Movement Disorders
Conditions
Brief summary
Effects of a physical therapy program combined with manual lymphatic drainage on shoulder pain and function, quality of life, lymphedema incidence in breast cancer patients with axillary web syndrome following axillary dissection: A randomized controlled trial.
Detailed description
This study's objective is to assess the effectiveness of physical therapy (PT) combined with manual lymphatic drainage (MLD) on shoulder pain and function, lymphedema, visible cords, and quality of life (QOL), compared to physical therapy alone, in subjects with breast cancer and suffering of axillary web syndrome (AWS).
Interventions
OTHERPhysical therapy program
group will be prescribed a usual physical therapy program three times a week for four weeks, which will be conducted in the clinic. The program consists of eight sessions comprising warm-up and cool-down, stretching activities, and strengthening exercises, and manual therapy. The program will start with 10-minute warm-up and 10-minute cool-down periods of physical therapy sessions
OTHERPhysical therapy program with lymphedema drainage
physical therapy program three times a week for four weeks, which will be conducted in the clinic. The program consists of eight sessions comprising warm-up and cool-down, stretching activities, and strengthening exercises,And manual lymphatic drainage prescribed 20 minutes of MLD daily. The program will be prescribed five times a week, for four weeks
Sponsors
Taif University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Double blinded
Intervention model description
Controlled parallel groups
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* had a breast cancer dissection with lymphadenectomy and/or sentinel lymph node biopsy and a subsequent appearance of AWS (diagnosed by physical examination and also by using the Screening Test AWS (ST-AWS)) \[35\]. * suffering of pain that exceeds 6-8 points (measured by the numeric rating scale (NRS)) in the region of the cording on the upper/lower arm, elbow, and dorsum site, and * have visible or palpable cords in the arm or breast.
Exclusion criteria
* suffering of both acute thrombosis and lymphedema, * suffering of skin issues like infections or musculoskeletal conditions like adhesive capsulitis, rheumatoid arthritis, pectoral muscle tightness, and diseases of the rotator cuff, and/or * having cording that doesn't involve an arm and only affects the chest or side of the thorax.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 5 weeks | Pain intensity will be assessed using the NRS (0-10). A score of 0 means there is no pain, while a score of 10 means presence of severe pain. |
| Disability | 5 weeks | Assessment of disability will be done using the Arabic Quick-DASH questionnaire which is an 11-item self-report questionnaire, The DASH has five response options for each item from 0=no difficulty to perform or no symptoms to 5=unable to do. A higher score reflects greater disability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Muscular strength | 5 weeks | Using a hand-held dynamometer, the maximum voluntary isometric contraction of the muscles will be used to assess their strength. |
| Limb Girth | 4 weeks | The limb girth will be measured using the tape measurement. Upper limb volumes will be calculated from circumference measurements taken at 4-cm intervals from the dorsum of the wrist to the axilla. The diagnostic criterion for lymphedema was ≥3 % volume increase from baseline in the affected upper limb. |
| Quality of life for participants | 5 weeks | The EORTC QLQ-C30 is a 30-item questionnaire including measuring Global Health status (2 items), Functional scales (15 items) and Symptoms scales/items (13 items). Items were measured using a 4-point Likert Scale ranging from Not at all (1) to Very much (4) |
| Range of motion | 5 weeks | The active ROM (AROM) will be assessed using a goniometer which has been proved to have reliability and concurrent validity for measuring shoulder mobility measurements |
| Cording | 5 weeks | lymphedema therapist (PT/CLT) will examine the arm and axilla for any visible or palpable cords. The findings will be either positive for cording or negative. It is a nominal qualitative variable. |
Contacts
Primary ContactIbrahim Alkayshan, Bachelorette
Backup ContactAlaa Baboor, Bachelorette
Outcome results
None listed