OBJECTIVES: Published studies of intradiscal thermal annuloplasty (IDTA) have shown at most 50% pain relief as an improved outcome with little focus on functional improvement in the treatment of discogenic pain. Previous studies have used a number of criteria for patient selection including low back pain unresponsive to conservative care, no compressive radiculopathy, positive provocative discography and absence of previous surgery at the same symptomatic level. The purpose of present study is to examine the hypothesis that additional inclusion criteria for patient selection such as disc height, absence of degenerative disc disease (DDD) in untreated discs, absence of herniated nucleus pulposus or lumbar canal stenosis may improve the outcome of treatment.
METHODS: In this prospective case-series study additional criteria of patient selection were introduced, namely disc height of at least 50%, no lumbar canal stenosis, one or two levels of DDD, no evidence of nucleus pulposus herniation on magnetic resonance image. Thirty-four patients were enrolled in the study and 32 of them were followed over a period of 12 months. The visual analog scale (VAS) pain score and seven activities of daily living (ADLs) were followed and reported on a scale from 0 to 10.
RESULTS: Sustained decrease of the VAS pain scores was observed from 3 to 12 months following IDTA. ADLs improved in all patients between 3 and 12 months post-treatment. Patients in the Bureau of Workers Compensation (BWC) group had a higher VAS score but showed the same level of improvement in ADLs as compared to commercial insurance or self-pay patients. In the non-BWC patient group an average VAS pain score decrease of more than 6 points on a 10-point scale was reported at 6 to 12 months following IDTA.
CONCLUSIONS: We found dramatic improvement of pain scores and ADLs following IDTA when strict patient selection was applied. We believe that IDTA is an effective, minimally invasive treatment for discogenic pain in properly selected patients.
Symptomatic degenerative disc disease (DDD) may lead to significant deterioration of quality of life and increased disability. Intradiscal thermal annuloplasty (IDTA) is a minimally invasive treatment for painful DDD. We hypothesized that there may be an improvement in pain scores and the pain disability index (PDI) of patients who have multilevel DDD after IDTA. Patients 24-66 yr old, male and female with multilevel DDD (MDDD) and matched 1 or 2 level DDD (1,2-DDD) patients were enrolled in the study. Visual analog pain scale (VAS) score and PDI were observed for 12 mo. The 1,2-DDD patient group had a 2.5 +/- 2.4 VAS score at 12 mo after annuloplasty compared to 7.7 +/- 2 before the procedure. The MDDD VAS score was 4.9 +/- 2.9 at 12 mo compared to 7.4 +/- 1.8 before the procedure. Similar improvements in PDI were found. The pain relief and PDI were significantly better in patients with 1,2-DDD than in the MDDD group (P = 0.0037 and P = 0.041, respectively). We concluded that IDTA is an effective treatment of discogenic pain and that the number of discs affected by degeneration is an important determinant of the procedure outcome.
BACKGROUND: Intradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested.
PURPOSE: To compare the efficacy of IDET with that of a placebo treatment.
STUDY DESIGN/SETTING: Randomized, placebo-controlled, prospective trial.
PATIENT SAMPLE: Patients were recruited by referral and the media. No inducements were provided to any patient in order to have them participate. Of 1,360 individuals who were prepared to submit to randomization, 260 were found potentially eligible after clinical examination and 64 became eligible after discography. All had discogenic low back pain lasting longer than 6 months, with no comorbidity. Thirty-seven were allocated to IDET and 27 to sham treatment. Both groups were satisfactorily matched for demographic and clinical features.
METHODS: IDET was performed using a standard protocol, in which the posterior annulus of the painful disc was heated to 90 C. Sham therapy consisted of introducing a needle onto the disc and exposing the patient to the same visual and auditory environment as for a real procedure. Thirty-two (85%) of the patients randomized to the IDET group and 24 (89%) of those assigned to the sham group complied fully with the protocol of the study, and complete follow-up data are available for all of these patients.
OUTCOME MEASURES: The principal outcome measures were pain and disability, assessed using a visual analog scale for pain, the Short Form (SF)-36, and the Oswestry disability scale.
RESULTS: Patients in both groups exhibited improvements, but mean improvements in pain, disability and depression were significantly greater in the group treated with IDET. More patients deteriorated when subjected to sham treatment, whereas a greater proportion showed improvements in pain when treated with IDET. The number needed to treat, to achieve 75% relief of pain, was five. Whereas approximately 40% of the patients achieved greater than 50% relief of their pain, approximately 50% of the patients experienced no appreciable benefit.
CONCLUSIONS: Nonspecific factors associated with the procedure account for a proportion of the apparent efficacy of IDET, but its efficacy cannot be attributed wholly to a placebo effect. The results of this trial cannot be generalized to patients who do not fit the strict inclusion criteria of this study, but IDET appears to provide worthwhile relief in a small proportion of strictly defined patients undergoing this treatment for intractable low back pain.
STUDY DESIGN: Retrospective study with independent evaluation of patient outcomes approximately 1 year post-intradiscal electrothermal therapy (IDET). OBJECTIVE.: To assess functional status, symptoms, and subsequent treatments of patients treated with IDET.
SUMMARY OF BACKGROUND DATA: IDET was introduced as a procedure for discogenic pain. Several studies reported improvement in >70% of patients.
METHODS: Seventeen physicians referred 60 patients. Each patient had a positive discogram and had been treated with IDET. Patients were contacted approximately 1 year post-IDET, answered a telephone interview, and completed a self-administered questionnaire. Overall patient satisfaction, pain, functional and work status, analgesic usage, and subsequent treatments were noted. Kaplan-Meier survival curve was generated to predict the percentage that would undergo lumbar surgery after IDET.
RESULTS: Average age was 40 years (range 25-64 years) with 66% males and 34% females. Of the 44 patients who responded, 6 patients had a lumbar surgery within 1 year. Their outcomes were excluded from descriptive analysis; 97% continued to have back pain, 11 (29%) reported more pain post versus pre-IDET, 15 (39%) had less pain, and 11 (29%) reported no change; 11 (29%) reported using more pain medication post-IDET, 10 (26%) used the same, 12 (32%) used less, and 5 (13%) used none; 19 (50%) were dissatisfied with IDET, 14 (37%) were satisfied, and 5 (13%) were undecided; 20 (53%) would have the procedure again, 12 (31%) would not, and 6 (16%) were unsure. Most patients wore a brace >6 hours/day after surgery (duration 1-15 months). Sixteen (42%) were employed full-time pre-IDET and 11 (29%) were employed full-time post-IDET.
CONCLUSION: At 1-year post-IDET, half of patients were dissatisfied with their outcome. The percentage of patients on disability remained constant. The estimated proportion of patients undergoing fusion was predicted to be 15% at 1 year and 30% at 2 years.
STUDY DESIGN: Case series.
OBJECTIVE: To describe the outcomes of workers' compensation (WC) claimants who have had a lumbar intradiscal electrothermal therapy (IDET) procedure.
SUMMARY OF BACKGROUND DATA: IDET was developed as a less invasive treatment alternative to fusion after failure of conservative treatment for discogenic low back pain (LBP). Initial IDET case series from single practices have reported improved pain, function, and return to work outcomes. Little is known about results when performed by a variety of providers or in WC populations.
MATERIALS AND METHODS: LBP cases that underwent IDET between December 1, 1998 and February 29, 2000 were identified from WC records. Data sources included hardcopy claim files, administrative medical billing data, and computerized claim file narrative reports. Outcomes included narcotic use 6 months or more after IDET, additional invasive treatment after IDET (low back injections or surgery), and improved work status 24 months after IDET.
RESULTS: One hundred forty-two cases from 23 states were identified, with 97 different providers performing the procedure. Mean duration of symptoms before IDET was 26 months. Mean follow-up duration after IDET was 22 months. Ninety-six (68%) of the cases did not meet one or more of the published inclusion criteria. Seventy-eight cases (55%) received at least two narcotic prescriptions 6 months or more after IDET. Fifty-three (37%) had at least one lumbar injection and 32 (23%) had lumbar surgery after IDET. A total of 55 (39%) were working at 24 months after IDET; of these, 28 (20%) were not working and 27 (19%) were working before IDET. Narcotic use after IDET was associated with narcotic use before IDET, the same provider performing discography and IDET (provider self-referral), and positive signs of radiculopathy (C = 0.80). Need for invasive lumbar procedures after IDET were associated with provider self-referral, narcotic use before IDET, and older age (C = 0.73). Continued work absence after IDET was associated with provider self-referral, male gender, litigation, narcotic use before IDET, and older age (C = 0.83). Conformance with published selection criteria for IDET was not associated with provider self-referral or outcomes, nor was duration before IDET associated with outcomes.
CONCLUSION: The procedure may be less effective when performed by a variety of providers than suggested by initial case series performed by single providers or practices in work-related LBP cases. Provider self-referral and narcotic use before IDET are significant risk factors for poor outcomes. Randomized controlled trials are needed to determine whether there is a subset of patients with discogenic back pain who derive substantial and sustained benefit from this procedure.
STUDY DESIGN: A bi-institutional, retrospective clinical data analysis.
OBJECTIVES: To determine risk factors for failure and complications of intradiscal electrothermal therapy, a treatment for discogenic back pain.
SUMMARY OF THE BACKGROUND DATA: Intradiscal electrothermal therapy is a relatively new treatment for discogenic back pain. Though previous studies have shown it to be an effective treatment, there are few published studies examining complications and none examining risk factors for failure.
METHODS: The authors treated 79 patients with discogenic back pain using intradiscal electrothermal therapy. Complications were assessed by patient report and, when indicated, further diagnostic testing. Success or failure was determined by visual analogue pain scores at 6-month follow-up. Variables examined for their relationship to failure and complications were age, sex, duration of pain, number of levels heated, smoking history, diabetes, obesity, leg pain, and previous back surgery.
RESULTS: Forty-eight percent of patients reported more than 50% pain relief at their 6-month follow-up. There were eight complications (10%), most of which were self-limited and transient. The only risk factor associated with intradiscal electrothermal therapy failure was obesity (P = 0.01). Whereas 54% of nonobese patients reported good pain relief at 6 months, only one out of 10 obese patients had successful intradiscal electrothermal therapy. The obese patients in our study were more likely to have a complication from intradiscal electrothermal therapy than they were to obtain pain relief.
CONCLUSION: The only risk factor found to be associated with IDET outcome was obesity, which was a strong predictor of failure. Obesity should be considered a relative contraindication to performing IDET.
OBJECTIVE: To determine the clinical efficacy of intradiskal electrothermal annuloplasty in treating patients with chronic constant lumbar diskogenic pain who have not responded to at least 6 months of aggressive nonoperative care.
DESIGN: Prospective case series.
SETTING: Academic-affiliated private physiatry practice.
PARTICIPANTS: Thirty-three patients with chronic constant lumbar diskogenic pain of more than 6 months in duration diagnosed with history and physical examination, with concordant pain on provocative pressure-controlled lumbar diskography, and with symptomatic annular tears and/or protrusions less than 5mm, who did not respond to aggressive nonoperative care.
INTERVENTION: Intradiskal electrothermal annuloplasty.
MAIN OUTCOME MEASURES: Visual analog scale (VAS) pain scores for the back and for the lower extremity, the Roland-Morris Disability Questionnaire (RMDQ), and the North American Spine Society Patient Satisfaction Index.
RESULTS: A total of 33 patients, with mean age of 40 years and a mean duration of symptoms of 46 months, were observed with a mean follow-up of 15 months. Relief of pain and improvement in physical function were associated with a mean change in the VAS score of 3.9 (P<.001), a mean change in the lower-extremity VAS score of 3.7 (P<.001), and a mean change in the RMDQ of 7.3 (P<.001). For patient satisfaction, 75.7% reported that they would undergo the same procedure for the same outcome. Complete pain relief was achieved in 24% of the patients, and partial pain relief in 46% of the patients.
CONCLUSIONS: Intradiskal electrothermal annuloplasty offers a safe, minimally invasive treatment option for carefully selected patients with chronic lumbar diskogenic pain who have not responded to aggressive nonoperative care.
BACKGROUND CONTEXT: Intradiscal electrothermal therapy (IDET) is a new treatment option for chronic discogenic low back pain that is minimally invasive and has demonstrated success rates equal to or better than those for spinal fusion at short-term follow-up.
PURPOSE: To report our experience with IDET in the management of chronic discogenic low back pain in active-duty soldiers.
STUDY DESIGN/SETTING: Consecutive case series at a US Army medical center.
OUTCOME MEASURES: The primary outcome measured was a reported 50% or greater reduction in pain at latest follow-up. Additional outcomes measured included analog pain scores, satisfaction, complications, duty status and subsequent spinal surgery.
METHODS: Between 1999 and 2001, 41 active-duty soldiers (34 men, 7 women) underwent IDET for chronic discogenic low back pain unresponsive to nonoperative therapy. Data were collected through clinic chart review and follow-up questionnaires. Success was defined as a stated "50% decrease in pain" from baseline.
RESULTS: During the study period, 36 of 41 patients underwent a single trial of IDET, and the remaining 5 underwent two trials of IDET. Only the results of the 36 patients who underwent one trial of IDET were used for statistical analysis. All 36 patients were available for follow-up at 6 months, whereas only 31 patients (86%) were reached for final follow-up (average, 29.7 months; range, 24 to 46). The success rate was 47% (17 of 36) at 6 months and 16% (5 of 31 patients) at latest follow-up. Although overall success rates were low, 20 of 31 soldiers (65%) had a persistent decrease in their analog pain score (average decrease of 2.5+/-1.6 on a 10-point scale), with 52% having 2-point or greater decrease. Nineteen of 31 soldiers (61%) were still on active duty at a minimum of 24 months after IDET. There were five transient complications (16%) from IDET, all reported within the first month. Seven of 31 soldiers (23%), all male, went on to spinal surgery within 24 months of failed IDET.
CONCLUSIONS: IDET is not a substitute for spinal fusion in the treatment of chronic discogenic low back pain in active-duty soldiers. Our reasonable early results diminished with time and up to 20% of patients report worsening of baseline symptoms at final follow-up. IDET will prove its role in the treatment of chronic discogenic low back pain as more outcome data are obtained, but for now we consider it, at best, an antecedent rather than alternative to spinal fusion.
OBJECTIVE: To determine the long-term efficacy of IDET in the treatment of chronic lumbar discogenic pain.
DESIGN: Prospective case series clinical outcome study.
METHODS: IDET was performed on 62 consecutive patients with chronic discogenic pain of greater than 6 months duration and consecutively enrolled in a non-randomized prospective case series outcome study. Outcome measures included visual numeric pain scale (VNS) for low back (LB) and lower extremity (LE) pain, Roland-Morris disability scale (RM), and North American Spine Society (NASS) patient satisfaction index. Outcome success was defined as a change of more than 2 points on VNS and RM as well as a positive NASS satisfaction response. Data were collected at baseline and post-procedure at 1, 3, and 6 months and then annually for up to 4 years.
RESULTS: Fifty-one out of 62 patients (82%) were available for a minimum of 2-year follow-up. Average age was 41.4 years; average symptom duration was 46 months; and average follow-up was 34 months. Overall, there was statistically significant improvement in LB-VNS, RM, and LE pain scores of 3.2, 6.6, and 2.3 (p<0.001), respectively. Twenty-seven of 51 (53%) patients demonstrated clinically significant VNS and RM improvements of greater than 2. On NASS index, 63% (32/51) responded positively. Neither the number of disc levels treated nor the insurance status of patients made any difference in outcome.
CONCLUSION: IDET appears to be an effective treatment for chronic lumbar discogenic pain in a well-selected group of patients with favorable long-term outcome.
Journal»European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
The goal of this study was to evaluate the short-term effects of intradiscal electrothermal treatment (IDET) for chronic discogenic low back pain. Twenty consecutive patients with symptomatic degenerative discs were treated with IDET and evaluated preoperatively, and 3 and 6 months postoperatively. Pain was measured with a 100-mm visual analog scale (VAS) and function was evaluated with the Oswestry score and SF-36 questionnaire. The VAS scores improved by 14 mm on average (P=0.046), but the individual scores show great variation. The Oswestry scores did not improve significantly. The SF-36 showed improvement, but only for the subscales vitality (P=0.023) and bodily pain (P=0.047). Based on these results, we conclude that IDET is not effective in reducing pain and improving functional performance in a sample of 20 patients treated for chronic discogenic low back pain after 6 months follow-up.
Published studies of intradiscal thermal annuloplasty (IDTA) have shown at most 50% pain relief as an improved outcome with little focus on functional improvement in the treatment of discogenic pain. Previous studies have used a number of criteria for patient selection including low back pain unresponsive to conservative care, no compressive radiculopathy, positive provocative discography and absence of previous surgery at the same symptomatic level. The purpose of present study is to examine the hypothesis that additional inclusion criteria for patient selection such as disc height, absence of degenerative disc disease (DDD) in untreated discs, absence of herniated nucleus pulposus or lumbar canal stenosis may improve the outcome of treatment.
METHODS:
In this prospective case-series study additional criteria of patient selection were introduced, namely disc height of at least 50%, no lumbar canal stenosis, one or two levels of DDD, no evidence of nucleus pulposus herniation on magnetic resonance image. Thirty-four patients were enrolled in the study and 32 of them were followed over a period of 12 months. The visual analog scale (VAS) pain score and seven activities of daily living (ADLs) were followed and reported on a scale from 0 to 10.
RESULTS:
Sustained decrease of the VAS pain scores was observed from 3 to 12 months following IDTA. ADLs improved in all patients between 3 and 12 months post-treatment. Patients in the Bureau of Workers Compensation (BWC) group had a higher VAS score but showed the same level of improvement in ADLs as compared to commercial insurance or self-pay patients. In the non-BWC patient group an average VAS pain score decrease of more than 6 points on a 10-point scale was reported at 6 to 12 months following IDTA.
CONCLUSIONS:
We found dramatic improvement of pain scores and ADLs following IDTA when strict patient selection was applied. We believe that IDTA is an effective, minimally invasive treatment for discogenic pain in properly selected patients.
