Tilak 2016.
Study characteristics | ||
Methods | RCT, parallel. | |
Participants | 26 participants with phantom limb pain to 2 groups. TENS group: 11 men, 2 women, 1 dropout therefore n = 12; mirror group: 12 men, 1 female, n = 13. Age (mean ± SD): TENS group: 36.38 ± 9.55 years; mirror group: 42.62 ± 10.69 years. Amputations: TENS group: 3 upper and 10 lower limb amputations; mirror group: 4 upper and 9 lower limb amputations. Onset of phantom limb pain from date of surgery: TENS group: 13 ± 1.6 days; mirror group: 13 ± 1.4 days. Formal neuropathic pain assessment: no. Sites of pain: upper and lower limb. Concomitant treatment: no detail supplied. |
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Interventions |
TENS group: no TENS frequency details supplied. Intensity: "strong but comfortable" without visible muscle contraction. Location: electrodes placed at site of pain on contralateral limb. Frequency of treatment: 1 session per day for 4 days. Duration: 20 minutes per session. Clinic administered. Mirror group: intact limb movements performed with mirror. Frequency: 1 session per day for 4 days. Duration: 20 minutes per session. Clinic administered. |
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Outcomes | Pain intensity: no details supplied as to parameters of pain rating (current pain, mean pain, etc.). 0‐10 cm VAS. Outcomes measured at baseline and 4 days later. Study did not report adverse events. |
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Notes | Funding from higher education institution acknowledged. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer generated sequence. |
Allocation concealment (selection bias) | Low risk | Opaque sealed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Both interventions active treatments. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Both interventions active treatments. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 participant dropout adequately described. |
Incomplete outcome data (participant exclusion from analysis) | Low risk | Dropout minimal. All participants analysed. |
Selective reporting (reporting bias) | Low risk | All outcomes reported. |
Other bias | Low risk | Adequate description and testing of baseline characteristics. |
Size of study | High risk | TENS group: n = 12; mirror group: n = 13. |