Pelvic Joint Instability, Pelvic Pain
Conditions
Keywords
Sacroiliac pain, Sacroiliac instability, Pelvic girdle pain, Sacroiliac arthrodesis, Arthrodesis, Surgery
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.
Interventions
PROCEDUREArthrodesis to the sacroiliac joint and symphysis
Standard surgical procedures will be used. When the patient has isolated pain in the symphysis isolated fixation will be performed. A 2x2 cm large bone block will be removed and replaced with spongy bone. For fixation the Matta-plate will be applied. To the sacroiliac joint we use an anterior approach. A 2x1,5 cm large bone block will be removed and replaced with spongy bone from the iliac crest. For joint fixation we either use 2 plates or sacroiliac screws. The same procedure will be used on the other side in the cases with bilateral symptoms. Only one side will be operated at a time. After one year it will be decided if it's necessary to perform contralateral surgery.
Sponsors
Stiftelsen Helse og Rehabilitering
Oslo University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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 * BMI\>30
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Healing Measured by CT | 12 months | Number of participants with healing as measured by CT data. The outcome was radiological healing vs no signs of radiological healing. In order to be classified as healed the CT scans had to show Clear signs of bone bridging across the sacroiliac joint. |
Countries
Norway
Participant flow
Recruitment details
During the study period, from 2007 and 2010, a total of 20 patients with PGP were referred Oslo University Hospital, but only 9 patients met the study's inclusion criteria.
Participants by arm
| Arm | Count |
|---|---|
| Sacroliac Joint Fusion Patients treated with sacroiliac joint fusion | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
Baseline characteristics
| Characteristic | Sacroliac Joint Fusion |
|---|---|
| Age, Continuous | 40 years |
| BMI | 25 kg/m2 |
| Duration of pain | 11 years |
| Etiology Post preganancy | 7 Participants |
| Etiology Trauma | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Region of Enrollment Norway | 9 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 0 Participants |
| Unilateral/Bilateral Bilateral pain | 8 Participants |
| Unilateral/Bilateral Unilateral pain | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 3 / 8 |
| serious Total, serious adverse events | 1 / 8 |
Outcome results
Primary
Oswestry Disability Index (ODI)
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sacroliac Joint Fusion | Oswestry Disability Index (ODI) | Baseline | 54 units on a scale |
| Sacroliac Joint Fusion | Oswestry Disability Index (ODI) | One year | 37 units on a scale |
Primary
Visual Analogue Scale (VAS) 0 to 10
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.
Time frame: 12 months
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Sacroliac Joint Fusion | Visual Analogue Scale (VAS) 0 to 10 | Baseline | 81 units on a scale |
| Sacroliac Joint Fusion | Visual Analogue Scale (VAS) 0 to 10 | One year | 57 units on a scale |
Secondary
Healing Measured by CT
Number of participants with healing as measured by CT data. The outcome was radiological healing vs no signs of radiological healing. In order to be classified as healed the CT scans had to show Clear signs of bone bridging across the sacroiliac joint.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sacroliac Joint Fusion | Healing Measured by CT | 8 Participants |