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

So 2018.

Study characteristics
Methods Study design: prospective, randomised, parallel‐group clinical trial
Setting: medical clinic of a local hospital (Kwong Wah Hopital), Hong Kong, China.
Participants Details of sampling frame:
Total n eligible = not reported
Total n excluded pre‐randomisation = not reported
Total n randomised = 50
Total n available for follow‐up = 50
Total n analysed = 50
Intervention group 1 (splint) n = 25
Intervention group 2 (steroid) n = 25
Gender distribution:
Intervention group 1 (splint): 22 males, 3 females
Intervention group 2 (steroid): 21 males, 4 females
Mean ± SD age:
Intervention group 1 (splint): 57.28 ± 9.75
Intervention group 2 (steroid): 57.32 ± 9.12
Median ± SD duration of CTS symptoms:
Intervention group 1 (splint): 104 weeks (range 39–1040)
Intervention group 2 (steroid): 78 weeks (range 12–1040)
Inclusion criteria:

  1. Clinical features: pain, paraesthesia or weakness in the median nerve distribution for at least 3 months


Exclusion criteria:

  1. Inflammatory arthritis

  2. Diabetes mellitus

  3. Hypothyroidism

  4. Renal failure

  5. Polyneuropathy

  6. History of significant local trauma

  7. Age younger than 18 years

  8. Pregnancy

  9. Previous treatments of CTS, namely injection, splinting and surgery

  10. Motor impairment or thenar muscle atrophy


CTS diagnostic criteria (case definition):

  1. Clinical features were pain, paraesthesia or weakness in the median nerve distribution for at least 3 months. The neurodiagnostic criteria were based on the American Academy of Neurology summary statement, which further classified the abnormalities as follows:

    1. mild abnormality, that is, abnormal comparative tests or prolonged median DSL (> 3.5 ms) but normal median DML;

    2. moderate abnormality, that is, prolonged median DSL and DML (> 4.2 ms); and

    3. severe abnormality, that is, absence of median SNAP or absent CMAPs.


CTS severity: 
Mild, moderate and severe NCV abnormality
Interventions Group 1 ‐ After randomisation, the hands of the participants in the splinting group were splinted in a neutral position with a standard cotton–polyester splint. Participants were instructed to use the splints during night‐time for 1 month. 
Group 2 ‐ the local injection of steroid was performed by the same investigator after the randomisation. Using a sterile technique, 20 mg methylprednisolone acetate premixed with lidocaine was injected using a 25‐guage 9 5/8” needle. The needle was inserted medially to the palmaris longus tendon at the distal palmar crease in the wrist at an angle of 45° to the forearm. The steroid was injected at approximately 1 cm below the skin. The needle was repositioned if there was any resistance to injection, or any pain or paraesthesia in the median nerve territory.
Outcomes Outcomes were assessed at baseline and at 4 weeks follow‐up.

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

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

  3. BCTQ total change

  4. Satisfaction score (1 to 5; higher is better)

  5. Nine hole peg test change (seconds; lower is better)

  6. Side effects (yes/no)

  7. Number changing treatment (crossing over after study period)
Funding Not reported
COI The authors reported no conflict of interest.
Notes The article reported the mean change on the BCTQ Symptom Severity Scale and Functional Status Scale, but the trial author provided end point scores (for Symptom Severity Scale and Functional Status Scale).
 
Participants were encouraged to mark each night they had worn the splints on a calendar to ensure compliance, but results for adherence were not reported.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "They were then allocated to one of the two treatment arms according to the randomization procedure using sequentially numbered opaque sealed envelopes (SNOSE). Two sets of [an] equal number of sealed opaque envelopes containing a sheet of paper marked Steroid Injection or Splinting were shuffled very thoroughly. The envelopes were then marked on the front with a unique number sequentially starting from one. Patients were thus randomly assigned to one of the two treatment arms according to what was marked in these envelopes."
Allocation concealment (selection bias) Low risk Quote: "They were then allocated to one of the two treatment arms according to the randomization procedure using sequentially numbered opaque sealed envelopes (SNOSE). Two sets of [an] equal number of sealed opaque envelopes containing a sheet of paper marked Steroid Injection or Splinting were shuffled very thoroughly. The envelopes were then marked on the front with a unique number sequentially starting from one. Patients were thus randomly assigned to one of the two treatment arms according to what was marked in these envelopes."
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "However, the open label design of the study means the potential ascertainment bias introduced by unblinding is not excluded."
Comment: Blinding of participants not attempted
Incomplete outcome data (attrition bias)
3 months or less Low risk Comment: Authors did not report any dropouts. Text did not explicitly give numbers in the follow‐up but the numbers in the table implied that there were no dropouts.
Selective reporting (reporting bias) Low risk Comment: All prespecified outcomes reported. Protocol available
Other bias Low risk Comment: Hand used as a unit. There was no apparent source of bias.