Gorodetskyi 2007.
Study characteristics | ||
Methods | Randomised controlled trial | |
Participants | Moscow City Hospital NO71, Moscow, Russia Period of study: February to November 2005 60 participants Inclusion: people aged between 60 and 75 years who had undergone stabilisation (dynamic hip screw or external fixation) of an A2 femoral trochanteric fracture. Informed consent Exclusion: limitations that might interfere with electrical stimulation including insulin pumps, pacemakers and neurostimulation implants; history of epilepsy or seizure; bilateral fractures; pathological fractures (excluding osteoporosis) Age: mean 71 years (range 63 to 75) % male: 33% Number lost to follow‐up: 0 | |
Interventions | Postoperative rehabilitation. Electrical stimulation or placebo (sham device) included in the standard rehabilitation started within 24 hours of surgery. Treatments and physiotherapy were carried out each morning and took 20 to 30 minutes to complete. Non‐steroidal anti‐inflammatory drug (ketorolac tromethamine) prescribed as needed. 1. Electrical stimulation (ES) for 10 days: use of a hand‐held, non‐invasive, interactive neurostimulation device (InterX 5000; Neuro Resource Group, Plano, Texas). (Device generates high peak amplitude averaging 17 volts on the skin with a low current of about 6 milliamperes (mA), and damped biphasic electrical impulses which are delivered to the tissue via a pair of concentric electrodes placed in direct contact with the target area. Device adjusts biphasic stimulus in accordance to the impedance of the underlying tissue by varying voltage to maintain constant peak current. Device applied for 20 to 30 minutes with electrodes at 3 sites close to surgical incision. Also corresponding areas on contralateral side. After adjustment for impedance, intensity increased to produce "comfortable sensation for patient"). versus 2. Sham device; same timing. All the participants received standard interdisciplinary postoperative care including routine assessment and daily care by an orthopaedic surgeon supported by a physiotherapist and nurse. |
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Outcomes | Length of follow‐up: 10 days (end of treatment) Pain score (VAS: 0 to 10: worst) 'Pain inventory': effects of pain on walking ability, sleep, mood and enjoyment of life (1: no interference; 10: absolute interference) Analgaesic consumption Surgeon's evaluation of participant's progress at 10 days in terms of improvement: none, minimal, average, substantial, full recovery |
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Notes | All participants were functionally independent before start of study.
Authors refer to reduced life expectancy in Russia. Funding / conflict of interest: "The author or one or more of the authors have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article. In addition, benefits have been or will be directed to a research fund, foundation, educational institution, or other nonprofit organisation with which one or more of the authors are associated". |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Insufficient information. "Fixed randomisation scheme with sealed envelopes" |
Allocation concealment (selection bias) | Unclear risk | "Fixed randomisation scheme with sealed envelopes" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | "The therapist who administered treatment was aware of the assignment of the patient to an active or sham device. However, all the assessing surgeons, patients and research personnel involved in determining and recording outcome measurements were blinded to this information. The sham device had an identical appearance and application to the active device with lights, buzzing and beeps, but did not produce interactive neurostimulation." Patient blinding may not be possible if they are familiar with neurostimulation. |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, some judgement | Low risk | All the assessing surgeons, patients and research personnel involved in determining and recording outcome measurements were blinded to this information (active v sham device). |
Blinding of outcome assessment (detection bias) Observer‐reported outcomes, no judgement | Low risk | Assessment of the outcome is not likely to be influenced by knowledge of group allocation. |
Incomplete outcome data (attrition bias) Observer‐reported outcomes, some judgement | Low risk | No loss to follow‐up |
Incomplete outcome data (attrition bias) Death, re‐admission, re‐operation, surgical complications, return to living at home | Unclear risk | Not reported |
Selective reporting (reporting bias) | Unclear risk | Possible but no trial protocol or trial registration available |
Free from baseline imbalance bias? | Low risk | Intervention groups appeared well matched. |
Free from performance bias due to non‐trial interventions? | Low risk | Same rehabilitation provided to all |