Effects of Lymph Drainage on Patients With Axillary Web Syndrome

NCT ID: NCT06438848

Last Updated: 2024-06-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2024-09-30

Brief 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.

Detailed 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).

Conditions

Movement Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Physical therapy program

Intervention Type: OTHER

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

Group Type: EXPERIMENTAL

Physical therapy program with lymphedema drainage

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taif University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Mohammad Alkayshan

Physical therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hassan Alzahrani, PHD

Role: STUDY_CHAIR

Taif University

Central Contacts

Ibrahim Alkayshan, Bachelorette

Role: CONTACT

Ibrahim.alkayshan@gmail.com

0096650127261

Alaa Baboor, Bachelorette

Role: CONTACT

Alaa.s.baboor@hotmail.com

00966596628155

Other Identifiers

24-1241

Identifier Type: -

Identifier Source: org_study_id