Lumbar Disc HerniationNCT00894972
Rehabilitation Following Lumbar Disc Surgery
A study testing Rehabilitation following lumbar disc surgery (discectomy) in people with Lumbar Disc Herniation and Radiculopathy, run by University of Utah at 1 site in United States.
Trial summary
The proposed study will be a randomized clinical trial designed to determine the most effective physical therapy program for individuals who have undergone lumbar discectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lumbar Disc Herniation, Radiculopathy
- What is being tested?
- Rehabilitation following lumbar disc surgery (discectomy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Apr 2012
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-60 years old
- Diagnosis of LDH based on imaging (MRI or CT scan) of the lumbar spine with concurring clinical examination findings (based on the judgment of the attending neurosurgeon)
- Appropriate surgical candidate based on the opinion of the attending spine surgeon, and scheduled for single-level lumbar discectomy (open or micro-discectomy).
- Able to attend weekly treatment sessions.
Who cannot join
- Prior surgery to the lumbar spine
- Spondylolytic or degenerative spondylolisthesis present on pre-surgical imaging
- Unable to speak and understand English
- Peri- or post-operative complication (infection, nerve injury, dural tear, vascular injury, etc.) that would limit or delay the ability to participate in post-operative rehabilitation.
- Multi-level surgery or the use of instrumentation during surgery (i.e., lumbar fusion)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah, Department of Physical Therapy
Salt Lake City, Utah, 84112
About this study
Official title: Examining the Effectiveness of a Post-operative Rehabilitation Program Emphasizing Restoration of Multifidus Muscle Function for Individuals Undergoing Lumbar Discectomy: a Randomized Clinical Trial
The proposed study will be a randomized clinical trial designed to determine the most effective physical therapy program for individuals who have undergone lumbar discectomy surgery. The study will compare two different post-operative physical therapy programs (general strengthening or general + specific strengthening). Both groups will begin treatment 2 weeks post-surgery. Subjects in both groups will receive weekly treatment sessions for 8 weeks with a treatment program emphasizing exercises shown to activate the large trunk muscles without imposing potentially harmful compression or shear forces. The general + specific strengthening group will also receive exercises shown to isolate activation of the deep trunk muscles, in particular the multifidus, with training augmented by the use of diagnostic ultrasound biofeedback. Patient assessments will be conducted pre- and post-surgery, as well as 10 (post-treatment) and 26 weeks after surgery.
- Conditions
- Lumbar Disc Herniation, Radiculopathy
- Being tested
- Rehabilitation following lumbar disc surgery (discectomy)
- Medical subject headings
- Intervertebral Disc Displacement, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation following lumbar disc surgery (discectomy)Other
Exercise: walking, range of motion, and general trunk strengthening with or without specific trunk muscle motor control exercises.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | General exercise. Participants in this group will perform aerobic exercise, range of motion exercise and general strengthening exercise. Receives: Other: Rehabilitation following lumbar disc surgery (discectomy) |
| 2 | Experimental | Specific exercise. Participants in this group will perform aerobic exercise, range of motion exercise, and specific motor control exercises. Receives: Other: Rehabilitation following lumbar disc surgery (discectomy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Oswestry disability index
Measured: Preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months
Secondary outcomes (1)
Lumbar multifidus muscle activation as estimated by diagnostic ultrasound imaging
Measured: preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Fritz, University of Utah
- Investigators
- Julie Fritz, PT, PhD, ATC, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894972
- Sponsor's protocol ID
- 32474
- Status last verified
- Nov 2012
- First submitted
- 5 May 2009
- Last updated
- 6 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of a Post-operative Rehabilitation Program Emphasizing Restoration of Multifidus Muscle Function for Individuals Undergoing Lumbar Discectomy: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00894972
- Acronym / sponsor ID
- 32474
- Conditions
- Lumbar Disc Herniation, Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 7 May 2009 (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 proposed study will be a randomized clinical trial designed to determine the most effective physical therapy program for individuals who have undergone lumbar discectomy surgery. The study will compare two different post-operative physical therapy programs (general strengthening or general + specific strengthening). Both groups will begin treatment 2 weeks post-surgery. Subjects in both groups will receive weekly treatment sessions for 8 weeks with a treatment program emphasizing exercises shown to activate the large trunk muscles without imposing potentially harmful compression or shear forces. The general + specific strengthening group will also receive exercises shown to isolate activation of the deep trunk muscles, in particular the multifidus, with training augmented by the use of diagnostic ultrasound biofeedback. Patient assessments will be conducted pre- and post-surgery, as well as 10 (post-treatment) and 26 weeks after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Other: Rehabilitation following lumbar disc surgery (discectomy)General exercise. Participants in this group will perform aerobic exercise, range of motion exercise and general strengthening exercise. |
| 2 | Experimental | Other: Rehabilitation following lumbar disc surgery (discectomy)Specific exercise. Participants in this group will perform aerobic exercise, range of motion exercise, and specific motor control exercises. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-60 years old
- Diagnosis of LDH based on imaging (MRI or CT scan) of the lumbar spine with concurring clinical examination findings (based on the judgment of the attending neurosurgeon)
- Appropriate surgical candidate based on the opinion of the attending spine surgeon, and scheduled for single-level lumbar discectomy (open or micro-discectomy).
- Able to attend weekly treatment sessions.
Key exclusion criteria (5 listed)
- Prior surgery to the lumbar spine
- Spondylolytic or degenerative spondylolisthesis present on pre-surgical imaging
- Unable to speak and understand English
- Peri- or post-operative complication (infection, nerve injury, dural tear, vascular injury, etc.) that would limit or delay the ability to participate in post-operative rehabilitation.
- Multi-level surgery or the use of instrumentation during surgery (i.e., lumbar fusion)
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 |
|---|---|---|
| Rehabilitation following lumbar disc surgery (discectomy)Exercise: walking, range of motion, and general trunk strengthening with or without specific trunk muscle motor control exercises. | Other | 1, 2 |
Primary outcome
Modified Oswestry disability index
Time frame: Preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months
1 secondary outcome
Lumbar multifidus muscle activation as estimated by diagnostic ultrasound imaging
Time frame: preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative months
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 6 Nov 2012.
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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.
Julie Fritz, PT, PhD, ATC principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation following lumbar disc surgery (discectomy) in people with Lumbar Disc Herniation and Radiculopathy, run by University of Utah 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 5 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 6 Nov 2012. 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?
Modified Oswestry disability index (time frame: Preoperative, 2 postoperative weeks, 10 postoperative weeks, 6 postoperative 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 6 Nov 2012.