Cast Or ePineural Suture for Digital Nerve Injuries - a Randomised Controlled Study
- Conditions
- Digital Nerve Injury
- Interventions
- Procedure: Epineural sutureProcedure: Non-operative treatment
- Registration Number
- NCT05536609
- Lead Sponsor
- Karolinska Institutet
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 166
- Clinical signs of isolated traumatic digital nerve injury in digits 2, 3, 4 or 5.
- Patient age => 20 years on day of injury.
- Injury location on volar aspect of finger.
- Acute sensory dysfunction in suspected digital nerve injury area.
- Digital nerve injury ot the thumb
- Digital nerve injury in the palm of the hand (i e proximal to the finger base)
- Patient does not speak or read the Swedish language.
- Abusive drug or alcohol use
- Dementia.
- Injury mor than 7 days at dianosis AND/OR operative treatment cannot be offered within 10 days from injury.
- Neurologic disease.
- Ongoing infektion in the injured finger.
- concomittant tendoninjury or fracture in injured or adjacent finger.
- Injury mechanism is of blunt or crush charachter
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epineural suture Epineural suture 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. Non-operative treatment Non-operative treatment 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.
- Primary Outcome Measures
Name Time Method Static two points discrimination (S2PD) one year after injury a static two points discrimination test performed by an occupational therapist of the injured finger
- Secondary Outcome Measures
Name Time Method Semmes-Weinstein monofilament test 3 and 6 months and 1 year Discriminatory sensory function as measured by Semmes-Weinstein monofilament test
Mini Sollerman test 3 and 6 months and 1 year Hand function as measured by the Mini Sollerman test
Quick-DASH 3 and 6 months and 1 year 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.
Pain catastrophising scale, (PCS) at inclusion Pain catastrophising scale, (PCS) measures 13 items on a 5 points Likert scale. Higher scores represent high degree of pain catastrophising scale, (PCS).
Wait for surgery 3 weeks The number of days that have passed from the day of injury to the day of surgery are reported
Active range of motion 3 and 6 months and 1 year Range of motion of the injured finger (sum of MCP + PIP + DIP joint motion measured in degrees)
Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger 3 and 6 months and 1 year Ratio between S2PD in injured finger and S2PD in uninjured contralateral finger
Grip strength 3 and 6 months and 1 year Grip strength of injured and non-injured hand as measured by Jamar dynamometer
HQ-8 3 and 6 months and 1 year Patient Rated Outcome measure (PROM) for hand function as measured by the HQ-8 (Eight item HAKIR questionnaire)
Anxiety and depression at inclusion Psychologic wellbeing as measured by Hospital Anxiety and Depression scale (HAD) (PCS)
Neuropathic pain 3 and 6 months and 1 year 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.
Sick leave time 1 year Days of absence from work
Time in operating theatre day of surgery Time in operating theatre is measured in minutes
Trial Locations
- Locations (1)
Karolinska Institutet Södersjukhuset, Department of clinical research and education
🇸🇪Stockholm, Sweden