Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap

• ClinicalTrials.gov Identifier: NCT01684839
• Recruitment Status: Completed
• First Posted: September 13, 2012
• Results First Posted: October 23, 2013
• Last Update Posted: October 23, 2013
• Sponsor: The Second Hospital of Tangshan
• Collaborators: Chinese PLA General Hospital; The Second Hospital of Qinhuangdao
• Information provided by (Responsible Party): The Second Hospital of Tangshan

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Painful Digital Neuroma
• Intervention: Device: Pedicled nerve flap
• Enrollment: 9

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.

Arm/Group Title	New Surgical Treatment
Arm/Group Description	Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
Period Title: Overall Study
Started	9
Completed	9
Not Completed	0

Baseline Characteristics

Arm/Group Title		New Surgical Treatment
Arm/Group Description		Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
Overall Number of Baseline Participants		9
Baseline Analysis Population Description		[Not Specified]
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants
	<=18 years	0 0.0%
	Between 18 and 65 years	9 100.0%
	>=65 years	0 0.0%
Age Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	9 participants
		31.4 (7.3)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants
	Female	2 22.2%
	Male	7 77.8%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
China	Number Analyzed	9 participants
		9

Outcome Measures

1. Primary Outcome

Title	Static 2-point Discrimination Test
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	New Surgical Treatment
Arm/Group Description:	Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
Overall Number of Participants Analyzed	9
Mean (Standard Deviation); Unit of Measure: mm
	7.3 (2.0)

2. Secondary Outcome

Title	Cold Intolerance Severity Score (CISS) Questionnaire
Description	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

Outcome Measure Data Not Reported

3. Other Pre-specified Outcome

Title	Tinel's Sign
Description	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

Outcome Measure Data Not Reported

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	New Surgical Treatment
Arm/Group Description	Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
All-Cause Mortality
	New Surgical Treatment
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	New Surgical Treatment
	Affected / at Risk (%)
Total	0/9 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	New Surgical Treatment
	Affected / at Risk (%)
Total	0/9 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Chao Chen
• Organization: The Second Hospital of Tangshan
• Phone: 86-13700350471
• EMail: ts_chenchao@163.com

Publications of Results:

Herndon JH, Eaton RG, Littler JW. Management of painful neuromas in the hand. J Bone Joint Surg Am. 1976 Apr;58(3):369-73.

Tupper 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.

• Responsible Party: The Second Hospital of Tangshan
• ClinicalTrials.gov Identifier: NCT01684839
• Other Study ID Numbers: HB-TS-120127; TSCHEN411206 ( Other Identifier: Ethics Committee of HeBei Province )
• First Submitted: September 11, 2012
• First Posted: September 13, 2012
• Results First Submitted: June 3, 2013
• Results First Posted: October 23, 2013
• Last Update Posted: October 23, 2013