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. 2012 Jul 11;2012(7):CD010003. doi: 10.1002/14651858.CD010003

Brininger 2007.

Methods Randomised controlled trial
No blinding reported
Ethics approval and informed consent obtained
Participants Total N = 61 (61 wrists) randomised
Intervention group 1 N =16 wrists randomised, 14 wrists completed
Intervention group 2 N = 17 wrists randomised, 13 wrists completed
Intervention group 3 N =16 wrists randomised, 11 wrists completed
Intervention group 4 N =12 wrists randomised, 13 wrists completed
10 males, 51 females*
Mean ± SD age:*
Intervention group 1: 49.0 ± 15.4 yrs
Intervention group 2: 51.9 ± 15.7 yrs
Intervention group 3: 46.6 ± 12.9 yrs
Intervention group 4: 50.1 ± 13.2 yrs
Inclusion criteria:
1. At least 18 years of age
2. Positive Tinel's test or Phalen maneuver
3. Complaints of nocturnal numbness and tingling
Exclusion criteria:
1. A neuropathy other than CTS in the past year
2. Pregnancy
3. Thenar atrophy
4. Steroid injection into the carpal canal in the past 3 months or a prior carpal tunnel release.
Interventions Intervention group 1: Fabricated neutral wrist and MCP splint with no exercises (neutral wrist and MCP): Participants received a customised, fabricated wrist splint positioning the wrist in neutral (0°) and the MCP joints from 0° to 10° of flexion. Participants were instructed to wear the splint during their regularly scheduled sleep time for 4 weeks.
Intervention group 2. Fabricated neutral wrist and MCP splint with tendon and nerve gliding exercises (neutral wrist and MCP‐exercise): Participants received a customised, fabricated wrist splint positioning the wrist in neutral (0°) and the MCP joints from 0° to 10° of flexion. Participants were instructed to wear the splint during their regularly scheduled sleep time for 4 weeks. In addition, participants received visual and verbal instructions on tendon and nerve gliding exercises. Participants were instructed to perform the exercises 3 to 5 times a day, with 10 repetitions in each position, and to hold each position for 5 seconds.  
Intervention group 3. Off‐the‐shelf, wrist cock‐up splint with no exercises (wrist cock‐up): Participants received a prefabricated, off‐the‐shelf wrist cock‐up splint that immobilised the wrist in 20° of extension. Participants were instructed to wear the splint during their regularly scheduled sleep time for 4 weeks. 
Intervention group 4. Off‐the‐shelf, wrist cock‐up splint with tendon and nerve gliding exercises (wrist cock‐up‐exercise): Participants received a prefabricated, off‐the‐shelf wrist cock‐up splint that immobilised the wrist in 20° of extension. Participants instructed to wear the splint during their regularly scheduled sleep time for 4 weeks. In addition, participants received visual and verbal instructions on tendon and nerve gliding exercises. Participants were instructed to perform the exercises 3 to 5 times a day, with 10 repetitions in each position, and to hold each position for 5 seconds.
Outcomes Outcomes assessed at baseline and at the end of four weeks of treatment :
1. Symptoms using carpal tunnel questionnaire (rates 11 items on ordinal scale 1: no symptoms, to 5: most severe pain)**
2. Hand function using carpal tunnel questionnaire (rates 8 items on ordinal scale 1: no difficulty with the activity, to 5: unable to perform activity)**
3. Functional sensibility using the Moberg Pick‐up Test: participants are timed on how quickly they pick up an assortment of objects such as a coin, safety pin, and paper clip, and place them in a small box**
4. Grip strength using a hand‐held dynamometer: participants were given 3 opportunities to exert maximum force; the mean of 3 successive trials was recorded (higher scores indicate less impairment)**
5. Pinch strength using a reliable and accurate hand‐held pinch meter. Participants had 1 opportunity to exert maximum force with 3 types of pinch: tip pinch, lateral pinch, and palmar pinch (higher scores indicate less impairment)**
6. Satisfaction using an exit survey developed by the primary investigator that was designed to evaluate their level of satisfaction with the treatment provided (measured at four weeks after treatment ended only). No information on how this outcome is rated by participants and scored by outcome assessors.**
Notes *Data only reported for participants completing treatment (n = 51)
**Data only reported overall from baseline to end of treatment or follow‐up for all intervention and control groups combined, and often only in the form of F and P values. Thus, no data appropriate for meta‐analysis were entered into RevMan. The authors were contacted in order to retrieve these data, but efforts were unsuccessful.
Interventions were only applied to one wrist per participant (even in bilateral CTS participants). Therefore, a unit of analysis error resulting from the correlation between two wrists in bilateral CTS participants could not have occurred.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Random allocation was made after subjects gave their informed consent and baseline assessments were completed. Subjects were randomized into groups by selecting a sealed opaque envelope that contained a number corresponding to an intervention group."
Comment: Probably done, but not enough information to determine the adequacy of the randomisation sequence generation.
Allocation concealment (selection bias) Low risk Quote: "Random allocation was made after subjects gave their informed consent and baseline assessments were completed. Subjects were randomized into groups by selecting a sealed opaque envelope that contained a number corresponding to an intervention group."
Comment: The allocation sequence was probably adequately concealed until interventions were assigned.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Comment: Unlikely that participants would have been blinded to which treatment they were allocated to.
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "Another limitation was that the person (TLB) who administered the treatment and evaluated outcomes was not masked to subjects' group assignments, and that may have biased the results."
Comment: The outcome assessor (who also administered the interventions) was probably not blinded to treatment allocation.
Incomplete outcome data (attrition bias) 
 3 months or less Low risk Quote: "Sixty‐one of 79 eligible patients enrolled in the study. Four subjects withdrew because: they had an injection or surgery (n = 2), developed an illness (n = 1), or moved out of the area (n = 1); 6 subjects were lost to follow‐up".
Comment: There were drop‐outs and losses to follow‐up in each of the four groups, and these were detailed, and unlikely to have biased the results.
Selective reporting (reporting bias) High risk Comment: Majority of the outcomes are reported incompletely (e.g., only as F values or P values from an ANOVA), and cannot be entered into a meta‐analysis.
Other bias Low risk Comment: No other sources of bias identified.