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. 2021 Mar 10;14(2):107–129. doi: 10.1007/s12178-021-09697-5

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Study characteristics of the unpublished trials registered in ClinicalTrials.gov or International Clinical Trials Registry Platform (ICTRP) included in the systematic review (n = 5)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.

NCT00438633

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.

NCT03217344

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.

NCT03786679

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.

NCT03498859

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