Low Back PainEarly Phase 1NCT01382771
Intraarticular Lumbar Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
A Early Phase 1 study testing Intra-articular corticosteroid injection and Intra-articular saline injection in people with Low Back Pain, run by University of Florida at 1 site in United States.
Trial summary
Subjects (N=120) who have had non-radicular low back pain, believed by clinical assessment and imaging to be consistent with lumbar zygapophysial joint (Z-joint) generated pain, who have failed conservative therapy including physical therapy, have had an initial >80% pain relief on a diagnostic medial branch block… Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Intra-articular corticosteroid injection and Intra-articular saline injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2012
- Phase
- Early Phase 1
- 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 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back pain episode greater than six months in duration
- NPR pain scale score three day average and present pain of at least four/ten at baseline (index pain)
- Previous medial branch block providing >80% pain relief for current painful episode
- Subject must be scheduled to undergo a second medial branch block for their back pain
Who cannot join
- Litigation
- Those seeking new or increased long-term remuneration
- Leg pain greater than back pain
- Radicular pain or evidence of neurological compromise in the lower limbs
- Those unable to read English and complete the assessment instruments
- Systemic inflammatory arthritis (e.g. rheumatoid, lupus)
Show all 14Show fewer
- Addictive behavior, severe clinical depression or psychotic features. The subjects will be identified at the sole discretion of the PI who per the current standard of care will consent the potential subjects to the study
- Significant lower extremity pathology that affects gait
- Sustained cervical or thoracic pain that is present at a level >3/10 on NPR
- Possible pregnancy or other reason that precludes the use of fluoroscopy
- Significant scoliosis
- Radicular/neurological deficits or focal disc herniation and/or stenosis, with correlating radicular symptoms
- Contra-indication to corticosteroid, including known allergies or sensitivities
- History of prior epidural spinal injections relieving their current pain, or prior lumbar surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
UF & Shands Orthopaedics and Sports Medicine Institute
Gainesville, Florida, 32607
About this study
Official title: A Randomized, Double-Blind, Placebo Controlled Perspective Study of Intraarticular Lumbar Zygapophysial Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
Subjects (N=120) who have had non-radicular low back pain, believed by clinical assessment and imaging to be consistent with lumbar zygapophysial joint (Z-joint) generated pain, who have failed conservative therapy including physical therapy, have had an initial >80% pain relief on a diagnostic medial branch block, and are scheduled to undergo a routine second medial branch block for facet mediated pain will be randomized. Both groups will receive the standard of care, a medial branch block. The treatment group will also receive one set of intra-articular lumbar Z-joint corticosteroid injection and the placebo group will receive intra-articular normal saline.
Read the detailed description
Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, chiropractic treatment, and/or alternative medicine. They will be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and will be schedule for a medial branch block as standard of care. As part of usual and standard care, patients will undergo lumbar medial branch blocks for diagnosis of zygapophysial joint pain.
Patients who obtain ≥ to 80% relief of their index pain with a first set of lumbar medial branch blocks will be offered the opportunity for possible inclusion in the study if they are scheduled to receive a second medial branch block. The definition of a positive response to MBB's is an 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks. If subjects are unable to render NPR scores or percentage estimate of improvement, then a 5 point global perception of effect tool will be used.
- Conditions
- Low Back Pain
- Being tested
- Intra-articular corticosteroid injection, Intra-articular saline injection
- Keywords
- low back pain, zygapophysial joint pain, medial branch block, > 6 months duration, non-radicular
- 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.
Intra-articular corticosteroid injectionDrug
Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint
Intra-articular saline injectionDrug
Intra-articular injection of 0.5 cc normal saline in each joint
| Study group | Role | What they receive |
|---|---|---|
| Intra-articular corticosteroid injection | Active comparator | Intra-articular corticosteroid injection in conjunction with confirmatory anesthetic medial branch blocks Receives: Drug: Intra-articular corticosteroid injection |
| Intra-articular saline injection | Placebo comparator | Intra-articular saline injections with confirmatory anesthetic medial branch blocks Receives: Drug: Intra-articular saline injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction
A positive response is defined as are ≥ 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks.
Measured: Hourly for 6 hours post injections
Secondary outcomes (6)
Numeric Pain Rating (NPR) Daily diary
The patient will be instructed to maintain a pain diary that records the degree and duration of any relief.
Measured: reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
Oswestry Disability Index (ODI)
Patient will complete ODI at the follow-up intervals.
Measured: 6 weeks, 3 months, 6 months, 12 months
Standard Form 36 (SF-36), General Health Survey
Patient will complete the SF-36 at the follow-up intervals. The SF-36 is a self-administered, generic, general health survey consisting of 36 questions. The questions focus on the functional health and well being of the subject completing the form.
Measured: 6 weeks, 3 months, 6 months, 12 months
Daily Work History Log
Patient will keep a Work History Log during participation. The Log should indicate the daily work activities of the subject.
Measured: reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up
Daily Analgesic Use Log
Patient will keep a Daily Analgesic Use Log during participation.
Measured: reviewed at 6 weeks, 3 months, 6 months, 12 months
Ancillary Treatment Log
Patient will keep an Ancillary Treatment Log during participation. This log will indicate any outside medical care, additional medial branch blocks or radiofrequency neurotomy treatments.
Measured: reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startOct 2010
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- D. J. Kennedy, M.D., Principal investigator, UF Department of Orthopaedics and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01382771
- Sponsor's protocol ID
- 319-2010
- Status last verified
- Oct 2013
- First submitted
- 23 Jun 2011
- Last updated
- 14 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo Controlled Perspective Study of Intraarticular Lumbar Zygapophysial Joint Corticosteroid Injection(s) as a Treatment of Chronic Low Back Pain in a Selected Population
- ClinicalTrials.gov ID
- NCT01382771
- Acronym / sponsor ID
- 319-2010
- Conditions
- Low Back Pain
- Keywords
- low back pain, zygapophysial joint pain, medial branch block, > 6 months duration, non-radicular
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 27 Jun 2011 (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.
Subjects (N=120) who have had non-radicular low back pain, believed by clinical assessment and imaging to be consistent with lumbar zygapophysial joint (Z-joint) generated pain, who have failed conservative therapy including physical therapy, have had an initial >80% pain relief on a diagnostic medial branch block, and are scheduled to undergo a routine second medial branch block for facet mediated pain will be randomized. Both groups will receive the standard of care, a medial branch block. The treatment group will also receive one set of intra-articular lumbar Z-joint corticosteroid injection and the placebo group will receive intra-articular normal saline.
Detailed description
Subjects will have failed conservative treatment, including, but not limited to oral medications, physical therapy, chiropractic treatment, and/or alternative medicine. They will be evaluated by a spine specialist in the Spine Division of the Department of Orthopaedics and will be schedule for a medial branch block as standard of care. As part of usual and standard care, patients will undergo lumbar medial branch blocks for diagnosis of zygapophysial joint pain.
Patients who obtain ≥ to 80% relief of their index pain with a first set of lumbar medial branch blocks will be offered the opportunity for possible inclusion in the study if they are scheduled to receive a second medial branch block. The definition of a positive response to MBB's is an 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks. If subjects are unable to render NPR scores or percentage estimate of improvement, then a 5 point global perception of effect tool will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intra-articular corticosteroid injection | Active comparator | Drug: Intra-articular corticosteroid injectionIntra-articular corticosteroid injection in conjunction with confirmatory anesthetic medial branch blocks |
| Intra-articular saline injection | Placebo comparator | Drug: Intra-articular saline injectionIntra-articular saline injections with confirmatory anesthetic medial branch blocks |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Low back pain episode greater than six months in duration
- NPR pain scale score three day average and present pain of at least four/ten at baseline (index pain)
- Previous medial branch block providing >80% pain relief for current painful episode
- Subject must be scheduled to undergo a second medial branch block for their back pain
Key exclusion criteria (14 listed)
- Litigation
- Those seeking new or increased long-term remuneration
- Leg pain greater than back pain
- Radicular pain or evidence of neurological compromise in the lower limbs
- Those unable to read English and complete the assessment instruments
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 |
|---|---|---|
| Intra-articular corticosteroid injectionIntra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint | Drug | Intra-articular corticosteroid injection |
| Intra-articular saline injectionIntra-articular injection of 0.5 cc normal saline in each joint | Drug | Intra-articular saline injection |
Primary outcome
Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction
Time frame: Hourly for 6 hours post injections
A positive response is defined as are ≥ 80% reduction in pain (by change in NPR scores or estimated patient improvement) AND the restoration of the ability to perform at least one previously painful posture, movement, or activity without increase in pain, during the anesthetic phase of the blocks.
6 secondary outcomes
Numeric Pain Rating (NPR) Daily diary
Time frame: reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
Oswestry Disability Index (ODI)
Time frame: 6 weeks, 3 months, 6 months, 12 months
Standard Form 36 (SF-36), General Health Survey
Time frame: 6 weeks, 3 months, 6 months, 12 months
Daily Work History Log
Time frame: reviewed at the 6 weeks, 3months, 6 months, 12 months follow-up
Daily Analgesic Use Log
Time frame: reviewed at 6 weeks, 3 months, 6 months, 12 months
Ancillary Treatment Log
Time frame: reviewed at 6 weeks, 3 months, 6 months, 12 months follow-up
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 Oct 2013.
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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.
D. J. Kennedy, M.D. principal investigator
UF Department of Orthopaedics and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intra-articular corticosteroid injection and Intra-articular saline injection in people with Low Back Pain, run by University of Florida 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 14 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 Oct 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Numeric Pain Rating (NPR) or patient estimation of improvement, >80% pain reduction (time frame: Hourly for 6 hours post injections). 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 Oct 2013.