont
- Investigators
- Sharon M Henry, PT, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611792
- Sponsor's protocol ID
- NIH/NCMRR/R01-HD040909
- Status last verified
- Oct 2017
- First submitted
- 1 Jun 2012
- Last updated
- 18 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Jones SL, Henry SM, Raasch CC, Hitt JR, Bunn JY. Individuals with non-specific low back pain use a trunk stiffening strategy to maintain upright posture. J Electromyogr Kinesiol. 2012 Feb;22(1):13-20. doi: 10.1016/j.jelekin.2011.10.006. Epub 2011 Nov 18.
PubMed 22100719Jacobs JV, Henry SM, Jones SL, Hitt JR, Bunn JY. A history of low back pain associates with altered electromyographic activation patterns in response to perturbations of standing balance. J Neurophysiol. 2011 Nov;106(5):2506-14. doi: 10.1152/jn.00296.2011. Epub 2011 Jul 27.
PubMed 21795622Stokes IA, Gardner-Morse MG, Henry SM. Abdominal muscle activation increases lumbar spinal stability: analysis of contributions of different muscle groups. Clin Biomech (Bristol). 2011 Oct;26(8):797-803. doi: 10.1016/j.clinbiomech.2011.04.006. Epub 2011 May 14.
PubMed 21571410Stokes IA, Gardner-Morse MG, Henry SM. Intra-abdominal pressure and abdominal wall muscular function: Spinal unloading mechanism. Clin Biomech (Bristol). 2010 Nov;25(9):859-66. doi: 10.1016/j.clinbiomech.2010.06.018. Epub 2010 Jul 23.
PubMed 20655636Jones SL, Henry SM, Raasch CC, Hitt JR, Bunn JY. Responses to multi-directional surface translations involve redistribution of proximal versus distal strategies to maintain upright posture. Exp Brain Res. 2008 May;187(3):407-17. doi: 10.1007/s00221-008-1312-1. Epub 2008 Feb 26.
PubMed 18299821Teyhen DS, Gill NW, Whittaker JL, Henry SM, Hides JA, Hodges P. Rehabilitative ultrasound imaging of the abdominal muscles. J Orthop Sports Phys Ther. 2007 Aug;37(8):450-66. doi: 10.2519/jospt.2007.2558.
PubMed 17877281Henry SM, Teyhen DS. Ultrasound imaging as a feedback tool in the rehabilitation of trunk muscle dysfunction for people with low back pain. J Orthop Sports Phys Ther. 2007 Oct;37(10):627-34. doi: 10.2519/jospt.2007.2555.
PubMed 17970410Anderson-Worth SG, Henry SM, Bunn JY. Use of real time ultrasound feedback enhances learning the abdominal hollowing exercise in patients with low back pain. New Zealand J Physiotherapy. 35(1):4-11, 2007.
Henry SM, Hitt JR, Jones SL, Bunn JY. Decreased limits of stability in response to postural perturbations in subjects with low back pain. Clin Biomech (Bristol). 2006 Nov;21(9):881-92. doi: 10.1016/j.clinbiomech.2006.04.016. Epub 2006 Jun 27.
PubMed 16806618Henry SM, Westervelt KC. The use of real-time ultrasound feedback in teaching abdominal hollowing exercises to healthy subjects. J Orthop Sports Phys Ther. 2005 Jun;35(6):338-45. doi: 10.2519/jospt.2005.35.6.338.
PubMed 16001905Lomond KV, Henry SM, Hitt JR, DeSarno MJ, Bunn JY. Altered postural responses persist following physical therapy of general versus specific trunk exercises in people with low back pain. Man Ther. 2014 Oct;19(5):425-32. doi: 10.1016/j.math.2014.04.007. Epub 2014 Apr 24.
PubMed 24853255
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects and Mechanisms of Specific Trunk Exercises in Low Back Pain
- ClinicalTrials.gov ID
- NCT01611792
- Acronym / sponsor ID
- NIH/NCMRR/R01-HD040909
- Conditions
- Low Back Pain
- Keywords
- Stabilization exercise, Strength and conditioning exercise, Physical therapy, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Mar 2003
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Posted 21 Aug 2017
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 affects 80% of Americans at some time during their lives. Although recovery usually occurs within 6 months, there is a 50% recurrence within one year's time. It has long been thought that poor control of trunk muscle may lead to abnormal forces across the spine, which then damage local spinal structures, thus, leading to low back pain. However, the investigators know little about the function of specific trunk muscles in healthy subjects during various activities of daily life. Furthermore, the precise muscle dysfunction associated with low back pain has not been well characterized at all. In addition, the investigators know little about which exercise protocol is most beneficial for particular subgroups of people with low back pain. Thus, the purposes of this study are to learn more about: 1) how trunk muscles are affected by low back pain; 2) which exercises might be most beneficial for people with certain kinds of low back pain; and 3) how these exercises influence trunk muscle function. By having a better understanding of which trunk muscles are affected by low back pain, rehabilitation specialists can design exercise programs and therapeutic interventions that are more specific and more effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stabilization | Experimental | Other: Stabilization exercise protocol |
| Strengthening and Conditioning | Active comparator | Other: Strength and conditioning exercise protocol |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- a history of chronic LBP with or without recurrences for a minimum of 12 months
- between 21 - 55 years of age
- able to stand and walk without assistance
- have an Oswestry Disability Score of 19% or higher
Key exclusion criteria (19 listed)
- any major structural spinal deformity including scoliosis, kyphosis, or stenosis
- spinal fracture or dislocation
- osteoporosis
- ankylosing spondylitis
- rheumatoid arthritis
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 |
|---|---|---|
| Stabilization exercise protocolAlso: Trunk stabilization exercises, Segmental stabilization exercisesThe stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities. | Other | Stabilization |
| Strength and conditioning exercise protocolAlso: General trunk exercise, General strength trainingThis protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises. | Other | Strengthening and Conditioning |
Primary outcome
Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%)
Time frame: Baseline and 11 weeks
Disability; Scale 0-100% Lower score is considered better/improved Negative value indicates improvement
Change From Baseline to 6 Months in Oswestry Disability Scale (0-100%)
Time frame: Baseline and 6 Months
Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement
Change From 11 Weeks to 6 Months in Oswestry Disability Scale (0-100%)
Time frame: 11 Weeks and 6 Months
Disability; Sacle 0-100% Lower score is considered better/improved; Negative value indicates improvement
Change From Baseline to 11 Weeks in Numeric Pain Rating Scale (0-10 Points)
Time frame: Baseline and 11 weeks
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
Change From Baseline to 6 Months in Numeric Pain Rating Scale (0-10 Points)
Time frame: Baseline and 6 months
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
Change From 11 Weeks to 6 Months in Numeric Pain Rating Scale (0-10 Points)
Time frame: 11 weeks and 6 months
Current Pain Scale 0-10 Lower score is better/improved; Negative value indicates improvement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22100719Jones SL, Henry SM, Raasch CC, Hitt JR, Bunn JY. Individuals with non-specific low back pain use a trunk stiffening strategy to maintain upright posture. J Electromyogr Kinesiol. 2012 Feb;22(1):13-20. doi: 10.1016/j.jelekin.2011.10.006. Epub 2011 Nov 18.
- Background: PubMed 21795622Jacobs JV, Henry SM, Jones SL, Hitt JR, Bunn JY. A history of low back pain associates with altered electromyographic activation patterns in response to perturbations of standing balance. J Neurophysiol. 2011 Nov;106(5):2506-14. doi: 10.1152/jn.00296.2011. Epub 2011 Jul 27.
- Background: PubMed 21571410Stokes IA, Gardner-Morse MG, Henry SM. Abdominal muscle activation increases lumbar spinal stability: analysis of contributions of different muscle groups. Clin Biomech (Bristol). 2011 Oct;26(8):797-803. doi: 10.1016/j.clinbiomech.2011.04.006. Epub 2011 May 14.
- Background: PubMed 20655636Stokes IA, Gardner-Morse MG, Henry SM. Intra-abdominal pressure and abdominal wall muscular function: Spinal unloading mechanism. Clin Biomech (Bristol). 2010 Nov;25(9):859-66. doi: 10.1016/j.clinbiomech.2010.06.018. Epub 2010 Jul 23.
- Background: PubMed 18299821Jones SL, Henry SM, Raasch CC, Hitt JR, Bunn JY. Responses to multi-directional surface translations involve redistribution of proximal versus distal strategies to maintain upright posture. Exp Brain Res. 2008 May;187(3):407-17. doi: 10.1007/s00221-008-1312-1. Epub 2008 Feb 26.
- Background: PubMed 17877281Teyhen DS, Gill NW, Whittaker JL, Henry SM, Hides JA, Hodges P. Rehabilitative ultrasound imaging of the abdominal muscles. J Orthop Sports Phys Ther. 2007 Aug;37(8):450-66. doi: 10.2519/jospt.2007.2558.
- Background: PubMed 17970410Henry SM, Teyhen DS. Ultrasound imaging as a feedback tool in the rehabilitation of trunk muscle dysfunction for people with low back pain. J Orthop Sports Phys Ther. 2007 Oct;37(10):627-34. doi: 10.2519/jospt.2007.2555.
- BackgroundAnderson-Worth SG, Henry SM, Bunn JY. Use of real time ultrasound feedback enhances learning the abdominal hollowing exercise in patients with low back pain. New Zealand J Physiotherapy. 35(1):4-11, 2007.
- Background: PubMed 16806618Henry SM, Hitt JR, Jones SL, Bunn JY. Decreased limits of stability in response to postural perturbations in subjects with low back pain. Clin Biomech (Bristol). 2006 Nov;21(9):881-92. doi: 10.1016/j.clinbiomech.2006.04.016. Epub 2006 Jun 27.
- Background: PubMed 16001905Henry SM, Westervelt KC. The use of real-time ultrasound feedback in teaching abdominal hollowing exercises to healthy subjects. J Orthop Sports Phys Ther. 2005 Jun;35(6):338-45. doi: 10.2519/jospt.2005.35.6.338.
- Background: PubMed 24853255Lomond KV, Henry SM, Hitt JR, DeSarno MJ, Bunn JY. Altered postural responses persist following physical therapy of general versus specific trunk exercises in people with low back pain. Man Ther. 2014 Oct;19(5):425-32. doi: 10.1016/j.math.2014.04.007. Epub 2014 Apr 24.
- Individual participant dataSharing planned: No
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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.
Sharon M Henry, PT, PhD principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilization exercise protocol and Strength and conditioning exercise protocol in people with Low Back Pain, run by University of Vermont 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 4 inclusion and 19 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 Oct 2017. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to 11 Weeks in Oswestry Disability Scale (0-100%) (time frame: Baseline and 11 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01611792, which also lists 11 linked publications.
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 Oct 2017.