Distal Radius FractureNCT03613922
Effects of Early Manual Therapy on Functional Outcomes After Volar Plating of Distal Radius Fractures
A study testing Early Manual Therapy and Routine Physiotherapy in people with Distal Radius Fracture, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to investigate the effects of early manual therapy on function, pain, range of motion (ROM), hand and pinch grip strength and disability level in patients underwent volar plating after distal radius fracture (DRF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture
- What is being tested?
- Early Manual Therapy and Routine Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2015to May 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An age of eighteen years or older
- An unstable fracture of the distal end of the radius
- Fixation with a volar locking plate
- Able to read, write, and understand Turkish
- Willing and able to attend the study
Who cannot join
- Previous fracture on the injured side
- Concurrent fracture in contralateral upper extremity
- Accompanied bony and soft tissue injuries other than radius fracture
- Inflammatory joint diseases, metabolic diseases and neurological diseases
- Mental and cognitive disorders that would seriously affect cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Early Manual Therapy on Functional Outcomes After Volar Plating of Distal Radius Fractures: A Randomized Controlled Trial
The aim of the study was to investigate the effects of early manual therapy on function, pain, range of motion (ROM), hand and pinch grip strength and disability level in patients underwent volar plating after distal radius fracture (DRF). Patients were randomly divided into two groups: Routin Physiotherapy (RP) or Early Manual Therapy (EMT). While RP group received routine physiotherapy, EMT group received routine physiotherapy plus Mulligan's Mobilization With Movement technique. All treatments were done two sessions a week, through 12 weeks. Function, pain, range of motion (ROM), hand and pinch grip strength and disability level of patients were assessed. Measurements were made at postoperative week 3, 6 and 12.
- Conditions
- Distal Radius Fracture
- Being tested
- Early Manual Therapy, Routine Physiotherapy
- Keywords
- manual therapy, radius fracture, function, disability, physiotherapy
- Medical subject headings
- Wrist Fractures, Radius Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Manual TherapyOther
Mulligan's Mobilization with Movement technique for radiocarpal,ulnocarpal, distal radioulnar and proximal radioulnar joints was applied.
Routine PhysiotherapyOther
Routine physiotherapy program consisted of range of motion, flexibility and strengthening exercises, and home exercise program was applied.
| Study group | Role | What they receive |
|---|---|---|
| Early Manual Therapy Group | Experimental | Routine physiotherapy program plus Mulligan's Mobilization with Movement technique were applied. Receives: Other: Early Manual Therapy; Other: Routine Physiotherapy |
| Routine Physiotherapy Group | Active comparator | Only routine physiotherapy program was applied Receives: Other: Routine Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in the function
Function was asssesed by using Patient Rated Wrist Evaluation (PRWE)
Measured: postoperative week 6, 12.
Secondary outcomes (4)
change in the severity of pain
Severity of pain was assessed by using Visual Analogue Scale (VAS), which ranges between 0-10 points, 0 represents no pain and 10 denotes maximum pain intensity.
Measured: postoperative day 1, postoperative week 3, 6, 12.
change in the range of motion (ROM)
ROM was assesed by using an universal goniometer
Measured: postoperative week 3, 6, 12.
change in hand and pinch grip strength
hand and pinch grip strength was assesed by using hydrolic hand and finger dynamometers.
Measured: postoperative week 3, 6, 12.
change in disability
Disability level was assesed by using Disabilities of Arm, Shoulder and Hand (DASH) questionnaire.
Measured: postoperative week 6, 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study startSep 2015
- Primary completionApr 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat TOMRUK, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613922
- Sponsor's protocol ID
- TomrukDRF
- Status last verified
- Nov 2018
- First submitted
- 26 Jul 2018
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Manual Therapy on Functional Outcomes After Volar Plating of Distal Radius Fractures: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03613922
- Acronym / sponsor ID
- TomrukDRF
- Conditions
- Distal Radius Fracture
- Keywords
- manual therapy, radius fracture, function, disability, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 3 Aug 2018 (actual)
- 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.
The aim of the study was to investigate the effects of early manual therapy on function, pain, range of motion (ROM), hand and pinch grip strength and disability level in patients underwent volar plating after distal radius fracture (DRF). Patients were randomly divided into two groups: Routin Physiotherapy (RP) or Early Manual Therapy (EMT). While RP group received routine physiotherapy, EMT group received routine physiotherapy plus Mulligan's Mobilization With Movement technique. All treatments were done two sessions a week, through 12 weeks. Function, pain, range of motion (ROM), hand and pinch grip strength and disability level of patients were assessed. Measurements were made at postoperative week 3, 6 and 12.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Manual Therapy Group | Experimental | Other: Early Manual Therapy, Other: Routine PhysiotherapyRoutine physiotherapy program plus Mulligan's Mobilization with Movement technique were applied. |
| Routine Physiotherapy Group | Active comparator | Other: Routine PhysiotherapyOnly routine physiotherapy program was applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- An age of eighteen years or older
- An unstable fracture of the distal end of the radius
- Fixation with a volar locking plate
- Able to read, write, and understand Turkish
- Willing and able to attend the study
Key exclusion criteria (5 listed)
- Previous fracture on the injured side
- Concurrent fracture in contralateral upper extremity
- Accompanied bony and soft tissue injuries other than radius fracture
- Inflammatory joint diseases, metabolic diseases and neurological diseases
- Mental and cognitive disorders that would seriously affect cooperation
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 |
|---|---|---|
| Early Manual TherapyMulligan's Mobilization with Movement technique for radiocarpal,ulnocarpal, distal radioulnar and proximal radioulnar joints was applied. | Other | Early Manual Therapy Group |
| Routine PhysiotherapyRoutine physiotherapy program consisted of range of motion, flexibility and strengthening exercises, and home exercise program was applied. | Other | Early Manual Therapy Group, Routine Physiotherapy Group |
Primary outcome
change in the function
Time frame: postoperative week 6, 12.
Function was asssesed by using Patient Rated Wrist Evaluation (PRWE)
4 secondary outcomes
change in the severity of pain
Time frame: postoperative day 1, postoperative week 3, 6, 12.
change in the range of motion (ROM)
Time frame: postoperative week 3, 6, 12.
change in hand and pinch grip strength
Time frame: postoperative week 3, 6, 12.
change in disability
Time frame: postoperative week 6, 12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Manual Therapy and Routine Physiotherapy in people with Distal Radius Fracture, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: finished, as of the sponsor's last update on 14 Nov 2018. 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in the function (time frame: postoperative week 6, 12.). 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 14 Nov 2018.