Mean change in static 2-Point Discrimination between baseline and 12 months

Number of subjects

Percent Change from Baseline of Moving 2-Point Discriminations at Month 12

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Percent Change from Baseline of Semmes-Weinstein Monofilament Assessment at Month 12

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Summary of Disability of the Arm, Shoulder, and Hand (DASH) scores (Core Module) at Month 12

The Disabilities of the Arm, Shoulder and Hand (DASH) core module questionnaire is a 30-item questionnaire includes 21 physical function items, 6 symptom items, and 3 social/role function items. It is a patient reported questionnaire used to assess physical function and severity of symptoms in patients with musculoskeletal disorders of the upper limb. Each of the items in the DASH use a 5-point Likert scale to assess the corresponding severity or functional parameter. The outcome measure is scored based on the formula ([sum of n responses)/ - 30 (minimum score]/1.2 (range of scores ÷100), where n represents the number of completed items. Computed scores range from 0 (no disability) to 100 (most severe disability).

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Summary of Disability of the Arm, Shoulder, and Hand (DASH) scores (Work Module) at Month 12

The Disabilities of the Arm, Shoulder and Hand (DASH) Work Module questionnaire is a 4-item questionnaire used to identify the job-specific difficulties that workers might experience but which may not affect their activities of daily living. It is a patient reported questionnaire used to assess the impact that musculoskeletal disorders of the upper limb have on a patient's ability to perform work-related tasks. Each of the items in the DASH Work Module use a 5-point Likert scale to assess the corresponding severity or functional parameter. The outcome measure is scored based on the formula ([sum of n responses)/ - 4 (minimum score]/0.16 (range of scores ÷100), where n represents the number of completed items. Computed scores range from 0 (no difficulty) to 100 (most severe difficulty).

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Summary of Disability of the Arm, Shoulder, and Hand (DASH) scores (Sports/Performing Arts Module) at month 12

The Disabilities of the Arm, Shoulder and Hand (DASH) Sports/Performing Arts Module questionnaire is a 4-item questionnaire used to identify the specific difficulties that professional athletes/performing artists might experience but which may not affect their activities of daily living. It is a patient reported questionnaire used to assess the impact that musculoskeletal disorders of the upper limb have on a patient's ability to perform sports or play a musical instrument. Each of the items in the DASH use a 5-point Likert scale to assess the corresponding severity or functional parameter. The outcome measure is scored based on the formula ([sum of n responses)/ - 4 (minimum score]/0.16 (range of scores ÷100), where n represents the number of completed items. Computed scores range from 0 (no difficulty) to 100 (most severe difficulty).

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Summary of Pain Assessment using Visual Analogue Scale (VAS) at Month 12

The Visual Analog Scale (VAS) For Pain is a patient reported outcomes scale whereby the patient indicates his/her current pain level by making a mark on a continuous horizontal 10 centimeter (100 millimeter) line. The distance from the 0 millimeter to the patient's mark corresponds to the amount of pain the subject is currently experiencing. VAS for Pain data are recorded as the number of millimeters from the left of the line to the patients mark across the range of 0-100 millimeters, with 0 millimeter representing no pain and 100 millimeters representing "the worst pain imaginable".

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Summary of Thermal Discretion at Month 12 as determined by the Investigator.

Thermal discretion was assessed by applying a hot and/or cold object to the patient's affected digit. Thermal discretion was reported as either present ("Yes") or not present ("No").

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Summary of Protective Sensation by Month 12

Semmes-Weinstein Monofilament (SWMF) assessment of protective sensation. The gauge of the monofilaments range from 2.83 (normal) to 6.65 (deep pressure sensation only). Protective Sensation Present (SWMF score of 3.61 or better), Protective Sensation Diminished (SWMF score of 4.31-3.84), Protective Sensation Absent (SWMF score of 4.56 or greater).

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.

Summary of Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months

Patients were assessed for functional recovery of sensation on a scale from S0 to S4 with S0 representing absence of sensibility, S1 representing recovery of deep cutaneous pain sensibility, S2 representing the return of some degree of superficial cutaneous pain and tactile sensibility, S3 representing return of superficial cutaneous pain and tactile sensibility, S3+ representing return of sensibility as in S3 and some recovery of 2-point discrimination (a 2-PD score between 7-15mm), and S4 representing complete recovery of normal sensation as assessed by 2-point discrimination (score between 2-6mm).

Modified Intent-to-Treat Population (mITT): All participants who were randomized, received one of the study treatments, and completed at least the 3 month follow-up visit.