Table 2.
Study characteristics of the unpublished trials registered in ClinicalTrials.gov or International Clinical Trials Registry Platform (ICTRP) included in the systematic review (n = 5)
| Author Identifier Date of registration Trial status Country Design |
Type of fracture | Number of included patients (N) Participants |
Intervention vs. comparison | Outcome measures and follow-up | Results |
|---|---|---|---|---|---|
|
Chen et al. February 22, 2007 Recruitment completed USA RCT |
PHF 82% non- or minimally displaced Non-operatively treated |
N = 62 Age limit ≥ 18 years Mean age in years: Intervention group 63 and control 62 Female/male: Intervention group 5/21 and comparison group 9/15 |
Intervention: Early mobilization with therapy starting immediately after injury Comparison: Late mobilization with therapy starting 3 weeks after injur |
Primary outcome • Shoulder flexion Secondary outcomes • Disability of the Arm, Shoulder, and Hand (DASH) • Abduction and external rotation • Shoulder Pain Likert scores (0–10) Follow-up: 3 and 6 months |
Numbers extracted from ClinicalTrials.gov No between-group difference in any of the outcomes at any follow-up |
|
Torrens et al. July 14, 2017 Recruitment completed Spain RCT |
PHF Non-operatively treated |
N = 130 Age limit: ≥ 60 years and < 85 years |
Intervention: Early mobilization with patients undergoing 1-week immobilization period in a sling Comparison: Late mobilization with patients undergoing a 3-week immobilization period in a sling |
Primary outcome • Visual Analog Scale (VAS) Secondary outcomes • Constant Shoulder Score (CS) • Fracture displacement • Simple Shoulder Test (SST) • Follow-up: 3 and 6 months and 1 year |
Numbers provided by author Carlos Torrens No between-group differences in any of the outcomes or at any follow-up |
|
Adolfsson et al. December 26, 2018 Not yet recruiting Sweden RCT |
PHF Non-operatively treated |
N = 400 Age limit ≥ 18 years |
Intervention: Early mobilization where patient are instructed to start rehabilitation 1 week after the trauma Control: Late mobilization after 4 weeks |
Primary outcome • Union of fracture Secondary outcomes • Oxford Shoulder Score • Numerical pain reporting scale • Quick DASH • Global assessment of improvement • Range of motion (ROM) Follow-up: 12 months |
No data available |
|
Østergaard et al. April 17, 2018 Recruiting Denmark RCT |
PHF 2-part fractures (Neer’s) Non-operatively treated |
N = 70 Age limit ≥ 60 years |
Intervention: Physiotherapist supervised exercise therapy once a week for 10 weeks + daily home exercises Comparison: Non-supervised exercise therapy at home (1 instruction given at inclusion) Both groups follow the same exercise protocol |
Primary outcome • Disabilities of the Arm, Shoulder, and Hand (DASH) Secondary outcomes • CS • Strength (isometric in 90° elevation in scapula plane) • Activity monitoring measured with accelerometer sensors • VAS • 15-dimensional score for HRQoL (15D) Follow-up: 3 and 12 months |
No data available |
|
Araya et al. RBR-59nbtf March 17, 2020 Recruitment completed Chile RCT |
DRF Extra-articular multifragmentary type FRD A3 after AO classification Non-operatively treated |
N = 74 Age limits ≥ 60 and ≤ 75 years |
Intervention: Physiotherapist-supervised exercise therapy + whirlpool and manual therapy (12 sessions, 2–3 times a week and approximately 1-h-long session) Comparison: Non-supervised home exercises program (all patients received a 30-min instruction by a physical therapist). They received a description of 6-week exercises |
Primary outcome • Patient-Rated Wrist Evaluation (PRWE) Secondary outcomes • Grip strength • VAS • ROM (wrist flexion and extension) Follow-up: 6 weeks, 6 and 12 months |
No data available |
The table provides available information regarding the participants, the interventions and comparisons, the outcomes, the follow-up times, and results