Carpal Tunnel SyndromeNCT04070924
Surgical Dressings After Endoscopic Carpal Tunnel Release
A study testing Bandaid and Conventional bulky soft tissue dressing in people with Carpal Tunnel Syndrome, run by Chris Grandizio.
Trial summary
Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper extremity. While carpal tunnel release (CTR), both open (OCTR) and endoscopic (ECTR), is safe and effective, there are questions regarding the use of postoperative dressings after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Bandaid and Conventional bulky soft tissue dressing
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to 20 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years of age or older
- Patients undergoing primary, elective, unilateral ECTR under monitored anesthesia care with local anesthesia.
Who cannot join
- Patients undergoing ECTR as part of a worker's compensation case
- Patients currently incarcerated
- Subject who cannot read and speak English
About this study
Official title: Surgical Dressings After Endoscopic Carpal Tunnel Release: A Randomized Controlled Trial
Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper extremity. While carpal tunnel release (CTR), both open (OCTR) and endoscopic (ECTR), is safe and effective, there are questions regarding the use of postoperative dressings after surgery. It is not currently known if dressing choices influence post-operative pain, function or patient satisfaction after ECTR. A less cumbersome dressing (bandaid) may allow patients to perform daily tasks with more ease after surgery. The purpose of this investigation is to compare postoperative pain scores and patient satisfaction after ECTR for patients treated with conventional post-operative bulky soft tissue dressings versus those treated with a bandaid after surgery. The hypothesis is that patients using a bandaid after surgery will have an easier time with functional tasks after surgery and that pain scores will not significantly differ between the two groups. Furthermore, this study aims to determine if there are differences in patient satisfaction, functional outcomes, complications, and unscheduled healthcare contact between these two groups. This will be a randomized, controlled investigation.
Read the detailed description
Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper extremity. While carpal tunnel release (CTR), both open (OCTR) and endoscopic (ECTR), is safe and effective, there are questions regarding the use of postoperative dressings after surgery. With recent attention to the opioid epidemic, there have been increasing efforts to reduce narcotic usage postoperatively while still controlling expected postoperative pain. Recent authors have found that many patients, particularly older patients, do not require any opioid analgesia after CTR with 47% of men and 36% of women consuming no narcotics after CTR (CHAPMAN). Furthermore, while splints have historically been used after surgery, their need has recently been questioned (LOGLI). It is not currently known if dressing choices influence post-operative pain, function or patient satisfaction after ECTR. A less cumbersome dressing (bandaid) may allow patients to perform daily tasks with more ease after surgery.
The purpose of this investigation is to compare postoperative pain scores and patient satisfaction after ECTR for patients treated with conventional post-operative bulky soft tissue dressings versus those treated with a bandaid after surgery. The hypothesis is that patients using a bandaid after surgery will have an easier time with functional tasks after surgery and that pain scores will not significantly differ between the two groups. Furthermore, this study aims to determine if there are differences in patient satisfaction, functional outcomes, complications, and unscheduled healthcare contact between these two groups. This will be a randomized, controlled investigation.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Bandaid, Conventional bulky soft tissue dressing
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BandaidOther
Bandaid dressing
Conventional bulky soft tissue dressingOther
Conventional bulky soft tissue dressing
| Study group | Role | What they receive |
|---|---|---|
| Conventional post-operative bulky soft tissue dressing | Active comparator | 1. Intraoperative: MAC-Local Anesthesia; Local anesthetic mixture will be distributed in both the subcutaneous tissue and within the carpal canal
2. Postoperative: Non-opioid medications only; Conventional post-operative bulky soft tissue dressing (Xeroform, 4x4s, Webril, Ace Wrap; Worn until first postoperative visit) Receives: Other: Conventional bulky soft tissue dressing |
| Bandaid post-operative dressing | Experimental | 1. Intraoperative: MAC-Local Anesthesia; Local anesthetic mixture will be distributed in both the subcutaneous tissue and within the carpal canal
2. Postoperative: Non-opioid medications only; Bandaid over incision (Patient given an edema glove to wear starting post-operative day 1; Dressing change be changed post-operative day 2 and as needed after that) Receives: Other: Bandaid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale Pain Score
best 0-10 worst; continuous scale to measure current pain level
Measured: 0-12 months
Secondary outcomes (12)
Boston Carpal Tunnel Questionnaire
ranges from 1 to 5, with a higher score indicating greater disability; -specific measure of self-reported symptom severity and functional status
Measured: 0-12 months
PROMIS Pain Interference
best 0-100 worst; measures the effects of a patient's pain on their daily activities and lifestyle
Measured: 0-12 months
PROMIS Self-Efficacy Manage Symptoms
best 0-100 worst; measures a patient's ability to cope with their symptoms related to the procedure
Measured: 0-12 months
PROMIS Upper Extremity
worst 0-100 best; measures physical function of upper extremities
Measured: 0-12 months
QuickDASH
best 0-100 worst; functional outcome score for disabilities of the arm, shoulder, and hand
Measured: 0-12 months
number of participants with unscheduled healthcare contact
unscheduled healthcare contact includes patient calls/messages, emergency room visits, or scheduled clinic visits
Measured: 0-12 months
morphine equivalents
morphine equivalents consumed for post-operative pain control
Measured: 0-12 months
number of participants with complications
complications after surgery including infection and delayed healing
Measured: 0-12 months
Satisfaction with overall outcome
11 point Likert scale; worst 0-10 best
Measured: 0-12 months
Satisfaction postoperative pain control
11 point Likert scale; worst 0-10 best
Measured: 0-12 months
Satisfaction with the dressing
11 point Likert scale; worst 0-10 best
Measured: 0-12 months
Grip Strength Measurement
Using Jamar Hand Dynamometer, in kilograms ranging from worst 0-90 best
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study startMar 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completion20 Mar 2024
Why it stopped: PI has chosen to prioritize other studies at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chris Grandizio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Chris Grandizio, Geisinger Clinic
- Investigators
- Christopher Grandizio, MD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04070924
- Sponsor's protocol ID
- 2019-0474
- Status last verified
- Apr 2024
- First submitted
- 24 Aug 2019
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Dressings After Endoscopic Carpal Tunnel Release: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04070924
- Acronym / sponsor ID
- 2019-0474
- Conditions
- Carpal Tunnel Syndrome
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has chosen to prioritize other studies at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chris GrandizioUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper extremity. While carpal tunnel release (CTR), both open (OCTR) and endoscopic (ECTR), is safe and effective, there are questions regarding the use of postoperative dressings after surgery. It is not currently known if dressing choices influence post-operative pain, function or patient satisfaction after ECTR. A less cumbersome dressing (bandaid) may allow patients to perform daily tasks with more ease after surgery. The purpose of this investigation is to compare postoperative pain scores and patient satisfaction after ECTR for patients treated with conventional post-operative bulky soft tissue dressings versus those treated with a bandaid after surgery. The hypothesis is that patients using a bandaid after surgery will have an easier time with functional tasks after surgery and that pain scores will not significantly differ between the two groups. Furthermore, this study aims to determine if there are differences in patient satisfaction, functional outcomes, complications, and unscheduled healthcare contact between these two groups. This will be a randomized, controlled investigation.
Detailed description
Carpal tunnel syndrome (CTS) is the most common compressive neuropathy in the upper extremity. While carpal tunnel release (CTR), both open (OCTR) and endoscopic (ECTR), is safe and effective, there are questions regarding the use of postoperative dressings after surgery. With recent attention to the opioid epidemic, there have been increasing efforts to reduce narcotic usage postoperatively while still controlling expected postoperative pain. Recent authors have found that many patients, particularly older patients, do not require any opioid analgesia after CTR with 47% of men and 36% of women consuming no narcotics after CTR (CHAPMAN). Furthermore, while splints have historically been used after surgery, their need has recently been questioned (LOGLI). It is not currently known if dressing choices influence post-operative pain, function or patient satisfaction after ECTR. A less cumbersome dressing (bandaid) may allow patients to perform daily tasks with more ease after surgery.
The purpose of this investigation is to compare postoperative pain scores and patient satisfaction after ECTR for patients treated with conventional post-operative bulky soft tissue dressings versus those treated with a bandaid after surgery. The hypothesis is that patients using a bandaid after surgery will have an easier time with functional tasks after surgery and that pain scores will not significantly differ between the two groups. Furthermore, this study aims to determine if there are differences in patient satisfaction, functional outcomes, complications, and unscheduled healthcare contact between these two groups. This will be a randomized, controlled investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional post-operative bulky soft tissue dressing | Active comparator | Other: Conventional bulky soft tissue dressing1. Intraoperative: MAC-Local Anesthesia; Local anesthetic mixture will be distributed in both the subcutaneous tissue and within the carpal canal 2. Postoperative: Non-opioid medications only; Conventional post-operative bulky soft tissue dressing (Xeroform, 4x4s, Webril, Ace Wrap; Worn until first postoperative visit) |
| Bandaid post-operative dressing | Experimental | Other: Bandaid1. Intraoperative: MAC-Local Anesthesia; Local anesthetic mixture will be distributed in both the subcutaneous tissue and within the carpal canal 2. Postoperative: Non-opioid medications only; Bandaid over incision (Patient given an edema glove to wear starting post-operative day 1; Dressing change be changed post-operative day 2 and as needed after that) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years of age or older
- Patients undergoing primary, elective, unilateral ECTR under monitored anesthesia care with local anesthesia.
Key exclusion criteria (3 listed)
- Patients undergoing ECTR as part of a worker's compensation case
- Patients currently incarcerated
- Subject who cannot read and speak English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BandaidBandaid dressing | Other | Bandaid post-operative dressing |
| Conventional bulky soft tissue dressingConventional bulky soft tissue dressing | Other | Conventional post-operative bulky soft tissue dressing |
Primary outcome
Visual Analog Scale Pain Score
Time frame: 0-12 months
best 0-10 worst; continuous scale to measure current pain level
12 secondary outcomes
Boston Carpal Tunnel Questionnaire
Time frame: 0-12 months
PROMIS Pain Interference
Time frame: 0-12 months
PROMIS Self-Efficacy Manage Symptoms
Time frame: 0-12 months
PROMIS Upper Extremity
Time frame: 0-12 months
QuickDASH
Time frame: 0-12 months
number of participants with unscheduled healthcare contact
Time frame: 0-12 months
morphine equivalents
Time frame: 0-12 months
number of participants with complications
Time frame: 0-12 months
Satisfaction with overall outcome
Time frame: 0-12 months
Satisfaction postoperative pain control
Time frame: 0-12 months
Satisfaction with the dressing
Time frame: 0-12 months
Grip Strength Measurement
Time frame: 0-12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2024.
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Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
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Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
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Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
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Not yet recruiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Grandizio, MD principal investigator
Geisinger Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Bandaid and Conventional bulky soft tissue dressing in people with Carpal Tunnel Syndrome, run by Chris Grandizio.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale Pain Score (time frame: 0-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2024.