Is additional manual lymphatic drainage on top of physical therapy effective in reducing arm volume, pain and improving quality of life among breast cancer patients with axillary web syndrome?
Date of publication of randomized controlled trial: May 2016
Design
Randomized controlled trial (RCT).
Participants
41 breast cancer patients who completed surgery for at least 4 weeks with pain over 3 points on the numeric rating scale (NRS), and with visible and palpable cords on the arm and axilla (mean age range: 39.8 to 60.3 years).
Intervention
Physical therapy (PT) plus manual lymphatic drainage (MLD) was used as an intervention. PT sessions first included a 10-minute warm‐up and cool-down, which consisted of eight stretching exercises and strengthening exercises. All exercises were performed under the supervision of a skilled physical therapist. The physical therapist then performed manual therapy for 30 minutes. Intensity of manual therapy was progressively increased from comfortable to mild discomfort within the tolerable range. The frequency of PT was 3 times per week for 4 weeks.
MLD was provided by a certified lymphedema therapist. Duration of MLD was 30 minutes and the frequency was 5 times per week for 4 weeks.
Comparator
Comparison: PT plus MLD versus PT alone.
Major Outcomes
Outcome 1: Change in arm volume at the end of the intervention;
Outcome 2: Change in pain severity as measured by the NRS at the end of the intervention. NRS ranged from 0 to 10 points, a higher score indicated more severe pain.
Outcome 3: Change in pain-related quality of life as measured by the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ‐C30) at the end of the intervention. A higher score indicated more severe pain.
Settings
The authors did not state whether the trials were conducted in inpatient or outpatient settings.
Comparison    PT plus MLD versus PT alone
Main Results
Compared to PT alone, PT plus MLD significantly reduced arm volume (mean difference (MD): -22.84, 95% CI: -41.90 to -3.78), relieved pain as measured by NRS (MD: -1.16, 95% CI: -1.97 to -0.34) and improved pain-related quality of life as measured by EORTC QLQ‐C30 (MD: -13.49, 95% CI: -23.52 to -3.46).
Comparison: PT plus MLD versus PT alone among breast cancer patients with axillary web syndrome
Outcomes No. of studies (Total number of participants) Mean (SD)/ No. of participants Heterogeneity test ( I2) MD (95% CI) p value Overall quality of evidence*
Intervention Comparator
1 (NA) 1(41) -1.1 (3.3)/21 21.8 (43.1)/20 Not applicable as there is only 1 trial -22.84 (-41.90 to -3.78) 0.029 High
2 (NA) 1(41) -4.8 (1.4)/21 -3.6 (1.1)/20 Not applicable as there is only 1 trial -1.16 (-1.97 to -0.34) 0.006 Moderate
3 (NA) 1(41) -30.2 (15.5)/21 -16.7 (16.2)/20 Not applicable as there is only 1 trial -13.49 (-23.52 to -3.46) 0.010 Moderate
Keys: SD= standard deviation; MD: mean difference; CI: confidence interval.
Comparison    PT plus MLD versus PT alone
Main Results
Compared to PT alone, PT plus MLD significantly reduced arm volume (mean difference (MD): -22.84, 95% CI: -41.90 to -3.78), relieved pain as measured by NRS (MD: -1.16, 95% CI: -1.97 to -0.34) and improved pain-related quality of life as measured by EORTC QLQ‐C30 (MD: -13.49, 95% CI: -23.52 to -3.46).
Comparison: PT plus MLD versus PT alone among breast cancer patients with axillary web syndrome
Outcomes 1 (NA) 2 (NA) 3 (NA)
No. of studies (Total number of participants) 1(41) 1(41) 1(41)
Mean (SD)/ No. of participants Intervention -1.1 (3.3)/21 -4.8 (1.4)/21 -30.2 (15.5)/21
Comparator 21.8 (43.1)/20 -3.6 (1.1)/20 -16.7 (16.2)/20
MD (95% CI) -22.84 (-41.90 to -3.78) -1.16 (-1.97 to -0.34) -13.49 (-23.52 to -3.46)
p value 0.029 0.006 0.010
Overall quality of evidence* High Moderate Moderate
Keys: SD= standard deviation; MD: mean difference; CI: confidence interval.
Conclusion
Benefits
This study showed that PT plus MLD was significantly better in reducing arm volume and relieving pain, as well as in improving pain-related quality of life, when compared to PT alone among breast cancer patients with axillary web syndrome. For outcome 1, the overall quality of evidence is high. Further research is unlikely to have an important impact on our confidence in this estimate of effect. For outcomes 2 and 3, the overall quality of evidence is moderate. Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
Harms
Adverse events were not reported in this trial.
Link to Original Article
https://www.ncbi.nlm.nih.gov/pubmed/26542271
The synopsis is based on the following article:
Cho Y, Do J, Jung S, Kwon O, Jeon JY. Effects of a physical therapy program combined with manual lymphatic drainage on shoulder function, quality of life, lymphedema incidence, and pain in breast cancer patients with axillary web syndrome following axillary dissection. Supportive Care in Cancer. 2016 May 1;24(5):2047-57.


* Interpretation of quality assessment results:
• Very low: Further research is most likely to have an important impact on our confidence in this estimate of effect.
• Low: Further research is likely to have an important impact on our confidence in this estimate of effect.
• Moderate: Further research is fairly likely to have an important impact on our confidence in this estimate of effect.
• High: Further research is unlikely to have an important impact on our confidence in this estimate of effect.
• Very high: Further research is most unlikely to have an important impact on our confidence in this estimate of effect.

Details of assessment method can be found at Chung VC, Wu XY, Ziea ET, Ng BF, Wong SY, Wu JC. Assessing internal validity of clinical evidence on effectiveness of CHinese and integrative medicine: Proposed framework for a CHinese and Integrative Medicine Evidence RAting System (CHIMERAS). European Journal of Integrative Medicine. 2015 Aug 31;7(4):332-41.