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Study flow diagram
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Figure 1

Study flow diagram

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'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies
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Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies

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'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study
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Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study

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Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 1 Shoulder function.
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Analysis 1.1

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 1 Shoulder function.

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Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 2 Shoulder function: number of participants with 'good function'.
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Analysis 1.2

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 2 Shoulder function: number of participants with 'good function'.

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Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 3 Pain: visual analogue scale (0 (no pain) to 10 (worst pain)).
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Analysis 1.3

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 3 Pain: visual analogue scale (0 (no pain) to 10 (worst pain)).

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Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 4 Pain: duration of painkiller consumption (days).
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Analysis 1.4

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 4 Pain: duration of painkiller consumption (days).

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Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 5 Clinical healing: time to clinical fracture consolidation (weeks).
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Analysis 1.5

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 5 Clinical healing: time to clinical fracture consolidation (weeks).

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Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 6 Adverse event.
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Analysis 1.6

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 6 Adverse event.

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Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 7 Time to return to previous activities (weeks).
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Analysis 1.7

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 7 Time to return to previous activities (weeks).

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Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 8 Patient dissatisfaction with course of treatment.
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Analysis 1.8

Comparison 1 Figure‐of‐eight bandage versus arm sling, Outcome 8 Patient dissatisfaction with course of treatment.

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Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 1 Pain: visual analogue scale (0 (no pain) to 10 (worst pain)).
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Analysis 2.1

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 1 Pain: visual analogue scale (0 (no pain) to 10 (worst pain)).

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Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 2 Pain: number of painkillers (tablets/28 days).
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Analysis 2.2

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 2 Pain: number of painkillers (tablets/28 days).

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Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 3 Treatment failure.
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Analysis 2.3

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 3 Treatment failure.

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Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 4 Clinical healing: time to clinical fracture consolidation (days).
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Analysis 2.4

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 4 Clinical healing: time to clinical fracture consolidation (days).

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Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 5 Adverse events: skin irritation.
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Analysis 2.5

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 5 Adverse events: skin irritation.

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Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 6 Time to return to previous activities (days).
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Analysis 2.6

Comparison 2 Low‐intensity pulsed ultrasound versus placebo, Outcome 6 Time to return to previous activities (days).

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Summary of findings for the main comparison. Summary of findings: figure‐of‐eight bandage versus arm sling

Figure‐of‐eight bandage compared with arm sling for treating fractures of the middle third of the clavicle

Patient or population: patients (mainly young male adults) with fractures of the middle third of the clavicle

Settings: hospital (initially)

Intervention: figure‐of‐eight bandage

Comparison: arm sling

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Arm sling

Figure‐of‐eight bandage

Shoulder function

Constant score (0 to 100 points: higher = better)

Follow‐up: 6 to 12 months

Mean (SD) population Constant score 89 (7)¹

Mean function in the figure‐of‐eight bandage groups was 0.75 points lower (3.72 lower to 2.39 higher)

MD ‐0.75 points (‐3.72 to 2.39)

51
(1 study)

⊕⊝⊝⊝
very low²

The 95% CI does not include a clinically important difference.³

Shoulder function was measured using non‐validated measures in two other trials (61 and 152 participants). Both trials found evidence of similar shoulder function in the two groups

Pain (early)

Visual Analogue Scale ‐ VAS (0 (no pain) to 10 (worst pain))

Follow‐up: 2 weeks

Mean pain in the arm sling groups ranged from
0.9 to 1.8 points

Mean pain in the figure‐of‐eight bandage groups was 0.43 points higher (0.35 lower to 1.21 higher)

MD 0.43 points (‐0.35 to 1.21)

203 (2 studies)

⊕⊝⊝⊝
very low⁴

The 95% CI do not include a clinically important difference.

A third trial (data for 61 participants) provided very low quality evidence based on a non‐validated scoring system of more pain and discomfort during the course of treatment in the figure‐of‐eight group

Treatment failure

(Number of participants who have undergone or are being considered for a surgical intervention)

See comment

See comment

Not estimable

‐

See comment

Poorly reported outcome. One trial (152 participants) reported that one participant in the arm sling group had successful surgery for a secondary plexus nerve palsy

Clinical healing ‐ time to clinical fracture consolidation (weeks)

Mean clinical healing in the arm sling group was 3.6 weeks

Mean clinical healing in the figure‐of‐eight bandage group was 0.20 weeks longer (0.11 week shorter to 0.51 week longer)

MD 0.20 weeks (‐0.11 to 0.51)

148
(1 study)

⊕⊝⊝⊝
very low²

In addition, there were four non‐unions in the figure‐of‐eight group; none were problematic

Adverse events ‐ total participants

with adverse events

See comment

See comment

Not estimable

‐

See comment

The very low evidence quality data for individual adverse outcomes (poor cosmetic appearance; change in allocated treatment due to pain and discomfort, worsened fracture position on healing; shortening > 15 mm; non‐symptomatic non‐union and permanent pain) did not confirm a difference between the two groups⁵

Quality of life

See comment

See comment

Not estimable

‐

See comment

Not measured in any trial

Return to previous activities ‐ Resumption of school/work (weeks)

Mean time to return to previous activities ranged across control groups from
3.5 to 4.6 weeks

Mean time to return to previous activities (weeks) ‐ resumption of school/work in the intervention groups was 0.12 weeks lower (0.69 lower to 0.45 higher)

MD ‐0.12 weeks (‐0.69 to 0.45)

176 (2 studies)

⊕⊝⊝⊝
very low⁶

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MD: mean difference; RR: risk ratio SMD: standardised mean difference; VAS: visual analogue scale.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

¹ These are based on the Constant score in healthy people as reported in Yian 2005.

² We downgraded the evidence for this outcome two levels for high risk of bias reflecting serious study limitations, which included inadequately concealed treatment allocation and lack of blinding. We downgraded the evidence one further level for imprecision given the wide confidence interval and that the available data were from only one trial.

³ For the purposes of this review, the minimally clinical important difference was considered to be 10 points for the Constant score (Kukkonen 2013).

⁴ We downgraded the evidence for this outcome two levels for high risk of bias reflecting serious study limitations, which included inadequately concealed treatment allocation and lack of assessor blinding. We downgraded the evidence one further level for inconsistency given the considerable heterogeneity between the findings of the two groups (I² = 74%).

⁵ Data for individual adverse outcomes (poor cosmetic appearance; change in allocated treatment due to pain and discomfort, worsened fracture position on healing; shortening > 15 mm; non‐symptomatic non‐union and permanent pain) confirmed a difference between the two groups.

⁶ We downgraded the evidence for this outcome two levels for high risk of bias reflecting serious study limitations, which included inadequately concealed treatment allocation and lack of assessor blinding. We downgraded the evidence one further level for imprecision given the low numbers of participants contributing data to this outcome.

Figuras y tablas -
Summary of findings for the main comparison. Summary of findings: figure‐of‐eight bandage versus arm sling
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Summary of findings 2. Summary of findings: low‐intensity pulsed ultrasound

Low‐intensity pulsed ultrasound compared with placebo for treating fractures of the middle third of the clavicle

Patient or population: patients with fractures of the middle third of the clavicle

Settings: hospital

Intervention: low‐intensity pulsed ultrasound

Comparison: placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo

Low‐intensity pulsed ultrasound

Shoulder function

See comment

See comment

Not estimable

‐

See comment

Not measured in the trial

Pain

Visual analogue scale ‐ VAS (0 (no pain) to 10 (worst pain))

Follow‐up: in the 28‐day treatment period

Mean pain in the control group was
3.55 points

Mean pain in the intervention group was 0.04 points lower (0.61 lower to 0.53 higher)

MD ‐0.04 (95% CI ‐0.61 to 0.53)

101 (1 study)

⊕⊕⊕⊝
moderate¹

Treatment failure ‐ Number who had surgical procedure

See comment

See comment

RR 1.13 (0.37 to 3.47)

101 (1 study)

⊕⊕⊕⊝
moderate¹

Only one trial assessed this comparison

Clinical healing ‐ Time to clinical fracture consolidation (days)

Mean clinical healing in the control group was 27.09 days

Mean clinical healing: time to clinical/radiographic fracture consolidation (days) in the intervention group was 0.32 days lower (5.85 lower to 5.21 higher)

MD ‐0.32 weeks (‐5.85 to 5.21)

101 (1 study)

⊕⊕⊕⊝
moderate¹

Adverse events ‐ total of adverse events

(Skin irritation)

Follow‐up: during the intervention

See comment

See comment

RR 0.94 (0.06 to 14.65)

101 (1 study)

⊕⊕⊕⊝
moderate¹

Only one trial assessed this comparison

Quality of life

See comment

See comment

Not estimable

‐

See comment

Not measured in the trial

Return to previous activities ‐ Resumption of work (days)

Mean time to return to previous activities in the control group was
15.05 days

Mean time to return to previous activities (days) ‐ resumption of work in the intervention group was 1.95 weeks higher (2.18 lower to 6.08 higher)

MD 1.95 days (‐2.18 to 6.08)

101 (1 study)

⊕⊕⊕⊝
moderate¹

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MD: mean difference; RR: risk ratio; VAS: visual analogue scale.

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

¹ We downgraded the evidence one level for imprecision given the wide confidence interval and that the available data were from only one trial.

Figuras y tablas -
Summary of findings 2. Summary of findings: low‐intensity pulsed ultrasound
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Comparison 1. Figure‐of‐eight bandage versus arm sling

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Shoulder function Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

1.1 Constant score (at end of follow‐up: 6 ‐ 12 months)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 ASES score (at end of follow‐up: 6 ‐ 12 months)

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Shoulder function: number of participants with 'good function' Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3 Pain: visual analogue scale (0 (no pain) to 10 (worst pain)) Show forest plot

2

Mean Difference (IV, Random, 95% CI)

Subtotals only

3.1 Pain on 1st day

2

203

Mean Difference (IV, Random, 95% CI)

0.63 [‐0.57, 1.83]

3.2 Pain on 1st week

2

203

Mean Difference (IV, Random, 95% CI)

0.20 [‐0.32, 0.73]

3.3 Pain on 2nd week

2

203

Mean Difference (IV, Random, 95% CI)

0.43 [‐0.35, 1.21]

3.4 Pain on 3rd week

1

51

Mean Difference (IV, Random, 95% CI)

0.10 [‐0.21, 0.41]

4 Pain: duration of painkiller consumption (days) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5 Clinical healing: time to clinical fracture consolidation (weeks) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

6 Adverse event Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

6.1 Poor cosmetic appearance post fracture healing

1

152

Risk Ratio (M‐H, Fixed, 95% CI)

1.32 [0.55, 3.16]

6.2 Change in allocated treatment due to pain and discomfort

1

79

Risk Ratio (M‐H, Fixed, 95% CI)

3.02 [0.35, 25.83]

6.3 Worsened fracture position on healing

1

61

Risk Ratio (M‐H, Fixed, 95% CI)

0.60 [0.15, 2.44]

6.4 Shortening > 15 mm

1

51

Risk Ratio (M‐H, Fixed, 95% CI)

1.01 [0.35, 2.90]

6.5 Non‐union

3

264

Risk Ratio (M‐H, Fixed, 95% CI)

9.48 [0.52, 173.09]

6.6 Permanent pain at mean 10 months

1

152

Risk Ratio (M‐H, Fixed, 95% CI)

9.48 [0.52, 173.09]

7 Time to return to previous activities (weeks) Show forest plot

2

Mean Difference (IV, Fixed, 95% CI)

Subtotals only

7.1 Resumption of school/work

2

176

Mean Difference (IV, Fixed, 95% CI)

‐0.12 [‐0.69, 0.45]

7.2 Resumption of sports activities

1

104

Mean Difference (IV, Fixed, 95% CI)

‐0.60 [‐1.48, 0.28]

8 Patient dissatisfaction with course of treatment Show forest plot

2

112

Risk Ratio (M‐H, Fixed, 95% CI)

2.73 [1.03, 7.23]
Figuras y tablas -
Comparison 1. Figure‐of‐eight bandage versus arm sling
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Comparison 2. Low‐intensity pulsed ultrasound versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Pain: visual analogue scale (0 (no pain) to 10 (worst pain)) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

2 Pain: number of painkillers (tablets/28 days) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

3 Treatment failure Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 Number who had surgical procedure

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Clinical healing: time to clinical fracture consolidation (days) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

5 Adverse events: skin irritation Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

6 Time to return to previous activities (days) Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

6.1 Resumption of household activities

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Resumption of professional work

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.3 Resumption of sport

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 2. Low‐intensity pulsed ultrasound versus placebo
Ir a la tabla de la revisión