A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain
Intradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested. To compare the efficacy of IDET with that of a placebo treatment. Randomized, placebo-controlled, prospective trial. Patients were recruited by referral and the...
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Published in | The spine journal Vol. 4; no. 1; pp. 27 - 35 |
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Main Authors | , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
Elsevier Inc
01.01.2004
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Subjects | |
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Abstract | Intradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested.
To compare the efficacy of IDET with that of a placebo treatment.
Randomized, placebo-controlled, prospective trial.
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.
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.
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.
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.
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. |
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AbstractList | Intradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested.BACKGROUNDIntradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested.To compare the efficacy of IDET with that of a placebo treatment.PURPOSETo compare the efficacy of IDET with that of a placebo treatment.Randomized, placebo-controlled, prospective trial.STUDY DESIGN/SETTINGRandomized, placebo-controlled, prospective trial.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.PATIENT SAMPLEPatients 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.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.METHODSIDET 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.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.OUTCOME MEASURESThe 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.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.RESULTSPatients 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.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.CONCLUSIONSNonspecific 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. Intradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested. To compare the efficacy of IDET with that of a placebo treatment. Randomized, placebo-controlled, prospective trial. 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. 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. 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. 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. 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. |
Author | Dreyfuss, Paul Howell, Susan Bogduk, Nikolai Dawson, Kathryn Peloza, John H Pauza, Kevin J |
Author_xml | – sequence: 1 givenname: Kevin J surname: Pauza fullname: Pauza, Kevin J email: kevinpauza@tyler.net organization: Texas Spine and Joint Hospital, 1814 Roseland Boulevard, Tyler, TX 75701, USA – sequence: 2 givenname: Susan surname: Howell fullname: Howell, Susan organization: East Texas Medical Center Neurological Institute, Tyler, TX 75701, USA – sequence: 3 givenname: Paul surname: Dreyfuss fullname: Dreyfuss, Paul organization: East Texas Medical Center Neurological Institute, Tyler, TX 75701, USA – sequence: 4 givenname: John H surname: Peloza fullname: Peloza, John H organization: Center for Spine Care, Dallas, TX 75231, USA – sequence: 5 givenname: Kathryn surname: Dawson fullname: Dawson, Kathryn organization: Virginia Commonwealth University, Richmond, VA 23219, USA – sequence: 6 givenname: Nikolai surname: Bogduk fullname: Bogduk, Nikolai organization: University of Newcastle, Royal Newcastle Hospital, Newcastle, NSW 2300, Australia |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/14749191$$D View this record in MEDLINE/PubMed |
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Keywords | Disc treatment Controlled trial Back pain Intradiscal electrothermal therapy Placebo IDET Discogenic pain |
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Prospective outcome study with a minimum 2-year follow-up publication-title: Spine – volume: 2 start-page: 1127 year: 1974 end-page: 1131 ident: BIB27 article-title: Measurement of pain publication-title: Lancet – year: 1999 ident: BIB3 article-title: Intradiscal electrothermal annuloplasty (IDET) for chronic disc disease: outcome assessment with minimum one year follow-up. 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A prospective outcome study with minimum 1-year follow-up publication-title: Spine doi: 10.1097/00007632-200010150-00013 – volume: 16 start-page: 87 year: 1983 ident: 10.1016/j.spinee.2003.07.001_BIB29 article-title: Assessment of chronic pain publication-title: Pain doi: 10.1016/0304-3959(83)90088-X – ident: 10.1016/j.spinee.2003.07.001_BIB37 – volume: 101 start-page: 31 year: 2002 ident: 10.1016/j.spinee.2003.07.001_BIB10 article-title: Effectiveness of intradiscal electrothermal therapy in increasing function and reducing chronic low back pain in selected patients publication-title: Wisconsin Med J – volume: 30 start-page: MS253 issue: suppl year: 1992 ident: 10.1016/j.spinee.2003.07.001_BIB32 article-title: The validity and relative precision of MOS Short-and Long-Form Health Status Scales and Dartmouth COOP charts: results from Medical Outcomes Study publication-title: Med Care doi: 10.1097/00005650-199205001-00025 – volume: 25 start-page: 382 year: 2000 ident: 10.1016/j.spinee.2003.07.001_BIB1 article-title: Management of chronic discogenic low back pain with a thermal intradiscal catheter. 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Prospective outcome study with a minimum 2-year follow-up publication-title: Spine doi: 10.1097/00007632-200205010-00017 – volume: 14 start-page: 353 year: 2001 ident: 10.1016/j.spinee.2003.07.001_BIB17 article-title: Intradiscal electrothermal annuloplasty: the IDET procedure publication-title: J Spinal Dis doi: 10.1097/00002517-200108000-00013 – year: 2001 ident: 10.1016/j.spinee.2003.07.001_BIB24 – ident: 10.1016/j.spinee.2003.07.001_BIB25 – volume: 3 start-page: 82 year: 2000 ident: 10.1016/j.spinee.2003.07.001_BIB8 article-title: Intradiscal electrothermal annuloplasty (IDET): a novel approach for treating chronic discogenic back pain publication-title: Neuromodulation doi: 10.1046/j.1525-1403.2000.00082.x – volume: 31 start-page: 247 year: 1993 ident: 10.1016/j.spinee.2003.07.001_BIB33 article-title: The MOS 36-item Short-Form Health Survey (SF-36): publication-title: Med Care doi: 10.1097/00005650-199303000-00006 – volume: 30 start-page: 473 year: 1992 ident: 10.1016/j.spinee.2003.07.001_BIB31 article-title: The MOS 36-item Short-Form Health Survey (SF-36): publication-title: Med Care doi: 10.1097/00005650-199206000-00002 – reference: 16721309 - Spine (Phila Pa 1976). 2006 May 20;31(12):1402; author reply 1402-3 |
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Snippet | Intradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously tested.
To compare the... Intradiscal electrothermal therapy (IDET) is a treatment for discogenic low back pain the efficacy of which has not been rigorously... |
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SubjectTerms | Adult Awards and Prizes Back pain Controlled trial Disc treatment Discogenic pain Electric Stimulation Therapy Female Humans Hyperthermia, Induced IDET Intervertebral Disc Displacement - complications Intervertebral Disc Displacement - physiopathology Intervertebral Disc Displacement - therapy Intradiscal electrothermal therapy Low Back Pain - etiology Low Back Pain - physiopathology Low Back Pain - therapy Male Orthopedics Placebo Prospective Studies Treatment Outcome United States |
Title | A randomized, placebo-controlled trial of intradiscal electrothermal therapy for the treatment of discogenic low back pain |
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