NCT05623865

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2022

Completed
Same day until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2023

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2023

Completed
Last Updated

August 2, 2023

Status Verified

August 1, 2023

Enrollment Period

8 months

First QC Date

November 15, 2022

Last Update Submit

August 1, 2023

Conditions

Keywords

Distal Radius Fracturekinesiotapingedema

Outcome Measures

Primary Outcomes (9)

  • 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)

  • 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

  • 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

  • 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)

  • 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

  • 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

  • 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)

  • 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

  • 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 Outcomes (3)

  • functionality

    0 (baseline)

  • functionality

    5th day

  • functionality

    10th day

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Other: kinesiotapingOther: exercise

Control group

OTHER

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.

Other: exercise

Interventions

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

Experimental group

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.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent plaster treatment for distal radius fracture
  • Patients over 18 years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahi Evran University

Kirşehir, City Centre, 40100, Turkey (Türkiye)

Location

Related Publications (6)

  • 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.

    PMID: 32169973BACKGROUND
  • 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.

    PMID: 16287669BACKGROUND
  • 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.

    PMID: 21193287BACKGROUND
  • 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.

    PMID: 23841976BACKGROUND
  • 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.

    PMID: 32459670BACKGROUND
  • 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.

    PMID: 11195876BACKGROUND

MeSH Terms

Conditions

Wrist FracturesEdema

Interventions

Exercise

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, BoneSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Levent Horoz, Asisst Prof

    Kirsehir Ahi Evran Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
medical doctor, asisst prof

Study Record Dates

First Submitted

November 15, 2022

First Posted

November 21, 2022

Study Start

November 15, 2022

Primary Completion

July 20, 2023

Study Completion

August 1, 2023

Last Updated

August 2, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations