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

NCT ID: NCT06194604

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-03

Study Completion Date

2024-09-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Distal Radius Fractures Instrument-assisted Soft Tissue Mobilization

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The Investigator and The outcomes assesor different persons

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

experimental group

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.

Group Type EXPERIMENTAL

Instrument-assisted soft tissue mobilization

Intervention Type DEVICE

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 programe

Intervention Type OTHER

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

Control group

Only the routine physical therapy program will be applied.

Group Type OTHER

Routine rehabilitation programe

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Routine rehabilitation programe

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ahi Evran University Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Levent Horoz

Asst Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Levent Horoz, Asst Prof

Role: PRINCIPAL_INVESTIGATOR

Kirsehir Ahi Evran University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kirsehir Research and Training Hospital

Kırşehir, Kişrsehşr, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

118349

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sensory Training in Distal Radius Fractures
NCT06894485 NOT_YET_RECRUITING NA