Spinal Stenosis LumbarStenosisNCT03863769
Chiropractic Distraction Spinal Manipulation- Lumbar Stenosis Study
An observational study of Spinal Stenosis Lumbar, run by Parker University at 1 site in United States.
Trial summary
To assess the effect of chiropractic distraction manipulation on postural sway and simple measures of performance in patients with the clinical diagnosis of lumbar spinal stenosis. Read more about this study
- Who is it for?
- Ages 48 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Stenosis Lumbar
- What is being tested?
- Lumbar Spinal Stenosis
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Mar 2019to 31 Dec 2020
- Phase
- Observational
- 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 48 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population studied will be existing and/or new patients at the Cox Certified Doctor's private practice.
Who may be able to join
- Age greater than 48 years old
- Patient has leg or buttock pain while walking
- Patient feels relief of symptoms with bending (flexing) forward
- Patient feels relief when using a shopping cart of bicycle
- Patient has motor or sensory disturbance while walking
- Patient has normal and symmetrical foot pulses
Show all 11Show fewer
- Patient has lower extremity weakness
- Patient has low back pain
- Duration of symptoms and signs for more than 1 month
- Able to stand and walk without assistive devices for at least 20 minutes
- Able to give written informed consent and complete interviews and questionnaires in English
Who cannot join
- Complicated spinal pain due to fracture, tumor, infection, or severe spondyloarthropathy
- Has other severe co-morbidities, including progressive neurological deficit
- Other serious pathologies of the locomotor system
- No correspondence availability through email
- Inability to read/ comprehend English
- Compensation or seeking compensation from a third-party liability or workers' compensation
- Previous spinal manipulation within the past month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Chiropractic Distraction Spinal Manipulation on Posture and Performance in Patients With Lumbar Spinal Stenosis.
To assess the effect of chiropractic distraction manipulation on postural sway and simple measures of performance in patients with the clinical diagnosis of lumbar spinal stenosis.
Read the detailed description
This study aims to assess the effect of chiropractic distraction manipulation in reducing postural sway and improving performance-based mobility and disability in patients with the clinical diagnosis of lumbar spinal stenosis. This study will identify if distraction spinal manipulation will reduce postural sway center of pressure (COP) movements as determined by a force plate, if distraction spinal manipulation will improve simple measures of performance-based mobility and if distraction spinal manipulation will improve perception of balance confidence and will reduce self-rated stenosis associated disability.
- Conditions
- Spinal Stenosis Lumbar
- Being tested
- Lumbar Spinal Stenosis
- Keywords
- Chiropractic manipulation, postural sway, distraction manipulation, performance-based mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar Spinal StenosisOther
Posture and Performance testing: ABC-6 Scale, low back pain NRS, buttock or leg pain NRS, five times sit-to-stand, timed up-and-go, PGIC, eyes open force plate assessment (30 seconds), and eyes closed force plate assessment (30 seconds).
| Study group | Role | What they receive |
|---|---|---|
| Lumbar Spinal Stenosis | Questionnaire, chiropractic treatment, and posture and performance testing. Receives: Other: Lumbar Spinal Stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance tracking
The primary outcome is static balance as assessed by center of pressure (COP) using a portable force plate (Balance Tracking Systems, BTrackS™).
Measured: Each participant will be tested for one minute
Secondary outcomes (5)
Questionnaire: Pain sclae
Pain severity of the lower back and buttock using a numerical rating scale (0-10)
Measured: 5 Minutes
Questionnaire: Disability
Stenosis specific disability using the Zurich Claudication Questionnaire; symptom and function. Zurich Claudication Questionnaire has a 7-item symptom severity subscale with scores from 1 to 5 and a 5-item physical function subscale with scores from 1 to 4. The total score range is 12 to 55 points, with higher scores indicating higher levels of self-reported disability.
Measured: 5 Minutes
Questionnaire: Balance
Balance Specific Confidence (ABC-6)
Measured: 5 Minutes
Questionnaire: Change
Patient Global Impression of Change, this 1-item question has a 7-point rating scale with 1 being no change and 7 being considerable improvement.
Measured: 5 Minutes
Sit to Stand
physical performance as assessed by the 5 Times Sit to Stand and Timed Up and Go tests.
Measured: 5 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start14 Mar 2019
- Primary completion30 May 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis LumbarStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parker University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Houston, Whittier College, Private Practice, Miami University
- Responsible party
- Sponsor
- Investigators
- Katie Pohlman, DC, MS, PhD, Principal investigator, Parker University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863769
- Sponsor's protocol ID
- Parker19_02
- Acronym
- Stenosis
- Status last verified
- Dec 2021
- First submitted
- 14 Feb 2019
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Yes: Information about this study and individual data will be made available per request and approval from all investigator members.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Chiropractic Distraction Spinal Manipulation on Posture and Performance in Patients With Lumbar Spinal Stenosis.
- ClinicalTrials.gov ID
- NCT03863769
- Acronym / sponsor ID
- Stenosis / Parker19_02
- Conditions
- Spinal Stenosis Lumbar
- Keywords
- Chiropractic manipulation, postural sway, distraction manipulation, performance-based mobility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Parker UniversityUniversity, hospital or other
- Collaborators
- University of Houston, Whittier College, Private Practice, Miami University
- Study start
- 14 Mar 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 5 Mar 2019 (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.
To assess the effect of chiropractic distraction manipulation on postural sway and simple measures of performance in patients with the clinical diagnosis of lumbar spinal stenosis.
Detailed description
This study aims to assess the effect of chiropractic distraction manipulation in reducing postural sway and improving performance-based mobility and disability in patients with the clinical diagnosis of lumbar spinal stenosis. This study will identify if distraction spinal manipulation will reduce postural sway center of pressure (COP) movements as determined by a force plate, if distraction spinal manipulation will improve simple measures of performance-based mobility and if distraction spinal manipulation will improve perception of balance confidence and will reduce self-rated stenosis associated disability.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumbar Spinal Stenosis | – | Other: Lumbar Spinal StenosisQuestionnaire, chiropractic treatment, and posture and performance testing. |
Who may qualify
- Ages
- 48 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population studied will be existing and/or new patients at the Cox Certified Doctor's private practice.
Key inclusion criteria (11 listed)
- Age greater than 48 years old
- Patient has leg or buttock pain while walking
- Patient feels relief of symptoms with bending (flexing) forward
- Patient feels relief when using a shopping cart of bicycle
- Patient has motor or sensory disturbance while walking
Key exclusion criteria (7 listed)
- Complicated spinal pain due to fracture, tumor, infection, or severe spondyloarthropathy
- Has other severe co-morbidities, including progressive neurological deficit
- Other serious pathologies of the locomotor system
- No correspondence availability through email
- Inability to read/ comprehend English
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 |
|---|---|---|
| Lumbar Spinal StenosisPosture and Performance testing: ABC-6 Scale, low back pain NRS, buttock or leg pain NRS, five times sit-to-stand, timed up-and-go, PGIC, eyes open force plate assessment (30 seconds), and eyes closed force plate assessment (30 seconds). | Other | Lumbar Spinal Stenosis |
Primary outcome
Balance tracking
Time frame: Each participant will be tested for one minute
The primary outcome is static balance as assessed by center of pressure (COP) using a portable force plate (Balance Tracking Systems, BTrackS™).
5 secondary outcomes
Questionnaire: Pain sclae
Time frame: 5 Minutes
Questionnaire: Disability
Time frame: 5 Minutes
Questionnaire: Balance
Time frame: 5 Minutes
Questionnaire: Change
Time frame: 5 Minutes
Sit to Stand
Time frame: 5 Minutes
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 14 Jan 2022.
- Individual participant dataSharing planned: Yes. Information about this study and individual data will be made available per request and approval from all investigator members.
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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.
Katie Pohlman, DC, MS, PhD principal investigator
Parker University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Stenosis Lumbar, run by Parker University 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 7 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 14 Jan 2022. 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?
Balance tracking (time frame: Each participant will be tested for one minute). 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 14 Jan 2022.