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

NCT02961959 | Completed

• 1 other identifier: SpinalSC,SI
• Study Type: interventional
• Target: 19
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 2.patients in this subgroup may be selected based on thorough symptom analysis, and
3. 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.

Conditions

Pelvic Pain; Low Back Pain

Outcome Measures

Primary Outcomes (2)

• Pelvic pain

  Balanced Inventory for Spinal Disorders questionnaire

  One year

• Pelvic pain

  Visual Analogue Scale

  One year

Secondary Outcomes (2)

• Function

  One year

• Function

  One year

Other Outcomes (2)

• Quality of life influenced by pelvic pain

  One year

• Quality of life influenced by pelvic pain

  One year

Study Arms (2)

Surgery

EXPERIMENTAL

Arthrodesis of SI-joint/s, physiotherapy

Procedure: Surgery

Non-surgery

ACTIVE COMPARATOR

Non-surgery, physiotherapy

Other: Non-surgery

Interventions

Surgery PROCEDURE

Arthrodesis of SI-joints, Physiotherapy

Surgery

Non-surgery OTHER

Physiotherapy

Non-surgery

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women 18-55 years old with pronounced pelvic pain for at least 2 years.
• Have tried ordinary physical therapy without improvement.
• Being on sick leave at least 50 percent.

You may not qualify if:

• Previous pelvic surgery.

Sponsors & Collaborators

• Spinal Surgery Clinic, Strängnäs: lead

MeSH Terms

Conditions

Pelvic Pain; Low Back Pain

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 1, 2016
• First Posted: November 11, 2016
• Study Start: October 1, 2008
• Primary Completion: November 1, 2012
• Study Completion: April 30, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share