Muscle WeaknessNCT04168411
Comparison Different Method Treatment in Tuberosity Fractures of the Proximal Fifth Metatarsal
A study testing Symptomatic Treatment in people with Muscle Weakness and Metatarsal Fracture, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
Fracture of the base of the fifth metatarsal is one of the most common injuries in ankle trauma. There are many conservative treatment protocols for fifth metatarsal base fractures which have up to 99% success. Short leg cast and walking boot are conservative treatment methods that aim to prevent weight-bearing. Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Muscle Weakness, Metatarsal Fracture, Healing Fracture of Bone
- What is being tested?
- Symptomatic Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2018to 9 Sep 2019
- 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 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged over 18 years
- Acute (presented within one week of injury) Zone 1 fractures of fifth metatarsi
Who cannot join
- Zone 2-3 fractures
- Diabetes mellitus
- Osteoporotic bone (T score<-2.5),
- History of osteoporotic drug therapy,
- Other lower extremity any fracture,
- Previous foot surgery or fracture in both lower extremity,
Show all 9Show fewer
- Chronic fracture, pathological fracture,
- Aged over 65 years (congruity of muscle strength test)
- Open fracture
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University, Istanbul Faculty of Medicine
Istanbul, Fatih, 34093
About this study
Official title: A Prospective Comparison of Clinical, Functional, and Isokinetic Outcomes Between Short Leg Cast Immobilization and Symptomatic Treatment in Tuberosity Fractures of the Proximal Fifth Metatarsal
Fracture of the base of the fifth metatarsal is one of the most common injuries in ankle trauma. There are many conservative treatment protocols for fifth metatarsal base fractures which have up to 99% success. Short leg cast and walking boot are conservative treatment methods that aim to prevent weight-bearing. There are many different conservative treatment methods that allow weight-bearing such as an elastic bandage. There was no significant difference between cast and symptomatic treatment in the previous studies. Muscle atrophy developing after immobilization with cast may adversely affect the daily activities of the patient in the first few months. However, there was no study comparing the effect of these two treatment methods on ankle muscle strength.
In this study, the investigators compared the strength of the ınjured and healthy ankle muscle when symptomatic and cast treatment methods are applied to patients with tuberosity fractures of proximal fifty metatars. In addition, patients' functional, clinic and radiological outcomes were also compared.
Read the detailed description
We prospectively treated 73 patients with 5th metatarsal base fractures (Zone 1) who came to the emergency department. Patients were allocated to a treatment group using an electronic random number generator. The generation of an even number randomized the participant to a below-knee cast, and an odd number to a double-layered elasticated bandage. In all, patients were allocated to wear a double layered elasticated bandage (group 1) applied by S.B and patients were given a below-knee cast (group 2) applied by D.K. Duration of both treatments were for four weeks and the cast removed in that time in our clinic. This reference form of treatment was the same as in previous reports.
The non-injured extremity was measured with isokinetic test at initial injury time for evaluation of side effect of immobilization after treatment. At that time, patients were asked for height, weight and pain scores. Body muscle index was calculated for all patients. Tobacco using was also asked.To measure clinical outcomes, using the validated Visual Analogue Scale Foot and Ankle (VAS-FA) score [7] and The EuroQol-5D visual analogue scale (EQ-5D VAS) score were used [8]. The VAS-FA score ranges from 0 to 100 points: higher scores indicate a better functional outcome. EQ-5D VAS score was used as a secondary outcome measure: this ranges from 0 to 100. Baseline functional scores were collected at the time of consult in the clinic.
Both ankle plantar-dorsiflexors and inversion-eversion'strength (peak torque %BW (Body Weight)) were measured with an isokinetic dynamometer (Cybex Humac Norm, CA, USA) at Isokinetic Test Laboratory of Sports Medicine in the Istanbul Medical Faculty. Test procedure was performed by the same investigator (T.Ş) in all cases for ensuring standardization. The muscle strength can be defined as the capacity of a muscle to withstand great force.
Injured extremity values were compared with non-injured extremity. The non-injured extremity was measured at initial injury time for evaluation of side effect of both treatment methods. The tests were started with non-injured sides of the patients and measurements at low angular velocity. The dynamometer was calibrated at the beginning of each testing session. Subjects were tested in prone position and stabilized in the exercise chair as per the manufacturer's recommendation. The anatomical axis of the ankle was aligned with the axis of the dynamometer while the foot was secured to the foot plate with velcros. Proximal stabilization was achieved with the straps at the thigh and calf. In the test, dorsiflexion-plantarflexion and inversion-eversion peak torque force (strength) measurements were performed in 3 trials and 3 tests repetitions at 30 degrees/sec angular speed for both side of the patient.
All of the patients were given follow-up appointments at 2, 4, 8, 12 and 24 week interval at our clinic. Radiographs were similarly scheduled for 4, 8, and 12 week intervals to assess bony healing. However, functional outcomes and isokinetic test was applied also at 24 week control. At second visit, isokinetic test was not applied. These studies were started on fixed ground and then continued on moving boards. Standard rehabilitation program was given for all patients each group included joint mobilizations, passive stretching, electrotherapy-ice compression for pain relieving and ankle proprioceptive exercises, as considered necessary by same author (T.Ş).
- Being tested
- Symptomatic Treatment
- Keywords
- metatarsal, fracture, muscle weakness, isokinetic test,
- Medical subject headings
- Muscle Weakness, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptomatic TreatmentProcedure or surgery
Conservative treatment methods of tuberosity fractures of the proximal fifth metatarsal
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic treatment group | Experimental | The patients were allocated to wear a double layered elasticated bandage for treatment 5th metatarsal base fractures (Zone 1). Receives: Procedure: Symptomatic Treatment |
| Cast group | Active comparator | The patients were given a below-knee cast for treatment 5th metatarsal base fractures (Zone 1). Receives: Procedure: Symptomatic Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changed of Baseline Isokinetic Muscle Strength at 6 months
Both ankle plantar-dorsiflexion muscle strength and inversion-eversion muscle strength (peak torque %BW (Body Weight)) were measured with an isokinetic dynamometer (Cybex Humac Norm, CA, USA) at Isokinetic Test Laboratory of Sports Medicine in the Istanbul Medical Faculty. Test procedure was performed by the same investigator in all cases for ensuring standardization. The muscle strength can be defined as the capacity of a muscle to withstand great force. Injured extremity values were compared with healthy extremity. he healthy extremity was measured at initial injury time for evaluation of side effect of both treatment methods.
Measured: Isokinetic Muscle Strength test was scheduled for baseline, 4, 8,12 and 24 week intervals to assess ankle muscle strength
Secondary outcomes (2)
Changed of Baseline VAS-FA Scores at 6 months
The investigators was measured clinical outcomes, using the validated "Visual Analogue Scale Foot and Ankle (VAS-FA) Score". VAS-FA score is numbered from 0 to 100. 100 is the best health and 0 is the worst health.
Measured: baseline, 2, 4, 8,12 and 24 weeks follow-up visit
Changed of Baseline EuroQol-5D VAS Scores at 6 months
The investigators was measured clinical outcomes using The EuroQol-5D visual analogue scale (EQ-5D VAS). (EQ-5D VAS is numbered from 0 to 100. 100 is the best health and 0 is the worst health.
Measured: baseline, 2nd, 4th, 8th,12th and 24th week follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start15 Apr 2018
- Primary completion20 Jun 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle WeaknessStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Bayram, Istanbul University
- Investigators
- Turgut Akgul, MD, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168411
- Sponsor's protocol ID
- 2018/536
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 19 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of Clinical, Functional, and Isokinetic Outcomes Between Short Leg Cast Immobilization and Symptomatic Treatment in Tuberosity Fractures of the Proximal Fifth Metatarsal
- ClinicalTrials.gov ID
- NCT04168411
- Acronym / sponsor ID
- 2018/536
- Keywords
- metatarsal, fracture, muscle weakness, isokinetic test,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 19 Nov 2019 (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.
Fracture of the base of the fifth metatarsal is one of the most common injuries in ankle trauma. There are many conservative treatment protocols for fifth metatarsal base fractures which have up to 99% success. Short leg cast and walking boot are conservative treatment methods that aim to prevent weight-bearing. There are many different conservative treatment methods that allow weight-bearing such as an elastic bandage. There was no significant difference between cast and symptomatic treatment in the previous studies. Muscle atrophy developing after immobilization with cast may adversely affect the daily activities of the patient in the first few months. However, there was no study comparing the effect of these two treatment methods on ankle muscle strength.
In this study, the investigators compared the strength of the ınjured and healthy ankle muscle when symptomatic and cast treatment methods are applied to patients with tuberosity fractures of proximal fifty metatars. In addition, patients' functional, clinic and radiological outcomes were also compared.
Detailed description
We prospectively treated 73 patients with 5th metatarsal base fractures (Zone 1) who came to the emergency department. Patients were allocated to a treatment group using an electronic random number generator. The generation of an even number randomized the participant to a below-knee cast, and an odd number to a double-layered elasticated bandage. In all, patients were allocated to wear a double layered elasticated bandage (group 1) applied by S.B and patients were given a below-knee cast (group 2) applied by D.K. Duration of both treatments were for four weeks and the cast removed in that time in our clinic. This reference form of treatment was the same as in previous reports.
The non-injured extremity was measured with isokinetic test at initial injury time for evaluation of side effect of immobilization after treatment. At that time, patients were asked for height, weight and pain scores. Body muscle index was calculated for all patients. Tobacco using was also asked.To measure clinical outcomes, using the validated Visual Analogue Scale Foot and Ankle (VAS-FA) score [7] and The EuroQol-5D visual analogue scale (EQ-5D VAS) score were used [8]. The VAS-FA score ranges from 0 to 100 points: higher scores indicate a better functional outcome. EQ-5D VAS score was used as a secondary outcome measure: this ranges from 0 to 100. Baseline functional scores were collected at the time of consult in the clinic.
Both ankle plantar-dorsiflexors and inversion-eversion'strength (peak torque %BW (Body Weight)) were measured with an isokinetic dynamometer (Cybex Humac Norm, CA, USA) at Isokinetic Test Laboratory of Sports Medicine in the Istanbul Medical Faculty. Test procedure was performed by the same investigator (T.Ş) in all cases for ensuring standardization. The muscle strength can be defined as the capacity of a muscle to withstand great force.
Injured extremity values were compared with non-injured extremity. The non-injured extremity was measured at initial injury time for evaluation of side effect of both treatment methods. The tests were started with non-injured sides of the patients and measurements at low angular velocity. The dynamometer was calibrated at the beginning of each testing session. Subjects were tested in prone position and stabilized in the exercise chair as per the manufacturer's recommendation. The anatomical axis of the ankle was aligned with the axis of the dynamometer while the foot was secured to the foot plate with velcros. Proximal stabilization was achieved with the straps at the thigh and calf. In the test, dorsiflexion-plantarflexion and inversion-eversion peak torque force (strength) measurements were performed in 3 trials and 3 tests repetitions at 30 degrees/sec angular speed for both side of the patient.
All of the patients were given follow-up appointments at 2, 4, 8, 12 and 24 week interval at our clinic. Radiographs were similarly scheduled for 4, 8, and 12 week intervals to assess bony healing. However, functional outcomes and isokinetic test was applied also at 24 week control. At second visit, isokinetic test was not applied. These studies were started on fixed ground and then continued on moving boards. Standard rehabilitation program was given for all patients each group included joint mobilizations, passive stretching, electrotherapy-ice compression for pain relieving and ankle proprioceptive exercises, as considered necessary by same author (T.Ş).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic treatment group | Experimental | Procedure: Symptomatic TreatmentThe patients were allocated to wear a double layered elasticated bandage for treatment 5th metatarsal base fractures (Zone 1). |
| Cast group | Active comparator | Procedure: Symptomatic TreatmentThe patients were given a below-knee cast for treatment 5th metatarsal base fractures (Zone 1). |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Aged over 18 years
- Acute (presented within one week of injury) Zone 1 fractures of fifth metatarsi
Key exclusion criteria (9 listed)
- Zone 2-3 fractures
- Diabetes mellitus
- Osteoporotic bone (T score<-2.5),
- History of osteoporotic drug therapy,
- Other lower extremity any fracture,
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 |
|---|---|---|
| Symptomatic TreatmentConservative treatment methods of tuberosity fractures of the proximal fifth metatarsal | Procedure or surgery | Cast group, Symptomatic treatment group |
Primary outcome
Changed of Baseline Isokinetic Muscle Strength at 6 months
Time frame: Isokinetic Muscle Strength test was scheduled for baseline, 4, 8,12 and 24 week intervals to assess ankle muscle strength
Both ankle plantar-dorsiflexion muscle strength and inversion-eversion muscle strength (peak torque %BW (Body Weight)) were measured with an isokinetic dynamometer (Cybex Humac Norm, CA, USA) at Isokinetic Test Laboratory of Sports Medicine in the Istanbul Medical Faculty. Test procedure was performed by the same investigator in all cases for ensuring standardization. The muscle strength can be defined as the capacity of a muscle to withstand great force. Injured extremity values were compared with healthy extremity. he healthy extremity was measured at initial injury time for evaluation of side effect of both treatment methods.
2 secondary outcomes
Changed of Baseline VAS-FA Scores at 6 months
Time frame: baseline, 2, 4, 8,12 and 24 weeks follow-up visit
Changed of Baseline EuroQol-5D VAS Scores at 6 months
Time frame: baseline, 2nd, 4th, 8th,12th and 24th week follow-up visit
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 19 Nov 2019.
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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.
Turgut Akgul, MD study director
Istanbul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptomatic Treatment in people with Muscle Weakness and Metatarsal Fracture, run by Istanbul 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 2 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: finished, as of the sponsor's last update on 19 Nov 2019. 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?
Changed of Baseline Isokinetic Muscle Strength at 6 months (time frame: Isokinetic Muscle Strength test was scheduled for baseline, 4, 8,12 and 24 week intervals to assess ankle muscle strength). 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 19 Nov 2019.