Distorted BalanceNCT02031562
Geriatrics Balance and Low Back Pain Study
A study testing chiropractic and physical therapy in people with Distorted Balance and Low Back Pain, run by Logan College of Chiropractic at 1 site in United States.
Trial summary
This study evaluates the effect of standard of care treatments (physical therapy versus manual therapy) in older adult patients who have balance problems with or without low back pain. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Distorted Balance, Low Back Pain
- What is being tested?
- chiropractic and physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 169 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Aug 2013
- 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
- Between ages 60-85
- self reported balance problems
- With or with out low back pain.
Who cannot join
- History of recent fracture or surgery of lumbar spine, pelvis, hip or femur
- History of recent neoplasm (minor skin cancers are not excluded)
- Acute infectious disease
- Chronic low back pain persisting for >8 weeks
- Severe disabling health problems so that patient is not ambulatory
- Non-mechanical low back pain
Show all 11Show fewer
- Recent unstable peripheral vascular disease and or cardiac disease requiring recent hospitalization < 6 months ago
- Patients with balance problems related to the following: Meniere's disease, vertigo, or vestibular disorders
- Recent history of self reported substance abuse
- Ongoing treatment for balance problems or low back pain by chiropractor, physical therapist, or orthopedic physician or other physician.
- Current use of medication from the following categories: antipsychotics, anxiolytics, and sedative/hypnotics
Trial locations and contacts
1 site in 1 country.
United States1 site
Logan College of Chiropractic
Chesterfield, Missouri, 63017
About this study
Official title: Geriatric Balance and Low Back Pain and Balance Assessment and Management
This study evaluates the effect of standard of care treatments (physical therapy versus manual therapy) in older adult patients who have balance problems with or without low back pain.
Read the detailed description
This study uses a randomized controlled research design and will enroll up to three hundred patients. Treatment will take place in outpatient facilities. It is hypothesized that among older adults with low back pain manual therapy will reduce low back pain and improve balance more than physical therapy; and that among older adults without low back pain manual therapy and physical therapy will be equally efficacious in improving balance. The results of this study will help to further define effective treatment protocols.
- Conditions
- Distorted Balance, Low Back Pain
- Being tested
- chiropractic, physical therapy
- Keywords
- Balance, Falls, Low back pain, Geriatric
- 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.
chiropracticOther
chiropractic
physical therapyOther
physical therapy
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic | Active comparator | Chiropractic Receives: Other: chiropractic |
| Physical therapy | Active comparator | Physical therapy Receives: Other: physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient balance parameters at baseline, 6 weeks and 12 weeks.
Participants complete functional performance tests and self-report questionnaires related to balance, pain, and quality of life. Testing is performed at baseline, after 6 weeks of care, and at 12 weeks. Balance tests included the Berg Balance Scale, The Timed Get up and Go (TGUG) test, Performance-oriented mobility assessment (POMA), NeuroCom Balance assessment tests which included the Limits of Stability (LOS) Test and Modified Clinical test for the sensory integration of Balance (Mod CTSIB).
Measured: Baseline, week 6 and week 12.
Secondary outcomes (1)
Change in patient pain levels at baseline, 6 weeks and 12 weeks.
Self reported questionnaires include the Falls Efficacy Scale (FES), Tampa Kinesiophobia Scale, Visual analogue scale (VAS), the 21-point Box Pain Scale, the Oswestry Questionnaire, SF-36 Questionnaire
Measured: Baseline, week 6 and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startOct 2009
- Primary completionJul 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distorted BalanceStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
- Collaborators
- St. Louis University
- Responsible party
- Principal investigator, Dennis Enix, DC, MBA, Logan College of Chiropractic
- Investigators
- Dennis E Enix, DC, MBA, Principal investigator, Logan College of Chiropractic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031562
- Sponsor's protocol ID
- RD1002090203
- Other IDs
- R18HP15125
- Status last verified
- Jan 2014
- First submitted
- 18 Dec 2013
- Last updated
- 9 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Balance and Low Back Pain and Balance Assessment and Management
- ClinicalTrials.gov ID
- NCT02031562
- Acronym / sponsor ID
- RD1002090203
- Conditions
- Distorted Balance, Low Back Pain
- Keywords
- Balance, Falls, Low back pain, Geriatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Collaborators
- St. Louis University
- Study start
- Oct 2009
- Primary completion
- Jul 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 9 Jan 2014 (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.
This study evaluates the effect of standard of care treatments (physical therapy versus manual therapy) in older adult patients who have balance problems with or without low back pain.
Detailed description
This study uses a randomized controlled research design and will enroll up to three hundred patients. Treatment will take place in outpatient facilities. It is hypothesized that among older adults with low back pain manual therapy will reduce low back pain and improve balance more than physical therapy; and that among older adults without low back pain manual therapy and physical therapy will be equally efficacious in improving balance. The results of this study will help to further define effective treatment protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiropractic | Active comparator | Other: chiropracticChiropractic |
| Physical therapy | Active comparator | Other: physical therapyPhysical therapy |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Between ages 60-85
- self reported balance problems
- With or with out low back pain.
Key exclusion criteria (11 listed)
- History of recent fracture or surgery of lumbar spine, pelvis, hip or femur
- History of recent neoplasm (minor skin cancers are not excluded)
- Acute infectious disease
- Chronic low back pain persisting for >8 weeks
- Severe disabling health problems so that patient is not ambulatory
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 |
|---|---|---|
| chiropracticchiropractic | Other | Chiropractic |
| physical therapyphysical therapy | Other | Physical therapy |
Primary outcome
Change in patient balance parameters at baseline, 6 weeks and 12 weeks.
Time frame: Baseline, week 6 and week 12.
Participants complete functional performance tests and self-report questionnaires related to balance, pain, and quality of life. Testing is performed at baseline, after 6 weeks of care, and at 12 weeks. Balance tests included the Berg Balance Scale, The Timed Get up and Go (TGUG) test, Performance-oriented mobility assessment (POMA), NeuroCom Balance assessment tests which included the Limits of Stability (LOS) Test and Modified Clinical test for the sensory integration of Balance (Mod CTSIB).
1 secondary outcome
Change in patient pain levels at baseline, 6 weeks and 12 weeks.
Time frame: Baseline, week 6 and week 12.
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 9 Jan 2014.
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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 Enix, DC, MBA principal investigator
Logan College of Chiropractic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chiropractic and physical therapy in people with Distorted Balance and Low Back Pain, run by Logan College of Chiropractic 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 3 inclusion and 11 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 9 Jan 2014. 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 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?
Change in patient balance parameters at baseline, 6 weeks and 12 weeks. (time frame: Baseline, week 6 and week 12.). 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 9 Jan 2014.