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

This study has been completed.
Sponsor:
Information provided by:
Sundsvall Hospital
ClinicalTrials.gov Identifier:
NCT00757016
First received: September 19, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Back Pain
Drug: Triamcinolone
Drug: Saline solution

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Injection Treatment of Slow-Release Corticosteroid to the Sacrospinous Ligament Insertions on Women With Long-Lasting Low Back Pain Starting in Pregnancy.

Resource links provided by NLM:


Further study details as provided by Sundsvall Hospital:

Primary Outcome Measures:
  • Reported pain intensity on visual analogue scale [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Physical function [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: October 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Lederspan, Meda AB, Solna, Sweden (Triamcinolone)

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00757016

Locations
Sweden
Sundsvall Hospital
Sundsvall, Sweden, SE-851 86
Sponsors and Collaborators
Sundsvall Hospital
Investigators
Principal Investigator: Per OJ Kristiansson, M.D., Ph.D. County Council of Västernorrland, Sweden
  More Information

No publications provided by Sundsvall Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director of Primary Health Care K-G Norberg, County Council of Västernorrland, Sweden
ClinicalTrials.gov Identifier: NCT00757016     History of Changes
Other Study ID Numbers: SundsvallH
Study First Received: September 19, 2008
Last Updated: September 19, 2008
Health Authority: Sweden: Medical Products Agency

Keywords provided by Sundsvall Hospital:
low back pain
randomised controlled trial
slow release corticosteroid
injection treatment

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 15, 2014