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The use of prolotherapy in the sacroiliac joint
M Cusi, J Saunders, B Hungerford, et al.
2010 44: 100-104 originally published online April 9, 2008 Br J Sports Meddoi: 10.1136/bjsm.2007.042044 Updated information and services can be found at: References
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Original article
The use of prolotherapy in the sacroiliac joint M Cusi,1 J Saunders,2 B Hungerford,3 T Wisbey-Roth,4 P Lucas,2 S Wilson1 anaesthetic SIJ blocks in a low-back pain popula- Objective: In this study the effectiveness of prolotherapy tion. Fifty-four patients completed the study, of in the treatment of deficient load transfer of the sacroiliac whom 10 (18.5%) were considered as having pain Programs, University of NewSouth Wales, Sydney, New originating from the SIJ.10 Given that the injections Design: A prospective descriptive study.
were administered into the synovial part of the Setting: Authors’ private practice.
joint and did not involve the posterior ligaments, it Participants: 25 patients who consented to treatment is possible that the SIJ is responsible for chronic low-back pain in a higher proportion of individuals.
and attended for at least one follow-up visit and The purpose of this study is to examine whether Study period: From April 2004 to July 2007.
prolotherapy injections into the dorsal interosseous Intervention: Three injections of hypertonic dextrose ligament of the SIJ (fig 1) can assist patients with a clinical diagnosis of deficient stability of the SIJ solution into the dorsal interosseous ligament of the affected SIJ, under CT control, 6 weeks apart.
that fails to respond to specific exercise therapy.
Main outcome measures: Quebec Back Pain Disability The null hypothesis is, therefore, that prolotherapy injections, in addition to exercise therapy, do not Scale, Roland–Morris 24, Roland–Morris 24 Multiform questionnaires and clinical examination by two authors improve the clinical examination parameters or Results: All patients included in this study attended atleast one follow-up visit at 3, 12 or 24 months. The number of patients at follow-up decreased at 12 and Patients were recruited from the private practices 24 months. Functional questionnaires demonstrated sig- of two sport and exercise medicine (SEM) physi- nificant improvements for those followed-up at 3, 12 and cians and two physiotherapists. Patients who 24 months (p,0.05). Clinical scores showed significant fulfilled the entry criteria were invited to partici- improvement from commencement to 3, 12 and pate in the prospective study after the treatment programme was explained in detail. Verbal and Conclusions: This descriptive study of prolotherapy in written information was provided before patients private practice has shown positive clinical outcomes for were asked to make a separate appointment to give the 76% of patients who attended the 3-month follow-up their written consent once they had their questions visit (76% at 12 months and 32% at 24 months). Similar answered and had reached a decision. This study results were found in the questionnaires (Quebec Back was conducted as a practice quality project and as Pain Disability Scale, Roland–Morris 24 and Roland– such did not require ethics approval or trial Morris 24 Multiform questionnaires) at 3, 12 and Maintenance of Professional Standards (MOPS)activity of the Australasian College of SportsPhysicians.
Prolotherapy treatment has been advocated for a Entry criteria included a diagnosis of persistent variety of soft tissue conditions, including non- suboptimal stability of the SIJ following a 3-month specific low-back pain, chronic musculoskeletal specific exercise programme. This diagnosis had to pain and hypermobility of joints.1 2 The goal of be made independently by a SEM physician (MC this therapy is to produce dense fibrous tissue to and JS) and a physiotherapist (BH and TWR) strengthen the attachment of ligaments, tendons, joint capsules and other fascial structures at their Clinical history included localised and/or radiat- fibro-osseous junctions.3 Prolotherapy has been ing low back or buttock pain in the vicinity of the defined as ‘‘the rehabilitation of an incompetent posterior superior iliac spine, worse on loading structure (as a ligament or tendon) by the induced positions such as standing, sitting, walking or proliferation of new cells’’.4 This procedure was negotiating stairs. Symptoms had to be present for initially used for treatment of spinal pain in the a minimum of 6 months before the initial assess- 1930s. Its use continues despite the controversy ment. Exclusion criteria were acute radiculopathy, that has surrounded it. A frequent indication is infection, pregnancy, inflammatory conditions of spinal or low-back pain. The injection techniques, substances used, volumes injected and the site or The clinical tests used were the SIJ glide test (anteroposterior and vertical arm, with and without The sacroiliac joint (SIJ) is a source of pain in the self-bracing),11 posterior pelvic pain provocation test lower back and buttocks in up to 15% of the (PPPP),12 active straight leg raise (ASLR)13–15 with and population,7 and there is evidence that dysfunction without self–bracing, and external manual compres- of this joint could, similar to a herniated lumbar sion and stork support (Gillett) test.16 A score of 1 disk, produce pain along the same distribution as was given for each positive finding. Clinical tests the sciatic nerve.8 9 Schwarzer et al10 administered were, therefore, not graded. Maximum score was 9.
Br J Sports Med 2010;44:100–104. doi:10.1136/bjsm.2007.042044
Original article
localised using the CT slice laser and axis/distance functionfrom the scanner and marked on the skin with a pen. The skinwas prepared with antiseptic Betadine and alcohol. The skinwas then anaesthetised with 3 ml of 1% Xylocaine.
The prolotherapy solution was prepared by drawing into a 5- ml syringe 1.8 ml of 50% glucose solution, 2.3 ml of bupivicaine1% and 0.8 ml of Isovue (iopamidol) 300 contrast (approxi-mately), and 0.8 ml was injected into the ligament.
After allowing time for the local anaesthetic to work, a 22-g spinal needle was inserted with the appropriate angle and depthto the interosseous ligament, as close to its ilial attachment aspossible. Once the needle was in place, 0.8 ml of theprolotherapy solution was injected as the needle was movedup and down in the ligament (fig 2). Care was taken to ensurethat only the ligament was injected but not the auricularsynovial portion of the joint.
After the procedure, patients were asked to keep pain records for 14 days. They were also given specific warnings aboutpossible complications such as bruising and the rare possibilityof infection. No adverse effects were reported.
RESULTSTwenty-five patients were treated between 2004 and 2007, witha 26-month average follow-up after injection (range 6–39 months). There were 5 male and 20 female patients(table 1). Their average age was 40.4 years (range 26–67 years).
One male patient was lost to follow-up after 12 months whenhe moved to another country; two others have had no formal (A) Posterior and (B) axial views of the SIJ. Auricular part of follow-up assessments but remained asymptomatic when the joint (arrow). The superficial posterior ligaments are not depicted.
contacted by phone. Two patients withdrew from follow-upat 2 years because of unrelated medical causes. Their scores had Twenty-five patients entered in the study after the exercise also improved considerably. One male patient received a fourth programme had shown no benefit. They underwent three injection in the sacrotuberous ligament, which successfully injections of prolotherapy solution 6 weeks apart. They were treated what were considered to be residual instability assessed within 24 h before each injection by both SEM physician and physiotherapist, and 1 week after each injection.
The main outcome measures were the negative findings in They continued to carry out the exercise programme under the clinical examination (patients had improved clinically) physiotherapist supervision. They filled in pain maps, the carried out independently by two of the authors (one SEM Quebec Back Pain Disability Scale, Roland–Morris 2417 and physician and one physiotherapist), the Quebec Back Pain Roland–Morris 24 Multiscale Disability questionnaires at the Disability Scale, and Roland–Morris 24 and Roland–Morris 24 point of entry and periodically over the following 2 years. They Multiform questionnaires. Statistical analysis was carried out were weaned from non-steroidal anti-inflammatory medication with SPSS software version 5 (SPSS, Chicago, Illinois).
before the first injection and for the duration of the treatment.
Nine clinical testing manoeuvres were performed independently Written informed consent was obtained in every case. All by two examiners, and a consensus score was given. Each injections were done under CT control, by the same radiologist positive test was given a score of 1. Maximum clinical score was (PL), on a Siemens Somoton plus 4 CT scanner, according to the 9. If a particular testing manoeuvre was not done, it was scored 0. Scores were analysed with the Student t test for matched The patient was positioned in the CT scanner with head first, pairs. Clinical scores on entry into the programme averaged 7.2 in prone position. Pillows were placed under chest and ankles, (range 4–9, SD 1.5) at the point of decision to proceed to the head resting on forearms and the face clear of the pillow.
injections. The mean clinical scores showed a significant Gentle respiration was allowed. Axial slices 5 mm apart were decrease of 4.5 points at 3 months, 5.0 points at 12 months obtained over the sacral area, and the appropriate level was (p,0.001) and 6.5 points at 2 years from the commencement selected for injection. The entry point on the patient was score before treatment (see table 1).
Clinical scores at 3, 12 and 24 months using t test for matched pairs Br J Sports Med 2010;44:100–104. doi:10.1136/bjsm.2007.042044
Original article
Quebec Back Pain Disability Scale Scores at commencement, 3, 12 and 24 months using t test for Interestingly, there was improvement before the course of injections was finished. Some changes were noted after the first Prolotherapy has been advocated in the treatment of low-back injection and more marked improvement after the second pain for many years. However, its published results have not injection. The PPPP test was the first one to become normal and been consistent. A large, well-conducted randomised controlled ASLR was the last. However, when the ASLR test was trial concluded that prolotherapy was no better than the combined with self-bracing and/or external compression of injection of normal saline.20 A Cochrane Collaboration report the anterior superior iliac spines by the examiner, it was normal concluded that, ‘‘There was no evidence that prolotherapy in 80% of cases by the time the third injection was given. The injections alone were more effective than control injections SIJ glide test results improved earlier. The stork test was alone, but in the presence of co-interventions, prolotherapy negative in two-thirds of the patients at the time of the third injections were more effective than control injections, more so when both injections and co-interventions were controlledconcurrently’’.21 Most studies that involve the use of prolotherapy in the treatment of spinal pain do not consider a specific clinical diagnosis for patient selection. Patient selection is based mainly The mean total score for the Quebec Back Pain Disability Scale on pain symptoms in the low back region, and the injections are at commencement was 58.1 (SD 19.4). The 3-month post- given in the painful sites. Injected volumes depend on the treatment scores were significantly improved by 20.7 points number of sites injected. This could explain the inconsistency of (95% confidence interval (CI) 11.3 to 30.1, p,001). At results,20 as there is no evidence that the proliferation of soft 12 months post-treatment, the improvement was 18.2 points tissue is analgesic per se. However, if injury to specific (95% CI 7.8 to 28.6, p,0.002), and at 24 months, 33.3 points structures, such as ligaments or fascia, can be related to a (95% CI 13.7 to 52.9, p,0.006). The improvement in Quebec specific clinical presentation and subsequent loss of function Back Pain Disability Scale scores remained significant at associated with pain, a case could be made for the use of 12 months and 2 years (see table 2).
prolotherapy. It is important, however, that appropriatetreatment protocols conducted by clinicians experienced in the Roland–Morris Back Pain Questionnaire (RMQ) effective rehabilitation of pelvic disorders be trialled before The mean total score for the RMQ at commencement was 13.3 (SD 5.0). The 3-month post-treatment scores were significantly Understanding the role of the SIJ has improved in recent improved by 6.1 points (95% CI 3.0 to 9.2, p = 0.001).19 25 28 At years. The muscular contribution to the dynamic stability of the pelvis has been verified in vivo.22 In the presence of pain, there is points (95% CI 0.0 to 5.0, p,0.047) and at 24 months, 4.4 evidence of altered muscle-recruiting patterns and altered load points (95% CI 0.8 to 15.7, p,0.035). The improvement in transfer.23 Symptoms and muscle-recruiting patterns can RMQ scores remained significant at 12 months and 2 years (see improve with appropriate exercise therapy.24 25 Clinical tests exist to examine the load transfer function of the SIJ.13–15 Incases where deficient stability of the SIJ has been established, Roland–Morris 24 Multiform Questionnaire clinical experience suggests that specific exercise programmes The mean total score for the Roland–Morris 24 Multiform designed to increase lumbopelvic stability may not be sufficient Questionnaire at commencement was 151.4 (SD 55.0). The 3- to decrease pain and improve function.
month post-treatment scores were significantly improved by It has been suggested that when specific exercise programmes 61.5 points (95% CI 30.0 to 93.0, p = 0.001). At 12 months fail, deficient ligament strength of the posterior elements of the post-treatment, the improvement was 37.9 points (95% CI 8.2 SIJ does not provide a sufficiently stable base to permit an to 67.7, p,0.016) and at 2 years, 90.0 points (95% CI 27.1 to effective muscle recruiting strategy.26 A mechanism that 152.9, p = 0.012). The improvement in Roland–Morris 24 increases the passive functional stiffness of the joint would Multiform Questionnaire scores remained significant at contribute to effective muscle recruitment to improve dynamic 12 months and 2 years (see table 4).
stability of the pelvis. In these cases, the increased ligamentous Roland–Morris Questionnaire Scores at commencement, 3, 12 and 24 months using t test for Br J Sports Med 2010;44:100–104. doi:10.1136/bjsm.2007.042044
Original article
Roland–Morris Multiform Questionnaire Scores at commencement, 3, 12 and 24 months using stiffness would have the effect of providing a more stable Ongley et al.28 Yelland et al20 also found no significant difference anchor for specific strengthening programmes to produce the between prolotherapy and normal saline injections for non- desired outcome. Experimental work in rats27 indicates that specific low-back pain; however, diagnosis, indications, injec- prolotherapy is effective in building up collagen fibres and, thus, tion sites and frequency of injections varied significantly to the The clinical tests chosen were those used normally by the Patients in our study were only included when a diagnosis of authors in their clinical daily work. Most of them have been failure of load transfer through the SIJ was made. The referenced in the literature11 13–15 23 and are specific for the SIJ.
theoretical intended effect of the injections was to increase The results of the main tests (PPPP, active SLR and stork tests) the stiffness of the dorsal interosseous ligament (fig 2). The showed similar progression from altered to normal. In parti- clinical results appear to confirm the hypothesis. The mechan- cular, the ASLR became normal earlier, before the end of the ism of action of prolotherapy is not sufficiently understood and injection period, when patients actively braced their abdomen requires further study: an inflammatory response could be or external lateral compression of the pelvis was applied by the triggered by a mechanical insult (volume of fluid injected), by examiner. Two-thirds of the patients had normal results for the an osmotic effect or by neural pathways (needle in position).
clinical tests by the time they had the third injection, and thepatient feedback was that pain levels had decreased and function increased. This is reflected in the questionnaires scores, The strength of this study is that there were no incentives or which were only done 3 months after the third injection was secondary gains for patients attending follow-up. Patients were either privately funded or funding was approved by the relevant This is a novel study of prolotherapy in patients with spinal- insurance company in work-related cases (n = 5).
related pain where the indication for treatment was loss of The weakness of the study is that patients acted as their own function from a specific clinical diagnosis, not pain alone. The controls and there was no non-intervention control group.
solution injected (hypertonic dextrose) was easily obtainable There was an insufficient cohort of control patients who fitted and is a common solution used for prolotherapy injections. The the criteria of entry but did not undergo the three injections and time between injections (6 weeks) was based on the assumption were, therefore, not entered for statistical analysis.
that the inflammatory reaction and formation of collagen takesup to 7 or 8 weeks, and it is not necessary for the injections to follow each other closely. Three injections were considered This descriptive study of the use of prolotherapy in combination sufficient to ensure a reasonable length of time for collagen with a specific exercise programme in private practice has shown improvement in clinical outcome scores for all the Ongley et al28 carried out a study of prolotherapy on patients patients who attended follow-up visits: 76% of patients with chronic low-back pain. There are major differences (n = 19) had been followed-up at 3 months, 76% (n = 19) between Ongley’s randomised control trial and our study. The at 12 months and 32% (n = 8) at 2 years. Three other patients diagnosis was different, individuals had a variety of different were verbally contacted at 12 months and reported good clinical combined treatments in both groups, and the location andfrequency of injections were also vastly different. It is, therefore,difficult to compare the results of this study with those of Prolotherapy acts by creating an inflammatory response. It hasbeen used for a long time in the treatment of axial pain. Thediagnosis is generally non-specific low-back pain, and theinjection technique, substances, volumes and sites injected varyfrom author to author, and the results, so far, have beeninconclusive.
This is the first study that uses coherent injection techniques toinfiltrate specifically the ligamentous structures of the SIJ. Theindication for prolotherapy is not pain but a specific clinicaldiagnosis following strict criteria. The site of injection is also very Prolotherapy solution and needle in situ. Solution injected precise and a very small volume is injected.
only in the deep interosseous ligament.
Br J Sports Med 2010;44:100–104. doi:10.1136/bjsm.2007.042044
Original article
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