Lumbar Degenerative Disc DiseaseNCT01689922
The Effectiveness of Anti-Gravity Treadmill Training
An observational study of Lumbar Degenerative Disc Disease, run by Justin Parker Neurological Institute at 1 site in United States.
Trial summary
The primary objective of this study is to compare the effectiveness of standard for our practice postoperative physical therapy (PT) program to a PT program that incorporates lower body positive pressure (LBPP) treadmill training for the patients after lumbar discectomy and fusion surgeries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lumbar Degenerative Disc Disease
- What is being tested?
- AlterG
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing one-level microdiscectomy or fusion surgeries
Who may be able to join
- Adults between 18 and 65 years old
- Willing and able to comply with protocol and PT requirements
- Patients with primarily radicular and back pain due to degenerative disc disease requiring one-level discectomy for herniated disc or lumbar fusion between L2 and S1
- Willing and able to sign a study specific informed consent
Who cannot join
- Require more than one-level surgery
- No previous lumbar surgery
- Any ongoing health condition that would make it difficult to adhere to postoperative PT requirements
- Peri-operative or post-operative complications (infection, pneumonia, nerve injury, dural tear, etc.) that would constraint or delay the ability to participate in postoperative PT
- BMI greater than 40
- Active local or systemic infection
Trial locations and contacts
1 site in 1 country.
United States1 site
Boulder Neurosurgical Associates
Boulder, Colorado, 80304
About this study
Official title: The Effectiveness of Anti-Gravity Treadmill Training in Patients After Lumbar Microdiscectomy and Fusion Surgeries
The primary objective of this study is to compare the effectiveness of standard for our practice postoperative physical therapy (PT) program to a PT program that incorporates lower body positive pressure (LBPP) treadmill training for the patients after lumbar discectomy and fusion surgeries.
Read the detailed description
A prospective, randomized, parallel group controlled clinical study is proposed. The patients will be divided into the two study groups according to the surgical procedure:
- patients undergoing one-level microdiscectomy for lumbar herniated disc
- patients undergoing one-level lumbar fusion for degenerative disc disease without notable spinal stenosis.
Each group will consist of 60 patients (see sample size calculations below) who will be randomized into the two equal groups to undergo:
- Standard postoperative rehabilitation program
- Standard postoperative rehabilitation program with addition of lower body positive pressure (LBPP) treadmill training
- Conditions
- Lumbar Degenerative Disc Disease
- Being tested
- AlterG
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlterGOther
All patients will begin an early postoperative rehabilitation program and standard PT no later than 4 weeks following surgery and continue for at least 6 weeks. The duration of standard PT program could be extended depending on the patient needs. The patients randomized to undergo (LBPP) treadmill training will have an additional 7-week 3 times a week training on the antigravity
| Study group | Role | What they receive |
|---|---|---|
| AlterG and Physical therapy | 2) Standard postoperative rehabilitation program with addition of lower body positive pressure (LBPP) treadmill training Receives: Other: AlterG | |
| Control group | 1) Standard postoperative rehabilitation program Receives: Other: AlterG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Questionnaire
10 points or 20% improvement on Oswestry Disability Questionnaire
Measured: 24 months
Secondary outcomes (1)
Patient Global Outcome Ratings and Health Quality Improvement
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative Disc DiseaseStudies 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
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Justin Parker Neurological Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alan T Villavicencio, MD, Principal investigator, Boulder Neurosurgical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01689922
- Sponsor's protocol ID
- JPNI-2
- Status last verified
- Feb 2017
- First submitted
- 12 Jun 2012
- Last updated
- 1 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Anti-Gravity Treadmill Training in Patients After Lumbar Microdiscectomy and Fusion Surgeries
- ClinicalTrials.gov ID
- NCT01689922
- Acronym / sponsor ID
- JPNI-2
- Conditions
- Lumbar Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Justin Parker Neurological InstituteUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 Sep 2012 (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 primary objective of this study is to compare the effectiveness of standard for our practice postoperative physical therapy (PT) program to a PT program that incorporates lower body positive pressure (LBPP) treadmill training for the patients after lumbar discectomy and fusion surgeries.
Detailed description
A prospective, randomized, parallel group controlled clinical study is proposed. The patients will be divided into the two study groups according to the surgical procedure:
- patients undergoing one-level microdiscectomy for lumbar herniated disc
- patients undergoing one-level lumbar fusion for degenerative disc disease without notable spinal stenosis.
Each group will consist of 60 patients (see sample size calculations below) who will be randomized into the two equal groups to undergo:
- Standard postoperative rehabilitation program
- Standard postoperative rehabilitation program with addition of lower body positive pressure (LBPP) treadmill training
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AlterG and Physical therapy | – | Other: AlterG2) Standard postoperative rehabilitation program with addition of lower body positive pressure (LBPP) treadmill training |
| Control group | – | Other: AlterG1) Standard postoperative rehabilitation program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing one-level microdiscectomy or fusion surgeries
Key inclusion criteria (4 listed)
- Adults between 18 and 65 years old
- Willing and able to comply with protocol and PT requirements
- Patients with primarily radicular and back pain due to degenerative disc disease requiring one-level discectomy for herniated disc or lumbar fusion between L2 and S1
- Willing and able to sign a study specific informed consent
Key exclusion criteria (6 listed)
- Require more than one-level surgery
- No previous lumbar surgery
- Any ongoing health condition that would make it difficult to adhere to postoperative PT requirements
- Peri-operative or post-operative complications (infection, pneumonia, nerve injury, dural tear, etc.) that would constraint or delay the ability to participate in postoperative PT
- BMI greater than 40
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 |
|---|---|---|
| AlterGAll patients will begin an early postoperative rehabilitation program and standard PT no later than 4 weeks following surgery and continue for at least 6 weeks. The duration of standard PT program could be extended depending on the patient needs. The patients randomized to undergo (LBPP) treadmill training will have an additional 7-week 3 times a week training on the antigravity | Other | AlterG and Physical therapy, Control group |
Primary outcome
Oswestry Disability Questionnaire
Time frame: 24 months
10 points or 20% improvement on Oswestry Disability Questionnaire
1 secondary outcome
Patient Global Outcome Ratings and Health Quality Improvement
Time frame: 24 months
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2017.
Related trials for Lumbar Degenerative Disc Disease
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruiting
Lumbar Fusion With Nanotube Versus Titanium Cage
Degenerative Disc Disease, Lumbar Fusion
RecruitingPhase 3
A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease
Degenerative Disc Disease
Recruiting
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
Degenerative Disc Disease, Spondylolisthesis
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.
Alan T Villavicencio, MD principal investigator
Boulder Neurosurgical Associates
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 Lumbar Degenerative Disc Disease, run by Justin Parker Neurological Institute 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 6 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: stopped early, as of the sponsor's last update on 1 Mar 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?
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
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?
Oswestry Disability Questionnaire (time frame: 24 months). 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 1 Mar 2017.