Effects Of Lymphatic Drainage on Axillary Web Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Axillary Web Syndrome

Intervention / Treatment
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* Other: Stretching exercises
* Other: Soft tissue mobilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer patients with pain over &gt;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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stretching exercises<br>Stretching exercise along with manual lymph drainage | Other: Stretching exercises<br>* Stretching exercises along with manual lymphatic drainage<br>|
| Experimental: soft tissue mobilization<br>soft tissue mobilization along with manual lymph drainage | Other: Soft tissue mobilization<br>* Soft tissue mobilization along with manual lymphatic drainage<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Axillary web syndrome, Manual lymphatic drainage