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

Atroshi 2019.

Study name Evaluation of wrist splinting for the treatment of carpal tunnel syndrome
Methods Study design: Prospective, randomised, parallel‐group superiority clinical trial
Setting: Department of Orthopedics, Hässleholm‐Kristianstad‐Ystad
Participants Details of sampling frame:
Total n for randomisation = 112
Gender distribution:
Age:
25 to 65 years old
Duration of CTS symptoms:
Inclusion criteria

  1. Primary, idiopathic CTS

  2. Age 25–65 years, either sex

  3. Symptoms of classic or probable CTS according to the criteria in the Katz hand diagram

  4. Two surgeons (specialists in orthopaedic or hand surgery) independently diagnose the participant’s CTS

  5. Symptom duration of at least 1 month


Exclusion criteria

  1. CTS classified as severe (thenar muscle atrophy or 2‐point discrimination exceeding 8 mm in at least one finger)

  2. Treatment of the study hand with a wrist splint in the past 12 months

  3. Previous steroid injection for CTS in the study hand

  4. Inflammatory joint disease

  5. Vibration‐induced neuropathy

  6. Polyneuropathy

  7. Current pregnancy

  8. Trauma to the study hand in the past 12 months

  9. Previous CTS surgery in the study hand

  10. Inability to complete questionnaires because of language difficulties or cognitive disorder

  11. Severe medical illness

  12. Known abuse of drugs or alcohol or both
Interventions Group 1: rigid wrist splint
Group 2: soft wrist bandage (placebo)
Splints and soft wrist bandages are going to be used initially for 6 weeks at night and, if possible, during the day
Outcomes Outcomes will be measured at baseline and at 6, 12, 24, and 52 weeks after treatment starts.

  1. 6‐item CTS symptoms scale

  2. 11‐item Disabilities of the Arm, Shoulder, and Hand (QuickDASH) scale

  3. EuroQol 5‐dimension (EQ‐5D) health status and quality of life measure

  4. Physical examination (grip strength and pinch strength)

  5. Nerve conduction tests

  6. Measurement of actual splint and bandage use

  7. Referral to surgery
Starting date Recruitment started 4 June 2018 and was expected to conclude by the end of 2020.
Contact information Correspondence: Isam Atroshi, isam.atroshi@med.lu.se
1. Department of Clinical Sciences – Orthopedics, Lund University, SE‐22100 Lund, Sweden
2. Department of Orthopedics Hässleholm‐Kristianstad, Hässleholm Hospital, SE‐28125 Hässleholm, Sweden
Notes