None listed
Conditions
Brief 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.
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 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
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.
Sponsors
SpineCorporation Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
-PGP equal to or grater than 4/10 on NRS -Increased pain or effort on ASLR test -Pain reduced with compression of the pelvis -Pain on one side of the posterior pelvis +/- pubis region -Male or Female -Age 18 to 40 years
Exclusion criteria
-Patients with pain increased with compression of the pelvis -Participants below 18 years of age and above 40 years -Pregnant women in 3rd trimester of pregnancy -Inflammatory arthritis -Unable to self fit the shorts -Unable to read/understand English - Known allergy to either Lycra and/or Meryl material
Outcome results
None listed