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

NCT06194604 | Completed

• 1 other identifier: 118349
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Distal Radius Fractures; Instrument-assisted Soft Tissue Mobilization

Keywords

Instrument-assisted soft tissue mobilization; Distal Radius Fractures; edema; manuel therapy

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (6)

• Gross Grip Strength:

  Day 0

• Gross Grip Strength:

  4th week

• Gross Grip Strength:

  6 th week

• Patient-Rated Wrist Evaluation (PRWE) questionnaire

  Day 0

• Patient-Rated Wrist Evaluation (PRWE) questionnaire

  4th week

Study Arms (2)

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.

Device: Instrument-assisted soft tissue mobilization; Other: Routine rehabilitation programe

Control group

OTHER

Only the routine physical therapy program will be applied.

Other: Routine rehabilitation programe

Interventions

Instrument-assisted soft tissue mobilization 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.

experimental group

Routine rehabilitation programe OTHER

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

Control group; experimental group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having volar plate applied due to distal radius fracture being over 18 years old
• No major postoperative complications (such as neurovascular injury, hematoma)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahi Evran University Education and Research Hospital: lead

Study Sites (1)

Kirsehir Research and Training Hospital

Kırşehir, Kişrsehşr, 40100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Wrist Fractures; Edema

Condition Hierarchy (Ancestors)

Wrist Injuries; Arm Injuries; Wounds and Injuries; Fractures, Bone; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Levent Horoz, Asst Prof

  Kirsehir Ahi Evran University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Investigator and The outcomes assesor different persons
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof

Model Details: Randomised controlled

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 8, 2024
• Study Start: January 3, 2024
• Primary Completion: August 16, 2024
• Study Completion: September 27, 2024
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)