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. 2015 Jun 15;2015(6):CD006142. doi: 10.1002/14651858.CD006142.pub3

Roche 1985.

Study characteristics
Methods Type of study: placebo‐controlled, parallel RCT.
Condition and number of participants randomised: haemophiliac participants (N = 36).
Groups: active TENS group (N = 28); placebo TENS group (N = 8).
Participants Demographics: N = 36, 35 ± 12 yrs (mean ±?SD), gender not detailed.
Setting: specialised outpatient clinic at hospital.
Inclusion:  haemophiliac participants suffering from unilateral haemorrhage into a joint.
Exclusion: participants attending for dental care or for treatment to haemorrhage in the region of the face, abdomen or cranium.
Withdrawals/dropouts: none.
Interventions Where applied: in hospital.
Applied by: clinician.
Waveform: square wave pulses.
Frequency: internal pulse frequency of trains was 100 Hz and repetition rate of trains was 5 Hz. In initial stage of trial, trains of pulses rather than continuous TENS reported by participants as being more tolerable, consequently this form of TENS was adopted throughout the trial.
Pulse duration: 1 ms pulses, 100 ms train duration.
Pulse amplitude/Intensity: raised to a level of definite but comfortable perception with no presence of muscle activation.
Placebo TENS Group: as for active group but no stimulation applied. Participants informed that a very high frequency of stimulation was being used which they might or might not feel.
Electrodes: 2 or 4, flexible carbon electrodes layered with electrode gel, 2x2 cm, over the major sensory nerves supplying affected area or as close as possible to area of bleed.
Duration and frequency of Rx: 25 min, 1 Rx.
Device/manufacturer: Digitimer Ltd, Model DS2.
Adverse effects: none.
Outcomes Pain outcome: MPQ (PRI, PPI, group scores for each category) before and after Rx for current pain.
ITT/per protocol analysis: no.
Statistical analysis: over 71% of participants receiving TENS reported changes in MPQ scores which represented pain relief > 50%. Only 2 placebo participants (25%) reported this amount of pain relief. The difference between participants reporting at least 50% relief was significantly different between groups using PRI and PPI. 9 TENS participants reported > 80% pain relief, 4 of these reported 100% pain relief. 2 placebo participants reported > 50% pain relief, neither reported 100%. Pre Rx PRI data divided into mild‐medium (PRI score of 0 to 25) and medium‐severe (PRI score of 26 to 50) based on highest recorded PRI score of 50. For TENS participants, difference between these 2 groups of scores was not significant.
Notes Abbreviation: MPQ‐ McGill pain questionnaire; PPI‐ present pain index; PRI‐ pain rating index.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk "The subjects were randomly assigned to one of two groups".
Allocation concealment (selection bias) Unclear risk No details provided.
Incomplete outcome data (attrition bias)
All outcomes Low risk Trial author responded "no" to question "Were there any dropouts/withdrawals?".
Source of funding bias Low risk "The research was supported by a grant from The British Medical Research Council (Grant No. 0979/723/N) awarded to K. Gijsbers".
Blinding (Participant) High risk It is impossible to adequately blind participants who receive electrical stimulation.
Author response "The study was single blind. The same researcher took measures and applied TENS. Specific TENS settings were screened from participants".
"The same apparatus and electrodes were used for the placebo group, but no stimulation was applied. These subjects were informed that a very high frequency of stimulation was being used which they might or might not feel".
The exclusion criteria were not provided so we do not know if participants had to be TENS naïve.
Blinding (Outcome Assessor) High risk Author response: "The study was single blind. The same researcher took measures and applied TENS. Specific TENS settings were screened from participants".
Sample Size High risk N = 28 TENS; N = 8 placebo TENS