Shoulder Symptoms After Lymph Node Dissection
Conditions
Brief summary
The most important prognostic indicator for the breast cancer patient is the axillary lymph node status. With the introduction of the sentinel lymph node biopsy, many women were spared the morbidity of a full axillary lymph node dissection(ALND) while having the axillary nodes assessed with a low false negative rate. Approximately 30% of women who undergo ALND experience shoulder/arm morbidity including numbness, pain, weakness and decreased range of motion. In addition, the sentinel lymph node dissection (SLND) held the promise that women with early stage breast cancer would be able to avoid the dreaded morbidity associated with axillary lymph node dissections including lymphedema, decreased range of motion and pain. Since the adoption of SLN, numerous papers have documented that SLN is superior to ALND. However, patients who undergo SLN still have a significant amount of pain with this procedure. There are few published studies which objectively assess the subjective and objective symptoms of SLND. Pulsed electromagnetic fields (PEMF) have been shown to be effective in the treatment of fractures and spinal fusion, relief of pain in acute sprains and whiplash injuries, improvement of skin blood flow, healing of venous stasis ulcers, and reduction of postmastectomy lymphedema. Indeed, radiofrequency PEMF devices are FDA approved for pain and edema relief. PEMF devices are economical and disposable, and can be incorporated unobtrusively in standard post-op dressings. We have recently reported, in a double-blind, placebo-controlled study on breast reduction, that post-op PEMF therapy produced a significant decrease in pain and pain medication use, along with a concomitant decrease in IL1-beta in the wound bed.1 The current pilot study will be designed to determine if PEMF treatment, given in addition to standard of care, can reduce post-operative discomfort and morbidity after lumpectomy and SLND, or lumpectomy and ALND. Lumpectomy and ALND/SLND patients enrolled in the double-blind, placebo-controlled study will undergo standard surgery, but will be randomized to one of two groups: the treatment group with a PEMF coil placed around the arm and the control group with a coil that delivers no PMF. We expect postoperative pain to be reduced in the PEMF-treated patients as well as improved arm mobility and strength. The use of PEMF might reduce the need for narcotic pain medications and their side effects of sedation, nausea, and vomiting. It may also reduce costs related to arm morbidity.
Detailed description
In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks.
Interventions
DEVICEPEMF Device
The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks.
DEVICESham PEMF Device
Inactive PEMF device, delivers no PMF
Sponsors
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria include patients undergoing axillary lymph node dissection or sentinel lymph node dissection for breast cancer. Patients undergoing lumpectomy with the axillary surgery will be included.
Exclusion criteria
* Patients undergoing mastectomy with the axillary surgery will be excluded. * Patients with prior axillary radiation or prior arm impairment will be excluded. * Patients with pacemakers will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Level on Visual Analog Scale | 2 weeks | Pain will be the primary outcome measured by patient level of pain as quantified by a visual analog scale with written descriptions, and amount of pain medication used hourly until the patient is discharged (up to a maximum of six hours post-op), then daily for a total of two weeks post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Jackson Pratt (JP) Drain Output | Post-Operative Day 1 & 2 (2 Days) | Total volume (in units of millimeters - mL) of Jackson Pratt (JP) drain output on post-operative day 1 and day 2 were recorded for patients in the study. |
| Patient Self-Assessment of Shoulder and Arm Symptoms Before and After PEMF | Pre- and Post-Operative Period | No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms; therefore, no meaningful results could be derived since there were no surveys to compare before and after PEMF data points. |
| Clinical Assessment of Shoulder and Arm Symptoms Before and After PEMF | Pre- and Post-Operative Period | No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. There was a lack of post-clinical assessment data as well as poor patient compliance with the 14 day mark follow up. Therefore, no meaningful results could be derived since there was no quantifiable means to compare before and after PEMF data points. |
| Lymphedema | Pre- and Post-Operative Period | No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed. |
| Narcotic Pain Medications | Post-Operative Period | No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs assessing need for pain medications and level of nausea and vomiting; therefore, no meaningful data could be analyzed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Sham PEMF Device Sham PEMF Device: Inactive PEMF device, delivers no PMF | 4 |
| PEMF Device PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks. | 3 |
| Total | 7 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | poor enrollment, no data analyzed | 9 | 6 |
Baseline characteristics
| Characteristic | Sham PEMF Device | PEMF Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
Primary
Pain Level on Visual Analog Scale
Pain will be the primary outcome measured by patient level of pain as quantified by a visual analog scale with written descriptions, and amount of pain medication used hourly until the patient is discharged (up to a maximum of six hours post-op), then daily for a total of two weeks post-op. The VAS pain scale ranges from 0 (no pain) to 10 (worst possible pain).
Time frame: 2 weeks
Population: Only 7 patients completed the study by quantifying the level of their pain post-operatively on a visual analog scale from 0-10. The medication logs and two week post-op analogs could not be utilized for the analysis since all 7 patients did not complete these logs.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham PEMF Device | Pain Level on Visual Analog Scale | 3.878 units on a scale | Standard Deviation 2.811 |
| PEMF Device | Pain Level on Visual Analog Scale | 5.239 units on a scale | Standard Deviation 2.979 |
Secondary
Clinical Assessment of Shoulder and Arm Symptoms Before and After PEMF
No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. There was a lack of post-clinical assessment data as well as poor patient compliance with the 14 day mark follow up. Therefore, no meaningful results could be derived since there was no quantifiable means to compare before and after PEMF data points.
Time frame: Pre- and Post-Operative Period
Population: No participants were assessed for this secondary outcome measure: clinical assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables due to lack of post-clinical assessment data and poor patient compliance with the 14 day mark follow up.
Secondary
Jackson Pratt (JP) Drain Output
Total volume (in units of millimeters - mL) of Jackson Pratt (JP) drain output on post-operative day 1 and day 2 were recorded for patients in the study.
Time frame: Post-Operative Day 1 & 2 (2 Days)
Population: For the 7 patients who completed the study, the mean and standard deviations for the total JP drain output (in milliliters - mL) from post-operative days 1 \& 2 (2 days total) were analyzed as a secondary outcome.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sham PEMF Device | Jackson Pratt (JP) Drain Output | 136.5 milliliters (mL) | Standard Deviation 74.633 |
| PEMF Device | Jackson Pratt (JP) Drain Output | 85.333 milliliters (mL) | Standard Deviation 39.272 |
Secondary
Lymphedema
No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed.
Time frame: Pre- and Post-Operative Period
Population: No participants were assessed for this secondary outcome measure: lymphedema. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. No meaningful quantifiable data could be obtained on degree of lymphedema, and thus effect of PEMF intervention could not be analyzed.
Secondary
Narcotic Pain Medications
No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs assessing need for pain medications and level of nausea and vomiting; therefore, no meaningful data could be analyzed.
Time frame: Post-Operative Period
Population: No participants were assessed for this secondary outcome measure: narcotic pain medications. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients were instructed to complete logs at home indicating narcotic pain medications, and patients did not submit necessary logs.
Secondary
Patient Self-Assessment of Shoulder and Arm Symptoms Before and After PEMF
No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms; therefore, no meaningful results could be derived since there were no surveys to compare before and after PEMF data points.
Time frame: Pre- and Post-Operative Period
Population: No participants were assessed for this secondary outcome measure: patient self-assessment of shoulder and arm symptoms before and after PEMF. No data was collected/calculated, and hence the data cannot be summarized to include in the data tables. Patients did not complete the necessary surveys assessing their shoulder and arm symptoms.