A clinical trial to develop new ways of measuring nerve healing after injury

Novel Outcome measures in Peripheral Nerve injury (OPEN study)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17886637

Enrollment

Registered

2019-05-21

Start date

2019-05-01

Completion date

Unknown

Last updated

2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral nerve injury Injury, Occupational Diseases, Poisoning Injury of nerve(s) of unspecified body region

Interventions

There are no study ‘interventions’ as such, just additional imaging measurements. These are as follows: Date of surgery (or within 7 days post-op): OCT scanning, high frequency 3D ultrasound scan (Hf

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. 18 – 80 years old 2. Peripheral nerve injury of ulnar or median nerve (or both) distal to the elbow 3. Having direct, epineural surgical repair within 1 week after injury 4. Capacity to consent

Exclusion criteria

Exclusion criteria: 1. Outside of stated age range 2. Outside stated location of injury 3. Nerve gap requiring alternative surgical management 4. Lacks capacity to consent

Design outcomes

Primary

Measure	Time frame
Measured at date of surgery (or within 7 days post-op), weeks 2 and 6, and months 3, 6 and 12: 1. Sweat gland density and epidermal thickness measured by Optical Coherence Tomography 2. Regenerative rate and volume of the regenerating nerve measured by high-frequency, three-dimensional ultrasound	—

Secondary

Measure	Time frame
Sensory outcome measures: 1. Tactile spatial discrimination measured using 2 Point Discrimination Test at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12 2. Pressure detection threshold measured using Weinstein Enhanced Sensory Test (WEST) monofilament at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12 3. Tactile spatial discrimination measured using locognosia at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12 4. Stereogenesis measured using Shape/Texture Identification Test at months 6 and 12 Motor outcome measures: 1. Individual muscle strength measured using manual muscle testing (MRC Grading) at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12 2. Grip strength measured using Jamar Dynamometer at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12 Patient-Reported Outcome Measures (PROMs): 1. Functional disability and pain caused by nerve injury measured using DASH and i-HAND at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12	—

Measure

Time frame

Sensory outcome measures: 1. Tactile spatial discrimination measured using 2 Point Discrimination Test at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12 2. Pressure detection threshold measured using Weinstein Enhanced Sensory Test (WEST) monofilament at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12 3. Tactile spatial discrimination measured using locognosia at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12 4. Stereogenesis measured using Shape/Texture Identification Test at months 6 and 12 Motor outcome measures: 1. Individual muscle strength measured using manual muscle testing (MRC Grading) at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12 2. Grip strength measured using Jamar Dynamometer at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12 Patient-Reported Outcome Measures (PROMs): 1. Functional disability and pain caused by nerve injury measured using DASH and i-HAND at week 1/baseline, week 2/baseline, week 6, months 3, 6 and 12

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026