NCT06302920

Brief Summary

Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. Afterwards, edema-reducing kinesiotaping will be applied to one group. The applied kinesio tape will remain on the patient for 5 days and will be taped again after 2 days without tape. In this way, taping will be done 3 times in total, once a week for 3 weeks. During this period, patients will continue their routine physical therapy program and measurements will be taken by the same researcher in the 1st week of treatment and 3 weeks later.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

February 7, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 20, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

February 7, 2024

Last Update Submit

March 7, 2024

Conditions

Keywords

complex regional pain syndromekinesiotapingKinesiophobia

Outcome Measures

Primary Outcomes (3)

  • Resting pain

    The resting pain level of the patients will be measured with the Visual Analogue Scale (VAS).A score between 0 and 10 will be determined by the patient, with 0 being no pain and 10 being the most severe pain level.

    Beginning, week 3 and week 6

  • Edema

    The patients will be physically examined and their wrist circumference and metacarpal circumference will be measured in centimeters.

    Beginning, week 3 and week 6

  • Kinesiophobia

    Kinesiophobia will be assessed using the Tampa Scale for Kinesiophobia. A score above 37 in the test is defined as an indicator of a high level of kinesiophobia.

    Beginning, week 3 and week 6

Study Arms (2)

Kinesiotaping group

ACTIVE COMPARATOR

Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support. Afterwards, edema-reducing kinesiotaping will be applied to one group.

Device: Kinesiotape

Control group

NO INTERVENTION

Patients will be divided into 2 groups according to the random numbers table, and both groups will receive a conventional physical therapy and rehabilitation program and nutritional support.

Interventions

Lymphatic correction technique

Kinesiotaping group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of reflex sympathetic dystrophy Ability to be included in a physical therapy program

You may not qualify if:

  • Hemiplegia Malignancy Polyacrylamide allergy Open wound in the area to be applied

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alanya Alaaddin Keykubat University

Antalya, Turkey (Türkiye)

Location

Related Publications (3)

  • Fischer SGL, Zuurmond WWA, Birklein F, Loer SA, Perez RSGM. Anti-inflammatory treatment of Complex Regional Pain Syndrome. Pain. 2010 Nov;151(2):251-256. doi: 10.1016/j.pain.2010.07.020. Epub 2010 Aug 7. No abstract available.

    PMID: 20692766BACKGROUND
  • Çeliker R, Güven Z, Aydoǧ T, et al. Kinezyolojik bantlama tekniǧi ve uygulama alanlari. Turkiye Fiz Tip ve Rehabil Derg. 2011;57(4):225-235.

    BACKGROUND
  • Roelofs J, van Breukelen G, Sluiter J, Frings-Dresen MHW, Goossens M, Thibault P, Boersma K, Vlaeyen JWS. Norming of the Tampa Scale for Kinesiophobia across pain diagnoses and various countries. Pain. 2011 May;152(5):1090-1095. doi: 10.1016/j.pain.2011.01.028.

    PMID: 21444153BACKGROUND

MeSH Terms

Conditions

Complex Regional Pain SyndromesKinesiophobia

Interventions

Athletic Tape

Condition Hierarchy (Ancestors)

Autonomic Nervous System DiseasesNervous System DiseasesPeripheral Nervous System DiseasesNeuromuscular DiseasesPhobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

BandagesEquipment and SuppliesOrthotic DevicesOrthopedic EquipmentSurgical Equipment

Study Officials

  • Deniz Bulut, A.professor

    Alanya Alaaddin Keykubat University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Deniz Bulut, A.professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

February 7, 2024

First Posted

March 12, 2024

Study Start

May 20, 2024

Primary Completion

June 20, 2024

Study Completion

December 20, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations