Effects of Lymph Drainage on Patients With Axillary Web Syndrome

NCT06438848 | Not Yet Recruiting

• 1 other identifier: 24-1241
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Movement Disorders

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Limb Girth

  4 weeks

• Cording

  5 weeks

• Muscular strength

  5 weeks

• Range of motion

  5 weeks

• Quality of life for participants

  5 weeks

Study Arms (2)

Physical therapy program

EXPERIMENTAL

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

Other: Physical therapy program

Physical therapy program with lymphedema drainage

EXPERIMENTAL

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

Other: Physical therapy program with lymphedema drainage

Interventions

Physical therapy program 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

Physical therapy program with lymphedema drainage 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

Physical therapy program with lymphedema drainage

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taif University: lead

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Hassan Alzahrani, PHD

  Taif University

  STUDY CHAIR

Central Study Contacts

Ibrahim Alkayshan, Bachelorette

CONTACT

0096650127261; Ibrahim.alkayshan@gmail.com

Alaa Baboor, Bachelorette

CONTACT

00966596628155; Alaa.s.baboor@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical therapist

Model Details: Controlled parallel groups

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 3, 2024
• Study Start: June 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: September 1, 2024
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share