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. 2023 Feb 27;2023(2):CD010003. doi: 10.1002/14651858.CD010003.pub2

Manente 2001.

Study characteristics
Methods Study design: RCT
Setting: Italy
Participants Details of sampling frame:
Total n eligible = 151 screened
Total n excluded pre‐randomisation = not reported
Total n randomised = 83 participants (83 wrists)
Intervention group 1 (splint) n = 41 participants (41 wrists)
Intervention group 2 (no treatment) n = 42 participants (42 wrists)
Post‐intervention follow‐up:
Total n available for follow‐up = 80 participants (80 wrists)
Total n analysed = 80 participants
Intervention group 1 (splint) n = 40 participants (40 wrists)
Intervention group 2 (no treatment) n = 40 participants (40 wrists)
Gender distribution:
Intervention group 1 (splint): 4 males, 36 females
Intervention group 2 (no treatment): 7 males, 33 females
Mean ± SD age:
Intervention group 1 (splint): 46.10 ± 12.94 years
Intervention group 2 (no treatment): 50.0 ± 12.65 years
Mean ± SD duration of CTS symptoms:
Not reported
Inclusion criteria:

  1. CTS symptoms (pain, numbness, paraesthesiae in median nerve distribution) exclusively or predominantly in one wrist

  2. CTS signs (hypoaesthesia in median nerve distribution, thenar atrophy, positive Phalen's test) exclusively or predominantly in one wrist

  3. At least one abnormal CTS electrodiagnostic study


Exclusion criteria:

  1. Previous CTS surgery

  2. Rheumatoid arthritis

  3. Systemic disease

  4. Pregnancy

  5. Clinical and electrophysiological signs of polyneuropathy


CTS diagnostic criteria (case definition):
On the basis of the electrophysiological results, hands were classified according to the following neurophysiological classification:

  1. extreme CTS, absence of median motor and sensory response

  2. severe CTS, absence of median sensory response and prolonged DML

  3. moderate CTS, slowed digit II–wrist SNCV and abnormal DML

  4. mild CTS, slowed median digit II–wrist SNCV and normal DML

  5. minimal CTS, normal digit II–wrist SNCV and DML, but abnormal segmental or comparison tests

  6. and negative, all tests normal
Interventions Group 1 ‐ splint: worn at night for 4 weeks (hand brace, called Manu)
Group 2 ‐ control (no treatment): participants were asked to wait for an observational period of 4 weeks.
All participants were required to agree not to receive other treatments, or change work duties or medications during the study, or otherwise report it.
Outcomes Outcome assessed at 2 weeks and at the end of 4 weeks of treatment

  1. BCTQ symptom severity score (1 to 5; higher is worse)

  2. BCTQ functional status score (1 to 5; higher is worse)

  3. Global impression of change (participant‐rated questionnaire rated in 4 categories: moderate or much improvement, minimal improvement, no change, worsening) (at 4 weeks only)

  4. Median DML (ms) (at 4 weeks only)

  5. Median SNCV (m/s) (at 4 weeks only)

  6. SNAP amplitude (uV) (at 4 weeks only)

  7. Changes of electrophysiological class of severity (4 weeks only)

  8. Compliance and tolerability

  9. Adverse effects
Funding This study was supported by a grant from the Italian Ministry for Scientific and Technological Research. 
COI First author is the owner of the patent for the brace, which was pending at the time of publication.
Notes Compliance and tolerability was assessed by a questionnaire asking how many nights in 4 weeks the participant wore the hand brace: all 28 nights; most (at least 21) nights; half (about 14) of the nights; and some (less than 7) nights, and whether there were adverse effects.
Of the 40 participants in the treated group, 38 wore the hand brace for all or most of the nights.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Subjects were randomized into two groups by having them select sealed envelopes containing a group assignment".
Comment: Insufficient information provided to determine whether an adequate method was used to generate random sequence
Allocation concealment (selection bias) Unclear risk Quote: "Subjects were randomized into two groups by having them select sealed envelopes containing a group assignment".
Comment: not specified whether envelopes were opaque or sequentially numbered and distributed
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: Participants, personnel, and outcome assessors were not blinded to treatment allocation (confirmed by study authors via personal communication). Assessment of symptoms, functional status, and global impression of change may be biased. 
Blinding of outcome assessment (detection bias)
All outcomes High risk Comment: However, since participants themselves assessed participant‐reported outcomes and they were likely to be aware of their allocated treatment in this study, we rated the risk as high.
Incomplete outcome data (attrition bias)
3 months or less Low risk Comment: Only 1 participant in the treatment group was lost to follow‐up and 2 participants in the control group were excluded after randomisation because they underwent surgery. This is unlikely to have introduced substantial bias in the comparison of outcomes for each group.
Selective reporting (reporting bias) Low risk Comment: All outcomes stated in the methods section of the publication were reported in the results.
Other bias High risk Comment: First author is the owner of the patent for the brace, which was pending at the time of publication.