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The Effect of Kinesio Taping on Edema Control and Wrist Functions in Conservatively Followed Distal Radius Fractures.

Primary Purpose

Distal Radius Fracture

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
kinesiotaping
exercise
Sponsored by
Ahi Evran University Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring Distal Radius Fracture, kinesiotaping, edema

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who underwent plaster treatment for distal radius fracture Patients over 18 years old Exclusion Criteria: To have been treated for lymphedema in the upper extremity before Patients who have been operated for breast cancer Bilateral distal raidus fracture History of previous surgery related to the same extremity Pathological fracture Open fracture, active infection in the involved extremity Presence of diseases with clinical course with peripheral edema such as heart failure, pulmonary hypertension Cognitive dysfunction that impairs perception of test instructions

Sites / Locations

  • Ahi Evran University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Experimental group

Control group

Arm Description

After the initial evaluation, the patients will be randomly divided into two groups as the Experimental group and the control group.Experimental group will receive kinesiotape treatment in addition to those applied in the control group. Kinesiotape to the kinesio tape group will be done by a PM&R spesialist doctor who has a certificate of kinesiotaping, in accordance with the literature, using the lymphedema method.

Elevation and cold application, which is applied in the prevention and treatment of classical edema, will be recommended to the control group. In addition, wrist, elbow, finger range of motion and stretching exercises will be taught as a home exercise program.

Outcomes

Primary Outcome Measures

volume measurement
The volume measurement of the patients after the cast will be measured with the upper extremity volumetric measuring device. The measurement will be made in comparison with each intact extremity. The measurement will be made standing up and at room temperature.Both extremity volume data will be recorded. The volume measurement of the patients after the cast will be measured with the upper extremity volumetric measuring device.The measurement will be made in comparison with each intact extremity. The measurement will be made standing up and at room temperature. Both extremity volume data will be recorded.
volume measurement
The volume measurement of the patients after the cast will be measured with the upper extremity volumetric measuring device. The measurement will be made in comparison with each intact extremity. The measurement will be made standing up and at room temperature.Both extremity volume data will be recorded. The volume measurement of the patients after the cast will be measured with the upper extremity volumetric measuring device.The measurement will be made in comparison with each intact extremity. The measurement will be made standing up and at room temperature. Both extremity volume data will be recorded.
volume measurement
The volume measurement of the patients after the cast will be measured with the upper extremity volumetric measuring device. The measurement will be made in comparison with each intact extremity. The measurement will be made standing up and at room temperature.Both extremity volume data will be recorded. The volume measurement of the patients after the cast will be measured with the upper extremity volumetric measuring device.The measurement will be made in comparison with each intact extremity. The measurement will be made standing up and at room temperature. Both extremity volume data will be recorded.
range of motion measurement
Wrist joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method.
range of motion measurement
Wrist joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method.
range of motion measurement
Wrist joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method.
Diameter Measurement
Both hands and wrists of the patient will be measured with the figure of eight method with the help of a tape measure.In addition, measurements will be made at the level of the bilateral wrist, metacarpophalangeal joint, and 6 cm proximal to the wrist.
Diameter Measurement
Both hands and wrists of the patient will be measured with the figure of eight method with the help of a tape measure.In addition, measurements will be made at the level of the bilateral wrist, metacarpophalangeal joint, and 6 cm proximal to the wrist.
Diameter Measurement
Both hands and wrists of the patient will be measured with the figure of eight method with the help of a tape measure.In addition, measurements will be made at the level of the bilateral wrist, metacarpophalangeal joint, and 6 cm proximal to the wrist.

Secondary Outcome Measures

functionality
The short version of the Arm, Shoulder and Hand Questionnaire (Quick-DASH) Disability will be used to evaluate the functional status of the patients. Quick-DASH is a self-report questionnaire designed to measure physical function and symptoms in people with upper extremity musculoskeletal conditions. Turkish validity and reliability was established.
functionality
The short version of the Arm, Shoulder and Hand Questionnaire (Quick-DASH) Disability will be used to evaluate the functional status of the patients. Quick-DASH is a self-report questionnaire designed to measure physical function and symptoms in people with upper extremity musculoskeletal conditions. Turkish validity and reliability was established.
functionality
The short version of the Arm, Shoulder and Hand Questionnaire (Quick-DASH) Disability will be used to evaluate the functional status of the patients. Quick-DASH is a self-report questionnaire designed to measure physical function and symptoms in people with upper extremity musculoskeletal conditions. Turkish validity and reliability was established.

Full Information

First Posted
November 15, 2022
Last Updated
August 1, 2023
Sponsor
Ahi Evran University Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05623865
Brief Title
The Effect of Kinesio Taping on Edema Control and Wrist Functions in Conservatively Followed Distal Radius Fractures.
Official Title
The Effect of Kinesio Taping on Edema Control and Wrist Functions in Conservatively Followed Distal Radius Fractures.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
July 20, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahi Evran University Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Kinesio tape is used successfully in the control of edema related to the extremity, especially in the control of lymphedema that develops after surgery.Kinesiotape is a non-allergic elastic tape applied to the skin surface.There are publications showing that kinesio tape applications are beneficial for edema control after interventional procedures such as anterior cruciate ligament surgery and knee prosthesis related to orthopedic surgical interventions. There is no publication on the effectiveness of kinesio tape application in the control and rehabilitation of post-cast edema of wrist fractures.It is planned to investigate the positive effects of kinesio tape in edema control and rehabilitation.
Detailed Description
The prevalence of distal radius fracture is increasing day by day. Circular cast is applied in 70-80% of patients treated for distal radius fractures.During the rehabilitation of patients after plaster application, joint stiffness, swelling on the hand and wrist, and edema are frequently encountered.Edema in the hand and wrist negatively affects the daily activities of patients, their quality of life, wrist and finger functions. Edema is the main problem in rehabilitation after upper extremity injuries.It is known that fibrosis and adhesions in soft tissues develop as a result of prolonged extremity edema. Elevation, massage, cold application, pressure gloves are used for edema control. Kinesio tape is used successfully in the control of edema related to the extremity, especially in the control of lymphedema that develops after surgery.Kinesiotape is a non-allergic elastic tape applied to the skin surface. Kinesio Tape working mechanism opens the distance between the skin and subcutaneous tissues after it is applied to the skin and increases lymphatic drainage. Kinesio tape also has the effect of supporting the joint and soft tissues around the joint. Research on kinesio tape has generally focused on the control of lymphedema that develops after breast cancer surgery or stroke. There are publications showing that kinesio tape applications are beneficial for edema control after interventional procedures such as anterior cruciate ligament surgery and knee prosthesis related to orthopedic surgical interventions. Considering the studies conducted for edema control in patients treated for distal radius fractures, the effect of massage applications on edema has been investigated and it has been shown that massage has positive effects on edema control and wrist functions(9). In another study, the effectiveness of modified massage methods in the treatment of edema was investigated and its positive effects were observed. There is no publication on the effectiveness of kinesio tape application in the control and rehabilitation of post-cast edema of wrist fractures. It is planned to investigate the positive effects of kinesio tape in edema control and rehabilitation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture
Keywords
Distal Radius Fracture, kinesiotaping, edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
Outcomes Assessor
Masking Description
The person who evaluates the outcome criteria and the person who makes the interventions are different. The person who evaluates the outcome criteria is blind.
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
After the initial evaluation, the patients will be randomly divided into two groups as the Experimental group and the control group.Experimental group will receive kinesiotape treatment in addition to those applied in the control group. Kinesiotape to the kinesio tape group will be done by a PM&R spesialist doctor who has a certificate of kinesiotaping, in accordance with the literature, using the lymphedema method.
Arm Title
Control group
Arm Type
Other
Arm Description
Elevation and cold application, which is applied in the prevention and treatment of classical edema, will be recommended to the control group. In addition, wrist, elbow, finger range of motion and stretching exercises will be taught as a home exercise program.
Intervention Type
Other
Intervention Name(s)
kinesiotaping
Intervention Description
Kinesio tape will be attached with lymphedema technique. The bands will be removed prior to each assessment so that they do not affect the evaluator's blinding. After evaluation, the new tape will be fitted by the invesitgatör
Intervention Type
Other
Intervention Name(s)
exercise
Intervention Description
Wrist, finger, elbow range of motion and stretching exercises will be taught to the patients and given as home exercises. In addition, patients will be given a leaflet containing illustrated and explanatory exercise visuals.
Primary Outcome Measure Information:
Title
volume measurement
Description
The volume measurement of the patients after the cast will be measured with the upper extremity volumetric measuring device. The measurement will be made in comparison with each intact extremity. The measurement will be made standing up and at room temperature.Both extremity volume data will be recorded. The volume measurement of the patients after the cast will be measured with the upper extremity volumetric measuring device.The measurement will be made in comparison with each intact extremity. The measurement will be made standing up and at room temperature. Both extremity volume data will be recorded.
Time Frame
0 (baseline)
Title
volume measurement
Description
The volume measurement of the patients after the cast will be measured with the upper extremity volumetric measuring device. The measurement will be made in comparison with each intact extremity. The measurement will be made standing up and at room temperature.Both extremity volume data will be recorded. The volume measurement of the patients after the cast will be measured with the upper extremity volumetric measuring device.The measurement will be made in comparison with each intact extremity. The measurement will be made standing up and at room temperature. Both extremity volume data will be recorded.
Time Frame
5th day
Title
volume measurement
Description
The volume measurement of the patients after the cast will be measured with the upper extremity volumetric measuring device. The measurement will be made in comparison with each intact extremity. The measurement will be made standing up and at room temperature.Both extremity volume data will be recorded. The volume measurement of the patients after the cast will be measured with the upper extremity volumetric measuring device.The measurement will be made in comparison with each intact extremity. The measurement will be made standing up and at room temperature. Both extremity volume data will be recorded.
Time Frame
10th day
Title
range of motion measurement
Description
Wrist joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method.
Time Frame
0 (baseline)
Title
range of motion measurement
Description
Wrist joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method.
Time Frame
5th day
Title
range of motion measurement
Description
Wrist joint range of motion (ROM) measurement with goniometer is the most commonly used method that provides objective evaluation and error-free measurement in clinical practice. In our study, wrist ROM measurements will be made with a goniometer using the neutral zero method.
Time Frame
10th day
Title
Diameter Measurement
Description
Both hands and wrists of the patient will be measured with the figure of eight method with the help of a tape measure.In addition, measurements will be made at the level of the bilateral wrist, metacarpophalangeal joint, and 6 cm proximal to the wrist.
Time Frame
0 (baseline)
Title
Diameter Measurement
Description
Both hands and wrists of the patient will be measured with the figure of eight method with the help of a tape measure.In addition, measurements will be made at the level of the bilateral wrist, metacarpophalangeal joint, and 6 cm proximal to the wrist.
Time Frame
5th day
Title
Diameter Measurement
Description
Both hands and wrists of the patient will be measured with the figure of eight method with the help of a tape measure.In addition, measurements will be made at the level of the bilateral wrist, metacarpophalangeal joint, and 6 cm proximal to the wrist.
Time Frame
10th day
Secondary Outcome Measure Information:
Title
functionality
Description
The short version of the Arm, Shoulder and Hand Questionnaire (Quick-DASH) Disability will be used to evaluate the functional status of the patients. Quick-DASH is a self-report questionnaire designed to measure physical function and symptoms in people with upper extremity musculoskeletal conditions. Turkish validity and reliability was established.
Time Frame
0 (baseline)
Title
functionality
Description
The short version of the Arm, Shoulder and Hand Questionnaire (Quick-DASH) Disability will be used to evaluate the functional status of the patients. Quick-DASH is a self-report questionnaire designed to measure physical function and symptoms in people with upper extremity musculoskeletal conditions. Turkish validity and reliability was established.
Time Frame
5th day
Title
functionality
Description
The short version of the Arm, Shoulder and Hand Questionnaire (Quick-DASH) Disability will be used to evaluate the functional status of the patients. Quick-DASH is a self-report questionnaire designed to measure physical function and symptoms in people with upper extremity musculoskeletal conditions. Turkish validity and reliability was established.
Time Frame
10th day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who underwent plaster treatment for distal radius fracture Patients over 18 years old Exclusion Criteria: To have been treated for lymphedema in the upper extremity before Patients who have been operated for breast cancer Bilateral distal raidus fracture History of previous surgery related to the same extremity Pathological fracture Open fracture, active infection in the involved extremity Presence of diseases with clinical course with peripheral edema such as heart failure, pulmonary hypertension Cognitive dysfunction that impairs perception of test instructions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Levent Horoz, Asisst Prof
Organizational Affiliation
Kirsehir Ahi Evran Universitesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahi Evran University
City
Kirşehir
State/Province
City Centre
ZIP/Postal Code
40100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32169973
Citation
Crowe CS, Massenburg BB, Morrison SD, Chang J, Friedrich JB, Abady GG, Alahdab F, Alipour V, Arabloo J, Asaad M, Banach M, Bijani A, Borzi AM, Briko NI, Castle CD, Cho DY, Chung MT, Daryani A, Demoz GT, Dingels ZV, Do HT, Fischer F, Fox JT, Fukumoto T, Gebre AK, Gebremichael B, Haagsma JA, Haj-Mirzaian A, Handiso DW, Hay SI, Hoang CL, Irvani SSN, Jozwiak JJ, Kalhor R, Kasaeian A, Khader YS, Khalilov R, Khan EA, Khundkar R, Kisa S, Kisa A, Liu Z, Majdan M, Manafi N, Manafi A, Manda AL, Meretoja TJ, Miller TR, Mohammadian-Hafshejani A, Mohammadpourhodki R, Mohseni Bandpei MA, Mokdad AH, Naimzada MD, Ndwandwe DE, Nguyen CT, Nguyen HLT, Olagunju AT, Olagunju TO, Pham HQ, Pribadi DRA, Rabiee N, Ramezanzadeh K, Ranganathan K, Roberts NLS, Roever L, Safari S, Samy AM, Sanchez Riera L, Shahabi S, Smarandache CG, Sylte DO, Tesfay BE, Tran BX, Ullah I, Vahedi P, Vahedian-Azimi A, Vos T, Woldeyes DH, Wondmieneh AB, Zhang ZJ, James SL. Global trends of hand and wrist trauma: a systematic analysis of fracture and digit amputation using the Global Burden of Disease 2017 Study. Inj Prev. 2020 Oct;26(Supp 1):i115-i124. doi: 10.1136/injuryprev-2019-043495. Epub 2020 Mar 13.
Results Reference
background
PubMed Identifier
16287669
Citation
Cheing GL, Wan JW, Kai Lo S. Ice and pulsed electromagnetic field to reduce pain and swelling after distal radius fractures. J Rehabil Med. 2005 Nov;37(6):372-7. doi: 10.1080/16501970510041055.
Results Reference
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PubMed Identifier
21193287
Citation
Knygsand-Roenhoej K, Maribo T. A randomized clinical controlled study comparing the effect of modified manual edema mobilization treatment with traditional edema technique in patients with a fracture of the distal radius. J Hand Ther. 2011 Jul-Sep;24(3):184-93; quiz 194. doi: 10.1016/j.jht.2010.10.009. Epub 2010 Dec 30.
Results Reference
background
PubMed Identifier
23841976
Citation
Bell A, Muller M. Effects of kinesio tape to reduce hand edema in acute stroke. Top Stroke Rehabil. 2013 May-Jun;20(3):283-8. doi: 10.1310/tsr2003-283.
Results Reference
background
PubMed Identifier
32459670
Citation
Tornatore L, De Luca ML, Ciccarello M, Benedetti MG. Effects of combining manual lymphatic drainage and Kinesiotaping on pain, edema, and range of motion in patients with total knee replacement: a randomized clinical trial. Int J Rehabil Res. 2020 Sep;43(3):240-246. doi: 10.1097/MRR.0000000000000417.
Results Reference
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PubMed Identifier
11195876
Citation
Haren K, Backman C, Wiberg M. Effect of manual lymph drainage as described by Vodder on oedema of the hand after fracture of the distal radius: a prospective clinical study. Scand J Plast Reconstr Surg Hand Surg. 2000 Dec;34(4):367-72. doi: 10.1080/028443100750059165.
Results Reference
background

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The Effect of Kinesio Taping on Edema Control and Wrist Functions in Conservatively Followed Distal Radius Fractures.

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