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

Chesterton 2018.

Study characteristics
Methods Study design: pragmatic, 2‐arm, parallel‐group, open‐label, RCT
Setting: 25 primary and community musculoskeletal clinics and services in England
Participants Details of sampling frame:
Total n eligible = 405 (750 assessed for eligibility)
Total n excluded pre‐randomisation = 516 
Total n randomised = 234 participants (hands)
Intervention group (splint) n = 118 participants (hands)
Intervention group (steroid injection) n = 116 participants (hands)
Post‐intervention follow‐up at 6 weeks:
Total n available for follow‐up (6 weeks) = 217 participants (hands)
Total n analysed (6 weeks) =  234 participants (hands)
Intervention group (splint) n = 109 participants (hands)
Intervention group (steroid injection) n = 108 participants (hands)
Post‐intervention follow‐up at 6 months:
Total n available for follow‐up (6 months) = 192 participants (hands)
Total n analysed (6 months) =  234 participants (hands)
Intervention group (splint) n = 96 participants (hands)
Intervention group (steroid injection) n = 96 participants (hands)
Gender distribution:
Intervention group 1 (splint):  37 males; 81 females
Intervention group 2 (steroid injection): 43 male; 73 females
Mean ± SD age:
Intervention group 1 (splint): 52.2 ± 14.9 (median 50.00, IQR 40.75–64.25)
Intervention group 2 (steroid injection): 52.6 ± 17 (median 53.50, IQR 39.25–65.00)
Duration of CTS symptoms (number of participants):
Splint < 3 months: 17
Splint 3–6 months: 33
Splint 6 months to 1 year: 27
Splint > 1 year: 39
Splint missing: 2
Steroid injection < 3 months: 19
Steroid injection 3–6 months: 37
Steroid injection 6 months to 1 year: 22
Steroid injection > 1 year: 34
Steroid injection missing: 4
Inclusion criteria:
1. Aged 18 years or older
2. Presented with a new episode of primary idiopathic mild or moderate CTS, which had been present for longer than 6 weeks
Exclusion criteria:

  1. Severe CTS exhibiting constant wrist and hand (specifically palm, index, or middle finger, or thumb) pain, numbness or sensory loss in the wrist and hand (specifically palm, index, or middle finger, or thumb), or thenar muscle atrophy

  2. Corticosteroid injection or night splint for CTS within the preceding 6 months

  3. Previous surgery in the affected wrist, trauma to the affected hand requiring surgery, or immobilisation in the previous 12 months

  4. Current or previous infection of the affected wrist, local or systemic sepsis or infection, or intercurrent illness

  5. Pregnant or lactating

  6. In receipt of anticoagulants

  7. History of hypersensitivity to methylprednisolone acetate or any of its excipients

  8. Allergic to any of the splint materials

  9. History of drug or alcohol abuse

  10. Undergoing ongoing litigation

  11. Unable to complete self‐report questionnaires written in English


CTS diagnostic criteria (case definition):
A general practitioner or trained clinician (physiotherapist or occupational therapist) made the clinical diagnosis, standardised on the basis of presenting symptoms, clinical history, and physical tests using criteria developed as part of a consensus survey of general practitioners from the UK Primary Care Rheumatology Society. Mild CTS was defined as intermittent paraesthesia in the distribution of the median nerve, and moderate as constant paraesthesia, and reversible numbness or pain of idiopathic nature.
CTS severity: 
Mild‐to‐moderate CTS
Interventions Group 1 ‐ night‐resting splint to be worn for 6 weeks: a Beta Wrist Brace, which immobilised the wrist in a neutral or slightly extended position (20° from neutral). The splint was fitted according to the size of the participant’s hand and arm with standard splints of differing sizes. The treating clinician showed the participants how to fit and remove the wrist splint and gave them two Arthritis Research UK patient leaflets: CTS and splints for arthritis of the hand and wrist. The clinician instructed the participants to do gentle range‐of‐motion exercises when removing the splint to prevent stiffness and reinforced adherence by verbal instruction.
Group 2 ‐ corticosteroid injection: received one injection of 20 mg methylprednisolone acetate (as 20 mg of Depo‐Medrone from 40 mg/mL; Pfizer) via a disposable needle (23 G or 25 G) and syringe which was inserted at the wrist between the proximal and distal wrist crease to infiltrate the carpal tunnel. We did not allow injections into the palm of the hand. Participants were treated by the diagnosing clinician who used a sterile no‐touch technique without local anaesthetic. Participants were advised to wait for 30 min following injection and to rest the injected arm for 48 hours They were given 2 Arthritis Research UK patient leaflets for CTS and local corticosteroid injections.
Both groups: no other types of therapy in either group were advised during the first 6 weeks, except for simple analgesia either prescribed or bought over the counter (paracetamol and NSAIDs).
Outcomes Outcomes evaluated before, 6 weeks and 6 months after treatment; Secondary outcome measures at 6 weeks, 6 months, 12 months, and 24 months

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

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

  3. BCTQ total score

  4. Hand–wrist symptom intensity (0–10 numerical rating scale)

  5. Referral for surgery

  6. Surgery

  7. Self‐reported adherence

  8. Secondary outcome measures at 6 weeks and 6 months only included interrupted sleep

  9. Secondary measures at 6 months, 12 months, and 24 months only were over‐the‐counter and prescribed analgesia, perceived benefit and satisfaction with treatment, impact of CTS on work and activities, general health (EuroQoL EQ‐5D‐5L), healthcare use and patient‐incurred costs, and use of co‐interventions

  10. Performance at work and days off work

  11. Serious or unexpected adverse events
Funding "This paper presents independent research funded by an Arthritis Research UK grant (Grant Number 20105). EMH is a National Institute for Health Research (NIHR) senior investigator. KSD is part‐funded by a Knowledge Mobilisation Research Fellowship (KMRF‐2014‐03‐002) from the NIHR and the NIHR Collaborations for Leadership in Applied Health Research and Care West Midlands. The views expressed in this paper are those of the author(s) and not necessarily those of the National Health Service, the NIHR, or the Department of Health and Social Care."
 
COI The authors declared no competing interests.
Notes Even though there was a dropout of participants at 6 weeks and 6 months, analyses were based on multiple imputed data.
Participants with bilateral CTS were permitted treatment for the non‐study hand according to normal clinical protocols in use at the research site.
Some participants were diagnosed with hypothyroidism and diabetes.
5/234 had had surgery for CTS. Outcomes were not reported for this subcohort separately, so we could not exclude these participants. As the proportion was low, we did not exclude this study.
In the corticosteroid injection group, 3 participants either received an incorrect injection (n = 2) or additionally to the injection wore a night splint (n = 1). In the night splint group, 28 participants either received a corticosteroid injection in addition to the night splint (n = 2), wore the splint on the wrong hand (n = 3), did not wear the splint for at least 4–6 nights per week (n = 4), or did not provide adherence data (n = 19).
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Participants were randomly assigned (1:1) to either treatment group with permutated blocks of sizes two and four, prestratified by research site. Randomisation was completed by the Keele University (Keele, UK) Clinical Trial Unit’s (CTU) online web or telephone randomisation service."
Allocation concealment (selection bias) Low risk Quote: "Randomisation was completed by the Keele University (Keele, UK) Clinical Trial Unit’s (CTU) online web or telephone randomisation service. The allocation sequence was not available to research team members. We could not mask treating clinicians or patients to treatment allocation, but we concealed the treatment group allocation during the analyses. A letter was sent to the GPs (general practitioners) of all participants informing them of their patient’s participation in the trial and their treatment allocation."
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "We could not mask treating clinicians or patients to treatment allocation, but we concealed the treatment group allocation during the analyses."
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "We could not mask treating clinicians or patients to treatment allocation, but we concealed the treatment group allocation during the analyses."
Incomplete outcome data (attrition bias)
3 months or less Low risk Comment: All participants were accounted for and reasons for dropouts and attrition were documented (9/118 versus 8/116 missing data at 6 weeks and 20/118 versus 20/118 at 6 months: balanced loss).
Authors also did per protocol sensitivity analysis (for 28/118 versus 3/116 participants treatment deviated from protocol).
Incomplete outcome data (attrition bias)
After 3 months Low risk Comment: All participants were accounted for and reasons for dropouts and attrition were documented (9/118 versus 8/116 missing data at 6 weeks and 20/118 versus 20/118 at 6 months: balanced loss).
Authors also did per protocol sensitivity analysis (for 28/118 versus 3/116 participants treatment deviated from protocol).
Selective reporting (reporting bias) Unclear risk Comment: Protocol available. Perceived benefit and satisfaction with treatment seems not to be reported, but since this was a secondary outcome, it was not clear if non‐reporting was related to the nature of the findings.
Other bias Low risk Comment: No other risk of bias detected