Postoperative recovery of carpal tunnel release comparing three surgical techniques: ultrasound-guided, endoscopic, and mini-open

ISRCTN	ISRCTN73622579
DOI	https://doi.org/10.1186/ISRCTN73622579
Sponsor	VZW AZ Maria Middelares hospital
Funder	Investigator initiated and funded

Submission date: 13/01/2026
Registration date: 14/01/2026
Last edited: 14/01/2026

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration.

Contact information

Dr Michiel Cromheecke
Principal investigator, Scientific, Public

Buitenring-Sint-Denijs 30
9000
Gent
Belgium

Phone	+32498855836
Email	michiel.cromheecke@gmail.com

Study information

Primary study design	Observational
Observational study design	Cohort study
Scientific title	Recovery profiles after carpal tunnel release: a prospective comparison of ultrasound-guided, endoscopic, and mini-open techniques
Study acronym	RECOVER-CTR
Study objectives	Existing comparative studies have mainly compared open and endoscopic releases, with high-quality data lacking for evaluation of the ultrasound-guided technique. Therefore, there is a need for prospective comparative research assessing functional outcomes and safety across all three techniques. We hypothesize that the ultrasound-guided technique might provide faster functional recovery, due to the minimally invasive aspect of the technique, while maintaining equal safety.
Ethics approval(s)	Approved 14/07/2025, Ethical Committee AZ Maria Middelares - AZ Sint Vincentius Deinze (Buitenring-Sint-Denijs 30, Gent, 9000, Belgium; +3292464646; ethisch.comite@mijnziekenhuis.be), ref: MMS.2025.027
Health condition(s) or problem(s) studied	Carpal tunnel syndrome
Intervention	Patients will be followed prospectively using standardized questionnaires and clinical examinations at the following postoperative time points: 1, 2, 3 and 4 weeks, 3 months, and 6 months. Clinical follow-up will be performed preoperatively, at 4 weeks, and at 3 months. Outcomes will be measured by Boston Carpal Tunnel Questionnaire (BCTQ), QuickDASH, Patient and Observer Scar Assessment Scale (POSAS) and Visual Analog Scale (VAS) . Statistical analysis will be performed on anonymized data using IBM® SPSS® Statistics. A two-sided p-value < 0.05 will be considered statistically significant except where multiplicity adjustments are needed. Descriptive and comparative analyses will be performed. All primary analyses will follow an intention-to-treat (ITT) principle: patients analysed in the group corresponding to the technique performed. A per-protocol analysis will be performed as sensitivity analysis. Power calculation and sample size rationale for the primary outcome (BCTQ-SSS change at 4 weeks) was performed. We plan a pragmatic, prospective, 3-arm study with equal allocation to mini-open, endoscopic and ultrasound-guided carpal tunnel release. Using the literature-derived Minimal Clinically Important Difference (MCID) for the BCTQ Symptom Severity Scale (SSS) of 0.64 points, a total of 32 patients per group would be needed for pairwise comparisons (two-sample t-tests) to obtain 80% power at α = 0.05. Considering a 10% drop-out and aiming to increase the reliability of our findings we will aim for 50 patients per group. ANCOVA test will be used to include baseline differences. Since ANCOVA typically increases power the above power calculation should be sufficient. To address potential confounding due to non-randomized treatment assignment multivariate regression models will adjust for baseline characteristics such as age, sex, symptom duration, hand dominance, diabetes, severity scores, occupation (manual vs administrative). Propensity score matching or weighting may be performed as sensitivity analysis if group imbalance occurs. Results will include estimates, 95% CIs and exact p-values. We will follow STROBE guidelines for observational cohort reporting and provide a flowchart of included/excluded patients.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	Early functional recovery measured using the Boston Carpal Tunnel Questionnaire (BCTQ) at baseline and 4 weeks Early functional recovery measured using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) at baseline and 4 weeks Early pain perception measured using a Visual Analog Scale (VAS) at baseline and 4 weeks Early functional recovery measured using Grip strength (Kg) at baseline and 4 weeks
Key secondary outcome measure(s)	Early postoperative pain measured using a Visual Analog Scale (VAS) at Daily for the first 2 weeks Scar characteristics and patient satisfaction measured measured using the Patient and Observer Scar Assessment Scale (POSAS) at 4 weeks, 3 months and 6 months Use of analgesics postoperative (duration and cumulative dose) measured using a questionnaire to collect data recorded on dose at 1 week, 2 weeks, 4 weeks, 3 months, 6 months Time to return to daily activities, return-to-work measured using a questionnaire (days) at 1 week, 2 weeks, 4 weeks, 3 months Patient satisfaction measured using a 5-point Likert scale at 1 week, 2 weeks, 4 weeks, 3 months, 6 months Postoperative complication rate, including, but not limited to, nerve injuries, infection, persistent symptoms, etc. measured using data recording (type) at 1 week, 2 weeks, 4 weeks, 3 months, 6 months Revision surgery rate and indications for revisions measured using a questionnaire to record yes/no at 3 and 6 months Longer term functional outcome measured using BCTQ, QuickDASH, grip strength, VAS scales at 3 and 6 months
Completion date	31/12/2026

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	99 Years
Sex	All
Target sample size at registration	150
Key inclusion criteria	1. Age between 18 years and 99 years 2. Receiving surgical treatment for solitary carpal tunnel syndrome 3. Preoperative availability of EMG and/or ultrasound
Key exclusion criteria	1. Concomitant surgical procedures in the same hand 2. Symptomatic osteoarthritis of the hand or wrist 4. Pregnancy 5. Dupuytren's disease with symptomatic MCP or PIP contracture 6. Bilateral carpal tunnel surgery within a 3-month interval 7. Symptomatic (poly)neuropathy confirmed by EMG 8. Active chemotherapy or malignancy 9. Cervical stenosis or herniation with electromyography (EMG) confirmation
Date of first enrolment	15/07/2025
Date of final enrolment	01/06/2026

Locations

Countries of recruitment

Belgium

Study participating centre

VZW AZ Maria Middelares hospital

Buitenring-Sint-Denijs 30
Gent
9000
Belgium

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan

Editorial Notes

14/01/2026: Study’s existence confirmed by the Ethical Committee AZ Maria Middelares - AZ Sint Vincentius Deinze, Belgium.