Table 1 Summary of the Eligible Studies
Author (Year) | Methods | Participants | Measurement | Findings |
|---|---|---|---|---|
Weiss et al (2006) [6] | Design: Case report Brace Type: Lordosing spinal orthosis Trade name: Physiologic Material: Polyethylene Proposed MOA: Sagittal re-alignment brace that has a lordosing action in the lumbar spine Additional treatment: NA Region: Germany | Sample size: 1 Age: 47 Sex: 1 Female Diagnosis: Degenerative Scoliosis Parameters: 55° Lumbar scoliosis Co-morbid Illness: Grade II spinal claudication Prescribed Brace Wear: NA | Primary outcome: VPRS Secondary outcome: Walking distance Number of F/U points: 3 Length of F/U: T1 = 2 days T2 = 10 days T3 = 8 weeks | Main finding: Reduction of 1 point on the VPRS after 10 days that remained stable at 8 weeks Additional findings: Increase in walking distance from 800 to 8000 at T1, then 8000 to 12,000 at T2. Improvements maintained at T3. Statistical significance: NA Brace compliance: NA Harms associated with bracing: NA |
Weiss et al (2006) [29] | Design: Prospective cohort study Brace type: Lordosing spinal orthosis Trade name: Physiologic Material: Polyethylene Proposed MOA: Sagittal re-alignment brace that has a lordosing action in the lumbar spine Additional treatment: NA Region: Germany | Sample size: 29 Age: 41 years (SD = 21) Sex: 29 Females Diagnosis: Scoliosis Scoliosis Parameters: 37° (SD = 22) Co-morbid Illness: NA Prescribed Brace Wear: Minimum prescription of 8 h per day for 7.5 months (SD = 5.6) | Primary outcome: Roland Morris verbal rating scale (0–5 point scale) Secondary outcome: NA Number of F/U: 2 Length of F/U: T1 = ≤1 week T2 = > 6 months (Avg = 7.5 months) | Main finding: A significant reduction in Roland Morris VRS between T0 and T1. Smaller but non-significant reduction in scores between T0 and T2 Additional findings: NA Statistical significance: Wilcoxon Test (p < 0.001) Brace compliance: Poor. Compliance lost in the majority of patients at the time of the follow-up period. Only 7 patients reported wearing the brace for > 4 h at the T2 Harms associated with bracing: NA |
Weiss et al (2009) [30] | Design: Prospective cohort study Brace type: Lordosing spinal orthosis Trade name: Physiologic Material: Polyethylene Proposed MOA: Sagittal re-alignment brace that has a lordosing action in the lumbar spine Additional treatment: NA Region: Germany | Sample size: 56 Age: NA Sex: Males and females Diagnosis: Idiopathic = 48, congenital = 2, de novo degenerative = 3, other = 3 with chronic lower back pain Scoliosis Parameters: 41° (Range = 10–91) Co-morbid Illness: NA Prescribed Brace Wear: 20 h per day for 6 months then on a case-by-case basis after that point | Primary outcome: Roland Morris verbal rating scale (0–5 point scale) Secondary outcome: progression to surgery for chronic lower back pain Number of F/U: 2 Length of F/U: T1 = ≤1 week T2 = average of 18 months | Main finding: Reduction of Roland Morris scores of 3.3 to 2.7 at T1, then 2.7 to 2.0 at T2 Additional findings: 21 patients were able to completely remove the brace after 6 months due to the alleviation of pain Statistical significance: Wilcoxon Test (p < 0.05) Brace compliance: NA Harms associated with bracing: NA |
De Mauroy et al (2011) [19] | Design: Retrospective cohort study Brace type: Rigid polyethylene bi-valve overlapped lumbar brace Trade name: Lyon brace Material: High density polyethylene Proposed MOA: Rebalancing of the spine in the frontal and sagittal plane Additional treatment: plaster cast (3 weeks), physiotherapy (3 weeks) Region: France | Sample size: 33 Age: 59.9 (SD = 10.8) [Range 33–77] Sex: 30 females, 3 males Diagnosis: Adult scoliosis (lumbar or thoracolumbar) Scoliosis Parameters: 37° SD = 18 (Range 10–75) Co-morbid Illness: NA Prescribed Brace Wear: Recommended > 4 h per day | Primary outcome: Coronal Cobb angle Secondary outcome: coronal and sagittal balance, rib hump (millimetres) Number of F/U: 3 Length of F/U: T1 = 6 months T2 = 2 years T3 = ≥5 years | Main finding: Cobb angle increased by > 5° in 5 patients, remained stable in 15 patients and decreased in 12 patients Additional findings: Secondary outcomes remained stable in 17 patients, improved in 12 patients and worsened in 2 patients Some patients were able to cease wearing the brace due to a complete abolishment of their symptoms. Statistical significance: Summary statistics only Brace compliance: 60% of patients were still wearing the brace for an average of 5 h per day at T3. Brace wear ranged from 2 to 23 h per day. Harms associated with bracing: NA |
Gallo (2014) [27] | Design: Case reports Brace type: Rigid TLSO Trade name: SBrace L Material: NA Proposed MOA: Restoring coronal or sagittal alignment according to the presenting features, tailored brace Additional treatment: Physiotherapy Region: NA | Sample size: 2 Age: Case 1 = 65, Case 2 = NA Sex: 2 Females Diagnosis: Degenerative scoliosis Scoliosis Parameters: NA Co-morbid Illness: NA Prescribed Brace Wear: Determined by the patient | Primary outcome: VAS and NPRS Secondary outcome: QOL and activity restriction Number of F/U: NA Length of F/U: NA | Main finding: Case 1: Reduction of 8/10 to 3/10 pain, 3/10 function up to 8/10 function Case 2: Reduction of 6 points in the VAS scale Additional findings: Case 2: Increased mobility noted Statistical significance: NA Brace compliance: NA Harms associated with bracing: NA |
Weiss et al (2016) [26] | Design: Case report Brace type: Rigid TLSO Trade Name: Gensingen Material: NA Proposed MOA: Restoring coronal or sagittal alignment according to the presenting features, tailored brace Additional treatment: Scoliosis specific exercise (Schroth 20–60 min per day) [Tailored], off the shelf TLSO on occasion Region: Germany | Sample size: 1 Age: 37 Sex: Female Diagnosis: Late Onset idiopathic scoliosis Scoliosis Parameters: 56° thoracic curve and a 50° lumbar curve Co-morbid Illness: NA Prescribed Brace Wear: 3–4 h per day for three days per week | Primary outcome: VAS Secondary outcome: Self-perceived QOL and Cobb angle Number of F/U: 2 Length of F/U: T1 = 12 months T2 = 16 months | Main finding: Lower back pain relieved. Only felt during heavy lifting Additional findings: Lumbar Cobb angle reduced from 50° to 32° Statistical significance: NA Brace compliance: NA Harms associated with bracing: NA |
De Mauroy et al (2016) [20] | Design: Prospective cohort study Brace type: Rigid TLSO (rigid lordosing bivalve polyethylene overlapping brace Trade name: Lyon Brace Material: Polyethylene Proposed MOA: Disk protection and a three-dimensional re-equilibration of the spine Additional treatment: Specific physiotherapy Region: France | Sample size: 158 Age: 56.08 (SD = 17.35) Sex: 144 females, 14 males Diagnosis: Adult scoliosis (lumbar or thoracolumbar) Scoliosis Parameters: 39.6 (SD = 16.76) Co-morbid Illness: NA Prescribed Brace Wear: 3 weeks of plaster cast, followed by 4 h of bracing each day for 6 months | Primary outcome: Coronal Cobb angle, coronal and sagittal balance, rib hump (millimetres) Secondary outcome: NA Number of F/U: 1 Length of F/U: T1 = 8.41 years (SD = 3.26) [Range 5–17 years] | Main finding: No significant change to coronal Cobb angle. 56% remained stable, 24% improved by > 5°, 20% worsened by > 5° Additional findings: No significant change to rib hump. Sagittal balance worsened on average Statistical significance: T-test (p = 0.008) Brace compliance: 23% were non-compliant with the prescribed brace wear hours Harms associated with bracing: No adverse events associated with bracing. |
Polastri et al (2017) [27] | Design: Case report Brace Type: Modified off the shelf brace Trade Name: NA Material: Elastic Proposed MOA: Create coronal shifting force towards concavity of the curve Additional Treatment: NA Region: Italy | Sample size: 1 Age: 40 Sex: Female Diagnosis: Progressive AIS in an adult Scoliosis Parameters: 22° lumbar curve Co-morbid Illness: NA Prescribed Brace Wear: NA | Primary outcome: NPRS and QPDS Secondary outcome: NA Number of F/U: 6 Length of F/U: T1 = 1 month T2 = 5 months T3 = 7 months T4 = 9 months T5 = 12 months T6 = 24 months | Main finding: The NPRS reduced from 8.5 at T0 to 2.0 at T6. The QPDS reduced from 43 at T0 down to 15 at T6. Additional findings: NA Statistical significance: NA Brace compliance: Patient adhered to the prescribed treatment and it was well tolerated, and the patient was comfortable with the use of the orthosis. Harms associated with bracing: No adverse events reported. |
Palazzo et al (2017) [28] | Design: Retrospective cohort study Brace Type: Rigid TLSO Trade Name: Vesinet Material: Plastic Proposed MOA: NA Additional Treatment: NA Region: France | Sample size: 38 Age: 61.3 (SD = 8.2) Sex: Female Diagnosis: 9 progressive idiopathic scoliosis, 29 degenerative scoliosis Scoliosis Parameters: 49.6° (SD = 17.7) Co-morbid Illness: NA Prescribed Brace Wear: Recommended > 6 h per day | Primary outcome: Coronal Cobb angle Secondary outcome: NA Number of F/U: 1 Length of F/U: T1 = ≥5 years | Main finding: The rate of curve progression reduced from 1.28° (SD = 0.79) at T0 to 0.21° (SD = 0.43) at T1 Additional findings: NA Statistical significance: Linear mixed-effects regression (p < 0.001) Brace compliance: 4/38 patients did not wear the brace for the prescribed hours each day Harms associated with bracing: NA |
Zaina et al (2018) [21] | Design: Pilot Prospective Cohort Study Brace Type: Soft TLSO Trade Name: Peak Scoliosis Brace Material: Fabric, elastic, plastic Proposed MOA: designed to alleviate chronic pain secondary to scoliosis in adults Additional Treatment: NA Region: Italy | Sample size: 20 Age: 67.8 (SD = 10.5) Sex: Female Diagnosis: Idiopathic or degenerative scoliosis < 30° Scoliosis Parameters: 61.9° (SD = 12.6) Co-morbid Illness: 3 patients had osteoporosis Prescribed Brace Wear: 2–4 h per day | Primary outcome: Graphical rating scale Secondary outcome: Roland Morris questionnaire, Core outcome measurement index, Oswestry disability index. Number of F/U: 1 Length of F/U: T1 = 4 weeks | Main finding: Worst pain, back pain, and leg pain significantly improved from 7.15 to 5.85, from 6.55 to 5.25, and from 5.65 to 3.55, respectively at T1 Additional findings: All other measures showed statistically significant improvement at T1 except the Oswestry disability index scores which remained stable at T1 Statistical significance: Paired t-test (p < 0.05) for the primary outcome Brace compliance: All patients were compliant with the prescribed hours of brace wear Harms associated with bracing: All but one patient reported satisfaction with the brace saying they felt more supported |