Painful Digital Neuroma
Conditions
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
Brief 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. 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.
Interventions
DEVICEPedicled nerve flap
This nerve flap is a vascularized nerve graft
Sponsors
Chinese PLA General Hospital
The Second Hospital of Qinhuangdao
The Second Hospital of Tangshan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Static 2-point Discrimination Test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cold Intolerance Severity Score (CISS) Questionnaire | 20-26 months postoperatively | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Tinel's Sign | 20-26 months postoperatively | Tinel's sign was graded as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma |
Countries
China
Participant flow
Recruitment details
Nine patients were included in the study. These patients were treated with the pedicled nerve flap. The type of location was medical clinic.
Pre-assignment details
No wash out, run-in or transition happened in the study.
Participants by arm
| Arm | Count |
|---|---|
| New Surgical Treatment Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | New Surgical Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age, Continuous | 31.4 years STANDARD_DEVIATION 7.3 |
| Region of Enrollment China | 9 participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
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.
Time frame: 20-26 months postoperatively
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| New Surgical Treatment | Static 2-point Discrimination Test | 7.3 mm | Standard Deviation 2 |
Secondary
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.
Time frame: 20-26 months postoperatively
Other Pre-specified
Tinel's Sign
Tinel's sign was graded as the following: grade 1=none; grade 2=mild, slight tingle; grade 3=moderate, very uncomfortable; and grade 4=severe, patient unable to use hand because of any stimulation of the neuroma
Time frame: 20-26 months postoperatively