Clinical trial NCT05463185: Effects Of Lymphatic Drainage on Axillary Web Syndrome
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Axillary Web Syndrome
Keywords: Axillary web syndrome
Manual lymphatic drainage
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 20
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: DASH
timeFrame: 10 months
measure: Numeric Pain Rating Scale
timeFrame: 10 months
measure: Goniometer.
timeFrame: 10 months
measure: Breast cancer specific QOL
timeFrame: 10 months
measure: Patient Specific Functional Scale
timeFrame: 10 months
measure: Dynamometer
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalābad
country: Pakistan
facility: Allied Hosptal
state: Punjab
Study officials:
affiliation: Riphah International University
name: Dr. Rabiya Noor, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.