What is the evidence for electrical bone stimulation for healing, pain management, and functional improvement in patients with fractures?
AMSTAR Rating
Summary
Patient Population:
This meta-analysis included 15 randomized sham-controlled trials (RCTs). Including 1247 participants (58.3% and 56.3% male in experimental and control groups, respectively) with an average age of 45, four studies looked at spinal fusion, five studies included fresh fractures, five studies examined nonunion fractures, and one study investigated surgical osteotomy. Studies examining the appendicular skeleton mainly had patients with tibial, femoral, femoral neck, scaphoid, or other long-bone fractures.
Intervention:
Twelve studies used pulsed electromagnetic field (PEMF) therapy, one study used direct current (DC) stimulation, and two studies used capacitive current (CC) stimulation. The treatment duration ranged from one month to one year. Treatment frequency also varied from half hour daily sessions to constant (24 hour) stimulation.
Comparison:
All studies included placebo machines which either were dummy devices, inactive devices, or had dummy electrodes.
Outcome:
Union was determined by a blinded, independent assessor examining radiographs and computed tomography (CT) scans. The Visual Analogue Scale (VAS), Dallas Pain Questionnaire (DPQ) and a categorical pain scale were used in four studies to examine pain. Two studies also examined functional outcomes by using the Short Form 36 (SF-36) health survey.
- Pooled effect estimate of the studies including pain outcome measures demonstrated statistically significant differences in pain between intervention and control groups (MD on the 100mm VAS=-7.67mm, 95% CI –13.92 to –1.43; p=0.02; I2 =0%) at three and six months. Pain was rated as “moderate quality” in the GRADE quality assessment due to imprecision, as the 95% CI crossed the minimal important difference (MID) threshold of 10 mm.
- Pooled effects estimate between the two studies reporting SF-36 functional outcomes revealed no statistically significant difference between intervention and control groups (MD –0.88, 95% CI –6.63 to 4.87, p=0.76) between three and six months.
- Pooled effects estimate between all intervention and control groups revealed a statistically significant difference in radiographic nonunion (risk ratio [RR]=0.65, 95% CI 0.53 to 0.81, p<0.01) at the last reported one-year follow-up. Researchers found that electrical stimulation reduced RR for nonunion or persistent nonunion by 35% and absolute risk by 15%.
Guideline Recommendations
| Source | Recommendation |
|---|---|
| AANS (2014) | HIGH RISK fractures |
| NASS (2016) | HIGH RISK fractures |
Outcomes Assessed
- Benefit
- Harm
- Inconclusive
Healing (Fusion)
Up to 1 year
Pain
3 months
6 months
Function
3 months
6 months
Relevant Clinical Info
Faldini, Cesarea; Cadossi, Matteoa; Luciani, Deianiraa; Betti, Emanueleb; Chiarello, Eugenioa; Giannini, Sandroa. Electromagnetic bone growth stimulation in patients with femoral neck fractures treated with screws: prospective randomized double-blind study. Current Orthopaedic Practice 21(3):p 282-287, May 2010. | DOI: 10.1097/BCO.0b013e3181d4880f
Faldini et al. (2010) was the most recent RCT that examined healing and pain outcomes in this meta-analysis. This study included a total of 65 participants (Male=13, Female=52) diagnosed with Garden I, II, or III femoral head fractures, with a mean age of 69 ± 5.8 years. This study was assessed to be sound with low risk for all Cochrane Risk of Bias criteria except for random sequence generation which was assessed to be high risk. Within seven days post-surgery, patients in the intervention group were given a PEMF stimulator to use for at least eight hours a day for 90 days. The PEMF stimulators emitted 75 Hz, 1.3 m/s duration of impulse, 2mTesla peak value of magnetic field. Individuals in the control group were given an inactive device with the same instructions. Researchers found that at 60 days, 90 days, and at a six month follow up 69%, 81%, and 94% of fractures (respectively) healed in intervention groups compared to 49%, 66%, and 69% of fractures (respectively) using the placebo stimulator (p<0.05). Similarly, it was found that VAS scores were significantly lower in intervention groups compared to control groups at day 30, 60, and 90: 8.1 ± 9.7 vs. 22.6 ± 23.5 (p<0.01), 13.5 ± 16.8 vs. 22.7 ± 20.1 (p<0.05), 10.4 ± 17.5 vs. 21.6 ± 23.6 (p<0.05), respectively.
Participant Information
of participants
were Male
The sample size was 1247
Mean age of 45 years.
There were 15 studies used.
