Sciatic NeuropathyNCT00934284
Effectiveness Study of Physical Therapy as an Adjunct to a Lumbar Therapeutic Selective Nerve Root Block
An observational study of Sciatic Neuropathy and Radiculopathy, run by University of Utah at 1 site in United States.
Trial summary
The purpose of this study is to determine if participation in physical therapy in conjunction with a selective nerve root block in the lumbar spine is more effective than just receiving the injection alone for patients with low back and leg pain from a disk herniation (sciatica). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Sciatic Neuropathy, Radiculopathy, Intervertebral Disk Displacement
- What is being tested?
- Lumbar injection and Rehabilitation following lumbar injection
- Type of treatment
- Injection or infusion
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Feb 2008
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Individuals with low back pain, with clinical and imaging findings consistent with lumbar disk herniation, and scheduled to receive a selective nerve root block.
Who may be able to join
- MRI evidence of disk herniation in the lumbar spine consistent with clinical presentation
- Pain and/or paresthesia in the lumbar spine and a distribution extending distal to the gluteal fold within 24 hours of enrollment
- Scheduled to receive a therapeutic selective nerve root block
Who cannot join
- Any lumbar surgery within six months of the baseline examination
- Any prior lumbar surgery involving fusion
- Medical red flags indicating a serious pathology such as neoplasm, infection, or fracture
Trial locations and contacts
1 site in 1 country.
United States1 site
Intermountain Healthcare
Salt Lake City, Utah, 84107
About this study
Official title: Effectiveness of Physical Therapy as an Adjunct to a Selective Nerve Root Block in the Treatment of Lumbar Radicular Pain From Disk Herniation
The purpose of this study is to determine if participation in physical therapy in conjunction with a selective nerve root block in the lumbar spine is more effective than just receiving the injection alone for patients with low back and leg pain from a disk herniation (sciatica).
Read the detailed description
Recent reviews report moderate to strong evidence for short-term relief but limited evidence for long-term improvement. Anecdotal reports and case studies suggest good outcomes with various physical therapy interventions however well-designed research studies examining treatments in combination are lacking. The management of lumbar radicular pain often includes the combination of physical therapy and therapeutic selective nerve root blocks with the rationale that reducing inflammation and pain will permit greater participation in physical therapy. The effectiveness of this combination of treatment has not been studied and is the purpose of this pilot study.
- Being tested
- Lumbar injection, Rehabilitation following lumbar injection
- Keywords
- sciatic neuropathy, physical therapy, spinal injections
- Medical subject headings
- Sciatic Neuropathy, Radiculopathy, Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumbar injectionOther
Patients are instructed to resume normal activity as tolerated.
Rehabilitation following lumbar injectionOther
Participants are referred to an average of four weeks of physical therapy after receiving a lumbar injection. Physical therapy designed to include end-range directional preference exercises and/or mechanical traction to reduce lower extremity symptoms and progress activity tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Injection only | Participants receive a therapeutic selective nerve root block and advice to return to normal activity as tolerated. Receives: Other: Lumbar injection | |
| Injection plus physical therapy | Participants are referred to physical therapy within one week of receiving a therapeutic selective nerve root block. Physical therapy consists of end-range movements in a directional preference and/or mechanical traction to reduce radicular symptoms. Receives: Other: Rehabilitation following lumbar injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Oswestry Disability Index
Measured: Baseline (pre-injection), 8 weeks (post-injection), 6 months post-injection
Secondary outcomes (1)
Global Rating of Change
Measured: 8 weeks (post-injection) and 6 months (post-injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2009 (estimated)
- Study startJan 2006
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sciatic NeuropathyStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Thackeray, University of Utah
- Investigators
- Julie M Fritz, PhD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934284
- Sponsor's protocol ID
- 00014476
- Status last verified
- Dec 2024
- First submitted
- 6 Jul 2009
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Thackeray A, Fritz JM, Brennan GP, Zaman FM, Willick SE. A pilot study examining the effectiveness of physical therapy as an adjunct to selective nerve root block in the treatment of lumbar radicular pain from disk herniation: a randomized controlled trial. Phys Ther. 2010 Dec;90(12):1717-29. doi: 10.2522/ptj.20090260. Epub 2010 Sep 23.
PubMed 20864600
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physical Therapy as an Adjunct to a Selective Nerve Root Block in the Treatment of Lumbar Radicular Pain From Disk Herniation
- ClinicalTrials.gov ID
- NCT00934284
- Acronym / sponsor ID
- 00014476
- Keywords
- sciatic neuropathy, physical therapy, spinal injections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 8 Jul 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 purpose of this study is to determine if participation in physical therapy in conjunction with a selective nerve root block in the lumbar spine is more effective than just receiving the injection alone for patients with low back and leg pain from a disk herniation (sciatica).
Detailed description
Recent reviews report moderate to strong evidence for short-term relief but limited evidence for long-term improvement. Anecdotal reports and case studies suggest good outcomes with various physical therapy interventions however well-designed research studies examining treatments in combination are lacking. The management of lumbar radicular pain often includes the combination of physical therapy and therapeutic selective nerve root blocks with the rationale that reducing inflammation and pain will permit greater participation in physical therapy. The effectiveness of this combination of treatment has not been studied and is the purpose of this pilot study.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection only | – | Other: Lumbar injectionParticipants receive a therapeutic selective nerve root block and advice to return to normal activity as tolerated. |
| Injection plus physical therapy | – | Other: Rehabilitation following lumbar injectionParticipants are referred to physical therapy within one week of receiving a therapeutic selective nerve root block. Physical therapy consists of end-range movements in a directional preference and/or mechanical traction to reduce radicular symptoms. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals with low back pain, with clinical and imaging findings consistent with lumbar disk herniation, and scheduled to receive a selective nerve root block.
Key inclusion criteria (3 listed)
- MRI evidence of disk herniation in the lumbar spine consistent with clinical presentation
- Pain and/or paresthesia in the lumbar spine and a distribution extending distal to the gluteal fold within 24 hours of enrollment
- Scheduled to receive a therapeutic selective nerve root block
Key exclusion criteria (3 listed)
- Any lumbar surgery within six months of the baseline examination
- Any prior lumbar surgery involving fusion
- Medical red flags indicating a serious pathology such as neoplasm, infection, or fracture
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 injectionPatients are instructed to resume normal activity as tolerated. | Other | Injection only |
| Rehabilitation following lumbar injectionParticipants are referred to an average of four weeks of physical therapy after receiving a lumbar injection. Physical therapy designed to include end-range directional preference exercises and/or mechanical traction to reduce lower extremity symptoms and progress activity tolerance. | Other | Injection plus physical therapy |
Primary outcome
Modified Oswestry Disability Index
Time frame: Baseline (pre-injection), 8 weeks (post-injection), 6 months post-injection
1 secondary outcome
Global Rating of Change
Time frame: 8 weeks (post-injection) and 6 months (post-injection)
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 13 Dec 2024.
- Results publication: PubMed 20864600Thackeray A, Fritz JM, Brennan GP, Zaman FM, Willick SE. A pilot study examining the effectiveness of physical therapy as an adjunct to selective nerve root block in the treatment of lumbar radicular pain from disk herniation: a randomized controlled trial. Phys Ther. 2010 Dec;90(12):1717-29. doi: 10.2522/ptj.20090260. Epub 2010 Sep 23.
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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 M Fritz, PhD principal investigator
Associate Professor
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 Sciatic Neuropathy 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 3 inclusion and 3 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 13 Dec 2024. 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: Baseline (pre-injection), 8 weeks (post-injection), 6 months post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00934284, which also lists 1 linked publication.
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 13 Dec 2024.