An interventional study of Epineural suture and Non-operative treatment in Digital Nerve Injury, sponsored by Karolinska Institutet. Recruiting at 1 site in Sweden. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Karolinska Institutet · Not applicable, Interventional, and Treatment
Nerve injury in the fingers is a common injury and affects people of all ages. The treatment usually offered to patients is surgery and various types of rehabilitation. There is a lack of knowledge and research on how these injuries should be treated in the best way and how well sensory function can be restored after an injury. In this research project, we will investigate results after treatment for digital nerve injuries by entailing a randomised controlled trial allocating patients with isolated digital nerve injuries to either surgical repair or non-operative treatment in a cast. Primary outcome is digital nerve function as measured by 2-points discrimination at 1 year after treatment. Secondary outcomes include finger mobility, dexterity, handfunction, occurence of pain and anxiety and time on sick leave.
Patients over the age of 20 with an acute traumatic isolated digital nerve injury to any of the fingers and not in the thumb will be investigated for inclusion in the study. After informed written consent a sealed envelope randomisation will allocate patients to treatment with either surgical exposure and epineural suture or non-operative treatment in a cast. Due to the nature of treatment arms the allocation will not be blinded. Clinical follow-up and investigation of primary and secondary outcomes will be conducted at 3 weeks, 3 months, 6 months and 1 year after inclusion.
Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The injured digital nerve is exposed during a surgical intervention and sutured with 2 or three epineural sutures 8.0 or 9.0 synthetic monofilament non-resorbable suture. Postoperative treatment includes 3 weeks in a plaster cast followed by rehabilitation.
Procedure: Epineural suture
The injured digital nerve is not surgically exposed. The skin is closed over the injury site and the finger is protected in a plaster cast for three weeks followed by rehabilitation.
Procedure: Non-operative treatment
2 or three sutures
Also known as: surgical repair
The injured finger is protected in a plaster cast
Also known as: cast
Static two points discrimination (S2PD)
a static two points discrimination test performed by an occupational therapist of the injured finger
Time frame: one year after injury
Active range of motion
Range of motion of the injured finger (sum of MCP + PIP + DIP joint motion measured in degrees)
Time frame: 3 and 6 months and 1 year
Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger
Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger
Time frame: 3 and 6 months and 1 year
Semmes-Weinstein monofilament test
Discriminatory sensory function as measured by Semmes-Weinstein monofilament test
Time frame: 3 and 6 months and 1 year
Mini Sollerman test
Hand function as measured by the Mini Sollerman test
Time frame: 3 and 6 months and 1 year
Grip strength
Grip strength of injured and non-injured hand as measured by Jamar dynamometer
Time frame: 3 and 6 months and 1 year
Quick-DASH
Patient Rated Outcome measure (PROM) for hand function as measured by the quick-DASH (Disability of the Arm, Shoulder and Hand). 11 items with 5-level Likert scales measures upper limb function. The scale ranges from 0 - 100 and 0 is the lowest possible disability.
Time frame: 3 and 6 months and 1 year
HQ-8
Patient Rated Outcome measure (PROM) for hand function as measured by the HQ-8 (Eight item HAKIR questionnaire)
Time frame: 3 and 6 months and 1 year
Neuropathic pain
Occurrence of neuropathic pain as measured by Doleur Neuropathic 4 questions (DN4). 4 aspects of neuropathic pain are evaluated by 10 questions, with higher scores representing a worse state.
Time frame: 3 and 6 months and 1 year
Anxiety and depression
Psychologic wellbeing as measured by Hospital Anxiety and Depression scale (HAD) (PCS)
Time frame: at inclusion
Pain catastrophising scale, (PCS)
Pain catastrophising scale, (PCS) measures 13 items on a 5 points Likert scale. Higher scores represent high degree of pain catastrophising scale, (PCS).
Time frame: at inclusion
Sick leave time
Days of absence from work
Time frame: 1 year
Wait for surgery
The number of days that have passed from the day of injury to the day of surgery are reported
Time frame: 3 weeks
Time in operating theatre
Time in operating theatre is measured in minutes
Time frame: day of surgery
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