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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12615000884505
• Date of registration: 24/08/2015
• Prospective Registration: No
• Primary sponsor: SpineCorporation Ltd
• Public title: A pilot study of the effects of the SacroFix Brace (SB) on pain, disability and emotional state in patients with pelvic girdle pain (SB2014).
• Scientific title: A pilot study of the effects of the SacroFix Brace (SB) on pain, disability and emotional state in patients with pelvic girdle pain (SB2014).
• Date of first enrolment: 31/07/2015
• Target sample size: 50
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12615000884505.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Adele Barnard

• Name: Dr Adele Barnard

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 40 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Reproductive Health and Childbirth - Other reproductive health and childbirth disorders

Musculoskeletal - Other muscular and skeletal disorders

Pelvic girdle pain;
Pelvic girdle pain

Physical Medicine / Rehabilitation - Occupational therapy

Intervention(s)

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.

Primary Outcome(s)

Emotional state as assessed by Depression, Anxiety and Stress Scale 41 (DASS41)[Baseline questionnaires will be issued prior to being fitted with the brace. Following this, follow up questionnaires will be scheduled at 3 and 6 weeks after baseline. The primary endpoint assessments will take place at the 3 week timepoint.]

Pain as assessed by numerical rating scale (NRS)[Baseline questionnaires will be issued prior to being fitted with the brace. Following this, follow up questionnaires will be scheduled at 3 and 6 weeks after baseline. The primary endpoint assessments will take place at the 3 week timepoint.]

Disability as assessed by Oswestry Disability Index (ODI)[Baseline questionnaires will be issued prior to being fitted with the brace. Following this, follow up questionnaires will be scheduled at 3 and 6 weeks after baseline. The primary endpoint assessments will take place at the 3 week timepoint.]

Secondary Outcome(s)

Emotional state as assessed by Depression, Anxiety and Stress Scale 41 (DASS41)[Baseline questionnaires will be issued prior to being fitted with the brace. Following this, follow up questionnaires will be scheduled at 3 and 6 weeks after baseline. The secondary endpoint assessments will take place at the 6 week timepoint.]

Pain as assessed by numerical rating scale (NRS)[Baseline questionnaires will be issued prior to being fitted with the brace. Following this, follow up questionnaires will be scheduled at 3 and 6 weeks after baseline. The secondary endpoint assessments will take place at the 6 week timepoint.]

Disability as assessed by Oswestry Disability Index (ODI)[Baseline questionnaires will be issued prior to being fitted with the brace. Following this, follow up questionnaires will be scheduled at 3 and 6 weeks after baseline. The secondary endpoint assessments will take place at the 6 week timepoint.]

Secondary ID(s)

Nil

Source(s) of Monetary Support

SpineCorporation Ltd

Secondary Sponsor(s)

Dr. Bruce Mitchell

Ethics review

Status: Approved
Approval date:
Contact:

Bellberry Ltd