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Distal Radius FractureNCT05623865

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

A study testing kinesiotaping and exercise in people with Distal Radius Fracture, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Distal Radius Fracture
What is being tested?
kinesiotaping and exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
61 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Nov 2022to 1 Aug 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Ahi Evran University

    Kirşehir, City Centre, 40100

Other trials in Turkey (Türkiye)

About this study

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.

Read the 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.

Being tested
kinesiotaping, exercise
Keywords
Distal Radius Fracture, kinesiotaping, edema
Medical subject headings
Wrist Fractures, Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • kinesiotapingOther

    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

  • exerciseOther

    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.

Study groups in NCT05623865
Study groupRoleWhat they receive
Experimental groupExperimentalAfter 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.
Receives: Other: kinesiotaping; Other: exercise
Control groupOtherElevation 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.
Receives: Other: exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 0 (baseline)

  2. 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.

    Measured: 5th day

  3. 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.

    Measured: 10th day

  4. 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.

    Measured: 0 (baseline)

  5. 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.

    Measured: 5th day

  6. 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.

    Measured: 10th day

  7. 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.

    Measured: 0 (baseline)

  8. 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.

    Measured: 5th day

  9. 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.

    Measured: 10th day

Secondary outcomes (3)
  1. 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.

    Measured: 0 (baseline)

  2. 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.

    Measured: 5th day

  3. 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.

    Measured: 10th day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2022
  2. Study start15 Nov 2022
  3. Primary completion20 Jul 2023
  4. Study completion1 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05623865
Sponsor's protocol ID
KAEK_
Status last verified
Aug 2023
First submitted
15 Nov 2022
Last updated
2 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32169973
  • 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.

    PubMed 16287669
  • 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.

    PubMed 21193287
  • 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.

    PubMed 23841976
  • 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.

    PubMed 32459670
  • 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.

    PubMed 11195876

Questions about this trial

What is this clinical trial studying?

A study testing kinesiotaping and exercise in people with Distal Radius Fracture, run by Ahi Evran University Education and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

volume measurement (time frame: 0 (baseline)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05623865, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.

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