Authors, publication, Year, country, setting

Study design/Randomization

Population characteristics

Intervention

Outcomes

Main conclusions

1. Orthoses for rehabilitation of acute vertebral fractures due to osteoporosis

Li et al., 2014, Hongkong, inpatients [5]

RCT pilot study

Women (n=51) aged > 55 years with acute vertebral fractures

1. Group 1 (n=27): 82 ± 8.3 years; Number of VFs: 15 single, 7 two, 5 three or more

2. Group 2 (n=21): 81 ± 6.6 years; Number of VFs: 10 single, 9 two, 5 three or more

3 weeks all: Week 1 rigid Orthosis

1. Backpack (Spinomed) up to 3 h daily, then LS brace rest of day for 2 weeks

2. LS brace throughout day for 2 weeks

Baseline and 3 weeks Primary outcome not specified Thoracic kyphosis, back pain (VAS), FIM, Elderly Mobility Scale, modified Ambulation Category Compliance

Pain, mobility, and activities of daily living improved significantly within each group. No significant differences between groups significant difference

Meccariello et al., 2013, Italy, inpatients [6]

Nonrandomized Controlled clinical Trial

Men (n=18) and women (n=25) with acute vertebral fractures

1. Group 1 (n=23): 10 men, 13 women; mean age 81.5 years

2. Group 2 (n=20): 8 men, 12 women; mean age 82.8 years

12 weeks

1. Three-point orthosis for 10 weeks while upright, weaned 2 weeks, trunk exercises

2. Backpack (Spinomed) for 10 weeks while upright, weaned 2 weeks, trunk exercises

Baseline, 1, 3, 6 months Primary outcome not specified Vertebral fracture height Thoracic kyphosis Delmas index (stiffness) Back pain (VAS), Oswestry Low Back Pain Disability Questionnaire

No difference in vertebral deformity or kyphosis between groups at any time Group 2 significantly less pain and disability at 3 and 6 months complications: 14/23 (60.8%) 3-point 3/20 (15%) Spinomed

Talic et al., 2012, Bosnia and Herzegovina Inpatient Clinic [7]

Nonrandomized Controlled clinical Trail

Men (n=21) and women (n=38) aged 52–80 years with acute vertebral fractures due to osteoporosis

1. Group 1 (n=25): 10 men, 15 women; 65.4 ± 7.7 years

2. Group 2 (n=34): 15 men, 23 women; 66.8 ± 7.8 years

Up to 16 weeks

1. Cast

2. Three-point orthosis

Baseline, every 2 weeks, up to 16 weeks, Primary outcome not specified Length of immobilization pain, complications; outcomes for pain not presented

Complications with casting 16% (4/25). Significantly longer duration of immobilization in orthosis group

2. Orthoses for rehabilitation of subacute vertebral fractures due to osteoporosis

Dionyssiotis et al., 2014, Greece, Outpatients [8]

Nonrandomized Controlled clinical trial Inclusion criteria as for Pfeifer

Women (n=50) aged > 50 years with subacute VF due to OPO, Kyphosis angle > 55°

1. Group 1a (n=10): 72.3 ± 8.3 years Group 1b (n=10): 72.6±8.5 years

2. Group 2 (n=20)

3. Group 3 (n=10): 61.0 ± 10.5 years

6 months

1. Backpack (Spinomed) for 2 h daily (Group 1a) Spine-X orthosis (Group 1b)

2. Garment orthosis (Spinomed active) 2 h daily

3. No orthosis

Baseline, 1, 6 months Primary outcome not specified. Back pain (VAS), back extensor and abdominal flexor strength. Compliance via diary and questionnaire

Group 1a significantly improved pain (9%), abdominal flexor (12%) and extensor (13%) strength compared with group 3 Overall compliance 66%: Spinomed 90%, Spine-X 30%

Pfeifer et al., 2004, Germany, Community-dwelling Patients [3]

RCT 12-months trial with planned crossover at 6 months

Women (n=62) aged > 60 years with subacute vertebral fractures.

Kyphosis angle > 60°

1. Group 1 (n=31): 72.8±7.1 years

2. Group 2 (n=31): 72.3 ± 6.7 years

Number of VF: 2.0 ± 2.8 years

12 months

1. Backpack (Spinomed) for 2 h daily

2. No orthotic care

Baseline, 3, 6, 12 months Primary outcome: Change in back extensor strength.

Secondary outcomes: Changes in abdominal flexor strength, thoracic kyphosis, postural sway, vital capacity, forced expiratory volume in 1 s Questionnaires regarding pain, daily activity, well-being

Significant improvements in orthosis via control group in back extensor strength (73%), abdominal strength (58%), pain (38%), kyphosis angle (11%), body sway (25%), well-being (15%), and daily living (27%). High compliance No complications

Pfeifer et al., 2011, Germany, Community-dwelling Patients [4]

RCT 12 months trial with planned crossover at 6 months

Women (n=108) > 60 years with VF within the last 6 months Kyphosis angle > 60°.

1. Group 1 (n=36): 72.8 ± 7.3 years

Number of VF: 2.1 ± 2.7

2. Group 2 (n=36): 72.3 ± 6.7 years

Number of VF: 1.6 ± 2.8

3. Group 3 (n=36): 69.7 ± 8.9 years

Number of VF: 1.1 ± 1.2 years

12 months

1. Backpack (Spinomed) for 2 h daily

2. Garment orthosis (Spinomed active) for 2 h daily

3. No orthotic care

As for Pfeifer 2004 (see above)

Significant improvements in both orthosis groups versus control in back extensor strength and abdominal strength, pain, balance, kyphosis angle, well-being, and daily living. No significant differences between orthoses Compliance high in both orthosis groups 1 and 2

3. Orthoses in longer-term rehabilitation

Gündogdu et al., 2013, Turkey, Outpatients [9]

RCT pilot study

Women (n=29) with vertebral osteoporosis, with and without past vertebral fractures Kyphosis angle > 50°

1. Group 1 (n=14): 71.5 ± 1.5 years

Number of VF: 1.0 ± 0.7

2. Group 2 (n=15): 68.3 ± 8.9 years

Number of VF: 1.1 ± 0.8

12 weeks

1. Kypho-Orthosis: Omuz Retraksyon ortezi for 8 h daily plus home exercise

2. Home exercise

Baseline, 1, 3 months Primary outcome not specified. Height, thoracic kyphosis TUG, single leg stand, Berg Balance Scale, Kinesthetic ability QUALEFFO

Significant greater height at 3 months in orthosis group Improvements in other outcomes within both groups at 3 months. Only seven participants (50%) wore orthosis as prescribed

Hübscher et al., 2010,

Germany,

community-dwelling

Patients

[10]

RCT

Women (n=72) with vertebral osteoporosis, with and without past vertebral fractures

1. Group 1 (n=38): 74.2 ± 8.1 years

Number of VF: 1.5 ± 2.0

2. Group 2 (n=34): 74.1 ±7.7 years

Number of VF: 0.9 ± 1.2

6 months

1. Garment orthosis (Osteomed) daily

2. No orthosis

Baseline, 3, 6 months.

Primary outcome: Postural sway: center of pressure fluctuation via force plate. Others: back extensor and quadriceps strength, QUALEFFO, back pain (VAS), physical activity, falls

Postural sway unchanged Back strength and pain improved significantly in orthosis group only.

Physical activity, quadriceps strength, falls, and quality of life unchanged Dropouts due to orthosis discomfort

Kaplan et al., 1996, USA, Outpatients [11]