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Completed

NCT Number: NCT02885701

Splinting After Mini-Open Carpal Tunnel Release

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.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients were required to have failed conservative treatment for symptomatic, isolated, nerve conduction study positive CTS.

Exclusion criteria

  • Exclusion criteria omitted patients who presented with acute onset CTS, concomitant peripheral neuropathy, metabolic disease, postoperative recurring CTS, or who required another operative procedure during carpal tunnel release.

Treatment and study plan

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.

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.

Primary outcomes

  1. QuickDASH

    Time frame: 10-14 days postoperatively

    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

  2. Levine-Katz Symptom Severity Scale (SSS)

    Time frame: 10-14 days postoperatively

    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. Numerical Pain Rating Scale

    Time frame: 10-14 days postoperatively

    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.

  4. Grip Strength

    Time frame: 10-14 days postoperatively

    Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.

  5. Wrist Flexion

    Time frame: 10-14 days postoperatively

  6. Lateral Pinch Strength

    Time frame: 10-14 days postoperatively

    Lateral pinch strength was taken with a Preston Pinch Gauge.

Secondary outcomes

  1. Demographic Information

    Time frame: Preoperatively

    Sex, age, BMI, Smoking Status, Hand Dominance, Workers' Compensation Status

  2. Complications

    Time frame: 10-14 days postoperatively

    Complications were observed for and recorded throughout the study.

Other outcomes

  1. QuickDASH

    Time frame: 6 weeks postoperatively

    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

  2. QuickDASH

    Time frame: 3 months postoperatively

    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. QuickDASH

    Time frame: 6 months postoperatively

    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

  4. QuickDASH

    Time frame: 12 months postoperatively

    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

  5. Levine-Katz Functional Status Scale (FSS)

    Time frame: 10-14 days postoperatively

    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. Levine-Katz Functional Status Scale (FSS)

    Time frame: 6 weeks postoperatively

    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.

  7. Levine-Katz Functional Status Scale (FSS)

    Time frame: 3 months postoperatively

    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.

  8. Levine-Katz Functional Status Scale (FSS)

    Time frame: 6 months postoperatively

    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.

  9. Levine-Katz Functional Status Scale (FSS)

    Time frame: 12 months postoperatively

    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. Levine-Katz Symptom Severity Scale (SSS)

    Time frame: 6 weeks postoperatively

    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.

  11. Levine-Katz Symptom Severity Scale (SSS)

    Time frame: 3 months postoperatively

    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. Levine-Katz Symptom Severity Scale (SSS)

    Time frame: 6 months postoperatively

    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.

  13. Levine-Katz Symptom Severity Scale (SSS)

    Time frame: 12 months postoperatively

    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.

  14. Numerical Pain Rating Scale

    Time frame: 6 weeks postoperatively

    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.

  15. Numerical Pain Rating Scale

    Time frame: 3 months postoperatively

    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.

  16. Numerical Pain Rating Scale

    Time frame: 6 months postoperatively

    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.

  17. Numerical Pain Rating Scale

    Time frame: 12 months postoperatively

    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.

  18. Grip Strength

    Time frame: 6 weeks postoperatively

    Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.

  19. Grip Strength

    Time frame: 3 months postoperatively

    Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.

  20. Grip Strength

    Time frame: 6 months postoperatively

    Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.

  21. Grip Strength

    Time frame: 12 months postoperatively

    Grip strength was taken with a Jamar Dynamometer in the 2nd hand position.

  22. Wrist Flexion

    Time frame: 6 weeks postoperatively

  23. Wrist Flexion

    Time frame: 3 months postoperatively

  24. Wrist Flexion

    Time frame: 6 months postoperatively

  25. Wrist Flexion

    Time frame: 12 months postoperatively

  26. Wrist Extension

    Time frame: 10-14 days postoperatively

  27. Wrist Extension

    Time frame: 6 weeks postoperatively

  28. Wrist Extension

    Time frame: 3 months postoperatively

  29. Wrist Extension

    Time frame: 6 months postoperatively

  30. Wrist Extension

    Time frame: 12 months postoperatively

  31. Lateral Pinch Strength

    Time frame: 6 weeks postoperatively

    Lateral pinch strength was taken with a Preston Pinch Gauge.

  32. Lateral Pinch Strength

    Time frame: 3 months postoperatively

    Lateral pinch strength was taken with a Preston Pinch Gauge.

  33. Lateral Pinch Strength

    Time frame: 6 months postoperatively

    Lateral pinch strength was taken with a Preston Pinch Gauge.

  34. Lateral Pinch Strength

    Time frame: 12 months postoperatively

    Lateral pinch strength was taken with a Preston Pinch Gauge.

  35. Complications

    Time frame: 6 weeks postoperatively

    Complications were observed for and recorded throughout the study.

  36. Complications

    Time frame: 3 months postoperatively

    Complications were observed for and recorded throughout the study.

  37. Complications

    Time frame: 6 months postoperatively

    Complications were observed for and recorded throughout the study.

  38. Complications

    Time frame: 12 months postoperatively

    Complications were observed for and recorded throughout the study.

Sponsors and collaborators

Lead sponsor

Anthony L. Logli

Other

Collaborators

  • University of Illinois at Chicago

Registry information

Official study title

A Prospective, Randomized Controlled Study of Splinting After Mini-Open Carpal Tunnel Release

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 31, 2016
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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