Effects of Lymph Drainage on Patients With Axillary Web Syndrome

Movement Disorders Clinical Trial

Official title:

Effects of a Physical Therapy Program Combined With Manual Lymphatic Drainage on Shoulder Function, , and Pain in Breast Cancer Patients With Axillary Web Syndrome Following Axillary Dissection: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06438848
• Other study ID #: 24-1241
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: September 2024

Study information

• Verified date: May 2024
• Source: Taif University
• Contact: Ibrahim Alkayshan, Bachelorette
• Phone: 0096650127261
• Email: Ibrahim.alkayshan[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Effects of a physical therapy program combined with manual lymphatic drainage on shoulder pain and function, quality of life, lymphedema incidence in breast cancer patients with axillary web syndrome following axillary dissection: A randomized controlled trial.

Description:

This study's objective is to assess the effectiveness of physical therapy (PT) combined with manual lymphatic drainage (MLD) on shoulder pain and function, lymphedema, visible cords, and quality of life (QOL), compared to physical therapy alone, in subjects with breast cancer and suffering of axillary web syndrome (AWS).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: September 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• had a breast cancer dissection with lymphadenectomy and/or sentinel lymph node biopsy and a subsequent appearance of AWS (diagnosed by physical examination and also by using the Screening Test AWS (ST-AWS)) [35].

• suffering of pain that exceeds 6-8 points (measured by the numeric rating scale (NRS)) in the region of the cording on the upper/lower arm, elbow, and dorsum site, and

• have visible or palpable cords in the arm or breast.

Exclusion Criteria:

• suffering of both acute thrombosis and lymphedema,

• suffering of skin issues like infections or musculoskeletal conditions like adhesive capsulitis, rheumatoid arthritis, pectoral muscle tightness, and diseases of the rotator cuff, and/or

• having cording that doesn't involve an arm and only affects the chest or side of the thorax.

Related Conditions & MeSH terms

• Movement Disorders

Intervention

Other:
• Physical therapy program
group will be prescribed a usual physical therapy program three times a week for four weeks, which will be conducted in the clinic. The program consists of eight sessions comprising warm-up and cool-down, stretching activities, and strengthening exercises, and manual therapy. The program will start with 10-minute warm-up and 10-minute cool-down periods of physical therapy sessions
• Physical therapy program with lymphedema drainage
physical therapy program three times a week for four weeks, which will be conducted in the clinic. The program consists of eight sessions comprising warm-up and cool-down, stretching activities, and strengthening exercises,And manual lymphatic drainage prescribed 20 minutes of MLD daily. The program will be prescribed five times a week, for four weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Taif University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Pain intensity will be assessed using the NRS (0-10). A score of 0 means there is no pain, while a score of 10 means presence of severe pain.	5 weeks
Primary	Disability	Assessment of disability will be done using the Arabic Quick-DASH questionnaire which is an 11-item self-report questionnaire, The DASH has five response options for each item from 0=no difficulty to perform or no symptoms to 5=unable to do. A higher score reflects greater disability.	5 weeks
Secondary	Limb Girth	The limb girth will be measured using the tape measurement. Upper limb volumes will be calculated from circumference measurements taken at 4-cm intervals from the dorsum of the wrist to the axilla. The diagnostic criterion for lymphedema was =3 % volume increase from baseline in the affected upper limb.	4 weeks
Secondary	Cording	lymphedema therapist (PT/CLT) will examine the arm and axilla for any visible or palpable cords. The findings will be either positive for cording or negative. It is a nominal qualitative variable.	5 weeks
Secondary	Muscular strength	Using a hand-held dynamometer, the maximum voluntary isometric contraction of the muscles will be used to assess their strength.	5 weeks
Secondary	Range of motion	The active ROM (AROM) will be assessed using a goniometer which has been proved to have reliability and concurrent validity for measuring shoulder mobility measurements	5 weeks
Secondary	Quality of life for participants	The EORTC QLQ-C30 is a 30-item questionnaire including measuring Global Health status (2 items), Functional scales (15 items) and Symptoms scales/items (13 items). Items were measured using a 4-point Likert Scale ranging from Not at all (1) to Very much (4)	5 weeks