Repetitive Transcranial Magnetic Stimulation

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PEDro Score

Research Design

Total Sample Size

Methods Outcome

Nardone et al. 2017

Italy

RCT

PEDro=9

N=12

Population: Mean age = 43.1±13.2 yr; Gender: males=9, females=3; Time since injury=10±5 yr; Level of injury: C=8, T=4, L=0; Severity of injury: A=2, B=5, C=2, D=3; Type of pain=neuropathic.

Intervention: Patients were randomized to either an active repetitive transcranial magnetic stimulation (rTMS) (1250 pulses at 1- Hz or a sham treatment for 10 sessions over 2 wk.

Outcome Measures: Visual analog scale (VAS), McGill pain questionnaire (MPQ) for pain, relative treatment effect (RTE), Hamilton rating scale for depression (HAM-D) and Hamilton rating scale for anxiety (HAM-A).

1.        Sum score of pain showed a significant main effect for group (p=0.02) and time (p<0.001).

2.        Significant interaction between group and time (p<0.001).

3.        RTE scores were observed to be lower in the treatment group versus the sham group.

4.        Post hoc tests revealed a significant difference between groups for RTE after the 2 wks of treatment (p<0.001).

5.        A significant main effect for time was shown HAM-D scores (p<0.001).

6.        Significant interaction between group and time for HAM-D scores in the treatment group (p<0.001).

7.        Variance-type tests for HAM-A revealed no significant effects.

Yilmaz et al. 2014

Turkey

RCT

PEDro=7

NInitial=17; NFinial=16

Population: Mean age=38.6 yr; Gender: males; Level of injury: paraplegia; Severity of injury: incomplete=6, complete=10; Mean time post injury=134 d; Type of pain=neuropathic.

Intervention: Participants were randomized to receive active (treatment, n=9) or sham (control, n=7) repetitive transcranial magnetic stimulation (rTMS, 1x/d, 10d). Outcomes were assessed pre and post treatment and at 6wk and 6mo follow-up.

Outcome Measures:  Visual Analogue Scale-Pain intensity (VAS-PI).

1.        There was a significant reduction I VAS-PI score in the treatment group at 10d and 6wk(p=0.004) and in the control group at 10d (p=0.02).

2.        There was no significant difference in VAS-PI score between groups at baseline, 10d, 6wk, or 6mo (P>0.05).

Jette et al. 2013

Canada

RCT

PEDro=7

N=16

Population: Mean age=50 yr; Gender: males=11, females=5; Level of injury: quadriplegia=4, paraplegia=12; Type of pain=neuropathic.

Intervention: SCI individuals with chronic neuropathic pain were randomly assigned to receive 3 sessions of active or sham rTMS over hand or leg area. Participants were then crossed over to receive the alternative treatment.

Outcome Measures: Numeric Rating Scale (NRS).

1.        Significant reduction in pain was seen in both band (p=0.003) and leg (p=0.047) conditions 20 min post treatment; while no significant difference was seen in the control group.

2.        Pain improvement lasted up to 48 hours in both the hand (p=0.021) and leg (p=0.008).

3.        Those with incomplete injury in the hand condition had greater reduction than those with complete (p=0.018).

Kang et al. 2009

South Korea

RCT

PEDro=9

N=13

Population: Mean age=54.8 yr; Gender: males=11, females=5; Time since injury=10±5 yr; Level of injury: quadriplegia=5, paraplegia=6; Type of pain=neuropathic.

Intervention: SCI individuals with chronic neuropathic pain were randomized to receive 5 sessions of rTMS or sham rTMS. Pariticipants were then crossed over to receive alternative treatment after a 12 wk washout period.

Outcome Measures: Numeric rating scale (NRS), Brief pain inventory (BPI).

1.        No significant effect of time or group was seen for rTMS on NRS scores post treatment and at 3 wk follow up.

2.        Significantly lower NRS scores for worst pain were seen 1 wk post rTMS period compared to those with sham rTMS (p=0.028).

3.        No significant effect of time or group was seen on the BPI.

Defrin et al. 2007

Israel

RCT

PEDro=12

Population: SCI: Mean age= 54 yr; Gender: males=7, females=4; Type of pain=neuropathic.

Intervention: Patients were randomly placed into two groups: real or sham 10 daily motor TMR treatments (500 trains at 5 Hz for 10 sec; total of 5000 pulses at intensity of 115% of motor threshold) over a 2 wk period, using figure-of-8 coil over the vertex.

Outcome Measures: Chronic pain intensity (visual analog scale (VAS)), Chronic pain experience (Mcgill pain questionnaire (MPQ)), pain threshold, and level of depression (Back depression inventory (BDI)).

1.        The real and sham TMS stimulated similar, significant decreases in VAS scores (p<0.001) following all of the 10 treatment sessions, and in VAS and MPQ scores following the final treatment series.

2.        The reduction in MPQ scores in the real TMS group continued during the follow-up period.

3.        There was no significance between group differences in the magnitude of pain reduction.

4.        At follow-up, patients in the TMS group reported a 30% reduction in chronic pain intensity, compared to a 10% pain reduction reported by patients in the sham TMS group.

5.        A significant increase in heat-pain threshold was found only for patients in the real TMS group (p<0.05) at the end of the series.

6.        There was a significant difference in the magnitude of change in pain threshold between the real and sham TMS groups (p<0.05).

7.        Real and ham TMS groups showed a significant decrease in BDI values following the treatment period in comparison to pre-treatment BDI values (p<0.01).

8.        This reduction was maintained by both groups at follow-up (p<0.01).

9.        Only patients in the TMS treatment group exhibited a decreased level of depression during follow-up in the comparison to the values at the end of the treatment (p<0.05).

Diet Post-SCI Pain

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Allison et al. 2016

Canada

RCT

PEDro=8

N=20

Population: 48.7±14.0 yr; Gender: males=10, females=10; Time since injury=13.1±10.8 yr; Level of injury: C=12, T=6, L=2; Severity of injury: AIS A=7, B=2, C=3, D=8; Type of pain=neuropathic.

Intervention: Participants were randomized to either a control group or an anti-inflammatory diet group for 12 wks.

Outcome Measures: Center for epidemiological studies depression scale (CES-D), self-report neuropathic pain questionnaire (NPQ), change in inflammatory mediators (IL-2, IL-6, IL-1β, TNF-α and IFN-y) and relationship between pain and inflammatory mediators.

1.     Significant group X time interaction for CES-D score (p=0.01) and significant reduction in CES-D score from baseline to 3 mo (p<0.01).

2.     Significant group X time interaction for sensory component of self-report neuropathic pain scores (p<0.01).

3.     Significant reduction in pain sensory scores from baseline to 3 mo in the treatment group (p<0.01).

4.     Significant increase in pain sensory scores from baseline to 1 mo in control group (p=0.04) but not from baseline to 3 mo (p=0.21).

5.     No significant group X interaction for the affective component of the self-report neuropathic pain scores (p=0.17).

6.     Change scores of sensitivity pain found not to be significantly different between treatment and control groups (p=0.35) and no significant changes within the group for sensitivity pain scores (treatment: p=0.19; control: p=0.96).

7.     Proinflammatory composite score (average of IL-2, IL-6, IL-1β, TNF-α and IFN-y) was significantly different between the control and treatment groups (p=0.01) and there was a significant reduction found in the treatment group from baseline to 3 mo (p=0.02) but no significant change in the control group (p=0.07).

8.     Mann-Whitney test indicated significantly different change scores between the treatment group and the control group for IFN-y (p=0.01), IL-1β (p=0.01), and IL-2 (p=0.01) and a trend for CRP (p = 0.10).

9.     Friedman test showed a statistically significant reduction in IFN-y (p=0.01), IL-1β (p<0.01), IL-6 (p<0.05), and a trend for CRP (p=0.10) in the treatment group and no significant changes in the control group (p>0.05).

10.   Wilcoxon signed-rank test indicated a significant reduction in IFN-y (p=0.01) and IL-1β (p<0.01) as well as a trend for IL-6 (p=0.08) in the treatment group with no significant changes in control group (p>0.05).

11.   Significant positive correlation between reduced pain score and PGE2 (p=0.01).

12.   Significant positive correlation between change in sensitivity score and proinflammatory cytokines IL-1β and IL-2 and eicosanoid PGE2 (p=0.008).

Allison and Ditor, 2018

Canada

Secondary Analysis of RCT (Allison et al. 2016)

N=5

Population: Mean age=51.5±15.3 yr; Gender: males=1, females=4; Time since injury=12.8±11.3 yr; Level of injury: C=2, T=3, L=0; Severity of injury: AIS A=2, B/C=0, D=3; Type of pain=neuropathic.

Intervention: Original study – Participants were randomized to either a control group or an anti-inflammatory diet group for 12 wks.

This study – Taking a look at 5 of the original participants 1 yr later and making assessments.

Outcome Measures: Dietary compliance and center for epidemiological studies depression scale (CES-D), neuropathic pain questionnaire (NPQ).

1.     Dietary compliance significantly varied between end of the study and the 1 yr follow-up (p<0.01) and a significant reduction in compliance scores from 3 mo to 1 yr (p<0.01) as they were no longer significantly different from baseline (p=0.18).

2.     CES-D showed a trend toward an increase from 3 mo to 1 yr follow-up (p=0.10) as they were no longer significantly different from baseline (p=0.74).

3.     No significant difference in NPQ sensory scores from 3 mo to follow-up (p=0.42), and scores remained significantly different from baseline (p=0.02).

4.     Significant increase in NPQ affective scores from 3 mo to follow-up (p=0.05) as they were not longer significantly different from baseline (p=0.24).

5.     No significant difference in NPQ sensitivity scores from 3 mo to follow-up (p=0.34) but follow-up scores were also not significantly different from baseline (p=0.15).

BreEstim Post-SCI Pain

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PEDro Score
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Karri et al. 2018

USA

RCT

PEDro=

N=21

Population: SCI+NP (n=10): Mean age=48.2 yr; Gender: males=10, females=0; Time since injury=13.3; Level of injury: C=7, T=0, L=3; Severity of injury: AIS A=2, B=1, C=4, D=3.

SCI-NP (n=11): Mean age=38.6 yr; Gender: males=8, females=3; Time since injury=11.4 yr; Level of injury= C=4, T=7, L=0; Severity of injury: AIS A=3, B=2, C=5, D=1; Type of pain=neuropathic.

Intervention: SCI+NP patients received a breathing-controlled electrical stimulation (BreEStim) or a fake BreEStim randomly on separate days with at least a 3 day break between, both SCI-NP and SCI+NP participants had their visual analog scale pain scores and heart rate variability taken for comparison. Note that only the SCI+NP group had the BreEStim (active and null).

Outcome Measures: VAS scores and HRV.

1.     Significant difference in VAS scores across time for the active treatment (p<0.01) but not for the null treatment group (p>0.01).

2.     At baseline both the HRV time domain (p=0.01) and the HRV frequency domain (p<0.05) were significantly lower in the SCI+NP group than in the SCI-NP group.

3.     Significant interaction between effects of time and treatment and HRV for both time parameters (p=0.04).

4.     Parasympathetic tone profoundly increased across time only for the active intervention (p<0.05).

5.     Significant increase across time with active treatment for both time parameters (p=0.02) but no differences for the null treatment (p>0.05).

6.     Frequency parameters showed o significant differences across time for the null or active treatments (p>0.05).

Li et al. 2018

USA

RCT Crossover

PEDro=6

N=12

Population: Mean age=43.4±11.7 yr; Gender: males=7, females=5; Time since injury=15.5±12.3 yr; Level of injury: C=10, T=2, L=0; Severity of injury: all incomplete; Type of pain=neuropathic.

Intervention: Participants completed both the real and sham transcranial direct cranial stimulation (tDCS) followed by active breathing-controlled electrical stimulation/conventional electrical stimulation (BreEStim and EStim respectively) and were randomized to which they would complete in the first session and three days later in the second session.

Outcome Measures: Visual analog scores (VAS) for pain and analgesic effects.

1.     10 of the 12 participants completed both conditions because of timing conflicts.

2.     Positive analgesic effects were seen in active tDCS, but only in 4 of 10 participants in the sham tDCS and in BreEStim all but one participant saw positive analgesic effects.

3.     No difference in active and sham tDCS seen at the group level.

4.     VAS decreased from 5.7-5.1 after active tDCS and from 6.0-5.4 after the sham tDCS.

5.     Significant decrease in VAS after BreEStim in the active and sham tDCS group (p<0.00001 for both).

6.     All 12 participants completed the active tDCS and BreEStim and a main effect of time was observed to be significant (p<0.00001).

7.     No significant change of VAS observed after active tDCS, but a significant change was seen after active BeEStim (p<0.05).

Li et al. 2016 (1)

USA

Pre-Post

N=13

Population: Mean age=48.5±12.3 yr; Gender: males=6, females=7; Time since injury=58.2±45.8 mo; Level of injury: C=7, T=4, L=2; Severity of injury: AIS A=2, B=6, C=1, D=4; Type of pain=neuropathic.

Intervention: In the first of two experiments in this study, each of the 13 participants received both breathing-controlled electrical stimulation (BreEStim) and conventional electrical stimulation (EStim) with at least 3 days between bouts and 120 electrical stimuli each.

Outcome Measures: Visual analog score (VAS) for pain and analgesic effects.

1.     VAS average scores decreased from 6.3-3.7 after BreEStim120 and from 5.2-4.4 after EStim120.

2.     Significant main effect of intervention (p<0.001) with no main effect if stim.

3.     Significant interaction between intervention and stim observed (p<0.001).

4.     Significantly greater reduction in VAS score after BreEStim120 than after EStim120 (p<0.001) and the duration of the analgesic effect was significantly longer after BreEStim120 compared to EStim120 (p=0.04).

5.     Significantly greater intensity of electrical current during EStim120 compared to BreEStim120 (p=0.0189).

FES Post-SCI Pain

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Research Design
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Wilbanks et al. 2016

USA

Pre-Post

N=10

Population: Mean age=47.0±12.0 yr; Gender: males=8, females=2; Time since injury=18.0±14.0 yr; Level of injury: all T; Severity of injury: AIS A=5, B=2, C=3, D=0; Type of pain=musculoskeletal.

Intervention: Participants engaged in 30 min of functional electrical stimulation (FES) rowing 3 days/wk for 6 wks for a total of 18 sessions.

Outcome Measures: VO2peak (FES-rowing and UBE conditions), distance rowed, arm power output, wheelchair user shoulder pain index (WUSPI), body composition, body weight, thigh lean mass, upper extremity strength, muscle activity, quality of life (QOL-SCI), participation (LIFE-H), and qualitative exit interview.

1.     Significantly reduced WUSPI scores (p=0.002).

NMES Post-SCI Pain

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PEDro Score
Research Design
Total Sample Size

Methods Outcome

Chen et al. 2018

China

PCT

N=54

Population: NMES+carbamazepine group: Mean age=41.8±12.6 yr; Gender: males=25, females=2; Time since injury=31.2±11.5 mo; Level of injury: C=12, T=13, L=2; Severity of injury: AIS A=16, B=3, C=5, D=3; Type of pain=neuropathic.

Carbamazepine group: Mean age=43.5±13.7 yr; Gender: males=23, females=4; Time since injury=29.7±10.8 mo; Level of injury: C=14, T=10, L=3; Severity of injury: AIS A=18, B=2, C=3, D=4; Type of pain=neuropathic.

Intervention: Participants were assigned to either an NMES + carbamazepine group or a carbamazepine only group for 3 mo of treatment with outcomes measures at baseline and post-intervention.

Outcome Measures: Pain intensity numerical rating scale (NRS), quality of life (QOL) sort form 36 (SF-36) scale, and adverse events.

*Neuromuscular electrical stimulation (NMES), neuropathic pain (NPP)

1.     No significant difference in NRS for NPP or the QOL in SF-36 in the NMES group (p>0.05).

2.     No serious adverse events in either group.

Table 10 Intermittent Positive Pressure Breathing for Acute SCI patients

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Author Year
Country
Research Design
Sample Size
Methods Outcomes
Stiller et al. (1992)
Australia
Pre-Post
N=5
Population: Mean age: 34 yr; Gender: male=3, female=2; Level of injury: C5-C7; Severity of injury: not specified.
Intervention: All patients received intermittent positive pressure breathing (IPPB).
Outcome Measures: Lung volume, vital capacity, tidal volume.
Chronicity: Patients were studied beginning within 24 hr of sustaining injury.
  1. On admission, patients had significantly reduced resting vital capacity compared to normal values (p<0.001).
  2. Lung volume was significantly higher during IPPB compared to resting values (p<0.001).
  3. Immediately after receiving IPPB, vital capacity (p<0.02), but not tidal volume (p>0.05), was significantly higher compared to resting levels.

Table 9 Effect of Diaphragm Pacing on Respiration during Acute SCI

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Author Year
Country
Research Design
PEDro
Sample Size
Methods Outcomes
Kerwin et al. (2018)
United States
Case Control
N=101
Population: DPS Group, n=40: Mean age: 45 yr; Gender: male=29, female=11; Level of injury: C1-C4= 35%, C5-C7= 65%; Severity of injury: complete=88%, incomplete=12%. No DPS Group, n=61: Mean age: 39 yr; Gender: male=54, female=7; Level of injury: C1-C4=33%, C5-C7=67%; Severity of injury: complete= 82%, incomplete= 15%.
Intervention: Patients either underwent diaphragm pacing system implantation or did not.
Outcome Measures: Ventilator days, ventilator associated pneumonia.
Chronicity: Patient population defined as acute.
  1. There were no significant differences between groups in terms of the number of days spent on ventilators.
  2. There were no significant differences between groups in terms of the rates of ventilator associated pneumonia.

Mindfulness Post-SCI Pain

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Author Year

Country
PEDro Score
Research Design
Total Sample Size

Methods Outcome

Hearn et al. 2018

United Kingdom

RCT

PEDro=7

Nstart=67

Nfinish=

Population: Mean age=44.4±10.4 yr; Gender: males=31, females=36; Time since injury (yr): 1-2=11, 2-4=18, 4-8=19, 8-12=6, 12-15=7, 15+=6; Level of injury: C=25, T=37, L=5; Severity of injury: AIS A=9, B=17, C=19, D=22; Type of pain=neuropathic.

Intervention: Participants were randomized to either an 8-wk online mindfulness intervention or an 8-wk internet delivered psychoeducation.

Outcome Measures: Depression symptom severity and anxiety (hospital anxiety and depression scale (HADS)), quality of life (QoL)(world health organization quality of life (WHOQOL-BREF) , pain perception (numeric rating scale), pain catastrophizing scale (PCS) and mindfulness (five facet mindfulness questionnaire (FFMQ).

1.     HADS scores for depression were much higher for those that discontinued the psychoeducation intervention than those who completed it (p=0.051) with no other significant differences between those who completed the intervention and those who did not.

2.     Significant differences post-intervention between groups for mindfulness facets of acting with awareness, describing and non-reactivity to inner experience (p<0.05) as well as total FFMQ score (p<0.05).

3.     No significant differences between groups for any QoL, pain intensity and mindfulness facets of observing and non-judging post-intervention (p>0.05).

4.     Significant between group difference in severity of depression and pain catastrophizing at 3-mo follow-up (p<0.050).

Table 8 Effect of Respiratory Muscle Training on Pulmonary Function during Acute SCI

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Author Year
Country
Research Design
PEDro
Sample Size
Methods Outcomes
Postma et al. (2014)
The Netherlands
RCT
PEDro=7
N=40
Population: Resistive inspiratory muscle training group (RIMT): Mean age: 47.1 yr; Gender: male=20, female=1; Control Group: Mean age: 46.6 yr; Gender: male=15, female=4; Level of injury: T12 and above; Severity of injury: complete=24, incomplete=16.
Intervention: Patients were randomly assigned to receive usual rehabilitation care plus RIMT with a threshold trainer (RIMT group), or usual rehabilitation care only (control group).
Outcome Measures: The following at baseline, after 8 weeks of intervention, 8 weeks after intervention, 1 yr after discharge from inpatient rehabilitation: maximum inspiratory pressure (MIP), maximum expiratory pressure (MEP), forced vital capacity (FVC), forced expiratory volume in one second (FEV1), peak expiratory flow rate, maximum ventilation volume, health-related quality of life (HRQoL), and 36-item short-form health survey (SF-36).
Chronicity: Median number of days since injury was 74 (RIMT group) and 88 (control group).
1.     MIP improved more in the RIMT group compared with the control group 1 week after the intervention period (mean difference=11.67 cm H2O, p=0.002); this difference was no longer significant 8 weeks after the intervention period (p=0.065) or at 1 yr after discharge from inpatient rehabilitation (p=0.271).

2.     No other between-group differences were found in any of the other measures of respiratory function.

3.     The RIMT group improved more in mental health compared with the control group 1 week after the intervention period (p=0.006).

Effect Sizes
Roth et al. (2010)
USA
RCT
PEDro=4
N=29
Population: Resistance Training Group: Mean age: 31.1 yr; Gender: male=81%, female=19%; Sham Training Group: Mean age: 28.9 yr; Gender: male=69%, female=31%; Level of injury: C4-C7, T1; Severity of injury: complete.
Intervention: Patients were randomly assigned to either expiratory muscle resistance training or sham training for a total of 6 weeks.
Outcome Measures: The following before and after the training program: forced vital capacity (FVC), forced expiratory volume in one second (FEV1), maximum expiratory pressure (MEP), maximum inspiratory pressure (MIP), inspiratory capacity, expiratory reserve volume (ERV), total lung capacity (TLC), functional residual capacity (FRC), and residual volume (RV).
Chronicity: Patients were invited to participate in the study if the SCI was recent and had occurred within 6 months’ time. No further information regarding time since injury was provided.
1.     Multivariate analysis did not reveal any significant differences between the resistance training and sham training groups for any of the pulmonary function tests (p=0.22).

2.     Univariate analysis revealed significant improvements in FVC (p=0.02), FEV1 (p=0.02), ERV (p=0.04), MIP (p=0.002), and MEP (p<0.001) in the resistance training group.

3.     Univariate analysis revealed significant improvements in FVC (p=0.04), FEV1 (p=0.01) and ERV (p<0.01) in the sham training group.

 

 

Derrickson et al. (1992)
USA
RCT
PEDro=3
N=11
Population: Age range: 16-41 yr; Gender: male=6, female=5; Level of injury: C4-5 to C7; Severity of injury: complete.
Intervention: Patients were randomly assigned to receive resistive inspiratory muscle training (RIMT) or abdominal weights (AbWts) training for 7 weeks. Training sessions consisted of two 15-minute treatments each day, 5 days a week.
Outcome Measures: The following after one week and seven weeks: forced vital capacity (FVC), inspiratory capacity (IC), maximal voluntary ventilation (MVV), peak expiratory flow (PEF) rate, and increased inspiratory mouth pressure (PImax).
Chronicity: Time since injury was an average of 12 days (RIMT group) and 25 days (AbWts group).
Between group comparison:

1.     There were no significant differences in FVC, MVV, PEFR, PImax, and IC between patients who received RIMT training and those who received AbWts training (p>0.05 in all cases).

Within group comparison:

2.     After 7 weeks, patients who received RIMT training experienced a significantly larger FVC (p<0.001), a larger MVV (p<0.05), a higher PEF (p<0.01), a lower PImax (p<0.001), and a higher IC (p<0.05) compared to these measures after 1 week.

3.     After 7 weeks, patients who received AbWts training experienced a significantly larger FVC (p<0.001), a larger MVV (p<0.001), a higher PEF (p<0.001), and a lower PImax (p<0.001) compared to these measures after 1 week.

Raab et al. (2018)
Switzerland
Case Control
N=79
Population: Inspiratory Muscle Training Group – AIS A/B: Mean age: 48 yr; Gender: male=10, female=5; Level of injury: N/R; Injury severity: tetraplegia=7, paraplegia=8. Inspiratory Muscle Training Group – AIS C/D: Mean age: 63 yr; Gender: male=22, female=5; Level of injury: N/R; Injury severity: tetraplegia=22, paraplegia=5. Combined In- and Expiratory Muscle Training Group – AIS A/B: Mean age: 44.5 yr; Gender: male=14, female=2; Level of injury: N/R; Injury severity: tetraplegia=7, paraplegia=9. Combined In- and Expiratory Muscle Training Group – AIS C/D: Mean age: 60 yr; Gender: male=18, female=3; Level of injury: N/R; Injury severity: tetraplegia=18, paraplegia=3.
Intervention: Individuals had up to 5 training sessions per week of either inspiratory muscle training or combined in- and expiratory muscle training.
Outcome Measures: Maximal inspiratory pressure (PImax), expiratory pressure (PEmax), forced vital capacity, forced expiratory volume, sniff nasal inspiratory pressure, and peak expiratory flow. Results were stratified by AIS groups A/B and C/D.
Chronicity: On average patients were 2.4 mo post injury.
1.     PI max was seen to significantly increase for those treated with combined muscle training, regardless of AIS score (p<0.001) and for those treated with inspiratory muscle training only (p=0.008).

2.     PEmax was seen to significantly increase for those treated with combined muscle training, regardless of AIS score (p<0.001) and for those with AIS scores of C or D treated with inspiratory only muscle training (p<0.001).

3.     Forced vital capacity was seen to significantly increase in those who were treated with combined muscle training, regardless of AIS score (p<0.001). The same trends were observed for those in the inspiratory only muscle training groups (p<0.05).

4.      Forced expiratory volume was found to significantly increase in individuals treated with combined muscle training, regardless of AIS score (p<0.05), while the same trend was observed for those treated with inspiratory only muscle training (p<0.05).

5.     Sniff nasal inspiratory pressure was found to significantly increase in those treated with combined muscle training (p<0.001), regardless of AIS score. No significant improvements were observed in the inspiratory only muscle training group.

6.     Peak expiratory flow was only seen to improve significantly in the AIS C and D groups regardless of type of intervention (p<0.05), but not the AIS A/B groups.

Berney et al. (2002)
Australia
Case Control
N=14
Population: Mean age: 28 yr; Gender: male=11, female=3; Level of injury: C5-C7; Severity of injury: complete.
Intervention: Patients who received a tracheostomy were compared to patients who were extubated and received physiotherapy.
Outcome Measures: The following at the time of extubation/the day of tracheostomy: forced vital capacity (FVC), ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2), total number of physiotherapy treatments, number of physiotherapy treatments in intensive care unit (ICU), length of stay in ICU, days requiring mechanical ventilation, length of stay in acute ward after discharge from ICU, days from injury to fixation.
Chronicity: Patients were studied beginning within 24 hr of injury.
1.     There was no significant difference in FVC between tracheostomized patients and physiotherapy patients (p>0.05).

2.     There was no significant difference in PaO2/FiO2 ratios between tracheostomized patients and physiotherapy patients (p>0.05).

3.     There was no significant difference in total number of physiotherapy treatments between tracheostomized patients and extubated patients. Patients who were extubated and received physiotherapy required significantly fewer treatments compared to tracheostomized patients in ICU (p=0.047).

4.     Tracheostomized patients spent significantly more days in ICU than physiotherapy patients (p=0.006) and required mechanical ventilation significantly longer than the physiotherapy group (p=0.018).

5.     There was no significant difference in the length of stay in the acute ward between groups (p>0.05).

6.     There was no significant difference in the time from injury to fixation between groups (p>0.05).

Table 5 Evaluation of the Use of Early versus Late Tracheostomy during Acute SCI

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Author Year
CountryResearch Design
Sample Size
Methods  Outcomes
Beom and Seo (2018)
Korea
Case Control
N=48
Population: Mean age: 53.6 yr; Gender: male=43, female=5; Level of injury: N/R; Severity of injury: Mean ASIA impairment scale score (tracheostomy)=14.1 points, mean ASIA impairment scale score (non-tracheostomy)=23.4 points.
Intervention: Patients either received an early tracheostomy (within 7 days of initial SCI surgery) or a late tracheostomy (after 7 days of initial SCI surgery) or no tracheostomy.
Outcome Measures: Length of ventilation, ICU duration.
Chronicity: Time since injury not specified, patients were treated on average 29 days after initial SCI surgical intervention.
  1. There were no significant differences in the duration of post-operative ventilation between early vs late tracheostomy patients.
  2. The early tracheostomy group had a significantly shorter length of stay in the ICU than the late tracheostomy group (p=0.03).
Flanagan et al. (2018)
United States
Case Control
N=70
Population: Mean age: 50.5 yr; Gender: male=53, female=17; Level of injury: C2=10, C3=12, C4=19, C5=9, C6=6, C7=2; Severity of injury: Mean ISS=19.6;
Intervention: Patients either received an early tracheostomy (<7 days) or late (>7 days) from their initial intubation.
Outcome Measures: Ventilator days, tracheostomy days, ICU length of stay, early pneumonia and surgical site infections, in-hospital mortality, 90-day mortality, 90-day readmission.
Chronicity: Patients are defined as being in the acute stage.
  1. Early tracheotomy patients had fewer ventilator days compared to late tracheotomy patients (p=0.028).
  2. There was no significant difference in the number of days from tracheostomy to decannulation between early and late tracheostomy patients.
  3. Patients with early tracheostomy had significantly fewer ICU stays (p=0.021).
  4. There was no significant difference in the rates of early pneumonia and surgical site infections between the two groups, although both groups had high incidences.
  5. There were no significant differences between groups in terms of in-hospital mortality, 90-day mortality, and 90-day readmission.
Kornblith et al. (2014)
USA
Case Control
N=344
Population: Mean age: 43 yr; Gender: male=275, female=69; Level of injury: cervical to lumbar; Severity of injury: complete=69, incomplete=275.
Intervention: Patients either had a tracheostomy or did not. Of those requiring a tracheostomy, patients either experienced an early tracheostomy or a late tracheostomy. In addition, patients were either mechanically ventilated at discharge or were not.
Outcome Measures: The following retrospectively: instances of prolonged mechanical ventilation, ventilator-associated pneumonia (VAP), acute lung injury (ALI), acute respiratory distress syndrome (ARDS), duration in intensive care unit (ICU), duration in hospital, number of ventilator-free days, extubation attempts, injury severity score (ISS).
Chronicity: Time since injury not specified. Average number of hospital days=20.
  1. Patients who received a tracheostomy had higher rates of VAP (p<0.05), higher rates of ALI (p<0.01), spent significantly more days in ICU (p<0.05) and hospital (p<0.05), and had fewer ventilator-free days (p<0.05) compared to patients who did not receive a tracheostomy.
  2. There were no significant differences with regards to death (p>0.05) between patients who received a tracheostomy and patients who did not.
  3. Patients who had a late tracheostomy had higher rates of VAP (p<0.05), ALI (p<0.05), and ARDS (p<0.05) compared to patients who had an early tracheostomy.
  4. Patients who required mechanical ventilation at discharge had a higher ISS (p<0.05), significantly higher rates of VAP (p<0.05) and ALI (p<0.05), and longer ICU (p<0.05) and hospital stays (p<0.05) compared to patients who did not require mechanical ventilation at discharge.
Choi et al. (2013)
Korea
Case Control
N=21
Population: Mean age: 50 yr; Gender: male=19, female=2; Level of injury: C1-C7; Severity of injury: complete=8, incomplete=13; AIS A-D.
Intervention: Patients either received an early tracheostomy (≤10 days after injury) or a late tracheostomy (>10 days after injury).
Outcome Measures: The following retrospectively: duration of mechanical ventilation.
Chronicity: Time since injury not specified. Average number of hospital days=78.
  1. Patients who received an earlier tracheostomy had a significantly shorter total ICU stay than patients who received a late tracheostomy (p=0.01).
  2. Patients who received an earlier tracheostomy experienced a significantly shorter duration of mechanical ventilation (p=0.009).
  3. There were no significant differences with regards to pneumonia (p=0.283) or tracheal stenosis (p=0.999) between the two groups.
Babu et al. (2013)
USA
Case Control
N=20
Population: Mean age: 47 yr; Gender: male=18, female=2; Level of injury: cervical; Severity of injury: complete=11, incomplete=9; AIS A-E.
Intervention:  Patients either received an early tracheostomy (≤6 days after anterior cervical spine fixation) or a late tracheostomy (>6 days after anterior cervical spine fixation).
Outcome Measures: The following retrospectively: length of hospital stay, incidence of complications, incidence and risk of complications.
Chronicity: Time since injury not specified. The mean time from hospital presentation to anterior cervical spine fixation was 2.8 days. The mean length of hospital stay was 39 days.
  1. Patients who underwent an early tracheostomy had a shorter hospitalization stay compared to those who received a late tracheostomy, but this difference was not significant (p=0.11).
  2. One patient developed pneumonia after tracheostomy. Patients who received a late tracheostomy were at a significantly increased risk for developing pulmonary complications (p=0.033).
Romero-Ganuza et al. (2011b)
Spain
Case Control
N=323
Population: Mean age: 42 yr; Gender: male=255, female=68; Level of injury: cervical to thoracic; Severity of injury: complete=229, incomplete=94.
Intervention: Patients either received a tracheostomy or did not. Of those who did, they either received a surgical tracheostomy or a percutaneous tracheostomy. They also either received an early tracheostomy (≤7 days post intubation) or a late tracheostomy (>7 days post intubation).
Outcome Measures: The following during hospital stay: incidence of mechanical ventilation and tracheostomy, injury level, injury severity, acute physiology and chronic health evaluation II (APACHE II) scores, incidence of complications, duration of mechanical ventilation, duration of intensive care unit (ICU) stay.
Chronicity: Mean interval from injury to admission=11.4 days.
  1. 92% (297/323) of patients required mechanical ventilation and 67% (215/323) required a tracheostomy.
  2. Patients who received a tracheostomy had significantly higher injury levels (p<0.001) more severe injuries (p<0.001), more associated injuries (p=0.003), and higher APACHE II scores (p=0.03) than patients who did not require a tracheostomy.
  3. There were 69 cases of perioperative complications following tracheostomy. Patients who received an early tracheostomy had significantly fewer cases of tracheal stenosis than patients who received a late tracheostomy (p=0.003). There were no significant differences in pneumonia (p=0.81), stomal cellulitis (p=0.45), bleeding (p=0.96), or mortality rate (p=0.22) between the two groups.
  4. Patients who received an early tracheostomy spent significantly fewer days on mechanical ventilation (p<0.001) and significantly fewer days in ICU (p<0.001) compared to patients who received a late tracheostomy.
  5. Patients who received a percutaneous tracheostomy spent significantly fewer days in ICU (p=0.004) and experienced fewer cases of pneumonia (p=0.011) compared to patients who received a surgical tracheostomy.
Romero et al. (2009)
Spain
Case Control
N=152
Population: Mean age: 41 yr; Gender: male=122, female=30; Level of injury: cervical to thoracic; Severity of injury: complete=119, incomplete=33; AIS A-D.
Intervention: Patients either received a tracheostomy early (≤7 days of admission) or late (>7 days of admission).
Outcome Measures: The following retrospectively: total time of mechanical ventilation, time of mechanical ventilation post tracheostomy.
Chronicity: Mean time interval between injury and admission=27 days.
  1. Patients who received an early tracheostomy had significantly fewer episodes of pneumonia during intubation than patients who received a late tracheostomy (p<0.001). There were no significant differences in incidences of pneumonia post tracheostomy (p=0.80) and total incidences of pneumonia (p=0.27) between the two groups.
  2. There were no differences in mortality between early vs late tracheostomy (p=0.12).
  3. Patients who received an early tracheostomy had significantly shorter post tracheostomy duration on mechanical ventilation (p<0.005) and total duration on mechanical ventilation (p<0.001) compared to patients who received a late tracheostomy.
  4. Patients who received an early tracheostomy spent significantly fewer post tracheostomy days in ICU (p<0.05) and total days in ICU (p<0.0010) than patients who received a late tracheostomy.
  5. Patients who received an early tracheostomy had significantly fewer total complications than patients who received a late tracheostomy (p<0.05).
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