Effects Of Lymphatic Drainage on Axillary Web Syndrome

Axillary Web Syndrome Clinical Trial

Official title:

Effects Of Lymphatic Drainage With And Without Soft Tissue Mobilization On Pain Threshold, Shoulder Mobility And Quality Of Life In Patients With Axillary Web Syndrome.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05463185
• Other study ID #: REC/RCR&AHS/22/0511
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2022
• Est. completion date: January 5, 2023

Study information

• Verified date: July 2022
• Source: Riphah International University
• Contact: Dr. Rabiya Noor, PhD
• Phone: 00923344355660
• Email: rabiya.noor[@]riphah.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Axillary web syndrome (AWS) is a common condition related to cording in axilla as a result of axillary lymph nodes dissection surgery in breast cancer patients. This condition comprises of 86% population who underwent breast cancer surgery, but this condition is usually under diagnosed. Usually characterized by pain full cording of soft tissue and contractures at axillary region. This study aims to see the effects of manual lymphatic drainage with or without soft tissue mobilization on patients with axillary web syndrome. It will be a randomized control trial which will be conducted in cancer centers in government sector hospitals. 30 participants will be enrolled by non probability sampling technique through lottery method into two groups, 15 participants in each group. One group will receive manual lymphatic drainage, while other group will receive manual lymphatic drainage in addition to soft tissue mobilization (3-5 treatment sessions per week for 4 weeks). Base line treatment regimen include stretching, range of motion and strengthening exercises. For outcome measures treatment will be assessed on questionnaires including Disabilities of Arm Shoulder and Hand questionnaire (DASH), Numeric Pain Rating scale (NRS), Breast cancer specific QOL questionnaires (EORTC QLQ-C30, EORTC QLQ BR-23), Patient specific Functional Scale (PSFS), Goniometer and Dynamometer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 5, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• Breast cancer patients with pain over >3 points, 4 weeks after surgery using
• Numeric Pain Rating scale on upper limb.
• With visible and palpable cords in axilla, arm and breast after surgery.

Exclusion Criteria:

• Acute Thrombosis, Musculoskeletal Disorders,Skin
• Problems: Infections, Osteoarthritis, Rheumatoid Arthritis, Rotator Cuff Syndrome, Adhesive Capsulitis,
• Any other Injury, Trauma and
• Any other Surgery.

Related Conditions & MeSH terms

• Axillary Web Syndrome
• Syndrome

Intervention

Other:
• Stretching exercises
Stretching exercises along with manual lymphatic drainage
• Soft tissue mobilization
Soft tissue mobilization along with manual lymphatic drainage

Locations

Country	Name	City	State
Pakistan	Allied Hosptal	Faisalabad	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (2)

Koehler LA, Haddad TC, Hunter DW, Tuttle TM. Axillary web syndrome following breast cancer surgery: symptoms, complications, and management strategies. Breast Cancer (Dove Med Press). 2018 Dec 20;11:13-19. doi: 10.2147/BCTT.S146635. eCollection 2019. Review. — View Citation

Leduc O, Sichere M, Moreau A, Rigolet J, Tinlot A, Darc S, Wilputte F, Strapart J, Parijs T, Clément A, Snoeck T, Pastouret F, Leduc A. Axillary web syndrome: nature and localization. Lymphology. 2009 Dec;42(4):176-81. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DASH	The DASH (Disabilities of the Arm, Shoulder and Hand) Outcome Measure is a 30-item, self-report questionnaire that measures physical function and symptoms in people with musculoskeletal disorders of the upper limb.	10 months
Primary	Numeric Pain Rating Scale	What is the numerical rating scale for pain? The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).	10 months
Primary	Goniometer.	A goniometer is a device used in physical therapy to measure a joint's range of motion (ROM).	10 months
Primary	Breast cancer specific QOL	European Organization for Research and Treatment of Cancer QOL Breast Cancer Specific Version (EORTC QLQ-BR23) . It is a 23-item self-administered breast cancer specific questionnaire, usually administered with the EORTC QLQ-C30, designed to measure QOL in the breast cancer population at various stages and with patients with differing treatment modalities. The assessment is comprised of five domains (body image, sexuality, arm symptoms, breast symptoms, and systemic therapy side effects)	10 months
Primary	Patient Specific Functional Scale	The Patient Specific Functional Scale (PSFS) is a self-reported valid, reliable, and responsive outcome measure for patients with back, neck, knee and upper extremity problems. It has also been shown to have a high test-retest reliability in both generic lower back pain and knee dysfunction issues.	10 months
Primary	Dynamometer	dynamometer, or "dyno" for short, is a device for measuring force, moment of force (torque), or power.	10 months