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

NCT00757016 | Completed DMC

• 1 other identifier: SundsvallH
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Back Pain

Keywords

low back pain; randomised controlled trial; slow release corticosteroid; injection treatment

Outcome Measures

Primary Outcomes (1)

• Reported pain intensity on visual analogue scale

Secondary Outcomes (1)

• Physical function

Study Arms (2)

B

PLACEBO COMPARATOR

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

A

ACTIVE COMPARATOR

1 ml triamcinolone 20mg/ml (Lederspan), Meda AB, Solna, Sweden) and 1 ml lidocaine hydrochloride 10mg/ml (Xylocain), Astra Zeneca, Södertälje, Sweden)

Drug: Triamcinolone

Interventions

Triamcinolone DRUG

1 ml triamcinolone 20mg/ml will be given once to the insertion of the sacrospinous ligament bilaterally.

Also known as: Lederspan, Meda AB, Solna, Sweden (Triamcinolone)

A

Saline solution DRUG

Saline solution

B

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• on-going low back pain with onset before pregnancy
• previous back surgery
• positive straight leg-raising test
• loss of tendinous reflex in the legs

Sponsors & Collaborators

• Sundsvall Hospital: lead

Study Sites (1)

Sundsvall Hospital

Sundsvall, SE-851 86, Sweden

Location

Related Publications (1)

• 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.

  PMID: 23713407 DERIVED

MeSH Terms

Conditions

Back Pain; Low Back Pain

Interventions

Triamcinolone; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Per OJ Kristiansson, M.D., Ph.D.

  County Council of Västernorrland, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 22, 2008
• Study Start: October 1, 2004
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: September 22, 2008

Record last verified: 2008-09

Locations

SE (1)