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Sacro-iliac Joint Arthrodesis or Non-operative Care for Treatment of Chronic Pelvic Pain. A Randomized Study.

NCT02961959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-11-01

No results posted yet for this study

Summary

Background: Pelvic pain is common during pregnancy and usually subsides after delivery. Some women, however, experience severe and long-standing pelvic pain, judged to emanate from the Sacro-iliac joints (SI-joints). Radiological correlates are absent and there are diverging opinions regarding the value of different clinical testing procedures and the use of anaesthetic blocks to reveal SI-joint origin of the pain. In case of slight or moderate pain the situation may be solved by the use of analgetics and physical therapy, but in case of severe pain the situation might end up in a discussion whether surgery with arthrodesis of the SI joint might be of value. To our knowledge, however, the results from surgical treatment has not been compared with non-surgical treatment in a randomized study.

Aim: The investigators´ hypothesis is that

1. there exists a specific identifiable subgroup of patients within the chronic low back pain (CLBP) group in whom the pain emanates from the sacro-iliac (SI) joints, and that
2. patients in this subgroup may be selected based on thorough symptom analysis, and
3. that arthrodesis of the actual joint/s may reduce the pelvic pain. Methods: A RCT with parallel group design with pre- and post-treatment data. Inclusion of women 18-55 years old with pronounced pelvic pain for at least 2 years and having tried ordinary physical therapy without improvement and being on sick leave at least 50 percent. Operation by posterior approach with bone transplantation between the iliac bone and the sacrum, using microsurgical technique. Patients in both groups, the surgical (S) and non-surgical (NS) were all treated by formal physiotherapy at a five days stay at the Clinic and instructed to continue their training at home according to the lines given at the Clinic.

Outcome: The primary outcome was perceived pelvic pain according to the assessments on the validated Balanced Inventory for Spinal Disorders questionnaire (BIS) and on a Visual Analogue Scale (VAS) before treatment and at follow-up one year after treatment. The perceived change in pain was also assessed on a transitional scale in the follow-up version of the BIS.

Secondary patient reported outcome measures (PROM) were pain related functions assessed on the Oswestry Disability Index questionnaire (ODI), the BIS and the Roland-Morris questionnaire. Health related quality of life was assessed by using the Short-Form 36 (SF-36) and Euro-Quol (EQ-5D) questionnaires.

Conditions

  • Pelvic Pain
  • Low Back Pain

Interventions

PROCEDURE

Surgery

Arthrodesis of SI-joints, Physiotherapy

OTHER

Non-surgery

Physiotherapy

Sponsors & Collaborators

  • Spinal Surgery Clinic, Strängnäs

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2012-11-30
Completion
2022-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02961959 on ClinicalTrials.gov