Alastair
03-17-2005, 09:32 AM
Saline Injections as Effective as Prolotherapy for Chronic Low-Back Pain CME
News Author: Laurie Barclay, MD
CME Author: Charles Vega, MD
Authors and Disclosures
To earn CME credit, read the news brief, the paragraphs that follow, and answer the questions below.
Release Date: January 9, 2004; Valid for credit through January 9, 2005
Credits Available
Physicians - up to 0.25 AMA PRA category 1 credit(s)
Jan. 9, 2004 � Ligament injections of saline are as effective as prolotherapy for chronic low-back pain, according to the results of a randomized trial published in the January issue of Spine. The editorialist praises the study.
"In chronic nonspecific low-back pain, significant and sustained reductions in pain and disability occur with ligament injections, irrespective of the solution injected or the concurrent use of exercises," write author Michael J. Yelland, FRACGP, FAFMM, from the University of Queensland in Brisbane, Australia, and colleagues.
This controlled trial with two-by-two factorial design was triple-blinded for injection status and single-blinded for exercise status. During the six-month study period, 110 subjects with nonspecific low-back pain (average duration, 14 years) were randomized to have repeated prolotherapy with 20% glucose/0.2% lidocaine (lignocaine) or normal saline injections into tender lumbo-pelvic ligaments. Subjects were also randomized to a program of flexion/extension exercises or to normal activity. Follow-up was maintained through 12 months in 96% of subjects and through two years in 80% of subjects.
Throughout the trial, ligament injections resulted in significant and sustained reductions in pain on the visual analog scale and in Roland-Morris disability scores. However, prolotherapy injections were no more effective than saline injections, and the exercise program did not confer any additional benefit over normal activity. Transient, minor adverse effects of injections occurred more often than documented in earlier trials.
At 12 months, more than 50% reduction in pain from baseline occurred in 46% of the prolotherapy group vs. 36% of the saline group, and in 41% of the exercise group vs. 39% of the normal activity group. More than 50% reduction in disability occurred in 42% of the prolotherapy group vs. 36% of the saline group, and in 36% of the exercise group vs. 38% of the normal activity group. None of these differences were statistically significant.
"This trial's success rates in reducing pain and improving disability are at least as good as those reported for spinal cord stimulation, surgery, or multidisciplinary treatment," the authors write. "The effect may lie in the needle rather than the specific injection solution, by a counterirritation effect."
National, foundation, and professional organization funds helped to support this study. The authors report no financial conflicts of interest.
In an accompanying editorial, John D. Loeser, MD, from the University of Washington in Seattle, calls this a "beautifully conceived and executed study in all respects." He discusses the many questions raised by these findings, including the role of physician-patient interaction.
"Every needle has a sharp end that goes into the patient and a blunt end that is attached to a health care provider," he writes. "Anyone who thinks that all of the action occurs at the sharp end does not understand human behavior."
News Author: Laurie Barclay, MD
CME Author: Charles Vega, MD
Authors and Disclosures
To earn CME credit, read the news brief, the paragraphs that follow, and answer the questions below.
Release Date: January 9, 2004; Valid for credit through January 9, 2005
Credits Available
Physicians - up to 0.25 AMA PRA category 1 credit(s)
Jan. 9, 2004 � Ligament injections of saline are as effective as prolotherapy for chronic low-back pain, according to the results of a randomized trial published in the January issue of Spine. The editorialist praises the study.
"In chronic nonspecific low-back pain, significant and sustained reductions in pain and disability occur with ligament injections, irrespective of the solution injected or the concurrent use of exercises," write author Michael J. Yelland, FRACGP, FAFMM, from the University of Queensland in Brisbane, Australia, and colleagues.
This controlled trial with two-by-two factorial design was triple-blinded for injection status and single-blinded for exercise status. During the six-month study period, 110 subjects with nonspecific low-back pain (average duration, 14 years) were randomized to have repeated prolotherapy with 20% glucose/0.2% lidocaine (lignocaine) or normal saline injections into tender lumbo-pelvic ligaments. Subjects were also randomized to a program of flexion/extension exercises or to normal activity. Follow-up was maintained through 12 months in 96% of subjects and through two years in 80% of subjects.
Throughout the trial, ligament injections resulted in significant and sustained reductions in pain on the visual analog scale and in Roland-Morris disability scores. However, prolotherapy injections were no more effective than saline injections, and the exercise program did not confer any additional benefit over normal activity. Transient, minor adverse effects of injections occurred more often than documented in earlier trials.
At 12 months, more than 50% reduction in pain from baseline occurred in 46% of the prolotherapy group vs. 36% of the saline group, and in 41% of the exercise group vs. 39% of the normal activity group. More than 50% reduction in disability occurred in 42% of the prolotherapy group vs. 36% of the saline group, and in 36% of the exercise group vs. 38% of the normal activity group. None of these differences were statistically significant.
"This trial's success rates in reducing pain and improving disability are at least as good as those reported for spinal cord stimulation, surgery, or multidisciplinary treatment," the authors write. "The effect may lie in the needle rather than the specific injection solution, by a counterirritation effect."
National, foundation, and professional organization funds helped to support this study. The authors report no financial conflicts of interest.
In an accompanying editorial, John D. Loeser, MD, from the University of Washington in Seattle, calls this a "beautifully conceived and executed study in all respects." He discusses the many questions raised by these findings, including the role of physician-patient interaction.
"Every needle has a sharp end that goes into the patient and a blunt end that is attached to a health care provider," he writes. "Anyone who thinks that all of the action occurs at the sharp end does not understand human behavior."