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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical therapy program | Experimental | 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 |
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| Physical therapy program with lymphedema drainage | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physical therapy program | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity | 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. | 5 weeks |
| Disability | 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. | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Limb Girth | 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. | 4 weeks |
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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].
Exclusion Criteria:
suffering of both acute thrombosis and lymphedema,
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ibrahim Alkayshan, Bachelorette | Contact | 0096650127261 | Ibrahim.alkayshan@gmail.com | |
| Alaa Baboor, Bachelorette | Contact | 00966596628155 | Alaa.s.baboor@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hassan Alzahrani, PHD | Taif University | Study Chair |
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| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Controlled parallel groups
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Double blinded
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| Physical therapy program with lymphedema drainage | Other | 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 |
|
| Cording |
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. |
| 5 weeks |
| Muscular strength | Using a hand-held dynamometer, the maximum voluntary isometric contraction of the muscles will be used to assess their strength. | 5 weeks |
| Range of motion | 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 | 5 weeks |
| Quality of life for participants | 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) | 5 weeks |