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

De Moraes 2021.

Study characteristics
Methods Study design: randomised, parallel‐group, single (investigator)‐blinded controlled trial
Setting: hand surgery and microsurgery section of Hospital Alvorada, Américas, São Paulo/SP
Participants Details of sampling frame:
Total n eligible = not reported 
Total n excluded pre‐randomisation = not reported
Total n randomised = 100 participants (hands)
Intervention group 1 (splint) n = 48 participants (hands)
Intervention group 2 (steroid injection) n = 52 participants (hands)
Post‐intervention follow‐up at 3 months:
Total n available for follow‐up (3 months) = 99 participants (hands)
Total n analysed (3 months) =  99 participants (hands)
Intervention group (splint) n = 47 participants (hands)
Intervention group (steroid injection) n = 52 participants (hands)
Post‐intervention follow‐up at 6 months:
Total n available for follow‐up (6 months) = 95 participants (hands)
Total n analysed (6 months) =  95 participants (hands)
Intervention group (splint) n = 45 participants (hands)
Intervention group (steroid injection) n = 50 participants (hands)
Gender:
Intervention group 1 (splint): 7 males; 41 females
Intervention group 2 (steroid injection): 10 males; 42 females
Mean age:
Intervention group 1 (splint):  54.4  years (SD not reported)
Intervention group 2 (steroid injection): 54.2 years (SD not reported)
Duration of CTS symptoms:
Inclusion criteria

  1. Adults aged 40 years or more

  2. Diagnosis confirmed with EMG

  3. Four or more of the following six clinical signs and symptoms suggested by Graham and colleagues (Graham 2006) (CTS‐6):

    1. Paraesthesia in the territory of the median nerve

    2. Hand paraesthesia at night

    3. Atrophy of thenar muscles

    4. Positive Tinel's sign

    5. Phalen's test positive

    6. Loss of 2‐point discrimination (> 6 mm)

  4. Signed informed consent

  5. Symptoms for at least 1 month

  6. A positive nerve conduction study indicating motor and sensory involvement, classified as moderate or severe


Exclusion criteria

  1. Pretreatment with corticosteroids and splint within last 6 months

  2. Prior surgical treatment for CTS

  3. Wrist conditions associated with trauma

  4. Non‐trauma‐associated conditions (cervical pain, shoulder girdle pain [chosen to rule out thoracic outlet syndrome], long‐term uncontrolled diabetes)

  5. Hypersensitivity or allergy to corticosteroids

  6. Presence of persistent paraesthesia in the median nerve territory (radial fingers)

  7. Refusal to participate


CTS diagnostic criteria (case definition): 
A CTS diagnosis was made clinically and supported by electrodiagnostic findings.
CTS severity: 
Moderate to severe CTS
Interventions Group 1 ‐ a forearm‐palmar orthosis with the wrist immobilised in a neutral position was used at night while sleeping and removed in the morning. The duration of orthosis use differed because sleeping times were different between individuals. The orthosis was used throughout the study period.
Group 2 ‐ corticosteroid injection: 6.43 mg (1 mL) of betamethasone dipropionate, 2.63 mg of betamethasone disodium phosphate, and 0.5 mL of 2% lidocaine (xylocaine), totaling 1.5 mL. After injection, a simple dressing was applied.
Outcomes Outcomes evaluated at baseline and after treatment (within the 1st week of the intervention, and 1, 3, and 6 months).

  1. Remission of nocturnal paraesthesia 

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

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

  4. Pain (VAS, 10 cm line; higher is worse)

  5. Adverse effects

  6. Failure (worsening of, or no improvement in, CTS‐related signs and symptoms, therefore requiring another therapeutic intervention)
Funding None declared
COI None declared
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The randomization procedure was performed by a person not directly involved in the study." 
Comment: Random sequence generation, however, not described 
Allocation concealment (selection bias) Low risk Quote: "The allocation of patients was performed using opaque envelopes with consecutive numbers. Envelopes were only opened after verification of inclusion criteria and signing of the informed consent form. The randomization procedure was performed by a person not directly involved in the study."
Comment: Adequate allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "Outcome assessments were performed by blinded researchers."
Comment: The participants were not blinded, and outcomes were partially or completely participant‐reported.
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "Outcome assessments were performed by blinded researchers."
Comment: The participants were not blinded, and outcomes were partially or completely participant‐reported.
Incomplete outcome data (attrition bias)
3 months or less Low risk Quote: "There was an overall loss to follow‐up of 5 patients (5%). In the orthosis group, 1 patient did not return in the third month of follow‐up, and another 2 were lost in the sixth month (6.25%). In the corticosteroid group, 2 patients (3.8%) did not return in the sixth month assessment."
Comment: Small and balanced loss, and reasons reported. Not likely to bias outcomes considerably
Incomplete outcome data (attrition bias)
After 3 months Low risk Small and balanced loss, and reasons reported. Not likely to bias outcomes considerably
Selective reporting (reporting bias) Low risk Main outcomes defined in the registration were reported. Graham criteria were defined as an outcome in the ClinicalTrials registry but not reported. This likely does not bias the results, as we did not consider those criteria as relevant in this review.
Other bias Low risk Randomisation and outcome measurement were performed at participant level. No other risk of bias detected