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

Not Applicable

Recruiting

• Conditions: Pelvic girdle pain; Musculoskeletal - Other muscular and skeletal disorders; Reproductive Health and Childbirth - Other reproductive health and childbirth disorders; Physical Medicine / Rehabilitation - Occupational therapy

• Registration Number: ACTRN12615000884505
• Lead Sponsor: SpineCorporation Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-24
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.];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.]

Secondary Outcome Measures

Name	Time	Method
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.];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.]