Post Mastectomy Shoulder Problems and Kinesio Taping

Post Mastectomy Complications Clinical Trial

Official title:

Investigating the Effect of Kinesio Tape Over the Conventional Physical Therapy Management of Shoulder Related Complications in Post-mastectomy Peri-menopausal Females: A Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749539
• Other study ID #: P.T.REC/012/001249
• Status: Completed
• Phase: N/A
• First received: April 17, 2016
• Last updated: April 22, 2016
• Start date: February 2015
• Est. completion date: January 2016

Study information

• Verified date: April 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

Applications of new treatment modality which is Kinesio tape in post mastectomy shoulder problems.

Description:

Post-mastectomy complications are often noted and complaints by breast cancer survivors. It often involves the development of chronic arm pain with accompanying limitation of shoulder motion. Aim of the study was to investigate the effect of the kinesio tape (KT) on the shoulder pain and range of motion (ROM).

Method: 74 female patients underwent modified radical mastectomy were involved in this study. They were randomly divided into two groups, experimental who received KT for shoulder joint in addition to conventional physiotherapy program while, the control group received the physiotherapy program only. Outcome measures were visual analogues scale, shoulder ROM and shoulder Pain and Disability Index.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 50 Years

Eligibility

Inclusion Criteria:

• Underwent modified radical mastectomy for at least 2 weeks and taking chemotherapy and radiation therapy for stage 1 or II breast cancer.

• Presence of shoulder pain with associated limitation of motion of the shoulder.

• Good compliance and willingness to participate in kinesio taping sessions with a written consent

Exclusion Criteria:

• Still diagnosed with active breast CA at the time of the study.

• Presence of skin hypersensitivity to kinesio tape material.

• Presence of treatment contraindications including the presence of a pacemaker, heart disease, pregnancy, infectious disease, epilepsy thrombophlebitis, arterial hypertension or metastatic cancer .

• Presence of mental disturbances of the sensorium or language problems which can make communication and cooperation problematic.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Post Mastectomy Complications

Intervention

Device:
• Kinesio tape
Standard 2 -inches ( 5-m) Kinesio TexR tape was used for application in the experimental group

Procedure:
• physiotherapy program
active-assistive range of motion exercises (AAROME), active stretching exercises and strengthening exercises for the shoulder joint. Likewise, patients also received postural correction exercises

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	It is a perpendicular line on the scale that corresponded to their perceived pain intensity.	2 weeks change from the baseline scores	Yes
Secondary	The Shoulder Pain and Disability Index (SPADI)	It consists of 13 items that assess two domains; a 5-item subscale which measures pain and an 8-item subscale which measures disability. Total score is calculated by averaging the pain and disability subscale scores.	2 weeks change from the baseline scores	Yes