Treatment of the sacroiliac joint in patients with leg pain: a randomized-controlled trial.
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ABSTRACT: Purpose
The sacroiliac joint (SIJ) may be a cause of sciatica. The aim of this study was to assess which treatment is successful for SIJ-related back and leg pain.Methods
Using a single-blinded randomised trial, we assessed the short-term therapeutic efficacy of physiotherapy, manual therapy, and intra-articular injection with local corticosteroids in the SIJ in 51 patients with SIJ-related leg pain. The effect of the treatment was evaluated after 6 and 12 weeks.Results
Of the 51 patients, 25 (56 %) were successfully treated. Physiotherapy was successful in 3 out of 15 patients (20 %), manual therapy in 13 of the 18 (72 %), and intra-articular injection in 9 of 18 (50 %) patients (p = 0.01). Manual therapy had a significantly better success rate than physiotherapy (p = 0.003).Conclusion
In this small single-blinded prospective study, manual therapy appeared to be the choice of treatment for patients with SIJ-related leg pain. A second choice of treatment to be considered is an intra-articular injection.
SUBMITTER: Visser LH
PROVIDER: S-EPMC3804708 | biostudies-literature | 2013 Oct
REPOSITORIES: biostudies-literature
Publications
Treatment of the sacroiliac joint in patients with leg pain: a randomized-controlled trial.
Visser L H LH Woudenberg N P NP de Bont J J van Eijs F F Verwer K K Jenniskens H H Den Oudsten B L BL
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 20130530 10
<h4>Purpose</h4>The sacroiliac joint (SIJ) may be a cause of sciatica. The aim of this study was to assess which treatment is successful for SIJ-related back and leg pain.<h4>Methods</h4>Using a single-blinded randomised trial, we assessed the short-term therapeutic efficacy of physiotherapy, manual therapy, and intra-articular injection with local corticosteroids in the SIJ in 51 patients with SIJ-related leg pain. The effect of the treatment was evaluated after 6 and 12 weeks.<h4>Results</h4>O ...[more]
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Project description:BACKGROUND:Sacroiliac joint pain is increasingly recognized as a cause of low back pain. We compared the safety and effectiveness of minimally invasive sacroiliac joint arthrodesis using triangular titanium implants and conservative management in patients with chronic sacroiliac joint pain. METHODS:This study was a prospective, multicenter randomized controlled trial of adults with chronic sacroiliac joint pain assigned to either conservative management or sacroiliac joint arthrodesis with triangular titanium implants. The study end points included self-rated low back pain (visual analog scale [VAS]), back dysfunction (Oswestry Disability Index [ODI]), and quality of life. Ninety percent of subjects in both groups completed the study. RESULTS:Between June 6, 2013, and May 15, 2015, 103 subjects were randomly assigned to conservative management (n = 51) or sacroiliac joint arthrodesis (n = 52). At 2 years, the mean low back pain improved by 45 points (95% confidence interval [CI], 37 to 54 points) after sacroiliac joint arthrodesis and 11 points (95% CI, 2 to 20 points) after conservative management, with a mean difference between groups of 34 points (p < 0.0001). The mean ODI improved by 26 points (95% CI, 21 to 32 points) after sacroiliac joint arthrodesis and 8 points (95% CI, 2 to 14 points) after conservative management, with a mean difference between groups of 18 points (p < 0.0001). Parallel improvements were seen in quality of life. In the sacroiliac joint arthrodesis group, the prevalence of opioid use decreased from 56% at baseline to 33% at 2 years (p = 0.009), and no significant change was observed in the conservative management group (47.1% at baseline and 45.7% at 2 years). Subjects in the conservative management group, after crossover to the surgical procedure, showed improvements in all measures similar to those originally assigned to sacroiliac joint arthrodesis. In the first 6 months, the frequency of adverse events did not differ between groups (p = 0.664). By month 24, we observed 39 severe adverse events after sacroiliac joint arthrodesis, including 2 cases of sacroiliac joint pain, 1 case of a postoperative gluteal hematoma, and 1 case of postoperative nerve impingement. The analysis of computed tomographic (CT) imaging at 12 months after sacroiliac joint arthrodesis showed radiolucencies adjacent to 8 implants (4.0% of all implants). CONCLUSIONS:For patients with chronic sacroiliac joint pain due to joint degeneration or disruption, minimally invasive sacroiliac joint arthrodesis with triangular titanium implants was safe and more effective throughout 2 years in improving pain, disability, and quality of life compared with conservative management. LEVEL OF EVIDENCE:Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
| S-EPMC6467578 | biostudies-literature
Project description:Sacroiliac joint pain is a challenging condition accounting for approximately 20% of cases of chronic low back pain. Currently, there are no effective long-term treatment options for sacroiliac joint pain.A randomized placebo-controlled study was conducted in 28 patients with injection-diagnosed sacroiliac joint pain. Fourteen patients received L4-L5 primary dorsal rami and S1-S3 lateral branch radiofrequency denervation using cooling-probe technology after a local anesthetic block, and 14 patients received the local anesthetic block followed by placebo denervation. Patients who did not respond to placebo injections crossed over and were treated with radiofrequency denervation using conventional technology.One, 3, and 6 months after the procedure, 11 (79%), 9 (64%), and 8 (57%) radiofrequency-treated patients experienced pain relief of 50% or greater and significant functional improvement. In contrast, only 2 patients (14%) in the placebo group experienced significant improvement at their 1-month follow-up, and none experienced benefit 3 months after the procedure. In the crossover group (n = 11), 7 (64%), 6 (55%), and 4 (36%) experienced improvement 1, 3, and 6 months after the procedure. One year after treatment, only 2 patients (14%) in the treatment group continued to demonstrate persistent pain relief.These results provide preliminary evidence that L4 and L5 primary dorsal rami and S1-S3 lateral branch radiofrequency denervation may provide intermediate-term pain relief and functional benefit in selected patients with suspected sacroiliac joint pain. Larger studies are needed to confirm these results and to determine the optimal candidates and treatment parameters for this poorly understood disorder.
| S-EPMC2666931 | biostudies-literature
Project description:BACKGROUND:Sacroiliac joint (SIJ) dysfunction is a prevalent cause of chronic, unremitting lower back pain. OBJECTIVE:To concurrently compare outcomes after surgical and nonsurgical treatment for chronic SIJ dysfunction. METHODS:A total of 148 subjects with SIJ dysfunction were randomly assigned to minimally invasive SIJ fusion with triangular titanium implants (n = 102) or nonsurgical management (n = 46). Pain, disability, and quality-of-life scores were collected at baseline and at 1, 3, 6, and 12 months. Success rates were compared using Bayesian methods. Crossover from nonsurgical to surgical care was allowed after the 6-month study visit was complete. RESULTS:Six-month success rates were higher in the surgical group (81.4% vs 26.1%; posterior probability of superiority > 0.9999). Clinically important (? 15 point) Oswestry Disability Index improvement at 6 months occurred in 73.3% of the SIJ fusion group vs 13.6% of the nonsurgical management group (P < .001). At 12 months, improvements in SIJ pain and Oswestry Disability Index were sustained in the surgical group. Subjects who crossed over had improvements in pain, disability, and quality of life similar to those in the original surgical group. Adverse events were slightly more common in the surgical group (1.3 vs 1.1 events per subject; P = .31). CONCLUSION:This Level 1 study showed that minimally invasive SIJ fusion using triangular titanium implants was more effective than nonsurgical management at 1 year in relieving pain, improving function, and improving quality of life in patients with SIJ dysfunction caused by degenerative sacroiliitis or SIJ disruptions. Pain, disability, and quality of life also improved after crossover from nonsurgical to surgical treatment.
| S-EPMC4605280 | biostudies-literature
Project description:STUDY DESIGN: Systematic reviewObjective: To compare the safety and effectiveness of fusion versus denervation for chronic sacroiliac joint pain after failed conservative management. SUMMARY OF BACKGROUND: METHODS of confirming the sacroiliac joint as a pain source have been extensively studied and reported in the literature. After confirmation of the origin of the pain by positive local anesthetic blocks, chronic sacroiliac joint pain is usually managed with a combination of medication, physical therapies, and injections. We have chosen to compare two alternative treatments for sacroiliac pain that was refractory to conservative therapies. METHODS: A systematic review of the English-language literature was undertaken for articles published between 1970 and June 2010. Electronic databases and reference lists of key articles were searched to identify studies evaluating fusion or denervation for chronic sacroiliac joint pain after failed conservative management. Studies involving only conservative treatment or traumatic onset of injury were excluded. Two independent reviewers assessed the level of evidence quality using the grading of recommendations assessment, development and evaluation (GRADE) system, and disagreements were resolved by consensus. RESULTS: We identified eleven articles (six fusion, five denervation) meeting our inclusion criteria. The majority of patients report satisfaction after both treatments. Both treatments reported mean improvements in pain and functional outcome. Rates of complications were higher among fusion studies (13.7%) compared to denervation studies (7.3%). Only fusion studies reported infections (5.3%). No infections were reported among denervation patients. The evidence for all findings were very low to low; therefore, the relative efficacy or safety of one treatment over another cannot be established. CONCLUSIONS: Sacroiliac joint fusion or denervation can reduce pain for many patients. Whether a true arthrodesis of the joint is achieved by percutaneous techniques is open to question and whether denervation of the joint gives durable pain relief is not clear. Further comparative studies of these two techniques may provide the answers.
| S-EPMC3427958 | biostudies-other
Project description:OBJECTIVES:The sacroiliac joint (SIJ) is an important and significant cause of low back pain. We sought to quantify the burden of disease attributable to the SIJ. METHODS:The authors compared EuroQol 5D (EQ-5D) and Short Form (SF)-36-based health state utility values derived from the preoperative evaluation of patients with chronic SIJ pain participating in two prospective clinical trials of minimally invasive SIJ fusion versus patients participating in a nationally representative USA cross-sectional survey (National Health Measurement Study [NHMS]). Comparative analyses controlled for age, sex, and oversampling in NHMS. A utility percentile for each SIJ subject was calculated using NHMS as a reference cohort. Finally, SIJ health state utilities were compared with utilities for common medical conditions that were published in a national utility registry. RESULTS:SIJ patients (number [n]=198) had mean SF-6D and EQ-5D utility scores of 0.51 and 0.44, respectively. Values were significantly depressed (0.28 points for the SF-6D utility score and 0.43 points for EQ-5D; both P<0.0001) compared to NHMS controls. SIJ patients were in the lowest deciles for utility compared to the NHMS controls. The SIJ utility values were worse than those of many common, major medical conditions, and similar to those of other common preoperative orthopedic conditions. CONCLUSION:Patients with SIJ pain presenting for minimally invasive surgical care have marked impairment in quality of life that is worse than in many chronic health conditions, and this is similar to other orthopedic conditions that are commonly treated surgically. SIJ utility values are in the lowest two deciles when compared to control populations.
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Project description:BackgroundMinimally invasive fusion of the sacroiliac joint as treatment for low back pain may reduce pain and improve function compared to non-operative treatment, although clear evidence is lacking. The aim of this trial was to evaluate the effect of minimally invasive sacroiliac joint fusion compared to sham surgery on sacroiliac joint pain reduction.MethodsIn this double-blind randomized sham surgery-controlled trial patients with clinical diagnosis of sacroiliac joint pain confirmed with sacroiliac joint injection were included at two university hospitals in Sweden and Norway. Patients were randomized by the operating surgeon at each site to minimally invasive sacroiliac joint fusion or sham surgery. The primary endpoint was group difference in sacroiliac joint pain on the operated side at six months postoperatively, measured by the Numeric Rating Scale (0-10). Un-blinding and primary analysis were performed when all patients had completed six months follow-up. The trial is closed for new participants and was registered at clinicaltrials.gov: NCT03507049.FindingsBetween September 1st, 2018 and October 22nd, 2021, 63 patients were randomized, 32 to the surgical group, 31 to the sham group. Mean age was 45 years (range 26-63) and 59 of 63 (94%) patients were female. The mean reduction in the operated sacroiliac joint from baseline to six months postoperative was 2.6 Numeric Rating Scale points in the surgical group and 1.7 points in the sham group (mean between groups difference -1.0 points; 95% CI, -2.2 to 0.3; p = 0.13).InterpretationThis double-blind randomized controlled trial could not prove that minimally invasive fusion of the sacroiliac joint was superior to sham surgery at six months postoperative.FundingSophies Minde Ortopedi supported a clinical research position for Engelke Marie Randers. Region Stockholm supported the cost for the Swedish ethical application and a clinical research appointment for Paul Gerdhem.
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Project description:BackgroundSacroiliac (SI) joint pain is a prevalent, underdiagnosed cause of lower back pain. SI joint fusion can relieve pain and improve quality of life in patients who have failed nonoperative care. To date, no study has concurrently compared surgical and non-surgical treatments for chronic SI joint dysfunction.MethodsWe conducted a prospective randomized controlled trial of 148 subjects with SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint disruptions who were assigned to either minimally invasive SI joint fusion with triangular titanium implants (N=102) or non-surgical management (NSM, n=46). SI joint pain scores, Oswestry Disability Index (ODI), Short-Form 36 (SF-36) and EuroQol-5D (EQ-5D) were collected at baseline and at 1, 3 and 6 months after treatment commencement. Six-month success rates, defined as the proportion of treated subjects with a 20-mm improvement in SI joint pain in the absence of severe device-related or neurologic SI joint-related adverse events or surgical revision, were compared using Bayesian methods.ResultsSubjects (mean age 51, 70% women) were highly debilitated at baseline (mean SI joint VAS pain score 82, mean ODI score 62). Six-month follow-up was obtained in 97.3%. By 6 months, success rates were 81.4% in the surgical group vs. 23.9% in the NSM group (difference of 56.6%, 95% posterior credible interval 41.4-70.0%, posterior probability of superiority >0.999). Clinically important (≥15 point) ODI improvement at 6 months occurred in 75% of surgery subjects vs. 27.3% of NSM subjects. At six months, quality of life improved more in the surgery group and satisfaction rates were high. The mean number of adverse events in the first six months was slightly higher in the surgical group compared to the non-surgical group (1.3 vs. 1.0 events per subject, p=0.1857).ConclusionsSix-month follow-up from this level 1 study showed that minimally invasive SI joint fusion using triangular titanium implants was more effective than non-surgical management in relieving pain, improving function and improving quality of life in patients with SI joint dysfunction due to degenerative sacroiliitis or SI joint disruptions.Clinical relevanceMinimally invasive SI joint fusion is an acceptable option for patients with chronic SI joint dysfunction due to degenerative sacroiliitis and sacroiliac joint disruptions unresponsive to non-surgical treatments.
| S-EPMC4360612 | biostudies-literature
Project description:IntroductionThe sacroiliac joint (SIJ) is a common source of low back pain. However, clinical and functional signs and symptoms correlating with SIJ pain are widely unknown. Pelvic belts are routinely applied to treat SIJ pain but without sound evidence of their pain-relieving effects. This case-control study compares clinical and functional data of SIJ patients and healthy control subjects and evaluates belt effects on SIJ pain.Methods17 SIJ patients and 17 healthy controls were included in this prospective study. The short-form 36 survey and the numerical rating scale were used to characterize health-related quality of life in patients in a six-week follow-up and the pain-reducing effects of pelvic belts. Electromyography data were obtained from the gluteus maximus, biceps femoris, rectus femoris and medial vastus. Alterations of muscle activity, variability and gait patterns were compared in patients and controls along with the belts' effects in a dynamic setting when walking.ResultsSignificant improvements were observed in the short-form 36 survey of the SIJ patients, especially in the physical health subscores. Minor declines were also observed in the numerical rating scale on pain. Belt-related changes of muscle activity and variability were similar in patients and controls with one exception: the rectus femoris activity decreased significantly in patients with belt application when walking. Further belt effects include improved cadence and gait velocity in patients and controls.ConclusionsPelvic belts improve health-related quality of life and are potentially attributed to decreased SIJ-related pain. Belt effects include decreased rectus femoris activity in patients and improved postural steadiness during locomotion. Pelvic belts may therefore be considered as a cost-effective and low-risk treatment of SIJ pain.Trial registrationClinicalTrials.gov NCT02027038.
| S-EPMC4549265 | biostudies-literature
Project description:Related to escalating health care costs and the questionable effectiveness of multiple interventions including lumbar facet joint interventions, cost effectiveness or cost utility analysis has become the cornerstone of evidence-based medicine influencing coverage decisions.Cost utility of therapeutic lumbar facet joint nerve blocks in managing chronic low back pain was performed utilizing data from a randomized, double-blind, controlled trial with a 2-year follow-up, with direct payment data from 2016. Based on the data from surgical interventions, utilizing the lowest proportion of direct procedural costs of 60%, total cost utility per quality adjusted life year (QALY) was determined by multiplying the derived direct cost at 1.67.Patients in this trial on average received 5.6 ± 2.6 procedures over a period of 2 years, with average relief over a period of 2 years of 82.8 ± 29.6 weeks with 19 ± 18.77 weeks of improvement per procedure. Procedural cost for one-year improvement in quality of life showed USD $2,654.08. Estimated total costs, including indirect costs and drugs with multiplication of direct costs at 1.67, showed a cost of USD $4,432 per QALY.The analysis of therapeutic lumbar facet joint nerve blocks in the treatment of chronic low back pain shows clinical effectiveness and cost utility at USD $2,654.08 for the direct costs of the procedures, and USD $4,432 for the estimated overall cost per one year of QALY, in chronic persistent low back pain non-responsive to conservative management.
| S-EPMC5780212 | biostudies-other
Project description:BackgroundIndividuals with chronic venous disease (CVeD) frequently experience associated leg pain that may influence disease management self-efficacy.ObjectiveTo evaluate the influence of a cooling intervention on leg pain associated with more severe stages of CVeD and self-efficacy. This was a secondary aim of the trial.DesignRandomized, blinded, comparator-controlled, multisite trial.SettingThree wound clinics and an academic medical research center in the United States of America.Participants276 participants (54.3% female, 46.7% male) with stage 4 and 5 CVeD were randomly assigned by computer generated tables to the cooling intervention group (n = 138) or control group (n = 138).InterventionsParticipants received either a cooling (intervention) leg cuff or placebo cuff (control) to apply topically over the affected skin area. Both groups performed standard of care including wearing compression wraps and elevating legs for 30 min during the intervention. Study visits occurred at baseline, and months 1, 3, 6, and 9.MethodsVisit measures included: Numeric Rating Scale (NRS) for short term pain; VEINES-QOL/Sym questionnaire for long-term pain; and, the Self Efficacy for Managing Chronic Disease Scale (SEMCD-6) for self-efficacy. Data were collected from September 2010 to December 2015 and analyzed using pooled t-tests, Chi-square tests, and mixed effects models. Observed 9-month patient retention rates were 94/138 (68.1%) in the intervention group and 91/138 (65.9%) in the control group. The primary analysis was based on the intention-to-treat principle.ResultsBoth the cooling intervention and control group experienced statistically significant decreases in unadjusted and adjusted mean NRS pain scores of 1.2 (95% CI: (-1.82, -0.64); p < 0.0001) and 1.8 (95% CI: (-2.31, -1.24); p < 0.0001) respectively from baseline, however, no statistically significant differences in change scores were observed between groups. The unadjusted mean VEINES-QOL/Sym pain scores had statistically significant decreases of 0.9 ((95% CI: (-1.07, -0.62) p < 0.0001 cooling)) and 0.8 (95% CI: (-1.09, -0.55) p < 0.0001 - control) points. When adjusting the scores for demographic and clinical features, both cooling and control groups maintained statistically significant decreases (p < 0.001 for both). No statistically significant differences in change scores were observed between groups. The unadjusted and adjusted mean self-efficacy scores had no statistically significant improvements from baseline to month 9 within and between the cooling and control groups.ConclusionsPain was reduced in both groups while self-efficacy did not change. Findings suggest that strictly implemented standard of CVeD care in each study group, with or without cooling, improved pain while there were no effects on self-efficacy.
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