Injection Treatment of Corticosteroid to Pelvic Ligament Insertions on Women With Longlasting Backpain After Pregnancy
Primary Purpose
Back Pain
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Triamcinolone
Saline solution
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain focused on measuring low back pain, randomised controlled trial, slow release corticosteroid, injection treatment
Eligibility Criteria
Inclusion Criteria:
- reported ongoing pain in the sacral region with onset during pregnancy with six months to seven years duration after delivery
- reported pain intensity at present between 30 and 50 mm on a 100 mm horizontal visual analogue scale (VAS)
- at least one positive pain provocation test out of three and pain elicited on internal palpation at the ischial spine at least unilaterally.
Exclusion Criteria:
- on-going low back pain with onset before pregnancy
- previous back surgery
- positive straight leg-raising test
- loss of tendinous reflex in the legs
Sites / Locations
- Sundsvall Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
B
A
Arm Description
0.99 ml saline solution 9mg/ml and 0.01 ml fat emulsion will be given once to the sacrospinous ligament insertion.
1 ml triamcinolone 20mg/ml (Lederspan), Meda AB, Solna, Sweden) and 1 ml lidocaine hydrochloride 10mg/ml (Xylocain), Astra Zeneca, Södertälje, Sweden)
Outcomes
Primary Outcome Measures
Reported pain intensity on visual analogue scale
Secondary Outcome Measures
Physical function
Full Information
NCT ID
NCT00757016
First Posted
September 19, 2008
Last Updated
September 19, 2008
Sponsor
Sundsvall Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00757016
Brief Title
Injection Treatment of Corticosteroid to Pelvic Ligament Insertions on Women With Longlasting Backpain After Pregnancy
Official Title
Injection Treatment of Slow-Release Corticosteroid to the Sacrospinous Ligament Insertions on Women With Long-Lasting Low Back Pain Starting in Pregnancy.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sundsvall Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the pain relief effect of locally injected corticosteroid treatment in women with long-lasting low back pain beginning in pregnancy. We hypothesize that the insertion of the sacrospinous ligament on the ischial spine would be a source of pain and therefore be a target for therapy.
Primary outcome measure is reported pain intensity on visual analogue scale and secondary outcome measures number of pain-drawing locations, pain-provoking test results and tests of function.
Detailed Description
Pregnancy related low back pain is a global problem. In most women low back pain induced in pregnancy disappears during the first six months after delivery. However, one of five women with pain during pregnancy from both sacroiliac regions and the symphysis still experienced disabling daily back pain two years after childbirth, which corresponded to 8% of the total study population. Hence, long-lasting low back pain with onset during pregnancy has to be considered a major public health problem, with high impact on the individual, family and society. Despite this, treatment and care is directed to general pain relief methods.
Precise localization of the site of pain release is fundamental in the search for an effective treatment. To date, the source of such pregnancy related low back pain is uncertain. However, the pelvic ligaments or their insertions have been proposed a source of pain and in particular the sacrospinous/sacrotuberous ligament has been indicated in this respect in pregnant and non-pregnant women.
Injection treatment with slow-release corticosteroid has shown a positive effect on pain conditions where the pain is thought to derive from collagen tissues.
We hypothesize that the insertion of the sacrospinous ligament on the ischial spine could be a source of pain in women with long-lasting low back pain beginning in pregnancy and might therefore be a target for therapy.
The women included will be randomized according to a computer generated random allocation sequence, with block size of four, concealed from the investigators until study closure.
A physiotherapist will perform the assessments at baseline and follow up four weeks after treatment. The assessment will consist of a questionnaire and a clinical examination of the back and pelvis.
Participants will be randomized to receive an injection treatment of either a compound of 1 ml triamcinolone 20mg/ml (Lederspan), Meda AB, Solna, Sweden) and 1 ml lidocaine hydrochloride 10mg/ml (Xylocain), Astra Zeneca, Södertälje, Sweden) or 0.99 ml saline solution 9mg/ml, 1 ml lidocaine hydrochloride and 0.01 ml fat emulsion (Intralipid), Fresenius Kabi, Uppsala, Sweden), the latter to make the solution opalescent as Lederspan.
Not the participant, the physician who will give the injection or the assessing physiotherapist will have information about what treatment that will be given.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
low back pain, randomised controlled trial, slow release corticosteroid, injection treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
0.99 ml saline solution 9mg/ml and 0.01 ml fat emulsion will be given once to the sacrospinous ligament insertion.
Arm Title
A
Arm Type
Active Comparator
Arm Description
1 ml triamcinolone 20mg/ml (Lederspan), Meda AB, Solna, Sweden) and 1 ml lidocaine hydrochloride 10mg/ml (Xylocain), Astra Zeneca, Södertälje, Sweden)
Intervention Type
Drug
Intervention Name(s)
Triamcinolone
Other Intervention Name(s)
Lederspan, Meda AB, Solna, Sweden (Triamcinolone)
Intervention Description
1 ml triamcinolone 20mg/ml will be given once to the insertion of the sacrospinous ligament bilaterally.
Intervention Type
Drug
Intervention Name(s)
Saline solution
Intervention Description
Saline solution
Primary Outcome Measure Information:
Title
Reported pain intensity on visual analogue scale
Secondary Outcome Measure Information:
Title
Physical function
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
reported ongoing pain in the sacral region with onset during pregnancy with six months to seven years duration after delivery
reported pain intensity at present between 30 and 50 mm on a 100 mm horizontal visual analogue scale (VAS)
at least one positive pain provocation test out of three and pain elicited on internal palpation at the ischial spine at least unilaterally.
Exclusion Criteria:
on-going low back pain with onset before pregnancy
previous back surgery
positive straight leg-raising test
loss of tendinous reflex in the legs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per OJ Kristiansson, M.D., Ph.D.
Organizational Affiliation
County Council of Västernorrland, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sundsvall Hospital
City
Sundsvall
ZIP/Postal Code
SE-851 86
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
23713407
Citation
Torstensson T, Lindgren A, Kristiansson P. Improved function in women with persistent pregnancy-related pelvic pain after a single corticosteroid injection to the ischiadic spine: a randomized double-blind controlled trial. Physiother Theory Pract. 2013 Jul;29(5):371-8. doi: 10.3109/09593985.2012.734009.
Results Reference
derived
Learn more about this trial
Injection Treatment of Corticosteroid to Pelvic Ligament Insertions on Women With Longlasting Backpain After Pregnancy
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