Effectiveness of Instrument-Assısted Soft Tissue Mobılızatıon in Patients With Operated Distal Radius Fracture

Distal Radius Fractures Clinical Trial

Official title:

Effectiveness of Instrument-Assısted Soft Tissue Mobılızatıon in Patients With Operated Distal Radius Fracture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194604
• Other study ID #: 118349
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2024
• Est. completion date: May 15, 2024

Study information

• Verified date: February 2024
• Source: Ahi Evran University Education and Research Hospital
• Contact: Levent Horoz, Asst Prof
• Phone: +90 386 280 39 00
• Email: dr.leventhoroz[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: May 15, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Having volar plate applied due to distal radius fracture being over 18 years old

• No major postoperative complications (such as neurovascular injury, hematoma)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Distal Radius Fractures
• Fractures, Bone
• Instrument-assisted Soft Tissue Mobilization
• Radius Fractures
• Wrist Fractures

Intervention

Device:
• Instrument-assisted soft tissue mobilization
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.

Other:
• Routine rehabilitation programe
Routine rehabilitation programe consisting of stretching and strengthening exercises will be applied.

Locations

Country	Name	City	State
Turkey	Kirsehir Research and Training Hospital	Kirsehir	Kisrsehsr

Sponsors (1)

Lead Sponsor	Collaborator
Ahi Evran University Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 0
Primary	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.	4th week
Primary	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.	6th week
Primary	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.	Day 0
Primary	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.	4th week
Primary	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.	6th week
Primary	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.	Day 0
Primary	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.	4th week
Primary	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.	6th week
Secondary	Gross Grip Strength:	Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength	Day 0
Secondary	Gross Grip Strength:	Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength	4th week
Secondary	Gross Grip Strength:	Jamar dynamometer wii use to evaluate gross grip strength.Higher values indicate increased grip strength	6 th week
Secondary	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.	Day 0
Secondary	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.	4th week
Secondary	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.	6 th week