RANDOMIZED CONTROLLED TRIAL OF LUMBAR TRANSFORAMINAL EPIDURAL STEROID INJECTIONS

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Lindsay Newton
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1 RANDOMIZED CONTROLLED TRIAL OF LUMBAR TRANSFORAMINAL EPIDURAL STEROID INJECTIONS Study Design A blinded randmized cntrlled trial f lumbar transframinal epidural sterid injectins versus intramuscular saline injectins in patients with acute lumbar radicular pain frm a disc herniatin, applied accrding t guidelines established by the Spine Interventin Sciety (SIS) Backgrund and Significance T be cmpleted by the prject s Principal Investigatr (PI). Hypthesis Patients underging a lumbar transframinal epidural sterid injectin (TFESI) will have greater success with radicular pain relief ( 50% reductin in pain) at ne-mnth pst-prcedure cmpared t thse receiving intramuscular (IM) saline. Specific Aims: 1. Cmpare success rates fr lwer limb pain ( 50% relief f gluteal, thigh, leg, ft pain) in thse receiving a lumbar TFESI vs IM saline. 2. Cmpare success rates fr lw back pain ( 50% relief) in thse receiving a lumbar TFESI vs IM saline. 3. Evaluate the functinal imprvement bserved in the entire chrt and the subgrups with fair and gd respnse t treatment and determine the crrelatin between reductin in pain and imprvement in functin. 5. Determine quality f life utcmes in bth the TFESI and IM saline grups. 6. Track analgesic medicatin use in bth the TFESI and IM saline grups. 7. Track duratin f pain relief in each grup. 8. Track return t wrk status in each grup. 9. Track the need fr surgery in each grup. 10. Reprt adverse effects. Recruitment Prcess Preferred: Identificatin f ptential study participants frm the research center s interventinal and surgical clinics. Allwed: Respnse t marketing in lcal primary care physician clinics, ther specialty clinics, and lcal media. Enrllment Prcess Presentatin f study and interview by physician r research crdinatr in either the clinic r by phne t screen fr study eligibility; determinatin (screening evaluatin) based n inclusin and exclusin criteria; and infrmed cnsent (bth written and verbal) f qualifying vlunteers. 1

2 Patients may be cmpensated fr their time and participatin upn enrllment and fr cmpletin f fllw-up intervals. Funding wuld be limited t cmpensatin t study sites based n enrlled patients nly. Patients wh decline randmizatin may be enrlled as a separate chrt t cmpare their utcmes at the same time pints as the study s enrlled subjects. Inclusin Criteria: - Adult patients aged capable f understanding and prviding cnsent and capable f cmplying with the utcme instruments used. - Lwer limb pain (gluteal, thigh, leg r ft) in clear radicular pattern that is greater in severity than axial lw back pain. - Physician assessment that pain is f a radicular quality, i.e., lwer limb pain f a lancinating, stabbing, r electric quality (as ppsed t dull ache) (Ghahreman et al. Pain Medicine 2010; 11: ) - Three-day average numeric pain rating scre (NPRS) fr radicular pain is 4/10 at baseline evaluatin. - Recent MRI (within last 6 mnths) shwing a disc herniatin at a segmental level cnsistent with the clinical features. - Tw interventinal r spine physicians have reviewed MRI and clinical data (radicular pattern, exam) and agree n etilgy. Exclusin Criteria: - Mderate-t-severe fixed/bny framinal r canal stensis - Severe mtr deficit - Histry f substance abuse - Inability t cmply with instruments fr utcme assessment - Previus surgery at the affected level - BMI > 40 - Bilateral radicular pain - Any spndyllisthesis at affected r adjacent level - Systemic inflammatry arthritis (e.g., rheumatid, lupus, sernegative spndylarthrpathy) - Prir epidural injectins fr the current painful episde. - Addictive behavir, severe clinical depressin, r psychtic features - Pssible pregnancy r ther reasn that precludes the use f flurscpy - Current infectin r treatment f infectin with antibitics within the past 7 days - Medical cnditins causing significant functinal disability (e.g., strke, COPD) - Receiving remuneratin fr their pain treatment (e.g. disability, wrker s cmpensatin, aut injury in litigatin r pending litigatin) - Incarceratin - Allergy t cntrast media 2

3 Outcme Instruments Baseline Only: - NIH Minimal Dataset, Task Frce n Research Standards fr Chrnic Lw-Back Pain ( Demgraphics Duratin f back pain - Nature f pain (i.e. bilateral, symmetrical, unilateral) - Duratin f symptms fr stratificatin purpses - NPRS fr leg pain and back pain - MRI grade f nerve rt cmpressin using a validated system (such as used in Ghahreman and Bgduk. Predictrs f a favrable respnse t transframinal injectin f sterids in patients with lumbar radicular pain due t disc herniatin. Pain Med 2011;12:871-79) Baseline & Fllw-up: - NIH Minimal Dataset, Task Frce n Research Standards fr Chrnic Lw-Back Pain - Analgesic use lg - Ancillary treatment lg Average NPRS back pain (7-day average) Physical functin Depressin Sleep disturbance Pain interference with activity Opiid use Emplyment status - Current NPRS fr leg pain and back pain - Physical examinatin - Need fr surgery - EQ-5D Quality f life - Average NPRS fr lwer limb pain ver the last week Fllw-Up Only: - Duratin f pain relief (duratin f > 50% pain relief) - Glbal perceptin f change - Adverse effects (e.g. pst-prcedural pain, ataxia, dysethesias, dizziness) Injectin Treatment: - It is suggested that investigatrs fllw the Ghahreman prtcl (Pain Medicine 2010; 11: ) f targeting the affected nerve with a TFESI. This typically implies a TF apprach t cver the affected nerve rt. Fr example, fr a L4-5 herniatin cmpressing the traversing L5 nerve, the TFESI wuld target the L5 nerve with a L5-S1 supraneural TFESI. A framinal disc herniatin at L4/5 affecting the exiting L4 nerve rt wuld require a L4/5 supraneural TFESI t cver the 3

4 L4 nerve rt. If the anatmy precludes safe needle placement with a supraneural apprach, an alternative transframinal apprach may be used, such as infraneural. If cntrast flw is deemed unsatisfactry at the chsen level, the injectinist may mdify the level and intra-framinal psitin t cver the affected nerve adequately. Sterid may nly be injected at a single level. - A minimum f 2 ml f cntrast shall be injected. Prcedural images shall be saved including a minimum f pre-injectin AP and lateral, pst cntrast injectin AP and lateral, and an AP washut (pst sterid injectin). - Injectin f dexamethasne accrding t techniques described in the Internatinal Spine Interventin Sciety s 2 nd Editin Practice Guidelines. The therapeutic dse(s) and vlume(s) must be standardized and specified by the investigatr. Investigatrs must cmply with infrmatin prvided in the latest Sciety guidelines. - An injectin may be repeated if inadequate respnse is btained (pain still 4/10) with timing f fllw-up questinnaires based n last injectin. Pwer Analysis T be cmpleted by prject s principal investigatr (PI) t demnstrate the size f the study sufficient t prvide acceptable cnfidence intervals fr the anticipated success rates in the different grups. The numbers culd be based n the Ghahreman study (Pain Medicine 2010; 11: ) Investigatrs t cnfirm that they perfrm a sufficient number f TFESI in patients with islated intervertebral disc herniatin t supprt the expectatin f reaching the target enrllment number in a reasnable amunt f time. Using a success rate f 54% (TFESI) vs 13% (IM saline) frm Ghahreman study: 20 per grup fr 80% pwer 23 per grup fr 85% pwer 26 per grup fr 90% pwer In the Ghahreman study, the success rates f all nn-tfesis was 15% (CI 8-22%) as ppsed t 13% success rate with IM saline. A mre cnservative pwer analysis culd be dne (enrlling mre subjects) but will be left t the discretin f the PI. The PI shuld cnfirm and prvide details f the pwer analysis in supprt f the target enrllment. N target enrllment is specified fr the nn-randmized chrt. Study Timeline Baseline: Participants wh meet inclusin and exclusin criteria will be enrlled int the study after cnsenting t and befre receiving a first lumbar TFESI. The baseline examinatin and all baseline questinnaires will be cmpleted within 2 weeks befre lumbar TFESI. Fllw-up: Fllw-up n utcme measures t be dne at 1 mnth (+/- 1 week), 3 mnths (+/- 2 weeks), and 12 mnths (+/- 2 weeks). The 12-mnth fllw-up may be a phne fllw-up with the intentin f capturing the natural histry f the disease. The 12-mnth fllw-up is nt a primary fllw-up pint t assess utcmes differences between grups. 4

5 Study Prtcl Cnsecutive patients presenting with acute lumbar radicular pain wh meet the abve-mentined inclusin and exclusin criteria and wh have prvided cnsent will be enrlled in the study. The target enrllment number is based n a pwer analysis as nted abve. Patients will be randmized t receive either a lumbar TFESI r IM saline. Bth grups will receive nging equivalent cnservative treatments (physical therapy and medicatins) per the directin f the principal investigatr. Prtcl shuld include a quality mnitring bard tasked with reviewing clinical ntes dcumenting inclusin/exclusin criteria and apprpriate technique, as well as prcedural images f final needle placement in AP and lateral views fr every prcedure fr the purpse f quality cntrl. Optins fr the quality mnitring bard include a grup f SIS Research Divisin and/r Bard members n a vlunteer basis r a grup f apprved SIS members. Subjects with sub-ptimal images shall be withdrawn frm the trial as prtcl vilatins. Grup Assignments: Patients are randmly assigned by a cmputerized randm number generatr prgram t the active treatment r cntrl grups. The principal investigatr shuld further describe the randmizatin prcess. Blinding: This is a single-blinded study. Patients will remain blinded t their grup assignments thrughut the study unless they meet criteria fr crssver treatment. The treating physician cannt be blinded and therefre, cannt als serve as the assessing clinician. The assessing clinician will remain blinded as t the patient s treatment grup and cllect utcme measures. Care shuld be taken t ensure that the patient remains blinded t the prcedure, especially if blinded t the placeb grup. Fr example, the prcedures culd take place as fllws: in every patient, the physician shall place the needle int the target psitin fr the TFI. Befre injecting anything, the nurse cnsults the randmizatin schedule. By a hand signal nt in view f the patient the nurse pints dwn if the allcatin is fr TFESI but pints up if the allcatin is IM saline. If the allcatin is IM saline, the physician gently withdraws the needle t an intramuscular depth, injects cntrast medium, then injects saline. Under this prtcl, three films must be kept: the needle in psitin fr TFESI, the needle withdrawn, and after the IM saline cntrast medium. T help determine the blinding success in this study, patients shuld be asked after their prcedure if they believe that they received the active treatment, the placeb, r if they culd nt sense t which grup they were assigned. Crssver: Patients will be assessed 7-10 days after their alltted treatment. If patients still have significant pain ( 4/10 n the NPRS), they will be ffered a repeat f the allcated treatment (TFESI r IM saline). After ne mnth, participants in the IM saline grup will be allwed t crss ver and receive a TFESI (rescue treatment) if pain remains severe. Any patient wh crsses ver wuld be cnsidered a treatment failure. Any patient underging surgery wuld be cnsidered a treatment failure as well. 5

6 Injectin: This study will investigate lumbar transframinal injectins f sterid. The intervertebral level f the injectin will be determined by the treating physician based n 1) clinical presentatin (distributin) f their pain and 2) and the lcatin f the patient s disc abnrmality seen n advanced imaging. C-interventins: Bth grups may receive nging equivalent cnservative treatments (physical therapy and medicatins) as per the directin f the principal investigatr. Any treatments related t the participant s spine cnditin will be reprted. Primary Outcmes: 1. Success rate fr lwer limb pain (gluteal, thigh, leg, ft), specifically defined as 50% reductin in pain frm baseline t 1-mnth pst-prcedure. Secndary Outcmes: 1. Success rate and duratin f lw back pain, specifically defined as 50% relief f lw back pain. 2. Physical functin 3. Health-related quality f life 4. Pain interference with activity 5. Health-care utilizatin fr back pain 6. Need fr surgery 7. Wrk status The same utcmes will be tracked in the chrt wh did nt agree t be randmized but did agree t have their utcmes tracked. Data Management Data will be cllected n standardized case reprt frms and entered int a HIPAA-cmpliant electrnic database (e.g. Micrsft Access) that prvides an apprpriate interface with a rbust statistical package (e.g. SPSS). All study-related hard cpy materials will be stred in lcked file cabinets. Analysis Overall success will be calculated fr bth grups by determining the prprtin f participants with 50% relief f index pain at 1 and 3 mnths fr lwer limb pain. Success rate again will be determined fr lw back pain ( 50% relief). These are all dichtmus utcmes that allw fr categrical data analysis. Secndary utcmes will be similarly evaluated. Functin and quality f life will be evaluated in the treatment grup cmpared t the cntrl grup at the 12-week fllw-up. Als, the percent f subjects wh are nt taking piids r partial piids will be categrized as well as return t wrk status. Need fr surgery will be a simple yes r n answer. Duratin f relief by each individual participant will be graphed using a life table analysis specifically dcumenting hw lng each subject maintained at least 50% pain relief. Quality f life measures (EQ- 5D) will be descriptive. 6

7 Analysis shall be perfrmed t determine the assciatin f utcmes in relatin t degree f nerve rt cmpressin. In additin, a kappa scre will be calculated fr agreement amng the blinded readers determining degree f nerve rt cmpressin. The prprtin f patients frm the study sites wh were eligible fr the study but declined t participate may als be analyzed as an pen chrt fr cmparisn t study subjects as well as t dcument the implementatin challenges assciated with randmized cntrlled trials in this field. At a minimum, the number f patients wh were eligible but did nt participate shuld be nted. 7

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