Effects Of Lymphatic Drainage on Axillary Web Syndrome

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Axillary Web Syndrome
• Intervention / Treatment: Other: Stretching exercises; Other: Soft tissue mobilization

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Faisalābad, Punjab, Pakistan, 54000
      • Recruiting
      • Allied Hosptal
      • Contact: tehniat aamir, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: stretching exercises; Stretching exercise along with manual lymph drainage	Other: Stretching exercises; Stretching exercises along with manual lymphatic drainage
Experimental: soft tissue mobilization; soft tissue mobilization along with manual lymph drainage	Other: Soft tissue mobilization; Soft tissue mobilization along with manual lymphatic drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Goniometer.	A goniometer is a device used in physical therapy to measure a joint's range of motion (ROM).	10 months
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
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
Dynamometer	dynamometer, or "dyno" for short, is a device for measuring force, moment of force (torque), or power.	10 months

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Dr. Rabiya Noor, Phd, Riphah International University

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Anticipated): December 15, 2022
• Study Completion (Anticipated): January 5, 2023

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 14, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Axillary web syndrome; Manual lymphatic drainage
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: REC/RCR&AHS/22/0511

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No