Effects of Lymph Drainage on Patients With Axillary Web Syndrome

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	20 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06438848
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Taif University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Hassan Alzahrani, PHD
Principal Investigator Affiliation	Taif University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Movement Disorders

Additional Details

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).

Arms & Interventions

Arms

Experimental: 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

Experimental: 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

Interventions

Other: - Physical therapy program

Other: - Physical therapy program with lymphedema drainage

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Ibrahim Alkayshan, Bachelorette

[email protected]

0096650127261

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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