Colles' FractureNRPNCT02396277
Structural and Functional Nerve Changes Following Immobilisation After Distal Radius Fracture - a Pilot Study (NRP)
An observational study of Colles' Fracture and Distal Radius Fracture, run by University of Tromso at 1 site in Norway.
Trial summary
Immobilization after radius fracture seems to increase the risk of developing a Complex regional pain syndrome (CRPS), a condition associated with pain, increased skin sensitivity and reduced epidermal nerve density. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colles' Fracture, Distal Radius Fracture
- What is being tested?
- Immobilization
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- May 2025to Dec 2028
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients referred to the Emergency Clinic at The University Hospital in North Norway Tromso day time
Who may be able to join
- Consent competence
- Acute stable distal radius fracture (less than 48 hours)
- Allocated to conservative treatment with 5-week immobilization
Who cannot join
- Comorbidity which may prevent completion of the study
- Serious and progressive disease
- Chronic shoulder disease with limited ROM and function.
- Sign peripheral nerve injury in the upper extremities
- Polyneuropathy
- Demyelination disease
Show all 9Show fewer
- Diabetes mellitus
- Anticoagulants including acetyl salicylic acid (ASA)
- Allergy to local anesthetics
Trial locations and contacts
1 site in 1 country.
About this study
Immobilization after radius fracture seems to increase the risk of developing a Complex regional pain syndrome (CRPS), a condition associated with pain, increased skin sensitivity and reduced epidermal nerve density.
The purpose of the study is to determine whether 5-week immobilisation leads to functional and structural sensory changes, and whether the changes are associated with persistent pain. The investigators plan an explorative, pilot study on six consenting patients immobilised after a distal radius fracture.
The baseline measurements will be recorded at the day of or the day after trauma: Demographics, psychological and physical comorbidity, pain characteristics and intensity, hand function, health related quality of life (HRQOL), quantitative sensory testing will be recorded while skin biopsies are analyzed for epidermal nerve fiber density. Following variables such as pain characteristics and intensity, hand function, health related quality of life, quantitative sensory testing and skin biopsies will be reassessed when the cast is removed and two months later.
Read the detailed description
Distal radius fracture is a prevalent injury, affecting 15.000 cases in Norway every year. About 5% of these patients suffer from longlasting pain and some develop a serious and chronic CRPS. Patients subjected to hand surgery frequently report pain one month after cast removal, and further examinations have revealed vascular and trophic changes, and increased sensitivity to pressure and cold as well as elevated skin levels of proinflammatory mediators.
Long term immobilization seems to increase the risk of developing CRPS symptoms. In a Danish study healthy volunteers demonstrated increased hyperalgesia to cold and mechanical stimuli even after 4-week immobilization which may indicate an early change in the nerve function.
In CRPS patients skin biopsies have demonstrated reduced epidermal nerve fiber density, but such data are lacking after radius fracture and during early stage of CRPS.
The purpose of this explorative, observational, pilot study is to investigate whether radius fracture followed by 5-week of immobilization, leads to functional and structural changes of the sensory system which are reversed after remobilization and whether the sensory changes are associated with persistent pain.
Our hypotheses are: 1) Patients with an immobilised arm following a radius fracture develops a) early cutaneous hypersensitivity (hyperalgesia and allodynia) for mechanical og thermal stimuli and b) reduced epidermal nerve fiber density.
- The changes of the sensory system are reversed after 2-month remobilization. 3) The functional and structural changes are correlated with patient reported outcome measures (PROM) such as disability of arm, shoulder and hand (DASH), with pain intensity (NRS), duration of the pain and HRQOL .
Eligible patients will be included throughout 2015, and results will be analyzed within December 2015.
Measurements:
Self reported: Demographics (age, gender, civil state, education, working status, social security benefits) and clinical data of comorbidity, pain characteristics (DN4) and intensity (NRS), blood pressure, smoking /other kind of nicotine use, pain medication, and assessment scales for mental distress (HSCL 25), pain catastrophizing (PCS), hand function (DASH), and HRQOL (EQ5D).
Examinations: Quantitative sensory testing (tactile and thermal stimuli) and skin biopsies are carried out 10 cm proximal to fracture line on the dorsum of the affected arm. Measurements for predictor analyses will only be performed at baseline while outcome measurements will be performed prior to and just after removal of the cast as well as two months later.
Statistical analyses:
Regression analyses will be performed to identify other predictors for the changes in sensory nervous system including blood pressure, smoking /other kind of nicotine use, medication, age, gender, and comorbidity. Longitudinal analyses of numerical outcome (ANOVA repeated measurement) will be carried out for outcome measurements such as pain intensity,hand function, HRQOL, sensory thresholds and epidermal nerve fiber density.
- Conditions
- Colles' Fracture, Distal Radius Fracture
- Being tested
- Immobilization
- Medical subject headings
- Colles' Fracture, Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImmobilizationProcedure or surgery
This is not an intervention study; but the patients are subjected to immobilization with a cast as part of a regular clinical treatment for distal radius fracture.
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in nerve fiber density at five weeks
ANOVA repeated measurements based on repeated skin biopsies
Measured: From baseline to five weeks after injury
Changes from baseline in sensitivity to thermal and tactile stimuli at five weeks
ANOVA repeated measurements based on repeated sensory quantitative testing
Measured: From baseline to five weeks after injury
Secondary outcomes (6)
Changes from five weeks in nerve fiber density at 13 weeks
ANOVA repeated measurements based on results from repeated skin biopsies
Measured: From five weeks to 13 weeks after injury
Changes from five weeks in sensitivity to thermal and tactile stimuli at 13 weeks
ANOVA repeated measurements based on sensory quantitative testing
Measured: From five to 13 weeks after injury
Correlation between changes in pain intensity and changes in nerve fiber density
Statistical regression analyses based on repeated assessments of self reported pain intensity and skin biopsies
Measured: From baseline to 13 weeks
Correlation between changes in pain intensity and changes in sensitivity to thermal and tactile stimuli
Statistical regression analyses based on repeated assessments of self reported pain intensity and quantitative sensory testing
Measured: From baseline to 13 weeks
Changes from baseline (preinjury) in disability of arm, shoulder and hand are correlated with changes in pain intensity at five and 13 weeks
Statistical regression analyses based on repeated self reports of pain intensity and DASH
Measured: From baseline to 13 weeks
Changes from baseline (preinjury) HRQOL are correlated with changes in pain intensity at five and 13 weeks
Statistical regression analyses based on repeated self reports of pain intensity and HRQOL (EQ5D)
Measured: From baseline to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2015 (estimated)
- Study startMay 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: Due to limited resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colles' FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gunnvald Kvarstein, PhD, Study chair, University of Tromso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02396277
- Sponsor's protocol ID
- 2014/86 (REK)
- Acronym
- NRP
- Status last verified
- May 2025
- First submitted
- 17 Mar 2015
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structural and Functional Nerve Changes Following Immobilisation After Distal Radius Fracture - a Pilot Study (NRP)
- ClinicalTrials.gov ID
- NCT02396277
- Acronym / sponsor ID
- NRP / 2014/86 (REK)
- Conditions
- Colles' Fracture, Distal Radius Fracture
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to limited resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Immobilization after radius fracture seems to increase the risk of developing a Complex regional pain syndrome (CRPS), a condition associated with pain, increased skin sensitivity and reduced epidermal nerve density.
The purpose of the study is to determine whether 5-week immobilisation leads to functional and structural sensory changes, and whether the changes are associated with persistent pain. The investigators plan an explorative, pilot study on six consenting patients immobilised after a distal radius fracture.
The baseline measurements will be recorded at the day of or the day after trauma: Demographics, psychological and physical comorbidity, pain characteristics and intensity, hand function, health related quality of life (HRQOL), quantitative sensory testing will be recorded while skin biopsies are analyzed for epidermal nerve fiber density. Following variables such as pain characteristics and intensity, hand function, health related quality of life, quantitative sensory testing and skin biopsies will be reassessed when the cast is removed and two months later.
Detailed description
Distal radius fracture is a prevalent injury, affecting 15.000 cases in Norway every year. About 5% of these patients suffer from longlasting pain and some develop a serious and chronic CRPS. Patients subjected to hand surgery frequently report pain one month after cast removal, and further examinations have revealed vascular and trophic changes, and increased sensitivity to pressure and cold as well as elevated skin levels of proinflammatory mediators.
Long term immobilization seems to increase the risk of developing CRPS symptoms. In a Danish study healthy volunteers demonstrated increased hyperalgesia to cold and mechanical stimuli even after 4-week immobilization which may indicate an early change in the nerve function.
In CRPS patients skin biopsies have demonstrated reduced epidermal nerve fiber density, but such data are lacking after radius fracture and during early stage of CRPS.
The purpose of this explorative, observational, pilot study is to investigate whether radius fracture followed by 5-week of immobilization, leads to functional and structural changes of the sensory system which are reversed after remobilization and whether the sensory changes are associated with persistent pain.
Our hypotheses are: 1) Patients with an immobilised arm following a radius fracture develops a) early cutaneous hypersensitivity (hyperalgesia and allodynia) for mechanical og thermal stimuli and b) reduced epidermal nerve fiber density.
- The changes of the sensory system are reversed after 2-month remobilization. 3) The functional and structural changes are correlated with patient reported outcome measures (PROM) such as disability of arm, shoulder and hand (DASH), with pain intensity (NRS), duration of the pain and HRQOL .
Eligible patients will be included throughout 2015, and results will be analyzed within December 2015.
Measurements:
Self reported: Demographics (age, gender, civil state, education, working status, social security benefits) and clinical data of comorbidity, pain characteristics (DN4) and intensity (NRS), blood pressure, smoking /other kind of nicotine use, pain medication, and assessment scales for mental distress (HSCL 25), pain catastrophizing (PCS), hand function (DASH), and HRQOL (EQ5D).
Examinations: Quantitative sensory testing (tactile and thermal stimuli) and skin biopsies are carried out 10 cm proximal to fracture line on the dorsum of the affected arm. Measurements for predictor analyses will only be performed at baseline while outcome measurements will be performed prior to and just after removal of the cast as well as two months later.
Statistical analyses:
Regression analyses will be performed to identify other predictors for the changes in sensory nervous system including blood pressure, smoking /other kind of nicotine use, medication, age, gender, and comorbidity. Longitudinal analyses of numerical outcome (ANOVA repeated measurement) will be carried out for outcome measurements such as pain intensity,hand function, HRQOL, sensory thresholds and epidermal nerve fiber density.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients referred to the Emergency Clinic at The University Hospital in North Norway Tromso day time
Key inclusion criteria (3 listed)
- Consent competence
- Acute stable distal radius fracture (less than 48 hours)
- Allocated to conservative treatment with 5-week immobilization
Key exclusion criteria (9 listed)
- Comorbidity which may prevent completion of the study
- Serious and progressive disease
- Chronic shoulder disease with limited ROM and function.
- Sign peripheral nerve injury in the upper extremities
- Polyneuropathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImmobilizationThis is not an intervention study; but the patients are subjected to immobilization with a cast as part of a regular clinical treatment for distal radius fracture. | Procedure or surgery | – |
Primary outcome
Changes from baseline in nerve fiber density at five weeks
Time frame: From baseline to five weeks after injury
ANOVA repeated measurements based on repeated skin biopsies
Changes from baseline in sensitivity to thermal and tactile stimuli at five weeks
Time frame: From baseline to five weeks after injury
ANOVA repeated measurements based on repeated sensory quantitative testing
6 secondary outcomes
Changes from five weeks in nerve fiber density at 13 weeks
Time frame: From five weeks to 13 weeks after injury
Changes from five weeks in sensitivity to thermal and tactile stimuli at 13 weeks
Time frame: From five to 13 weeks after injury
Correlation between changes in pain intensity and changes in nerve fiber density
Time frame: From baseline to 13 weeks
Correlation between changes in pain intensity and changes in sensitivity to thermal and tactile stimuli
Time frame: From baseline to 13 weeks
Changes from baseline (preinjury) in disability of arm, shoulder and hand are correlated with changes in pain intensity at five and 13 weeks
Time frame: From baseline to 13 weeks
Changes from baseline (preinjury) HRQOL are correlated with changes in pain intensity at five and 13 weeks
Time frame: From baseline to 13 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
Related trials for Colles' Fracture
Active, not recruitingPhase 4
Brachial Plexus Nerve Block Versus Haematoma Block for Closed Reduction of Distal Radius Fracture in Adults - The BLOCK Trial. A Multicentre Randomised Controlled Trial.
Distal Radius Fractures, Fracture Dislocation
Recruiting
Wrist Injury Strengthening Exercise (WISE) Versus Usual Care Advice for Improving Pain and Function
Distal Radius Fracture, Colles Fracture
Recruiting
Comparative Study Between Cannulated Screws and K-wires in the Fixation of Distal Radius Fractures
Distal Radius Fractures
Not yet recruiting
Comparison of Functional Outcomes of Closed Reduction With Cast Versus Closed Reduction With K-Wire Fixation in Colles' Fracture
Colles' Fracture
Recruiting
Comparison of Kaltenborn Mobilization and Mobilization With Movement (MWM) in Wrist Hypomobility After Colle's Fracture
Colles Fracture, Hypomobility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunnvald Kvarstein, PhD study chair
University of Tromso
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colles' Fracture and Distal Radius Fracture, run by University of Tromso at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in nerve fiber density at five weeks (time frame: From baseline to five weeks after injury). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.