Injection Treatment of Corticosteroid to Pelvic Ligament Insertions on Women With Longlasting Backpain After Pregnancy

September 19, 2008 updated by: Sundsvall Hospital

Injection Treatment of Slow-Release Corticosteroid to the Sacrospinous Ligament Insertions on Women With Long-Lasting Low Back Pain Starting in Pregnancy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Sundsvall, Sweden, SE-851 86
        • Sundsvall Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: B
0.99 ml saline solution 9mg/ml and 0.01 ml fat emulsion will be given once to the sacrospinous ligament insertion.
Drug: Saline solution
Saline solution
Active Comparator: A
1 ml triamcinolone 20mg/ml (Lederspan), Meda AB, Solna, Sweden) and 1 ml lidocaine hydrochloride 10mg/ml (Xylocain), Astra Zeneca, Södertälje, Sweden)
Drug: Triamcinolone
1 ml triamcinolone 20mg/ml will be given once to the insertion of the sacrospinous ligament bilaterally.
Other Names:
  • Lederspan, Meda AB, Solna, Sweden (Triamcinolone)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reported pain intensity on visual analogue scale

Secondary Outcome Measures

Outcome Measure
Physical function

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sundsvall Hospital

Investigators

  • Principal Investigator: Per OJ Kristiansson, M.D., Ph.D., County Council of Västernorrland, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 19, 2008

First Submitted That Met QC Criteria

September 19, 2008

First Posted (Estimate)

September 22, 2008

Study Record Updates

Last Update Posted (Estimate)

September 22, 2008

Last Update Submitted That Met QC Criteria

September 19, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SundsvallH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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