Non-pharmacologic Therapy: Prevention (Within 12 Months of Injury)
Author Year; Country Score Research Design Total Sample Size |
Methods | Outcome |
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FES-Cycling | FES-Cycling | FES-Cycling |
Lai et al. 2010; Taiwan |
Population: 24 participants; 12 treatment (10 men, 2 women; age: 28.9 ± 5.3 years; TPI: 35.3 ± 6.1 days; C5 – T7) and 12 control (10 men, 2 women; age: 28.2 ± 5.7 years; TPI: 34.9 ± 8.0 days; C5 – T7). Treatment: FES-cycling 3x/week for first 3 months, suspended for next 3 months. Cycling time gradually increased up to 30 min. Outcome Measures: Right femoral neck BMD and distal femur BMD between femoral condyles 2cm above knee joint space (DXA). Measurements at baseline, after 3-month intervention, and 3 months post-intervention |
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Eser et al. 2003; Switzerland |
Population: 38 participants (34 men, 4 women); age: 32.9 years; complete traumatic injuries between C5-T12, (19 participants, 19 controls). Treatment: FES-cycling. Progressive training sessions until able to cycle for 30 minutes, then 3x/week for 6 months from this baseline. On the remaining 2 days of the week, there was passive standing. Control group performed 30 min of passive standing 5 days/week. Outcome measures: cortical BMD of right tibia diaphysis (50% site, and 5cm proximal and distal to the 50% site) computed tomography (CT) |
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NMES | NMES | NMES |
Groah et al. 2010; USA |
Population: 26 participants (22 men, 4 women) with traumatic SCI; age: ³18 years; AIS A or B at time of entry, TPI: 39.5 days; above T12. |
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Effect Sizes: Forest plot of standardized mean differences (SMD ± 95%CI) as calculated from pre- to post-intervention data and pre-intervention to retention/follow-up data
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Arija-Blázquez et al. 2013; Spain |
Population: 8 men with acute motor complete traumatic SCI were allocated to Treatment group (n=5; AIS A; T4 – T 12; age: 42 years; TPI: 5.5 weeks) or Control group (n=3; age: 36years; TPI: 5.8 weeks). |
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Effect Sizes: Forest plot of standardized mean differences (SMD ± 95%CI) as calculated from pre- and post-intervention data
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Arija-Blázquez et al. 2013; Spain |
Population: 10 participants with recent traumatic thoracic SCI (10 men, AIS A); age: 39.4 ± 12.3 years; TPI: 8 weeks; BMI: 25.1 ± 3.6 kg/m2. 10 age-matched non-disabled participants for comparison; age: 36.7 ± 8.9 years, BMI: 23.3 ± 3.3 kg/m2. Treatment: Immediately after basal blood samples were drawn, NMES was conducted (1 set of currents was applied bilaterally at each knee angle; total of 80 contractions; total NMES time was 47 min per participant). Outcome Measures: BMD lower limb, total hip, femoral neck, intertrochanteric region (DXA), muscle cross-sectional area (MRI), testosterone, cortisol, and Type I collagen CTX (blood samples) |
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Dudley-Javoroski & Shields 2008a; USA Case-control Level 3 N=19 (12 SCI) |
Population: 12 men with motor complete SCI; age: 21–72 years; TPI: 0.3–22 years; C5–T11; AIS A–B; 9 matched SCI subjects as controls. 7 matched non-SCI controls. Treatment: Unilateral soleus NMES 5x/week 15 Hz every 2 s for 120 contractions (8000 contractions/month). Outcome measures: pQCT (trabecular vBMD of distal tibia 4% site) of one leg versus the other leg annually for up to 6 years. |
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Dudley-Javoroski & Shields 2008b; USA |
Population: 1 man; T4 AIS A traumatic paraplegia; age: 21 years; TPI: 7 weeks. Treatment: Four bouts of 125 soleus contractions over 30 minutes 5 times per week in one leg; actual 8,000 contractions per month Outcome measures: trabecular vBMD of distal tibia 4% site (pQCT) of one leg versus the other leg after 1 year, 3 years |
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Clark et al. 2007; Australia |
Population: 33 participants; 15 tetraplegia and 18 paraplegia; AIS A-D. Treatment: NMES, 5 months Low-intensity stimulation to leg muscles, 15 min, 2x/day 5 days/week, 5 months (n=23; age 28.6 ± 8.6 years; C4–T10, 13 tetraplegic; ; n=21 traumatic; n=2 nontraumatic); or control group (no treatment) (n=10; age: 31.0 ± 10.7 years; C5–T12, 4 tetraplegic; n=9 traumatic; n=1 nontraumatic). Outcome measures: total body, lumbar spine and hip BMD (DXA) at 3 weeks, 3- and 6-months post-injury. |
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Shields et al. 2007; USA |
Population: 4 men with SCI; age: 52.3 ± 11.2 years; T1-7; AIS A; TPI: 8.9 ± 4.1 years. Treatment: Trained 1 leg using an isometric plantarflexion NMES protocol (the untrained limb serving as within-subject control) for 30min/day, 5 days/week, for 6 to 11 months. Mean estimated compressive loads delivered to the tibia were ~110% body weight. Outcome Measures: BMD of the proximal tibia by DXA at baseline and post-intervention. |
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Shields et al. 2006a; USA |
Population: 6 participants with complete injuries from C5-T10; age: 27.6 years (range: 21-43); TPI: 2.1 months; 70% training compliance. Within-participant design. Treatment: NMES at 1.5 times bodyweight for 3 years. Treatment leg only received a home program of NMES to stimulate leg plantar flexors with a 35-min protocol (4 bouts with 5-min rest between bouts) for 5x/week Outcome measures: BMD of the spine, hips and knee regions (proximal tibial analysis protocol) by DXA at baseline and 1,2 and 3 years. |
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Shields et al. 2006b; USA |
Population: 7 men with complete injuries from C5-T10; age: 29.1 years (range: 21-43); TPI: < 4.5 months. Within-participant design. Treatment: NMES at 1.5 times body weight; 2-3 years. Treatment leg only received a home program of NMES to stimulate leg plantar flexors with a 35-min protocol (4 bouts/day with 5-min rest between bouts) for 5x/week). Outcome measures: cortical BMD of the tibia bilaterally at the 4%, 38%, and 66% sites (pQCT). |
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Standing/Walking | Standing/Walking | Standing/Walking |
Ben et al. 2005; Australia |
Population: 20 participants (16 men and 4 women); TPI: 4 ± 2 months; age: 34 ± 15; 8 paraplegia, 12 tetraplegia. Within-participant design. |
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Effect Sizes: Forest plot of standardized mean differences (SMD ± 95%CI) as calculated from pre- and post-intervention data
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de Bruin et al. 1999; Switzerland |
Population: 19 men; ages 19-59; traumatic injuries between C4-T12; AIS: A-D. Treatment: Standing/Walking. Group 1 had 0-5 hour per week loading exercises with a standing frame. Group 2 had 5+hour of standing exercises per week (standing). Group 3 had 5+hours of standing and treadmill (walking). Interventions lasted 25 weeks Outcome measures: trabecular BMD, cortical BMD moment of inertia of the left tibia proximal to the ankle joint line and in the diaphysis (pQCT). |
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Dudley-Javoroski & Shields 2013; USA |
Population: 12 participants (9 men, 3 women; age: 22-48 years) non-disabled controls and 12 (11 men, 1 woman; age: 16-44 years old; 11 AIS A, 1 AIS B; 10 out of 12 subjects had TPI <1-year at first scan) participants with SCI. Treatment: Individuals with SCI experienced active-resisted stance with FES of the quadriceps (n=7) or passive stance (n=5) for up to 3 years. Outcome Measures: trabecular BMD of the distal femur 12% femur length measured distal to proximal (pQCT) |
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Treadmill Training | Treadmill Training | Treadmill Training |
Giangregorio et al. 2005; Canada |
Population: 5 participants (2 men, 3 women); age: 19-40 years, traumatic injuries between C3-C8; AIS: B and C; no controls; TPI: 114.2 days. Treatment: Body-weight supported treadmill training. Initial session started at 5mins and was increased gradually to 10-15 mins in all but 1 participant during 48 sessions of 2x/week-training over 6-8 months. Outcome measures: BMD lumbar spine, hip, distal femur and proximal tibia by DXA and mid femur 60% site and proximal tibia 66% site CT; bone turnover markers (osteocalcin, DPD). |
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Ultrasound | Ultrasound | Ultrasound |
Warden et al. 2001; |
Population: 15 men; age: 29 years (range: 17-40); traumatic injuries between C5-T10; AIS: A-B; TPI: 110.3 days; within-group design. |
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Effect Sizes: Forest plot of standardized mean differences (SMD ± 95%CI) as calculated from pre- and post-intervention data
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Physical Activity | Physical Activity | Physical Activity |
Astorino et al. 2013; USA |
Population: 13 participants with SCI (11 men, 2 women); 2 chronic, 11 acute SCI; age: 29.4 ± 7.8 years; TPI: 1.9 ± 2.7 years. Treatment: 2-3h/day of activity-based therapy targeting regions below the level of injury a minimum of 2 days/week for 6 months. Activity-based therapy consisted of the following modalities: active assisted exercise, upper/lower body and core resistance training, load-bearing, cycle ergometry, gait training and vibration. Outcome measures: BMD of the whole body, lumbar spine, right and left total hip, femoral neck and intertrochanteric region distal femur, proximal tibia (DXA) at baseline, 3 and 6 months. Serum P1NP; serum CTX; |
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* All data expressed as mean±SD, unless expressed otherwise.
Discussion
Evidence for non-pharmacological prevention of SLOP includes data from seventeen investigations (n=270 participants). This includes five RCTs (88 participants), five non-randomized controlled trials (160 participants) and three pre-post studies (22 participants) (Table 11). As with pharmacological studies, there were difficulties with interpretation because of low numbers of participants and variability with the primary outcome measures. For each of the different rehab modalities, there is limited evidence available and there was variability in the selection of the primary outcomes. The therapeutic ultrasound study by Warden and colleagues (2001) found no significant improvement in bone health after a 6-week intervention. Although prospective observational data (Frey-Rindova et al. 2000) highlight the loss of bone in the early phase (first 6-months post-SCI), there was no significant influence of self-reported physical activity level. Training adherence was: 78.4% for FES-cycling, 79.4% for NMES, 94.4 for standing/walking and 100% for ultrasound and physical activity. Overall, the evidence suggests that rehabilitation modalities did not prevent bone mass decline in the acute phase after SCI, although general training compliance was relatively high.
Conclusions
There is level 1 evidence (one RCT) that 6 weeks of pulsed calcaneal ultrasound has no effect on calcaneal BMD measured by DXA or QUS. (Warden et al. 2001)
There is level 1 evidence (one RCT) that NMES training of quadriceps 5 days per week for 14 weeks did not result in significant changes in lower limb or hip region BMD. (Arija-Blázquez et al. 2014)
There is level 2 evidence (from 1 non-randomized prospective controlled trial) that NMES of plantar flexors for 2-3years initiated after 2-4 months of injury reduced the decline in tibia vBMD (Shields et al. 2006a; 2006b).
There is level 2 evidence (from 1 non-randomized prospective controlled trial) that FES-cycling 30 minutes thrice weekly for 6 months did not improve or maintain cortical BMD of the right tibial diaphysis in the acute phase. (Eser et al. 2003)
There is level 1 evidence (from 1 RCT) that standing thrice weekly for 12 weeks initiated within 4-6 months of injury did not prevent proximal femur BMD decline (Ben et al. 2005).
There is level 3/4 evidence that active-assisted standing (FES) with for 2-3 years was effective in mitigating BMD decline of the trabecular BMD of the distal femur (Dudley-Javoroski & Shields 2013).
There is level 4 evidence (from 1 pre-post study) that BWSTT twice weekly for 6-8 months more than three months post-injury did not prevent declines in hip or knee region bone mineral density (DXA or QCT). (Giangregorio et al. 2005)
There is level 4 evidence (from 1 pre-post study) that activity-based training 2-3 hours/day for a minimum of 2 days a week for 6 months increased spine BMD (Astorino et al. 2013).