Chronic Low Back Pain (CLBP)NCT06782919
Trunk Control Training and Walking in Older Adults
A study of Chronic Low Back Pain (CLBP) and Aging, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The goal of this observational study and clinical trial is to evaluate control of trunk posture and walking biomechanics in 20 older adults with chronic low back pain and 20 older adult healthy volunteers. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain (CLBP), Aging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2025to Sep 2026
- 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women, ages 60 - 85 years
- English fluent
- Able to perform activities such as walking, standing, sitting, bending, or lifting without assistance
- Low back pain-free for at least 1 months, characterized by a pain numerical rating scale of <2 (out of 10), and/or <5 (out of 24) on the Roland Morris Disability Questionnaire
- Able to walk without assistance on surfaces of brick, sidewalk, dirt, grass, treadmill, and flat walkway
- Men and women, ages 60 - 85 years
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- English fluent
- Current chronic low back pain (lasting at least 1 months) that care was sought for at BIDMC within the past year.
- Pain numerical rating scale of 2-7 (out of 10) and/or 5-19 (out of 24) on the Roland Morris Disability Questionnaire
- Able to perform activities such as walking, standing, sitting, bending, or lifting without assistance
- Able to walk without assistance on surfaces of brick, sidewalk, dirt, grass, treadmill, and flat walkway
Who cannot join
- Self-reported conditions that might alter spine biomechanics, such as a history of traumatic spine injury or spinal surgery; severe scoliosis which needed brace or surgical treatment; neuromuscular conditions such as Parkinson's disease, hemiplegia, symptomatic spinal stenosis, multiple Sclerosis, or muscular dystrophy.
- Back pain with confirmed diagnosis of underlying diseases or structural anomalies such as rheumatoid arthritis, meningitis, or cancer.
- Severe LBP of greater than 7 (out of maximum 10) on self-report pain VAS. (Subjects otherwise eligible and interested will be followed up weekly and scheduled if LBP subsides to below 7/10 on pain VAS).
- Experienced dizziness, lightheadedness, vertigo, or imbalance within the past three months that occurs frequently (3 times or more) or two or more falls in the past year.
- Use of narcotics
- Latex allergies
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- Visual problems that are not corrected by glasses/contact lenses.
- Self-reported recent musculoskeletal injury that is currently severely affecting normal activity or movement. Examples of this could include sprains, strains, dislocations, or fractures that prevent one from walking, standing, sitting, bending, or lifting in a normal manner.
- A score ≥10 on the Short Blessed Test, suggesting possible impaired cognitive function or dementia.
- Two* or more of the following self-reported limits in physical function:
- Needing help in activities of daily living (ADLs, such as walking across a small room, bathing, toileting, transferring from bed to chair);
- Unable to walk up and down one flight of stairs without help;
- Unable to walk half a mile without help.
- Short Physical Performance Battery (SPPB) score <4*
- No exclusion criteria shall be based on race, ethnicity, or sex. We will assign subjects to men and women groups for recruitment purposes based on their assigned sex at birth.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Evaluating the Effect of Biofeedback-Based Training on Trunk Neuromuscular Control and Spinopelvic Motion and Loading During Gait in Older Adults With and Without Chronic Low Back Pain
The goal of this observational study and clinical trial is to evaluate control of trunk posture and walking biomechanics in 20 older adults with chronic low back pain and 20 older adult healthy volunteers. A second objective of this study is to evaluate the effect of weekly biofeedback-based trunk control training to control of trunk posture and walking biomechanics. The main question it aims to answer is:
- Does training trunk control improve walking biomechanics in older adults? Researchers will compare older adults with and without chronic low back pain to see if trunk control, walking biomechanics, and the effects of training differ between the groups.
Participants will undergo measurements of trunk control in the laboratory, and of walking in both laboratory and outdoor settings. Trunk training will take place once a week for four weeks, and measurements will be repeated after the training protocol.
- Conditions
- Chronic Low Back Pain (CLBP), Aging
- Being tested
- Trunk control training
- Keywords
- Gait, Walking, Neuromuscular control, Wearable Sensors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk control trainingOther
Four sessions of biofeedback trunk movement training, provided once per week.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | No intervention | For comparison of trunk control and walking between low back pain and health groups. |
| Trunk control training | Experimental | Trunk control training is received after baseline measurements in this arm. Receives: Other: Trunk control training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk neuromuscular control
Error in performing trunk tracking tasks.
Measured: Baseline, Training sessions (weekly for 4 weeks), and Followup (approximately week 5, 1 week after training completed).
Spinopelvic and lower limb motion
Joint ranges of motion evaluated during walking
Measured: Baseline, and Followup (approximately week 5, 1 week after training completed).
Spinopelvic forces
Peak and average spine joint compression and shear forces during walking.
Measured: Baseline, and Followup (approximately week 5, 1 week after training completed).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study startMay 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Why it stopped: NIH Funding terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), Hebrew SeniorLife
- Responsible party
- Principal investigator, Dennis Anderson, Beth Israel Deaconess Medical Center
- Investigators
- Dennis E Anderson, Ph.D., Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782919
- Sponsor's protocol ID
- 2024P000980
- Other IDs
- T32AG023480
- Status last verified
- Sep 2025
- First submitted
- 8 Jan 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not currently a plan for sharing in this small preliminary trial; this does not preclude future sharing.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Biofeedback-Based Training on Trunk Neuromuscular Control and Spinopelvic Motion and Loading During Gait in Older Adults With and Without Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT06782919
- Acronym / sponsor ID
- 2024P000980
- Conditions
- Chronic Low Back Pain (CLBP), Aging
- Keywords
- Gait, Walking, Neuromuscular control, Wearable Sensors
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: NIH Funding terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), Hebrew SeniorLife
- Study start
- May 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 20 Jan 2025 (actual)
- 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 goal of this observational study and clinical trial is to evaluate control of trunk posture and walking biomechanics in 20 older adults with chronic low back pain and 20 older adult healthy volunteers. A second objective of this study is to evaluate the effect of weekly biofeedback-based trunk control training to control of trunk posture and walking biomechanics. The main question it aims to answer is:
- Does training trunk control improve walking biomechanics in older adults? Researchers will compare older adults with and without chronic low back pain to see if trunk control, walking biomechanics, and the effects of training differ between the groups.
Participants will undergo measurements of trunk control in the laboratory, and of walking in both laboratory and outdoor settings. Trunk training will take place once a week for four weeks, and measurements will be repeated after the training protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | –For comparison of trunk control and walking between low back pain and health groups. |
| Trunk control training | Experimental | Other: Trunk control trainingTrunk control training is received after baseline measurements in this arm. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women, ages 60 - 85 years
- English fluent
- Able to perform activities such as walking, standing, sitting, bending, or lifting without assistance
- Low back pain-free for at least 1 months, characterized by a pain numerical rating scale of <2 (out of 10), and/or <5 (out of 24) on the Roland Morris Disability Questionnaire
- Able to walk without assistance on surfaces of brick, sidewalk, dirt, grass, treadmill, and flat walkway
Key exclusion criteria (15 listed)
- Self-reported conditions that might alter spine biomechanics, such as a history of traumatic spine injury or spinal surgery; severe scoliosis which needed brace or surgical treatment; neuromuscular conditions such as Parkinson's disease, hemiplegia, symptomatic spinal stenosis, multiple Sclerosis, or muscular dystrophy.
- Back pain with confirmed diagnosis of underlying diseases or structural anomalies such as rheumatoid arthritis, meningitis, or cancer.
- Severe LBP of greater than 7 (out of maximum 10) on self-report pain VAS. (Subjects otherwise eligible and interested will be followed up weekly and scheduled if LBP subsides to below 7/10 on pain VAS).
- Experienced dizziness, lightheadedness, vertigo, or imbalance within the past three months that occurs frequently (3 times or more) or two or more falls in the past year.
- Use of narcotics
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 control trainingFour sessions of biofeedback trunk movement training, provided once per week. | Other | Trunk control training |
Primary outcome
Trunk neuromuscular control
Time frame: Baseline, Training sessions (weekly for 4 weeks), and Followup (approximately week 5, 1 week after training completed).
Error in performing trunk tracking tasks.
Spinopelvic and lower limb motion
Time frame: Baseline, and Followup (approximately week 5, 1 week after training completed).
Joint ranges of motion evaluated during walking
Spinopelvic forces
Time frame: Baseline, and Followup (approximately week 5, 1 week after training completed).
Peak and average spine joint compression and shear forces during walking.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No. There is not currently a plan for sharing in this small preliminary trial; this does not preclude future sharing.
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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.
Dennis E Anderson, Ph.D. principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Chronic Low Back Pain (CLBP) and Aging, run by Beth Israel Deaconess Medical Center 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 11 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: withdrawn, as of the sponsor's last update on 10 Sep 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
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, Training sessions (weekly for 4 weeks), and Followup (approximately week 5, 1 week after training completed).). The study lists 3 primary outcomes in all. 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 10 Sep 2025.