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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05623865
Other study ID # KAEK_
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2022
Est. completion date August 1, 2023

Study information

Verified date August 2023
Source Ahi Evran University Education and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date August 1, 2023
Est. primary completion date July 20, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Patients who underwent plaster treatment for distal radius fracture 2. Patients over 18 years old Exclusion Criteria: 1. To have been treated for lymphedema in the upper extremity before 2. Patients who have been operated for breast cancer 3. Bilateral distal raidus fracture 4. History of previous surgery related to the same extremity 5. Pathological fracture 6. Open fracture, active infection in the involved extremity 7. Presence of diseases with clinical course with peripheral edema such as heart failure, pulmonary hypertension 8. Cognitive dysfunction that impairs perception of test instructions

Study Design


Intervention

Other:
kinesiotaping
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
exercise
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.

Locations

Country Name City State
Turkey Ahi Evran University Kirsehir City Centre

Sponsors (1)

Lead Sponsor Collaborator
Ahi Evran University Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
0 (baseline)
Primary 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.
5th day
Primary 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.
10th day
Primary 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.
0 (baseline)
Primary 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.
5th day
Primary 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.
10th day
Primary 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. 0 (baseline)
Primary 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. 5th day
Primary 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. 10th day
Secondary 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. 0 (baseline)
Secondary 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. 5th day
Secondary 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. 10th day
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