Distal Radius FracturesNCT06194604
Effectiveness of Instrument-Assısted Soft Tissue Mobılızatıon in Patients With Operated Distal Radius Fracture
A study testing Instrument-assisted soft tissue mobilization and Routine rehabilitation programe in people with Distal Radius Fractures and Instrument-assisted Soft Tissue Mobilization, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Distal radius fractures are the most common fractures when looking at upper extremity fractures . The incidence of distal radius fractures is increasing day by day, and when looking at the databases of various countries, the annual prevalence reaches 70,000 in the UK and 640,000 in the USA. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Distal Radius Fractures, Instrument-assisted Soft Tissue Mobilization
- What is being tested?
- Instrument-assisted soft tissue mobilization and Routine rehabilitation programe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jan 2024to 27 Sep 2024
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having volar plate applied due to distal radius fracture being over 18 years old
- No major postoperative complications (such as neurovascular injury, hematoma)
Who cannot join
- presence of polytrauma
- Surgical intervention other than volar plate
- History of previous limb-related surgery
- Hemiplegia in the involved limb
- Contracture in the involved limb
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kirsehir Research and Training Hospital
Kırşehir, Kişrsehşr, 40100
About this study
Distal radius fractures are the most common fractures when looking at upper extremity fractures . The incidence of distal radius fractures is increasing day by day, and when looking at the databases of various countries, the annual prevalence reaches 70,000 in the UK and 640,000 in the USA. Most of them are related to osteoporosis, and if appropriate treatment is not given, they cause loss of work capacity, permanent disability, and limitation in daily activities . There are publications showing that short immobilization and appropriate rehabilitation after surgery provide good clinical results. In cases that are not properly rehabilitated after surgery, there may be an average delay of 12 weeks in returning to normal life and returning to work. When patients who were given early mobilization and rehabilitation after surgery were examined, it was observed that there was a significant improvement in wrist functions, range of motion, and grip strength . Instrumented soft tissue mobilization is a unique soft tissue mobilization combined with active mobility and stretching exercises that is prescribed to increase joint range of motion in patients with musculoskeletal injuries. The various sizes and beveled edges of the stainless steel instruments allow physical therapists to tailor the treatment to different muscle structures that experience myofascial restrictions. Instrumented soft tissue mobilization aims to reduce fascial limitations by increasing circulation. Increases in localized blood flow and soft tissue realignment promote muscle function, increased normal joint movement, and decreased pain.
Read the detailed description
Instrument-assisted soft tissue mobilization (IATSM) has been studied in musculoskeletal system diseases of the upper extremity, lower extremity and spine. The first randomized controlled study examining the effect of the IASTM technique in trigger point treatment was conducted in 2014. A recent review reports that interest in the IASTM technique in musculoskeletal diseases has increased in recent years, but there is not enough evidence to support its use. It has been reported that randomized controlled studies have a high bias rate and are of low quality. In a recent article, IASTM was applied to cases with limited joint range of motion due to elbow fracture. Bhosale et al. They reported its effectiveness on pain, pain-related disability and joint range of motion .
Reducing pain and edema after Distal Radius fracture is an important part of postoperative rehabilitation. Various mobilization methods have been applied to this patient population in the postoperative period. There is no study in the literature evaluating the effectiveness of adding IASTM to the postoperative rehabilitation program in patients who underwent surgery for distal radius fractures.
This study aimed to evaluate the effect of adding IASTM to the postoperative rehabilitation program on pain, edema, joint range of motion and functionality in patients who underwent surgery due to distal radius fracture.
- Being tested
- Instrument-assisted soft tissue mobilization, Routine rehabilitation programe
- Keywords
- Instrument-assisted soft tissue mobilization, Distal Radius Fractures, edema, manuel therapy
- Medical subject headings
- Wrist Fractures, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument-assisted soft tissue mobilizationDevice
Instrumented soft tissue mobilization is a type of manual therapy method.Istrumented soft tissue mobilization aims to reduce fascial limitations by increasing circulation. Increases in localized blood flow and soft tissue realignment promote muscle function, increased normal joint movement, and decreased pain.
Routine rehabilitation programeOther
Routine rehabilitation programe consisting of stretching and strengthening exercises will be applied.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | In addition to the routine physical therapy program, Instrument-assisted soft tissue mobilization will be applied 3 days a week, for a total of 18 sessions. Each session will last 5 minutes. Receives: Device: Instrument-assisted soft tissue mobilization; Other: Routine rehabilitation programe |
| Control group | Other | Only the routine physical therapy program will be applied. Receives: Other: Routine rehabilitation programe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale
Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale. Patients are asked to indicate their pain level, with 0 points being no pain, 5 points being moderate pain, and 10 points being unbearable pain. Increased scores indicate higher pain levels. Activity and rest VAS will be evaluated.
Measured: Day 0
Visual analog scale
Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale. Patients are asked to indicate their pain level, with 0 points being no pain, 5 points being moderate pain, and 10 points being unbearable pain. Increased scores indicate higher pain levels. Activity and rest VAS will be evaluated.
Measured: 4th week
Visual analog scale
Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale. Patients are asked to indicate their pain level, with 0 points being no pain, 5 points being moderate pain, and 10 points being unbearable pain. Increased scores indicate higher pain levels. Activity and rest VAS will be evaluated.
Measured: 6th week
Wrist joint range of motion
Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Measured: Day 0
Wrist joint range of motion
Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Measured: 4th week
Wrist joint range of motion
Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Measured: 6th week
Circumference (mm)
Environmental Measurement; Both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.
Measured: Day 0
Circumference (mm)
Environmental Measurement; Both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.
Measured: 4th week
Circumference (mm)
Environmental Measurement; Both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.
Measured: 6th week
Secondary outcomes (6)
Gross Grip Strength:
Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength
Measured: Day 0
Gross Grip Strength:
Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength
Measured: 4th week
Gross Grip Strength:
Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength
Measured: 6 th week
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Patient-Rated Wrist Evaluation (PRWE) questionnaire: PRWE is a 15-item questionnaire.High scores indicate functional impairment designed to measure wrist pain and disability in activities of daily living.The maximum score that can be obtained from the pain subscale is 50 and the minimum is 0.
The maximum score that can be obtained from the function subscale is 50 and the minimum is 0.
Measured: Day 0
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Patient-Rated Wrist Evaluation (PRWE) questionnaire: PRWE is a 15-item questionnaire.High scores indicate functional impairment designed to measure wrist pain and disability in activities of daily living.The maximum score that can be obtained from the pain subscale is 50 and the minimum is 0.
The maximum score that can be obtained from the function subscale is 50 and the minimum is 0.
Measured: 4th week
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Patient-Rated Wrist Evaluation (PRWE) questionnaire: PRWE is a 15-item questionnaire.High scores indicate functional impairment designed to measure wrist pain and disability in activities of daily living.The maximum score that can be obtained from the pain subscale is 50 and the minimum is 0.
The maximum score that can be obtained from the function subscale is 50 and the minimum is 0.
Measured: 6 th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start3 Jan 2024
- Primary completion16 Aug 2024
- Study completion27 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Distal Radius FracturesStudies 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
- Model description
- Randomised controlled
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahi Evran University Education and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Levent Horoz, Ahi Evran University Education and Research Hospital
- Investigators
- Levent Horoz, Asst Prof, Principal investigator, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194604
- Sponsor's protocol ID
- 118349
- Status last verified
- Oct 2024
- First submitted
- 22 Dec 2023
- Last updated
- 28 Oct 2024
- 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 28 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Instrument-Assısted Soft Tissue Mobılızatıon in Patients With Operated Distal Radius Fracture
- ClinicalTrials.gov ID
- NCT06194604
- Acronym / sponsor ID
- 118349
- Keywords
- Instrument-assisted soft tissue mobilization, Distal Radius Fractures, edema, manuel therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Ahi Evran University Education and Research HospitalUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 27 Sep 2024 (actual)
- First posted
- 8 Jan 2024 (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.
Distal radius fractures are the most common fractures when looking at upper extremity fractures . The incidence of distal radius fractures is increasing day by day, and when looking at the databases of various countries, the annual prevalence reaches 70,000 in the UK and 640,000 in the USA. Most of them are related to osteoporosis, and if appropriate treatment is not given, they cause loss of work capacity, permanent disability, and limitation in daily activities . There are publications showing that short immobilization and appropriate rehabilitation after surgery provide good clinical results. In cases that are not properly rehabilitated after surgery, there may be an average delay of 12 weeks in returning to normal life and returning to work. When patients who were given early mobilization and rehabilitation after surgery were examined, it was observed that there was a significant improvement in wrist functions, range of motion, and grip strength . Instrumented soft tissue mobilization is a unique soft tissue mobilization combined with active mobility and stretching exercises that is prescribed to increase joint range of motion in patients with musculoskeletal injuries. The various sizes and beveled edges of the stainless steel instruments allow physical therapists to tailor the treatment to different muscle structures that experience myofascial restrictions. Instrumented soft tissue mobilization aims to reduce fascial limitations by increasing circulation. Increases in localized blood flow and soft tissue realignment promote muscle function, increased normal joint movement, and decreased pain.
Detailed description
Instrument-assisted soft tissue mobilization (IATSM) has been studied in musculoskeletal system diseases of the upper extremity, lower extremity and spine. The first randomized controlled study examining the effect of the IASTM technique in trigger point treatment was conducted in 2014. A recent review reports that interest in the IASTM technique in musculoskeletal diseases has increased in recent years, but there is not enough evidence to support its use. It has been reported that randomized controlled studies have a high bias rate and are of low quality. In a recent article, IASTM was applied to cases with limited joint range of motion due to elbow fracture. Bhosale et al. They reported its effectiveness on pain, pain-related disability and joint range of motion .
Reducing pain and edema after Distal Radius fracture is an important part of postoperative rehabilitation. Various mobilization methods have been applied to this patient population in the postoperative period. There is no study in the literature evaluating the effectiveness of adding IASTM to the postoperative rehabilitation program in patients who underwent surgery for distal radius fractures.
This study aimed to evaluate the effect of adding IASTM to the postoperative rehabilitation program on pain, edema, joint range of motion and functionality in patients who underwent surgery due to distal radius fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: Instrument-assisted soft tissue mobilization, Other: Routine rehabilitation programeIn addition to the routine physical therapy program, Instrument-assisted soft tissue mobilization will be applied 3 days a week, for a total of 18 sessions. Each session will last 5 minutes. |
| Control group | Other | Other: Routine rehabilitation programeOnly the routine physical therapy program will be applied. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having volar plate applied due to distal radius fracture being over 18 years old
- No major postoperative complications (such as neurovascular injury, hematoma)
Key exclusion criteria (5 listed)
- presence of polytrauma
- Surgical intervention other than volar plate
- History of previous limb-related surgery
- Hemiplegia in the involved limb
- Contracture in the involved limb
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 |
|---|---|---|
| Instrument-assisted soft tissue mobilizationInstrumented soft tissue mobilization is a type of manual therapy method.Istrumented soft tissue mobilization aims to reduce fascial limitations by increasing circulation. Increases in localized blood flow and soft tissue realignment promote muscle function, increased normal joint movement, and decreased pain. | Device | experimental group |
| Routine rehabilitation programeRoutine rehabilitation programe consisting of stretching and strengthening exercises will be applied. | Other | Control group, experimental group |
Primary outcome
Visual analog scale
Time frame: Day 0
Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale. Patients are asked to indicate their pain level, with 0 points being no pain, 5 points being moderate pain, and 10 points being unbearable pain. Increased scores indicate higher pain levels. Activity and rest VAS will be evaluated.
Visual analog scale
Time frame: 4th week
Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale. Patients are asked to indicate their pain level, with 0 points being no pain, 5 points being moderate pain, and 10 points being unbearable pain. Increased scores indicate higher pain levels. Activity and rest VAS will be evaluated.
Visual analog scale
Time frame: 6th week
Visual analog scale (VAS) was used for pain assessment. VAS is a 10-point Likert scale. Patients are asked to indicate their pain level, with 0 points being no pain, 5 points being moderate pain, and 10 points being unbearable pain. Increased scores indicate higher pain levels. Activity and rest VAS will be evaluated.
Wrist joint range of motion
Time frame: Day 0
Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Wrist joint range of motion
Time frame: 4th week
Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Wrist joint range of motion
Time frame: 6th week
Wrist joint range of motion: Measurement of wrist joint range of motion (ROM) with a goniometer is the most frequently used method in clinical practice that provides objective evaluation and error-free measurement. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method. This method is a painless and non-invasive measurement method.
Circumference (mm)
Time frame: Day 0
Environmental Measurement; Both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.
Circumference (mm)
Time frame: 4th week
Environmental Measurement; Both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.
Circumference (mm)
Time frame: 6th week
Environmental Measurement; Both hands and wrists of the patient will be measured with the help of a tape measure using the figure of eight method. The cm difference between both upper extremities will be recorded.
6 secondary outcomes
Gross Grip Strength:
Time frame: Day 0
Gross Grip Strength:
Time frame: 4th week
Gross Grip Strength:
Time frame: 6 th week
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Time frame: Day 0
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Time frame: 4th week
Patient-Rated Wrist Evaluation (PRWE) questionnaire
Time frame: 6 th week
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 28 Oct 2024.
- 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.
Levent Horoz, Asst Prof principal investigator
Kirsehir Ahi Evran Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument-assisted soft tissue mobilization and Routine rehabilitation programe in people with Distal Radius Fractures and Instrument-assisted Soft Tissue Mobilization, run by Ahi Evran University Education and Research Hospital 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 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 28 Oct 2024. 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?
Visual analog scale (time frame: Day 0). The study lists 9 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 28 Oct 2024.