Painful Digital NeuromaNCT01684839
Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap
A study testing Pedicled nerve flap in people with Painful Digital Neuroma, run by The Second Hospital of Tangshan at 1 site in China.
Trial summary
Neuroma excision and digital nerve reconstruction remain the best option for the treatment of Painful Digital Neuroma (PDN). When the distal nerve end is preserved, conventional nonvascularized nerve grafting is the primary option to bridge the defect. Read more about this study
- Who is it for?
- Ages 15 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Painful Digital Neuroma
- What is being tested?
- Pedicled nerve flap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- May 2007to Mar 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- a patient with PDN in a scarred wound bed or poor coverage
- a PDN located between the middle of the distal phalanx and the palmar digital crease
- a defect of the digital nerve after neuroma resection equal to or less than 3 cm in length
Who cannot join
- a PDN in healthy soft tissue
- a digital nerve defect longer than 3 cm
- injury to the course of the pedicle or the donor nerve
- a thumb neuroma
Trial locations and contacts
1 site in 1 country.
About this study
Neuroma excision and digital nerve reconstruction remain the best option for the treatment of Painful Digital Neuroma (PDN). When the distal nerve end is preserved, conventional nonvascularized nerve grafting is the primary option to bridge the defect. The investigators hypothesize the pedicled nerve flap taken from the dorsal branch of the homolateral digital nerve is better than conventional methods for reconstruction of the digital nerve defect after painful neuroma resection.
This study reports treatment of painful digital neuroma using a pedicled nerve flap taken from the dorsal branch of homolateral digital nerve. From May 2007 to March 2010, the patients had previous nerve injuries with or without nerve repair. The mechanisms of injury include sharp cut, avulsion and crush. The defects were between the middle of the distal phalanx and the palmar digital crease.
Read the detailed description
Our selection criteria in this study included a patient with PDN in a scarred wound bed or poor coverage, a PDN located between the middle of the distal phalanx and the palmar digital crease, and a defect of the digital nerve after neuroma resection equal to or less than 3 cm in length. The exclusion criteria included a PDN in healthy soft tissue, a digital nerve defect longer than 3 cm, injury to the course of the pedicle or the donor nerve, and a thumb neuroma. A finger with a small distal end of the digital nerve was also excluded, because neurorrhaphy was extremely difficult in this situation.
- Conditions
- Painful Digital Neuroma
- Being tested
- Pedicled nerve flap
- Keywords
- Painful digital neuroma, nerve defect, dorsal branch of the digital nerve, digital nerve, pedicled nerve flap, Pain Disorder Associated with Psychological and Physical Factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedicled nerve flapDevice
Also called Surgical flap, Island flap
This nerve flap is a vascularized nerve graft
| Study group | Role | What they receive |
|---|---|---|
| new surgical treatment | Other | Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve. Receives: Device: Pedicled nerve flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Static 2-point Discrimination Test
The Static 2-point Discrimination Test determined the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm). The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side). Each area was tested 3 times with a discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and consider this normal. The measurements were performed at a single time point at the final follow up.
Measured: 20-26 months postoperatively
Secondary outcomes (1)
Cold Intolerance Severity Score (CISS) Questionnaire
The maximum score was 100 and was grouped into 4 ranges (0-25; 26-50; 51-75; and 76-100), corresponding to mild, moderate, severe, and extreme severity, respectively.
Measured: 20-26 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startMay 2007
- Primary completionMar 2010
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Painful Digital NeuromaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Tangshan
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, The Second Hospital of Qinhuangdao
- Responsible party
- Sponsor
- Investigators
- Gang Zhao, MD., Study chair, The Second Hospital of Tangshan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684839
- Sponsor's protocol ID
- HB-TS-120127
- Other IDs
- TSCHEN411206
- Status last verified
- Jun 2012
- First submitted
- 11 Sep 2012
- Last updated
- 15 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Herndon JH, Eaton RG, Littler JW. Management of painful neuromas in the hand. J Bone Joint Surg Am. 1976 Apr;58(3):369-73.
PubMed 1262369Tupper JW, Booth DM. Treatment of painful neuromas of sensory nerves in the hand: a comparison of traditional and newer methods. J Hand Surg Am. 1976 Sep;1(2):144-51. doi: 10.1016/s0363-5023(76)80008-1.
PubMed 1032972
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap
- ClinicalTrials.gov ID
- NCT01684839
- Acronym / sponsor ID
- HB-TS-120127
- Conditions
- Painful Digital Neuroma
- Keywords
- Painful digital neuroma, nerve defect, dorsal branch of the digital nerve, digital nerve, pedicled nerve flap, Pain Disorder Associated with Psychological and Physical Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The Second Hospital of TangshanUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, The Second Hospital of Qinhuangdao
- Study start
- May 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 13 Sep 2012 (estimated)
- Results
- Posted 23 Oct 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuroma excision and digital nerve reconstruction remain the best option for the treatment of Painful Digital Neuroma (PDN). When the distal nerve end is preserved, conventional nonvascularized nerve grafting is the primary option to bridge the defect. The investigators hypothesize the pedicled nerve flap taken from the dorsal branch of the homolateral digital nerve is better than conventional methods for reconstruction of the digital nerve defect after painful neuroma resection.
This study reports treatment of painful digital neuroma using a pedicled nerve flap taken from the dorsal branch of homolateral digital nerve. From May 2007 to March 2010, the patients had previous nerve injuries with or without nerve repair. The mechanisms of injury include sharp cut, avulsion and crush. The defects were between the middle of the distal phalanx and the palmar digital crease.
Detailed description
Our selection criteria in this study included a patient with PDN in a scarred wound bed or poor coverage, a PDN located between the middle of the distal phalanx and the palmar digital crease, and a defect of the digital nerve after neuroma resection equal to or less than 3 cm in length. The exclusion criteria included a PDN in healthy soft tissue, a digital nerve defect longer than 3 cm, injury to the course of the pedicle or the donor nerve, and a thumb neuroma. A finger with a small distal end of the digital nerve was also excluded, because neurorrhaphy was extremely difficult in this situation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| new surgical treatment | Other | Device: Pedicled nerve flapTreatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve. |
Who may qualify
- Ages
- 15 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- a patient with PDN in a scarred wound bed or poor coverage
- a PDN located between the middle of the distal phalanx and the palmar digital crease
- a defect of the digital nerve after neuroma resection equal to or less than 3 cm in length
Key exclusion criteria (4 listed)
- a PDN in healthy soft tissue
- a digital nerve defect longer than 3 cm
- injury to the course of the pedicle or the donor nerve
- a thumb neuroma
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 |
|---|---|---|
| Pedicled nerve flapAlso: Surgical flap, Island flapThis nerve flap is a vascularized nerve graft | Device | new surgical treatment |
Primary outcome
Static 2-point Discrimination Test
Time frame: 20-26 months postoperatively
The Static 2-point Discrimination Test determined the minimal distance at which a subject can sense the presence of two needles. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm). The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side). Each area was tested 3 times with a discriminator (Ali Med, Dedham, MA). Two out of 3 correct answers were considered proof of perception before proceeding to another lower value. We stopped at 4mm as a limit of 2PD and consider this normal. The measurements were performed at a single time point at the final follow up.
1 secondary outcome
Cold Intolerance Severity Score (CISS) Questionnaire
Time frame: 20-26 months postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 1262369Herndon JH, Eaton RG, Littler JW. Management of painful neuromas in the hand. J Bone Joint Surg Am. 1976 Apr;58(3):369-73.
- Results publication: PubMed 1032972Tupper JW, Booth DM. Treatment of painful neuromas of sensory nerves in the hand: a comparison of traditional and newer methods. J Hand Surg Am. 1976 Sep;1(2):144-51. doi: 10.1016/s0363-5023(76)80008-1.
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Neuroma
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.
Gang Zhao, MD. study chair
The Second Hospital of Tangshan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedicled nerve flap in people with Painful Digital Neuroma, run by The Second Hospital of Tangshan at 1 site in China.
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 4 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: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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. 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?
Yes. Results are posted in the registry (first posted 23 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Static 2-point Discrimination Test (time frame: 20-26 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01684839, which also lists 2 linked publications.
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 15 Feb 2024.