NCT05463185|UnknownDMC
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Sponsor study identifier
interventional
20
1 country
1
Study Start
April 15, 2022
Actual (reported)Primary Completion
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 5, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 5, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 15, 2022
Actual (reported)April 15, 2022
Actual (reported)July 18, 2022
Actual (reported)December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 5, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Stretching exercise along with manual lymph drainage
soft tissue mobilization along with manual lymph drainage
Stretching exercises along with manual lymphatic drainage
Soft tissue mobilization along with manual lymphatic drainage
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Allied Hosptal
Faisalābad, Punjab Province, 54000, Pakistan
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.
Dr. Rabiya Noor, Phd
Riphah International University
First Submitted
April 15, 2022
First Posted
July 18, 2022
Study Start
April 15, 2022
Actual (reported)Primary Completion
December 15, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Contact the study team to confirm eligibility.
Meer TA, Noor R, Bashir MS, Ikram M. Comparative effects of lymphatic drainage and soft tissue mobilization on pain threshold, shoulder mobility and quality of life in patients with axillary web syndrome after mastectomy. BMC Womens Health. 2023 Nov 10;23(1):588. doi: 10.1186/s12905-023-02762-w.
Study Completion
January 5, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 18, 2022
Record last verified: 2022-07
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