Carpal Tunnel SyndromePhase 4NCT04017390
The Effect of Theraworx Foam in Carpal Tunnel Syndrome
A Phase 4 study testing Theraworx Foam and Theraworx Foam and night splint in people with Carpal Tunnel Syndrome, run by John Fowler at 2 sites in United States.
Trial summary
Participation will be for approximately 21 days (3 study visits,1 week apart with allowance for scheduling conflicts). A topical (or placebo) foam alone or with a splint will be used. Demographic and symptom information will be obtained. 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?
- Theraworx Foam and Theraworx Foam and night splint
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2022to 3 Jan 2022
- Phase
- Phase 4
- 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
- Diagnosis of Carpal Tunnel Syndrome
- Age 18 years or older
- Interest in non-surgical treatment of carpal tunnel syndrome
Who cannot join
- Prior carpal tunnel release
- Non-English speaking
- Skin lesions/rashes on hand being treated
- Current use of topical anti-inflammatory medication
- Other diagnoses that would impact results (determined by PI)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Kaufmann Building
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The Effect of Theraworx Foam on the Cross-sectional Area of the Median Nerve in Patients With Carpal Tunnel Syndrome
Participation will be for approximately 21 days (3 study visits,1 week apart with allowance for scheduling conflicts). A topical (or placebo) foam alone or with a splint will be used. Demographic and symptom information will be obtained. At each visit 3 questionnaires (BCT, CTS-6, and DASH) will be completed and an ultrasound of the wrist (median nerve) will be done to document any change in symptoms and/or in the size of the nerve. Random assignment will be to one of 4 groups: foam or placebo with or without a night splint. We will provide instruction on how to apply the foam, whether or not and how to wear the splint, and return visits.
Read the detailed description
The PI will identify potential participants from his clinical practice. Evaluation of symptoms will be by exam, questionnaires, and ultrasound of the median nerve. These will document baseline/change in the size of the median nerve and improvement in function/symptoms. The questionnaires are 1.) Boston Carpal Tunnel (BCT). 2.) Carpal Tunnel-6 (CTS-6); and 3.) Disabilities of the Arm, Shoulder and Hand (DASH). These will be used to document a baseline and change (if any) in nerve size and hand symptoms, over a 2 week time frame, that are common in carpal tunnel syndrome (including numbness, pain, tingling, and/or decreased function).
- The Boston Carpal Tunnel is a 19 question tool that assesses function (8 items) and symptom severity (11 items). Score range is from 0 to 95 with a high number indicating more severe/worsening symptoms and lower number less severe/improving symptoms.
- The CTS-6 is a six item tool that combines reported symptoms with a physical exam of the hand. Scores range from 0 to 26 with a higher score reflecting increased severity.
- The DASH is a 30 item tool with each scored 1 to 5. Scores can range from 0 to 150 and the higher the score the worse the symptoms/disability.
Treatment groups are as follows:1.) Theraworx foam alone; 2.) Theraworx foam with night time splint; 3.) Placebo foam alone; 4.) Placebo foam with night time splint. The active ingredient in Theraworx foam is magnesium sulfate and will not be in the placebo foam. Instructions on how to apply the foam, whether or not and how to wear the splint, and return visits will be provided. If in a group that requires night time splinting, the subject must wear the splint only at night and for a minimum of 8 hours.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Theraworx Foam, Placebo Foam, Theraworx Foam and night splint, Placebo Foam and night time splint
- Keywords
- Hand Pain/Numbness
- 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.
Theraworx FoamDrug
Apply Theraworx Foam alone
Placebo FoamDrug
Apply placebo foam alone
Theraworx Foam and night splintOther
Apply Theraworx Foam and night time splint
Placebo Foam and night time splintOther
Apply placebo foam and night time splint
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Theraworx Foam alone | Experimental | Theraworx foam only Receives: Drug: Theraworx Foam |
| Arm 2: Theraworx Foam and night splint | Active comparator | Theraworx foam with a night time splint Receives: Other: Theraworx Foam and night splint |
| Arm 3: Placebo foam alone | Placebo comparator | Placebo foam alone Receives: Drug: Placebo Foam |
| Arm 4: Placebo foam and night splint | Other | Placebo foam with a night time splint Receives: Other: Placebo Foam and night time splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement (decrease) in size of median nerve at the wrist
Decrease in cross sectional area of median nerve as determined by ultrasound exam
Measured: 2 weeks
Secondary outcomes (3)
Improvement (decrease) in Boston Carpal Tunnel Questionnaire (BCTQ)
Improvement in PRO as indicated by a decreased score on questionnaire indicating improved in function and decreased symptoms
Measured: 2 weeks
Improvement (decrease) in Carpal Tunnel 6 (CTS-6) score
Improvement in patient reported outcome (PRO) as determined by a lower CTS-6 score number than at baseline. Score ranges from 26 (worst) to 0 (best)
Measured: 2 weeks
Improvement (decrease) in Disabilities of Arm, Shoulder, Hand (DASH) score
Improvement in patient reported outcome (PRO) as determined by decreased DASH score from baseline. Score ranges from 150 (worst) to 30 (best)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Jan 2022 (estimated)
- Primary completion3 Jan 2022
- Study completion3 Jan 2022
Why it stopped: Lack of Funding from Sponsor
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization will be to one of four groups: 1.) Theraworx foam alone; 2.) Theraworx foam plus night time splint; 3.) Placebo foam alone; 4.) Placebo foam plus night time splint. Theraworx Foam is an FDA registered (NDC 61594-001-02) topical agent (active ingredient: magnesium sulfate superficia 6 x 0.05% HPUS) for muscle cramp and spasm relief.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- John Fowler
- Sponsor type
- University, hospital or other
- Collaborators
- Avadim Technologies, Inc.
- Responsible party
- Sponsor-investigator, John Fowler, University of Pittsburgh
- Investigators
- John Fowler, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017390
- Sponsor's protocol ID
- STUDY19040180
- Status last verified
- Jan 2022
- First submitted
- 4 Jul 2019
- Last updated
- 21 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The ultrasound measurements and PRO questionnaire scores will be shared with the sponsor Avadim Technologies at a minimum of approximately 60 day intervals throughout the study (1 year) and at the discretion of the PI. In addition, final data will be provided within 12 months of completion of last participant
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Theraworx Foam on the Cross-sectional Area of the Median Nerve in Patients With Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT04017390
- Acronym / sponsor ID
- STUDY19040180
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Hand Pain/Numbness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of Funding from Sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- John FowlerUniversity, hospital or other
- Collaborators
- Avadim Technologies, Inc.
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 3 Jan 2022 (actual)
- First posted
- 12 Jul 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.
Participation will be for approximately 21 days (3 study visits,1 week apart with allowance for scheduling conflicts). A topical (or placebo) foam alone or with a splint will be used. Demographic and symptom information will be obtained. At each visit 3 questionnaires (BCT, CTS-6, and DASH) will be completed and an ultrasound of the wrist (median nerve) will be done to document any change in symptoms and/or in the size of the nerve. Random assignment will be to one of 4 groups: foam or placebo with or without a night splint. We will provide instruction on how to apply the foam, whether or not and how to wear the splint, and return visits.
Detailed description
The PI will identify potential participants from his clinical practice. Evaluation of symptoms will be by exam, questionnaires, and ultrasound of the median nerve. These will document baseline/change in the size of the median nerve and improvement in function/symptoms. The questionnaires are 1.) Boston Carpal Tunnel (BCT). 2.) Carpal Tunnel-6 (CTS-6); and 3.) Disabilities of the Arm, Shoulder and Hand (DASH). These will be used to document a baseline and change (if any) in nerve size and hand symptoms, over a 2 week time frame, that are common in carpal tunnel syndrome (including numbness, pain, tingling, and/or decreased function).
- The Boston Carpal Tunnel is a 19 question tool that assesses function (8 items) and symptom severity (11 items). Score range is from 0 to 95 with a high number indicating more severe/worsening symptoms and lower number less severe/improving symptoms.
- The CTS-6 is a six item tool that combines reported symptoms with a physical exam of the hand. Scores range from 0 to 26 with a higher score reflecting increased severity.
- The DASH is a 30 item tool with each scored 1 to 5. Scores can range from 0 to 150 and the higher the score the worse the symptoms/disability.
Treatment groups are as follows:1.) Theraworx foam alone; 2.) Theraworx foam with night time splint; 3.) Placebo foam alone; 4.) Placebo foam with night time splint. The active ingredient in Theraworx foam is magnesium sulfate and will not be in the placebo foam. Instructions on how to apply the foam, whether or not and how to wear the splint, and return visits will be provided. If in a group that requires night time splinting, the subject must wear the splint only at night and for a minimum of 8 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Randomization will be to one of four groups: 1.) Theraworx foam alone; 2.) Theraworx foam plus night time splint; 3.) Placebo foam alone; 4.) Placebo foam plus night time splint. Theraworx Foam is an FDA registered (NDC 61594-001-02) topical agent (active ingredient: magnesium sulfate superficia 6 x 0.05% HPUS) for muscle cramp and spasm relief.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Theraworx Foam alone | Experimental | Drug: Theraworx FoamTheraworx foam only |
| Arm 2: Theraworx Foam and night splint | Active comparator | Other: Theraworx Foam and night splintTheraworx foam with a night time splint |
| Arm 3: Placebo foam alone | Placebo comparator | Drug: Placebo FoamPlacebo foam alone |
| Arm 4: Placebo foam and night splint | Other | Other: Placebo Foam and night time splintPlacebo foam with a night time splint |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of Carpal Tunnel Syndrome
- Age 18 years or older
- Interest in non-surgical treatment of carpal tunnel syndrome
Key exclusion criteria (5 listed)
- Prior carpal tunnel release
- Non-English speaking
- Skin lesions/rashes on hand being treated
- Current use of topical anti-inflammatory medication
- Other diagnoses that would impact results (determined by PI)
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 |
|---|---|---|
| Theraworx FoamApply Theraworx Foam alone | Drug | Arm 1: Theraworx Foam alone |
| Placebo FoamApply placebo foam alone | Drug | Arm 3: Placebo foam alone |
| Theraworx Foam and night splintApply Theraworx Foam and night time splint | Other | Arm 2: Theraworx Foam and night splint |
| Placebo Foam and night time splintApply placebo foam and night time splint | Other | Arm 4: Placebo foam and night splint |
Primary outcome
Improvement (decrease) in size of median nerve at the wrist
Time frame: 2 weeks
Decrease in cross sectional area of median nerve as determined by ultrasound exam
3 secondary outcomes
Improvement (decrease) in Boston Carpal Tunnel Questionnaire (BCTQ)
Time frame: 2 weeks
Improvement (decrease) in Carpal Tunnel 6 (CTS-6) score
Time frame: 2 weeks
Improvement (decrease) in Disabilities of Arm, Shoulder, Hand (DASH) score
Time frame: 2 weeks
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 21 Jan 2022.
- Individual participant dataSharing planned: Yes. The ultrasound measurements and PRO questionnaire scores will be shared with the sponsor Avadim Technologies at a minimum of approximately 60 day intervals throughout the study (1 year) and at the discretion of the PI. In addition, final data will be provided within 12 months of completion of last participant
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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.
John Fowler, MD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Theraworx Foam and Theraworx Foam and night splint in people with Carpal Tunnel Syndrome, run by John Fowler at 2 sites in United States.
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 3 inclusion and 5 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 21 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Improvement (decrease) in size of median nerve at the wrist (time frame: 2 weeks). 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 21 Jan 2022.