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Novel approaches to improve pain and function in those with sacro-iliac joint dysfunction

Prolotherapy versus placebo injections to improve pain and function in patients with form failure of load transfer of the sacroiliac joint

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12610000823077
Acronym
prolosij
Enrollment
80
Registered
2010-10-01
Start date
2010-09-17
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patients with low back pain who fulfil the diagnostic criteria for deficient load transfer through the sacro-iliac joint (SIJ) (Hungerford et al, 2004; Mens et al, 2001) (sacro-iliac joint dysfunction) and who do not respond to exercise therapy have deficient ligamentous function. 1. The primary hypothesis of this study is that the injection of 20% Glucose solution into the posterior ligaments of the SIJ will stimulate the formation of new collagen and increase ligament strength. Tis will be measured by improvement in the following tests: a) Stork test (Hungerford et al Spine 2004), b) Active straight leg raise (ASLR) (Mens et al, 2001 and 2002) , c) Posterior pelvic pain provocation test (PPPP) (Ostgaard et al, 1994, Vleeming et al, 2002) d) Palpation of the long dorsal sacro-iliac ligament (Vleeming at al, 1996) 2. The secondary hypothesis is that the improvement in the ligament function will lead to a decrease in symptoms and an improvement in quality of life measured by a) Quebec Back Pain Disability Scale (Kopek et al, 1995) and b) Patient Generated Index Questionnaire (PGI) Ruta at al, 1994 Both have been used previously in back pain studies. The aim of the study is to compare by randomised trial wether CT guided injection of 20% glucose solution into the ligaments of the sacroiliac joint as compared to a sham injection control results in a) A negative Stork test b) A negative ASLR test c) A negative PPPP test d) A lower Quebec score e) Improvement in the PGI, as measured three months after the intervention

Interventions

Injection of 1.0ml of 20% Dextrose in 0.5% Bupivicaine in the dorsal interosseous ligament of the Sacro-Iliac Joint (SIJ)versus placebo needle. Maximum of six injections. A previous observational trial with three injections (same protocol) yielded good results (Cusi et al, BJSM 2010). The total six injections maximum corresponds to three placebo injections and the cross over three Dextrose injections. Injections are every six weeks. Unblinding after the third injection. If the patient has made

Injection of 1.0ml of 20% Dextrose in 0.5% Bupivicaine in the dorsal interosseous ligament of the Sacro-Iliac Joint (SIJ)versus placebo needle. Maximum of six injections. A previous observational trial with three injections (same protocol) yielded good results (Cusi et al, BJSM 2010). The total six injections maximum corresponds to three placebo injections and the cross over three Dextrose injections. Injections are every six weeks. Unblinding after the third injection. If the patient has made adequate improvement no further injections may be required. Six weeks after the third injection unblinding takes place, and cross over takes place at that time.

Sponsors

Dr Manuel (Mel) Cusi
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

Failure of load transfer not improved with specific lumbopelvic stability exercises

Exclusion criteria

Infection, fracture, cancer, psychiatric disorders, pregnancy, previous prolotherapy in the same SIJ

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026