RecruitingACTRN12615000884505

A pilot study of the effects of the SacroFix Brace (SB) on pain, disability and emotional state in patients with pelvic girdle pain (SB2014).

Sponsor

SpineCorporation Ltd

Enrollment

50 participants

Start Date

Jul 31, 2015

Study Type

Interventional

Conditions

Pelvic girdle pain

Summary

Sacroiliac Joint Dysfunction (SIJD) and Pregnancy Related Pelvic Girdle Pain (PRPGP) can be grouped together under the heading of ‘Pelvic Girdle Pain’ (PGP) which makes up part of the generic ‘Low Back Pain’ (LBP) group. As a main pain source it is reported to account for between 10% and 30% of all nonspecific LBP. The cost to an industrialized country, from PGP, is significant (USA alone in the region of $10 to $60 billion a year). Treatment for SIJD and PRPGP tends to encompass either/and pain relieving modalities (acupuncture, pain medication, use of pillows and belts) and exercise. The overall evidence on the outcome of these modalities is poor. The use of pelvic belts has developed from biomechanical studies that have shown that the external forces from a belt can help increase the ‘force closure’ of the pelvis. Another important aspect is the position of the belt with greater stability being produced on the pelvis with the belts being positioned higher, just below the anterior superior iliac crests, as opposed to the symphysis pubis. The product being investigated is the SpineCor SI Brace (SSIB). The SSIB consists of a unique design of compressive shorts with an integrated belt that allows a variable amount and direction of compression to be applied to the pelvic girdle. It was felt that a more comfortable and biomechanically effective design could help this patient group. The hypothesis of this study is that the use of the SacroFix brace will result in a reduction in pain and disability and an improvement in the emotional state of patients suffering with pelvic girdle pain.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 40 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether a special type of compression shorts called the SacroFix Brace can reduce pain and disability in people with pelvic girdle pain — pain around the hip, pelvis, and lower back area. This pain is common in people with sacroiliac joint problems and can be very limiting in daily life. You may be eligible if: - You are between 18 and 40 years old (male or female) - You have pelvic girdle pain rated 4 or higher out of 10 - Your pain is reduced when pressure is applied to the pelvis - You have pain on one side of the back of your pelvis You may NOT be eligible if: - Your pain gets worse with compression of the pelvis - You are in your third trimester of pregnancy - You have inflammatory arthritis - You cannot fit the shorts yourself - You cannot read or understand English - You have a known allergy to Lycra or Meryl fabric Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Six week observation of patients fitted with the SacroFix Brace for management of pelvic girdle pain (PGP). SacroFix compression shorts provide a general supportive compression to the whole of the

Six week observation of patients fitted with the SacroFix Brace for management of pelvic girdle pain (PGP). SacroFix compression shorts provide a general supportive compression to the whole of the pelvic girdle whilst producing targeted compression to either the Sacroiliac joints or the Symphysis pubis. Duration of use is a minimum of 4 hours per day, but not during the night. The total duration of the intervention is 6 weeks. Participants will be required to record device usage in a daily diary which will be returned to the clinic upon completion of the study. Participants will attend the clinic for fitting of the brace, estimated to take approximately 45 minutes.