Celiker 2002.
| Methods | Randomised controlled trial No blinding Ethics approval and informed consent obtained Randomisation occurred at the level of participants, where participants with bilateral CTS received the same intervention for both affected wrists. |
|
| Participants | Total N = 23 (37 wrists) randomised Intervention group N = 11 (16 wrists) randomised Control group N = 12 (21 wrists) randomised 1 male, 22 females Mean ± SD (range) age: Intervention group 1: 49.6 ± 15.3 yrs Control group 2: 46.9 ± 10.0 yrs Mean ± SD duration of CTS symptoms: Intervention group 1: 6.9 ± 6.9 months (range 1 to 24 months) Control group 2: 8.5 + 16.4 months (range 1 to 60 months) Inclusion criteria: 1. Electrodiagnostic confirmation of unilateral or bilateral CTS Exclusion criteria: 1. Presence of thenar atrophy |
|
| Interventions | Intervention: Splinting and acemetacine 120 mg/day was received by participants. Lightweight, neutral‐positioned wrist splints were used just at night. The duration of splint‐wearing and NSAID taking was eight weeks Control: Local corticosteroid injection (40 mg methylprednisolone acetate (1 mL)). The point of entry was about 4 cm proximal to the wrist at the midline or just to the radial side of the palmaris longus. A 22‐guage needle was angled almost horizontally and passed its full length into the carpal tunnel without piercing either the tendon or the nerve. If median paraesthesias were elicited, the needle was repositioned, and then the steroid suspension was injected. The entire suspension was discharged under the transverse ligament. The number of injections received over the 8‐week study period was not reported. |
|
| Outcomes | Outcomes assessed at baseline and at two weeks and at the end of eight weeks of treatment: 1. Tinel's test 2. Phalen's test and reverse Phalen's test, which were both performed for a minimum of 60 sec. 3. Pain: measured using a VAS. The authors did not report the measurement units of this VAS, but based on the data reported, MP assumes that a 0 to 10 VAS was used. 4. Symptom severity using a Swedish translated version of the Levine CTS Symptom Severity Scale, with the mean of 11 items rated from 1 to 5 reported (higher scores denote worse symptoms). Outcomes assessed at baseline and at 8 weeks (end of treatment: 1. Nerve conduction: median nerve motor conduction velocity*, median nerve motor latency, median nerve sensory conduction velocity*, median nerve distal sensory latency, ulnar motor nerve conduction velocity*, ulnar motor nerve distal latency* 2. Adverse effects: the authors did not report how this outcome was recorded. |
|
| Notes | *Data not reported in the publication The results of neurophysiologic parameters that were reported in the publication were reported as both endpoint and change from baseline values. There were no differences between endpoint and change from baseline values in terms of statistical significance, so we chose to be consistent and only include endpoint values (as we included endpoint values where available for all other studies included in the review). Analysis was undertaken at the participant‐level for pain and symptom severity score, and at the wrist‐level for Tinel's test, Phalen's test, reverse Phalen's test, and nerve conduction studies, though some participants in each group had bilateral CTS. Bilateral cases had the same intervention applied to each wrist. 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. No attempt was made to adjust outcome data. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were randomly assigned to one of the two groups by using sequentially numbered sealed opaque envelopes." Comment: Not enough information to determine the adequacy of the allocation sequence generation. |
| Allocation concealment (selection bias) | Low risk | Quote: "Patients were randomly assigned to one of the two groups by using sequentially numbered sealed opaque envelopes." Comment: The allocation sequence was probably adequately concealed until interventions were assigned. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "This study was a prospective, unblinded, randomized clinical trial with an 8‐wk follow‐up." Comment: Due to the nature of the interventions, participants were probably aware of which treatment they received. |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "This study was a prospective, unblinded, randomized clinical trial with an 8‐wk follow‐up." Comment: Outcome assessors were probably aware of which treatment participants were allocated to. |
| Incomplete outcome data (attrition bias) 3 months or less | Low risk | Quote: No withdrawals/losses to follow‐up were reported, and the tables of data indicate that the reported data were based on the complete randomised sample. |
| Selective reporting (reporting bias) | High risk | Comment: The outcomes of median nerve motor conduction velocity, median nerve sensory conduction velocity, ulnar motor nerve conduction velocity, and ulnar motor nerve distal latency were specified to have been measured at baseline and at 8 weeks follow‐up in the Methods section of the publication but were not reported in the Results section. |
| Other bias | Low risk | Comment: No other sources of bias identified. |