Multicenter pragmatic study of carpal tunnel release with ultrasound guidance

Figures & data

Figure 1. Carpal tunnel release with ultraGuideCTR and real-time ultrasound guidance. A. ultraGuideCTR device, consisting of hand piece and distal working tip. B. close-up view of device tip from ‘bird’s eye view’ demonstrating inflated balloons which increase the device diameter from 4 mm to 8 mm to create space within the carpal tunnel. C. cross-sectional view of the distal carpal tunnel with the device placed directly below the transverse carpal ligament (TCL) and between the median nerve (MN) and the hook of the hamate bone (HAM). the balloons (yellow asterisks) have been inflated to create space between the MN and the ulnar artery (UA). top = superficial, left = radial.

Table 1. Characteristics of patients treated using carpal tunnel release with ultrasound guidance

Variable	Value (n = 373)
Demographics
Age (yr)	55 ± 14
18–34	6.2% (23/373)
35–64	68.9% (257/373)
≥65	24.9% (93/373)
Female sex	70.5% (263/373)
BMI (kg/m^2)	33 ± 9
BMI ≥30	54.2% (202/372)
Medical history
Anxiety	24.5% (89/364)
Depression	23.4% (85/364)
Diabetes	13.7% (50/364)
Thyroid disease	12.9% (47/364)
Arthritis	9.3% (34/364)
Tobacco use	9.0% (33/367)
Chronic pain syndrome	7.1% (26/364)
Polyneuropathy or other nerve disorder	3.0% (11/364)
Current opioid use	2.7% (10/367)
Renal failure	0.3% (1/364)
Carpal tunnel history
Symptom duration
≤6 months	11.6% (34/292)
>6 months – 1 year	21.6% (63/292)
>1 year – 2 years	15.1% (44/292)
>2 years	51.7% (151/292)
Operative hand
Dominant	50.1% (187/373)
Nondominant	35.4% (132/373)
Bilateral	14.5% (54/373)
Employment history
Current employment	61.7% (230/373)
Desk	52.2% (120/230) ^a
Light manual activity	30.9% (71/230) ^a
Heavy manual activity	17.0% (39/230) ^a
Worker compensation case	4.4% (10/227) ^a
Symptoms and function
QDASH (0–100 scale)	41.7 ± 20.1
BCTQ-SSS (1–5 scale)	3.0 ± 0.7
BCTQ-FSS (1–5 scale)	2.4 ± 0.8

^aAmong currently employed individuals.

BCTQ-FSS = Boston Carpal Tunnel Questionnaire Functional Status Scale; BCTQ-SSS = Boston Carpal Tunnel Questionnaire Symptom Severity Scale; BMI = body mass index; QDASH = Quick Disabilities of the Arm, Shoulder, and Hand Questionnaire.

Figure 2. Change in QDASH score over 6 months following carpal tunnel release with ultrasound guidance. plotted values are absolute mean change and 95% confidence interval. asterisk denotes p < 0.001 for change relative to baseline. the minimal clinically important difference (MCID) for postoperative change was 15 points [14]. QDASH = Quick Disabilities of the Arm, Shoulder, and Hand Questionnaire.

Figure 3. Change in BCTQ-SSS and BCTQ-FSS score over 6 months following carpal tunnel release with ultrasound guidance. plotted values are the absolute mean change and 95% confidence interval. asterisk denotes p < 0.001 for change relative to baseline. the minimal clinically important difference (MCID) for postoperative change was 0.74 for BCTQ-FSS and 1.14 points for BCTQ-SSS [15]. BCTQ-FSS = Boston carpal tunnel questionnaire functional status scale; BCTQ-SSS = Boston Carpal Tunnel Questionnaire Functional Status Scale, and Boston Carpal Tunnel Questionnaire Symptom Severity Scale.

Table 2. Change in main outcomes reported as a standardized effect size over 6 months following carpal tunnel release with ultrasound guidance.^a.

Preoperative	2 weeks	1 month	3 months	6 months
QDASH	0.98	1.14	1.39	1.55
BCTQ-SSS	1.71	1.74	1.89	2.12
BCTQ-FSS	0.75	1.05	1.18	1.38

^aData reported using the Cohen’s d statistic where values of 0.2, 0.5, 0.8, and 1.0 were defined as small, medium, large, and very large effect sizes, respectively.

BCTQ-FSS = Boston Carpal Tunnel Questionnaire Functional Status Scale; BCTQ-SSS = Boston Carpal Tunnel Questionnaire Symptom Severity Scale; QDASH = Quick Disabilities of the Arm, Shoulder, and Hand Questionnaire.

Figure 4. Percentage of patients who returned to normal activities following carpal tunnel release with ultrasound guidance. median time to return to normal activities was 3 days (interquartile range: 2–5 days).

Figure 5. Percentage of employed patients who returned to work following carpal tunnel release with ultrasound guidance. median time to return to work was 5 days (interquartile range: 3–9 days).

Table 3. Subgroup analysis of main outcomes following carpal tunnel release with ultrasound guidance

Baseline characteristic	RTNA (days)^a	RTW (days)^a	QDASH change^a	BCTQ-SSS change^a	BCTQ-FSS change^a
Age group (years)
18–34 (n = 23)	4 (2–6)	6 (4–9)	−32 (−38, −26)	−1.5 (−1.7, −1.3)	−1.1 (−1.3, −0.9)
35–64 (n = 257)	3 (2–5)	5 (3–9)	−32 (−33, −30)	−1.6 (−1.7, −1.6)	−1.1 (−1.1, −1.0)
≥65 (n = 93)	3 (1–6)	4 (2–7)	−27 (−30, −24)	−1.6 (−1.7, −1.4)	−0.9 (−1.0, −0.8)
Sex
Female (n = 263)	3 (2–5)	5 (3–9)	−32 (−34, −30)	−1.7 (−1.7, −1.6)	−1.1 (−1.2, −1.0)
Male (n = 110)	3 (1–5)	4 (3–7)	−27 (−30, −24)	−1.4 (−1.5, −1.3)	−0.9 (−1.0, −0.8)
Body mass index (kg/m^2)
≥30 (n = 202)	3 (2–5)	5 (3–8)	−31 (−33, −29)	−1.6 (−1.7, −1.5)	−1.1 (−1.1, −1.0)
<30 (n = 170)	3 (2–6)	5 (3–10)	−30 (−32, −28)	−1.6 (−1.7, −1.5)	−1.0 (−1.1, −0.9)
Diabetes
Yes (n = 50)	3 (1–6)	4 (3–7)	−30 (−34, −26)	−1.6 (−1.8, −1.5)	−1.0 (−1.2, −0.9)
No (n = 314)	3 (2–5)	5 (3–9)	−31 (−32, −29)	−1.6 (−1.7, −1.5)	−1.1 (−1.1, −1.0)
Tobacco use
Yes (n = 33)	3 (2–6)	6 (3–11)	−30 (−35, −26)	−1.6 (−1.8, −1.4)	−1.0 (−1.2, −0.8)
No (n = 334)	3 (2–5)	5 (3–9)	−31 (−32, −29)	−1.6 (−1.7, −1.6)	−1.1 (−1.1, −1.0)
Worker compensation case
Yes (n = 10)	3 (2–7)	4 (2–7)	−26 (−34, −18)	−1.5 (−1.8, −1.2)	−1.0 (−1.3, −0.7)
No (n = 217)	3 (2–6)	5 (3–9)	−31 (−32, −29)	−1.6 (−1.7, −1.6)	−1.0 (−1.1, −1.0)
Bilateral simultaneous procedure
Yes (n = 54)	3 (2–6)	6 (3–9)	−34 (−41, −14)	−1.6 (−1.9, −1.1)	−1.0 (−1.8, −0.3)
No (n = 319)	3 (2–5)	5 (3–8)	−30 (−43, −18)	−1.5 (−2.1, −1.1)	−1.0 (−1.6, −0.5)

^aValues are median (interquartile range).

^aValues are the absolute change (95% confidence interval) over 6 months adjusted for preoperative values. All change values were statistically significant compared to preoperative values. Minimal clinically important differences (MCIDs) for postoperative change were 15 points for QDASH [14], 1.14 points for BCTQ-SSS [15], and 0.74 points for BCTQ-FSS [15].

BCTQ-FSS = Boston Carpal Tunnel Questionnaire Functional Status Scale; BCTQ-SSS = Boston Carpal Tunnel Questionnaire Symptom Severity Scale; QDASH = Quick Disabilities of the Arm, Shoulder, and Hand Questionnaire; RTNA = return to normal activity; RTW = return to work.

Table 4. Comparison of results using carpal tunnel release with ultrasound guidance vs. open/mini-open carpal tunnel release

Variable	CTR with ultrasound guidance	Open/mini-open CTR
	Current study	Median (Range) ^a	References
Median days to return to normal activity	3	23 (14 to 26)	[7,27–29]
Median days to return to work	5	23 (13 to 28)	[28–35]
Mean QDASH change^a
2 weeks	−20.3	−9.8 (−15.1 to −4.4)	[7,35]
6 months	−30.8	−36.9 (−37.3 to −36.4)	[7,35]
Mean BCTQ-SSS change^a
2 weeks	−1.3	−1.3 (−1.5 to −1.1)	[29,32,36]
6 months	−1.6	−1.5 (−2.8 to −1.3)	[23,29,37]
Mean BCTQ-FSS change^a
2 weeks	−0.7	−0.3 (−0.6 to −0.2)	[29,32,36]
6 months	−1.0	−0.9 (−2.9 to −0.7)	[23,29,37]
Major neurovascular complication	0%	0% (0% to 4%)	[30]

^aMinimal clinically important differences (MCIDs) for postoperative change were 15 points for QDASH [14], 1.14 points for BCTQ-SSS [15], and 0.74 points for BCTQ-FSS [15].

^aMedian and range of values reported in each study.

BCTQ-FSS = Boston Carpal Tunnel Questionnaire Functional Status Scale; BCTQ-SSS = Boston Carpal Tunnel Questionnaire Symptom Severity Scale; CTR = carpal tunnel release; QDASH = Quick Disabilities of the Arm, Shoulder, and Hand Questionnaire.

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Data Availability Statement

Raw data will not be made available since this is an ongoing registry.