A Series of Clinical Observational Parameters In Nerve reGeneration
Research type
Research Study
Full title
A Series of Clinical Observational Parameters In Nerve reGeneration
IRAS ID
212529
Contact name
Suzanne Beale
Contact email
Sponsor organisation
Queen Elizabeth Hospitals Birmingham Charities
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Research Summary
Why: This study is an observational study of 12 patients who have had surgery to repair a nerve to the hand. The research question is "can the use of four basic clinical assessments be used to assess the regeneration or re-growing of a nerve to indicate any problems in the nerve recovery early on within the first 12 weeks. If there is a set of assessments that do indicate early on a problem with nerve recovery then this would highlight the need for further surgery before it is considered too late surgically to intervene and a patient is left with muscle weakness and loss of movement.
What: The area being studied is nerve recovery following a surgical repair to the median nerve to the hand.
Who: All patients following a repair to a injury to the median nerve at the wrist level
Where: The study will be carried out within a hospital setting within the upper limb/hand clinic.
How: It is proposed that the study is carried out over 18months. Although primarily the study will look at early nerve recovery, it will also look to see if there is a indication of early nerve recovery and final outcome with patients sensory, motor, function and well-being.Summary of Results
Target recruitment was reduced from 12 to 9 patients due to early termination of the study due to COVID-19 pandemic restrictions. Three patients discontinued: 1 was withdrawn owing to not being a complete nerve repair, I died, I due to pandemic. Six subjects completed the final follow up pathway. One patient achieved SMRC 4, one SMRC 3+, three SMRC3 and one SMRC2+. Tinel’s sign progression was observed in all subjects. Tinel’s progression rate predicted the final outcome in 5/6 cases (1 failure and 4 good/excellent). In the last case the Tinel’s progression was poor and the patient achieved good sensory outcome. In this case the differential Tinel’s sign predicted a good outcome: Faced with a struggling nerve repair progression, the differential Tinel should be used to provide a further guide to the final outcome. The tender muscle test was assessed in all patents but was positive in only 2/6. Five participants achieved MRC recovery of thenar function. The test did not predict the timing or quality of motor recovery. Cold intolerance affected all patients and was still present at 18 months. Thermal imaging has shown a lower average temperature of 2.8 degrees Celsius in median compared to ulnar nerve distribution in 4 out of 6 patients. Timing of the return of sweating did not predict the final outcome in terms of sensory recovery. Cold intolerance was a feature in all patients and persisted to 18 months. DASH score mean reduction was 50.4 and PEM score 27 between recruitment and final follow up.
Conclusion: The Tinel’s rate of progression and the differential Tinel’s sign may predict the final outcome after nerve repair when used hierarchically in combination.REC name
West of Scotland REC 5
REC reference
17/WS/0125
Date of REC Opinion
15 Jun 2017
REC opinion
Favourable Opinion