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Clinical Trials/NCT00900601
NCT00900601
Completed
Not Applicable

Surgical Treatment of Pelvic Joint Instability in Patients With Severe Pelvic Girdle Pain After Pregnancy and Trauma - A Study to Measure Effect of Surgery, Analysis of Clinical Tests and Detection of Sacroiliac Instability Using RSA.

Oslo University Hospital1 site in 1 country9 target enrollmentJanuary 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Joint Instability
Sponsor
Oslo University Hospital
Enrollment
9
Locations
1
Primary Endpoint
Oswestry Disability Index (ODI)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Pelvic girdle pain (PGP) related to pregnancy is a common reason to sick leave during pregnancy. Low back pain and PGP affects about 50% of women during pregnancy. Most of the women recover, however about 10% of the women still have complaints after birth. Most patients have positive effect from conservative treatment, but unfortunately some do still have much pain despite intensive conservative rehabilitation. Surgery has been tried on these women with various results. Surgical treatment is controversial and there is a lack of documentation. The investigators will operate 20 patients with arthrodesis to the sacroiliac joint and symphysis. Radiostereometric analysis (RSA) will be used to evaluate the joint movement in different part of the process.

Hypothesis: Severe pelvic girdle pain is caused by pelvic joint instability in some cases and surgically fixation of the affected joints can help these women to get back to a normal life.

Registry
clinicaltrials.gov
Start Date
January 2007
End Date
June 2011
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Oslo University Hospital
Responsible Party
Principal Investigator
Principal Investigator

Thomas Johan Kibsgård

Consultant

Oslo University Hospital

Eligibility Criteria

Inclusion Criteria

  • Pain in one or more pelvic joints.
  • Minimum 2 positive clinical tests.
  • High pain and disability score
  • Tried adequate physiotherapy without effect.

Exclusion Criteria

  • Known psychiatric diagnosis
  • Other spine pathology
  • CT verified ankylosis

Outcomes

Primary Outcomes

Oswestry Disability Index (ODI)

Time Frame: 12 months

Oswestry Disability Index is a 10 item questionnaire comprises 10 questions about physical function. Each item has a 0-5 scale and the raw score is multiplied by 2 and the sum is the total score. Zero represents excellent physical function and 100 is more or less bedridden. This is the most used outcome measure in low back pain studies.

Visual Analogue Scale (VAS) 0 to 10

Time Frame: 12 months

Visual Analogue Scale is a 0 -10 scale. Zero is no pain and 10 is the worst pain you can imagine. In this study the patients were asked to report the morgning and evening pain by this scale.

Secondary Outcomes

  • Healing Measured by CT(12 months)

Study Sites (1)

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