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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
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The purpose of this study is to determine if any difference exists among 3 different postoperative splinting regimens- no splint, removable splint, and plaster non-removable splint- following mini-open carpal tunnel release (CTR) surgery.
We sought to determine if any significant difference in patient-reported or clinical outcomes existed among 3 different postoperative splinting regimens- no splint, removable splint, and plaster non-removable splint- following mini-open carpal tunnel release (CTR) surgery for symptomatic, isolated, nerve conduction study positive carpal tunnel syndrome (CTS).
A total of 249 patients received a mini-open CTR and were subsequently randomized into 1 of the 3 splinting regimens to be removed at the first postoperative visit 10-14 days later. Patient-reported outcomes included QuickDASH surveys, Levine-Katz Symptom Severity Scale (SSS) and Functional Status Scale (FSS) and Pain at Rest and in Action using a Numerical Pain Rating Scale (NPRS). Clinical outcomes included wrist range of motion (ROM), grip and lateral pinch strengths. All outcomes were evaluated bilaterally at 10-14 days, 6 weeks, 3 months, 6 months and 12 months after surgery. Demographic information was obtained preoperatively and complications were observed for and recorded throughout the study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No splint | Experimental |
| |
| Removable Splint | Experimental |
| |
| Non-removable Splint | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Splint | Other | The no splint group received a soft dressing consisting of an occlusive petroleum gauze strip (Xeroform, Mansfield, MA) over the wound, one folded 4x4 gauze, and a single wrap of roll gauze around the hand, and the wrist was placed and secured by a Coban wrap (3M, St. Paul, MN). The dressing permitted wrist and finger motion. Patients were further instructed to remove the dressing at five days and place an adhesive bandage (Band-Aid, Johnson & Johnson, New Brunswick, NJ) over the incision. |
| Measure | Description | Time Frame |
|---|---|---|
| QuickDASH | The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition. Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time | 10-14 days postoperatively |
| Levine-Katz Symptom Severity Scale (SSS) | The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported. | 10-14 days postoperatively |
| Numerical Pain Rating Scale | Patients are asked to describe their level of pain intensity over the last 24 hours. The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively. The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity. | 10-14 days postoperatively |
| Grip Strength | Grip strength was taken with a Jamar Dynamometer in the 2nd hand position. | 10-14 days postoperatively |
| Wrist Flexion | 10-14 days postoperatively | |
| Lateral Pinch Strength | Lateral pinch strength was taken with a Preston Pinch Gauge. | 10-14 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic Information | Sex, age, BMI, Smoking Status, Hand Dominance, Workers' Compensation Status | Preoperatively |
| Complications | Complications were observed for and recorded throughout the study. |
| Measure | Description | Time Frame |
|---|---|---|
| QuickDASH | The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition. Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian J Bear, MD | OrthoIllinois | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12371039 | Background | Patterson JD, Simmons BP. Outcomes assessment in carpal tunnel syndrome. Hand Clin. 2002 May;18(2):359-63, viii. doi: 10.1016/s0749-0712(01)00002-6. | |
| 3350401 | Background | Jessurun W, Hillen B, Huffstadt AJ. Carpal tunnel release; postoperative care. Handchir Mikrochir Plast Chir. 1988 Jan;20(1):39-40. |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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|
| Removable Splint | Other | The removable splint group received a V-strap Wrist support (Medical Specialties, Inc., Charlotte, NC) placed over the identical soft dressing that was placed on the no splint group. The cock-up wrist splint was designed to keep the wrist fixed in a 20 degree extended wrist position. Patients were instructed to wear the splint for comfort as needed during day and night. While the patient was wearing the cock-up splint, only finger motion was permitted. Wrist motion was permitted when the cock-up splint was removed. |
|
| Non-removable Splint | Other | The plaster non-removable splint group received an occlusive petroleum gauze strip placed over the wound, followed by a 4X4 gauze, and a Webril cotton roll wrap (Covidien, Inc., Covidien, Ireland). A 4- inch, 15-layer thick plaster splint was placed across the volar wrist and molded to keep the wrist in approximately 20 degrees of extension allowing full digital range of motion (ROM). The splint was to be kept dry and not removed by the patient. |
|
| 10-14 days postoperatively |
| 6 weeks postoperatively |
| QuickDASH | The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition. Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time | 3 months postoperatively |
| QuickDASH | The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition. Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time | 6 months postoperatively |
| QuickDASH | The Quick Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure was designed in 1998 with the goal of providing a more accurate depiction of the everyday symptoms and handicaps exclusively experienced by a patient with an upper extremity musculoskeletal condition. Designed as a patient-completed questionnaire, the DASH Outcome Measure can be administered multiple times throughout patient care to measure changes in function and symptoms over time | 12 months postoperatively |
| Levine-Katz Functional Status Scale (FSS) | The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function. | 10-14 days postoperatively |
| Levine-Katz Functional Status Scale (FSS) | The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function. | 6 weeks postoperatively |
| Levine-Katz Functional Status Scale (FSS) | The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function. | 3 months postoperatively |
| Levine-Katz Functional Status Scale (FSS) | The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function. | 6 months postoperatively |
| Levine-Katz Functional Status Scale (FSS) | The Levine-Katz Functional Status Scale (FSS) has 8 questions self-rated on a 5-point scale on difficulty with 5 meaning so difficult patient is unable to perform the function. | 12 months postoperatively |
| Levine-Katz Symptom Severity Scale (SSS) | The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported. | 6 weeks postoperatively |
| Levine-Katz Symptom Severity Scale (SSS) | The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported. | 3 months postoperatively |
| Levine-Katz Symptom Severity Scale (SSS) | The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported. | 6 months postoperatively |
| Levine-Katz Symptom Severity Scale (SSS) | The Levine-Katz Symptom Severity Scale (SSS) assesses pain, weakness, and sensation with 11 questions the patient rates on a 5-point scale with 5 indicating the most difficult; the average score is reported. | 12 months postoperatively |
| Numerical Pain Rating Scale | Patients are asked to describe their level of pain intensity over the last 24 hours. The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively. The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity. | 6 weeks postoperatively |
| Numerical Pain Rating Scale | Patients are asked to describe their level of pain intensity over the last 24 hours. The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively. The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity. | 3 months postoperatively |
| Numerical Pain Rating Scale | Patients are asked to describe their level of pain intensity over the last 24 hours. The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively. The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity. | 6 months postoperatively |
| Numerical Pain Rating Scale | Patients are asked to describe their level of pain intensity over the last 24 hours. The pain scale anchor points 0 and 10 correspond to no pain and worst imaginable pain, respectively. The NPRS can be used multiple times throughout patient care, but has the greatest value in describing post-operative pain-related morbidity. | 12 months postoperatively |
| Grip Strength | Grip strength was taken with a Jamar Dynamometer in the 2nd hand position. | 6 weeks postoperatively |
| Grip Strength | Grip strength was taken with a Jamar Dynamometer in the 2nd hand position. | 3 months postoperatively |
| Grip Strength | Grip strength was taken with a Jamar Dynamometer in the 2nd hand position. | 6 months postoperatively |
| Grip Strength | Grip strength was taken with a Jamar Dynamometer in the 2nd hand position. | 12 months postoperatively |
| Wrist Flexion | 6 weeks postoperatively |
| Wrist Flexion | 3 months postoperatively |
| Wrist Flexion | 6 months postoperatively |
| Wrist Flexion | 12 months postoperatively |
| Wrist Extension | 10-14 days postoperatively |
| Wrist Extension | 6 weeks postoperatively |
| Wrist Extension | 3 months postoperatively |
| Wrist Extension | 6 months postoperatively |
| Wrist Extension | 12 months postoperatively |
| Lateral Pinch Strength | Lateral pinch strength was taken with a Preston Pinch Gauge. | 6 weeks postoperatively |
| Lateral Pinch Strength | Lateral pinch strength was taken with a Preston Pinch Gauge. | 3 months postoperatively |
| Lateral Pinch Strength | Lateral pinch strength was taken with a Preston Pinch Gauge. | 6 months postoperatively |
| Lateral Pinch Strength | Lateral pinch strength was taken with a Preston Pinch Gauge. | 12 months postoperatively |
| Complications | Complications were observed for and recorded throughout the study. | 6 weeks postoperatively |
| Complications | Complications were observed for and recorded throughout the study. | 3 months postoperatively |
| Complications | Complications were observed for and recorded throughout the study. | 6 months postoperatively |
| Complications | Complications were observed for and recorded throughout the study. | 12 months postoperatively |
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| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |