NCT Number: NCT05536609
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.
Interested in participating?
Request Info20 year and older
All sexes
Interventional
Not applicable
Stockholm, Stockholm County, 11883, Sweden
Location status: Recruiting
Carin Carlsson, MD
CONTACT
Carin Carlsson, MD
SUB_INVESTIGATOR
Cecilia Mellstrand Navarro, MD, PhD
CONTACT
Cecilia Mellstrand Navarro, MD, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 or three sutures
Other names: surgical repair
The injured finger is protected in a plaster cast
Other names: cast
Time frame: one year after injury
a static two points discrimination test performed by an occupational therapist of the injured finger
Time frame: 3 and 6 months and 1 year
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
Time frame: 3 and 6 months and 1 year
Discriminatory sensory function as measured by Semmes-Weinstein monofilament test
Time frame: 3 and 6 months and 1 year
Hand function as measured by the Mini Sollerman test
Time frame: 3 and 6 months and 1 year
Grip strength of injured and non-injured hand as measured by Jamar dynamometer
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: at inclusion
Psychologic wellbeing as measured by Hospital Anxiety and Depression scale (HAD) (PCS)
Time frame: 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).
Time frame: 1 year
Days of absence from work
Time frame: 3 weeks
The number of days that have passed from the day of injury to the day of surgery are reported
Time frame: day of surgery
Time in operating theatre is measured in minutes
Contact information is provided by the study sponsor or research team.
Carin Carlsson, MD
CONTACT
Cecilia Mellstrand Navarro, MD, PhD
CONTACT
Karolinska Institutet
Other
Acronym: COPS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06867185
Digital Nerve Injury, Digital Nerve Lesion
Indianapolis, Indiana, United States
View Trial DetailsNCT07524465
Digital Nerve Injury, Nerve Reconstruction
Charlotte, North Carolina, United States
View Trial DetailsNCT04327154
Digital Nerve Injury, Nervous System Diseases
Brisbane, Queensland, Australia
View Trial DetailsNCT05337917
Digital Nerve Injury
Stockholm, Sweden
View Trial Details