de Entrambasaguas 2006.
| Methods | Randomised, single‐blind controlled trial Blinded outcome assessor Unclear if ethics approval and informed consent obtained It is unclear whether randomisation occurred at the level of participants or wrists, and whether all bilateral CTS participants received the same or different intervention for each wrist |
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| Participants | Total N = 75 wrists randomised; 38 participants (52 wrists) completed (number of participants randomised not clear) Intervention group 1 N = 26 wrists randomised; 18 wrists completed Intervention group 2 N = 24 wrists randomised; 18 wrists completed Intervention group 3 N = 25 wrists randomised; 16 wrists completed Number of male wrists not clear, 44 females wrists Mean ± SD (range) age: 50.7 ± 10.3 (25 to 73) (group‐specific ages not reported) Inclusion criteria: 1. Mild CTS (increase of sensory or mixed latencies of the median nerve, regardless of the amplitude of potentials) or moderate CTS (criteria for mild CTS plus increase of distal motor latency of the median nerve) Exclusion criteria: 1. Severe CTS (absence or low amplitude of sensory or motor potentials, with presence of denervation or reinnervation on needle EMG). 2. CTS previously treated, surgically or otherwise. 3. Presence of any condition aetiologically related to CTS, with the exception of manual work. 4. Treatment being carried out at the time for whatever reason with anti‐inflammatory drugs. |
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| Interventions | Intervention group 1: Splinting – each splint was modelled individually for each hand, and worn for 12 hours daily for four weeks; if uncomfortable, splint was adjusted. Intervention group 2: Steroid injection ‐ injection of 40 mg of triamcinolone with 10 mg of lidocaine Intervention group 3: Phonophoresis ‐ diclofenac gel was used to administer ultrasound pulses in 10‐minute sessions, five days per week, for four weeks |
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| Outcomes | Outcomes assessed at baseline and one month after treatment ended: 1. Sensory symptoms: tingling, numbness, pain, autonomic manifestations (sweating of palms, changes in skin colour, subjective swelling or clumsiness) measured as 'better', 'worse' or 'no change'. 2. Physical exam: pinprick: median territory vs ulnar, abductor pollicis brevis muscle vs abductor digiti minimi, Tinel's test at the wrist. Each measured as 'better', 'worse' or 'no change' 3. Nerve conduction: sensory distal latency of median nerve (third digit‐wrist, longest), mixed median nerve (palm‐wrist, shortest) |
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| Notes | Written in Spanish, and some details were translated by a translator recruited by the Neuromuscular Disease Review Group. Some participants had bilateral CTS, and analysis was undertaken at the wrist‐level for outcomes, However, it is not clear whether bilateral CTS participants received the same intervention for both wrists. The trialists did not report how the correlation between both wrists was accounted for in the analysis, and attempts to clarify this information from the trialists were unsuccessful. Therefore, it is not clear whether a unit of analysis error occurred. Outcome data were not translated, so the only information regarding the results of this study comes from the English abstract: "The outcome of clinical parameters could not differentiate one treatment from another. Nerve conduction studies improved significantly in the steroid injection group when compared with the phonophoresis group, but not in the rest of the analysis. One nerve conduction parameter showed a minor significant improvement when compared with the basal study in the wrist splinting group. Phonophoresis had no effect on nerve conduction studies." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: No information regarding how the random sequence was generated was reported. |
| Allocation concealment (selection bias) | Unclear risk | Comment: No information regarding the method of allocation was reported. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: Given the nature of the interventions (splint versus injection versus phonophoresis), it is likely that participants and personnel were aware of which treatment they received. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: The outcome assessor who rated symptoms, physical exam and nerve conducted was reported as being blind to treatment allocation. |
| Incomplete outcome data (attrition bias) 3 months or less | High risk | Comment: A flow chart details the number of wrists assigned to the each group, plus the number of wrists in each group where participants rejected treatment, did not show up, or were excluded because follow‐up was carried out by physicians not directly involved in the study or because participants did not follow instructions. The amount of loss to follow‐up and reasons for these were not equally balanced across the groups. |
| Selective reporting (reporting bias) | Low risk | Comment: According to the translator, all outcomes reported in the Methods section were fully reported in the Results section of the report. |
| Other bias | Low risk | Comment: No other sources of bias identified. |