Abstract
Objectives: Integrative therapies have been incorporated increasingly into health and wellness in the United States in recent decades. Their potential benefits are under evaluation in various situations, including pain and symptom relief for cancer patients and survivors. This pilot study evaluated whether combining two integrative complementary approaches augments a patient's benefit by reducing postoperative stress, pain, anxiety, muscle tension, and fatigue compared with one integrative complementary approach alone.
Design: Patients undergoing autologous tissue breast reconstruction were randomly assigned to one of two postoperative complementary alternative therapies for three consecutive days. All participants were observed for up to 3 months.
Subjects: Forty-two participants were recruited from January 29, 2016 to July 11, 2018.
Interventions: Twenty-one participants were randomly assigned to massage alone and 21 to massage and acupuncture.
Outcome measures: Stress, anxiety, relaxation, nausea, fatigue, pain, and mood (score 0–10) were measured at enrollment before surgery and postoperative days 1, 2, and 3 before and after the intervention. Patient satisfaction was evaluated.
Results: Stress decreased from baseline for both Massage-Only Group and Massage+Acupuncture Group after each treatment intervention. Change in stress score from baseline decreased significantly more in the Massage-Only Group at pretreatment and posttreatment (p = 0.03 and p = 0.04). After adjustment for baseline values, change in fatigue, anxiety, relaxation, nausea, pain, and mood scores did not differ between groups. When patients were asked whether they would recommend the study, 100% (19/19) of Massage-Only Group and 94% (17/18) of Massage+Acupuncture Group responded yes (p = 0.49).
Conclusion: No additive beneficial effects were observed with addition of acupuncture to massage for pain, anxiety, relaxation, nausea, fatigue, and mood. Combined massage and acupuncture was not as effective in reducing stress as massage alone, although both groups had significant stress reduction. These findings indicate a need for larger studies to explore these therapies further.
Keywords: acupuncture, integrative therapy, massage, stress
Introduction
Breast cancer is the most common malignancy diagnosed among women in the United States. Approximately 12% of U.S. women will receive the diagnosis of breast cancer at some point in their lives.1 Most women who receive a breast cancer diagnosis have breast surgery, either lumpectomy or mastectomy. For many women undergoing mastectomy, breast reconstruction is an important part of their treatment plan. Reconstruction options include prosthetic devices (e.g., tissue expanders, saline, or silicone implants) and autologous tissue reconstruction (ATR) with tissue flaps from donor sites.
Autologous breast reconstruction most commonly uses tissue flaps harvested from the lower abdomen with skin, fat, and, occasionally, muscles to create a breast mound. Use of the patient's own tissue typically results in a more natural appearance and feel. However, compared with prosthetic reconstruction, ATR is a longer procedure with a more lengthy recovery. This extended recovery is mostly due to the multiple surgical sites (chest and abdomen) compared with implant reconstruction. Postoperative anxiety, pain, stress, and fatigue are common among patients having breast cancer surgery generally and, especially, those who undergo complex ATR procedures.
Although conventional management can provide adequate symptom control, it is imperfect and has limitations because of associated adverse effects and possible negative interactions with the multitude of other required medications. Complementary therapies have shown beneficial effects in cancer patients for symptomatic relief and are relatively free from risks. Their potential benefit is being actively evaluated in various clinical situations, including treatment of pain and relief of symptoms for cancer patients and cancer survivors. The most up-to-date clinical practice guidelines on evidence-based use of integrative therapies during and after breast cancer treatment recommend massage therapy as an option for the treatment of depression and mood disorders and recommend acupuncture as an optional therapy for treatment-induced nausea and vomiting.2 In addition, a recent systematic review has shown acupuncture to be most effective to help control pain and massage therapy most beneficial in anxiety reduction.3
Massage therapy is a widely used form of integrative therapy. It is used to help patients with various health conditions, including prenatal depression, autism, arthritis, fibromyalgia, hypertension, multiple sclerosis, and immune conditions such as HIV infection, neurologic diseases such as Parkinson and dementia, and cancers such as breast cancer.4 In the National Health Interview Survey of 2012, massage therapy was 1 of the 10 most common health approaches among U.S. adults, with 6.9% participating in this form of integrative medicine.5 Massage therapy is successfully used in outpatient and inpatient clinical settings, including the postoperative period.4,6–15 At the institution, it has been available for hospitalized patients on request since 2005.
Acupuncture has been in use for more than 3000 years globally. Evidence has supported its effectiveness in chronic pain conditions such as low back pain, fibromyalgia, muscle spasm, trigeminal neuralgia, tension headache, rheumatic arthritic pain, and osteoarthritis.16 More recently, acupuncture has been reported to be beneficial postoperatively.17–19 At the institution, acupuncture has been available for hospitalized patients on request since 2012.
A series of small pilot studies reported that acupuncture was helpful for women who had breast surgery. In one study of 30 women undergoing breast cancer surgery, acupuncture reduced the severity of symptoms (pain, nausea, and anxiety) and improved the patients' ability to cope with these symptoms.20 In a study of nine women, investigators observed that acupuncture treatment reduced lymphedema in patients who had undergone breast surgery.21 Finally, a separate study of 20 women with breast cancer reported decreased anxiety and tension or muscular pain with use of acupuncture.17
The present study explored whether the addition of acupuncture to massage therapy provided greater benefit than massage alone for postoperative symptoms, such as stress, pain, anxiety, nausea, fatigue, and mood, in women who have ATR after mastectomy for breast cancer.
Methods
Study overview
This study was an open-label pilot trial, in which participants received three consecutive daily, randomized treatments of either massage alone or massage with acupuncture following autologous tissue breast reconstruction surgery. Participants were randomly assigned to one of two intervention treatments: massage for 20 min (Massage-Only Group) or massage for 20 min followed by acupuncture for an additional 20 min (Massage+Acupuncture Group). To be eligible for study, patients had to have undergone mastectomy for breast cancer and ATR, have the ability to speak English, and have the ability to complete the study questionnaires and sign informed consent. Participants were excluded if they were taking anticoagulation medication or were in a severe immunocompromised state.
The Mayo Clinic Institutional Review Board reviewed and approved the study, and written informed consent was obtained for all study participants. The primary outcomes of this trial were change in postoperative stress, anxiety, relaxation, nausea, fatigue, pain, and mood.
Trial setting
Potential participants were recruited between January 29, 2016 and July 11, 2018, from a list of breast cancer patients scheduled to undergo autologous tissue breast reconstruction surgery. This report is based on all participants who consented and received treatment in the study. This study adheres to the Consolidated Standards of Reporting Trials (CONSORT) guidelines.22
Participants
Study-eligible patients had undergone a mastectomy as part of their clinical care and, at the time of study recruitment, were scheduled to undergo autologous tissue breast reconstruction. Potential participants were screened and invited to participate in this trial. Prescreened patients consented to participation, signed a written informed consent document, and completed trial-required data collection for the baseline visit. Sealed randomization envelopes labeled with subject ID numbers were created by the Section of Biostatistics using a computer-generated randomization schedule. After informed consent was obtained, the patient was assigned the next sequential subject ID number, and the corresponding sealed envelope was used to reveal the randomized treatment assignment. Next, patients underwent the ATR surgery required for study participation. On postoperative day 1, patients were approached at bedside to verify their willingness to participate, and the assigned intervention treatments commenced at the bedside on postoperative days 1, 2, and 3.
Interventions
Massage
All participants received massage treatments daily for three consecutive days. Massage was provided by a hospital-trained, nationally board-certified massage therapist for 20 min at each session. The sessions were individualized according to patient preference and reported symptoms. The individualization included location of massage, techniques and pressure used, positioning of the patient, and environment, including the use of music, aromatherapy, and room light settings. The aromatherapy choices for inhalation were lavender, orange, ginger, frankincense, spearmint, and lemon. Two massage techniques were offered: reflexology for the feet or Swedish massage, or a combination of the two techniques. To achieve the best therapeutic result, the therapist adjusted the pace and pressure of the massage technique according to patient needs and physiologic responses.
Massage and acupuncture
After massage treatment was complete, patients assigned to the Massage+Acupuncture Group received acupuncture provided by a trained, nationally board-certified, licensed acupuncturist. Each treatment was individualized to (1) the patient's reported symptoms based on visual analog scale (VAS) scores and (2) the patient's verbal reporting and preference for body positioning, music, and dimming of lights. For example, if the patient reported nausea, acupuncture points were included to address this symptom. Patients were positioned according to their physical comfort, either supine in the hospital bed or sitting upright in the reclining chair. The acupuncturist used single-use sterile needles, which were placed and retained for 20 min.
Outcomes
The VAS scores (0–10) were used for assessment of stress (0, none; 10, extreme), anxiety (0, none; 10, extreme), relaxation (0, poor; 10, best possible), nausea (0, none; 10, worst possible), fatigue (0, none; 10, worst possible), pain (0, none; 10, worst possible), and mood (0, poor; 10, best possible) and were used at enrollment and on postoperative days 1, 2, and 3, before and after the intervention. At week 4 (i.e., the end of the study), patient satisfaction was evaluated with a Was It Worth It (WIWI) survey. The WIWI survey is composed of a series of individual questions that assess the patient's satisfaction with the study and intervention participation. It was developed at Mayo Clinic and is individualized per study. It currently is submitted for publication. In addition, the safety measures included documentation of reported adverse events and concomitant medication use.
Study schedule
Study visits were defined as three phases: screening, treatment, and posttreatment. The screening phase was a prescreening phone interview and a combined face-to-face visit that included consent, screening, and randomization. After randomization, participants entered the treatment phase (i.e., daily treatments for 3 days) on day 1 after ATR. If randomly assigned to the Massage-Only Group, a participant began massage treatments; if in the Massage+Acupuncture Group, the participant received massage followed by acupuncture treatments. All participants were in the study for 4 weeks, and each participant entered the posttreatment phase after completing their last scheduled intervention session—in most cases, on postoperative day 3.
For all treatment visits, vital signs were recorded from the electronic health record. Participants were asked seven questions using the VAS covering stress, anxiety, relaxation, nausea, fatigue, pain, and mood. On these 3 days, the VAS questions were asked before and after each treatment, by a neutral person who was not an interventionist. Discussions about changes to the patient's health also occurred after each treatment. Three weeks after their last inpatient intervention session (week 4), participants received a final follow-up phone call. During the call, participant satisfaction was measured with the WIWI self-assessment survey.
Statistical analysis
Baseline patient characteristics were summarized as mean (standard deviation), with minimum and maximum for continuous variables and frequency percentages for categorical variables. Each VAS outcome was assessed at a baseline visit before the first treatment and before and after treatment at each subsequent visit. An overall analysis was performed, which included data from the three treatment visits. This analysis was performed with use of mixed linear model with lag-1 autoregressive covariance structure to account for the repeated measures of participants.
Results from these analyses were summarized with point estimate and 95% confidence interval (CI) for the effect of acupuncture. The VAS score from each pre- and posttreatment visit was compared with baseline with use of a paired t test. Results from the posttreatment satisfaction survey were compared between groups with use of Fisher's exact test. In all cases, a two-tailed p < 0.05 was considered statistically significant. Data were entered into the Research Electronic Data Capture (REDCap).23 Analysis was done with statistical software (SAS version 9.4; SAS Institute, Inc.).24
A sample size of 20 patients per treatment group was chosen for this pilot study after accounting for required resources and the logistics involved in studying this patient population.
Results
Fifty women were prescreened for this study, of which 42 were randomly assigned to either the Massage-Only Group or the Massage+Acupuncture Group (Fig. 1). In the Massage+Acupuncture Group, two persons stopped their participation before any treatment was initiated. In total, 40 women were included in the analysis. Among these 40 patients, one patient from the Massage-Only Group did not complete the last treatment visit. In the Massage+Acupuncture Group, one person completed the massage portion of visit 3 but, because of an unrelated adverse effect, was advised by their physician not to complete the acupuncture portion. The Massage+Acupuncture Group also had one person who did not complete the acupuncture portion of their treatment in visit 2 and then dropped out of the study.
FIG. 1.
Participant flow in trial from first contact to last contact.
The mean age of participants was 50.2 years (range 28–67 years) (Table 1). The ATR for 31 patients (78%) was constructed with deep inferior epigastric perforator free transverse rectus abdominis myocutaneous (TRAM) flaps. Other procedures used free TRAM flaps (10%), muscle-sparing free TRAM flaps (10%), and pedicled TRAM flaps (3%).
Table 1.
Descriptive Characteristics of Patients
| Characteristic | Treatmenta |
||
|---|---|---|---|
| Overall (N = 40) | Massage-only group (n = 21) | Massage+Acupuncture group (n = 19) | |
| Age, years | |||
| Mean (SD) | 50.15 (9.01) | 50.95 (6.93) | 48.89 (10.89) |
| Range | 28–67 | 39–64 | 28–67 |
| Race | |||
| White | 34 (85.0) | 19 (90.5) | 15 (78.9) |
| Black/African American | 1 (2.5) | 1 (4.8) | 0 (0.0) |
| American Indian/Alaskan Native | 1 (2.5) | 0 (0.0) | 1 (5.3) |
| Asian-Korean | 1 (2.5) | 0 (0.0) | 1 (5.3) |
| Other | 2 (5.0) | 1 (4.8) | 1 (5.3) |
| Chose not to disclose | 1 (2.5) | 0 (0.0) | 1 (5.3) |
| Reconstruction type | |||
| Immediate | 2 (5.0) | 2 (9.5) | 0 (0.0) |
| Delayed | 38 (95.0) | 19 (90.5) | 19 (100.0) |
| Type of ATR flap | |||
| Free TRAM | 4 (10.0) | 3 (14.3) | 1 (5.3) |
| MS-TRAM | 4 (10.0) | 1 (4.8) | 3 (15.8) |
| DIEP | 31 (77.5) | 17 (81.0) | 14 (73.7) |
| Pedicled TRAM | 1 (2.5) | 0 (0.0) | 1 (5.3) |
Values are presented as n (%) of patients unless specified otherwise.
ATR, autologous tissue reconstruction; DIEP, deep inferior epigastric perforator; MS-TRAM, muscle-sparing free transverse rectus abdominis myocutaneous; SD, standard deviation; TRAM, transverse rectus abdominis myocutaneous.
VAS scores were obtained at the baseline visit and before and after the intervention at each treatment visit (Table 2). Results from the paired t test showed that stress and anxiety decreased significantly from baseline at each visit posttreatment for both treatment groups. The difference in relaxation at each visit compared with baseline increased significantly for both groups posttreatment. Before each treatment visit, the pain score for both groups was significantly higher than at baseline. The first visit for the Massage+Acupuncture Group showed stress and anxiety increased and relaxation decreased from baseline values. This response went against the trend for the other massage and acupuncture visits.
Table 2.
Pretreatment Versus Posttreatment for Visual Analog Scale Scores
| VAS criterion | Start of session |
End of session |
||||
|---|---|---|---|---|---|---|
| Massage only, mean (SD) (n = 21)a | Massage+Acupuncture, mean (SD) (n = 19)a | Effect estimate (95% CI), pb | Massage only, mean (SD) (n = 21)a | Massage+Acupuncture, mean (SD) (n = 19)a | Effect estimate (95% CI), pb | |
| Stress | ||||||
| Baseline (screen pretest) | 4.57 (2.96) | 3.95 (2.67) | 4.57 (2.96) | 3.95 (2.67) | ||
| Δ at visit 1 | −1.90 (3.37)c | +0.42 (2.14) | 1.13 (0.10–2.16), 0.03 | −3.76 (2.93)c | −2.16 (2.39)c | 0.69 (0.02–1.36), 0.04 |
| Δ at visit 2 | −1.71 (2.53)c | −0.21 (2.70) | −3.48 (2.66)c | −2.22 (2.76)c | ||
| Δ at visit 3 | −1.75 (2.24)c | −1.17 (2.81) | −3.10 (2.53)c | −2.50 (2.55)c | ||
| Anxiety | ||||||
| Baseline (screen pretest) | 4.14 (3.14) | 3.74 (2.49) | 4.14 (3.14) | 3.74 (2.49) | ||
| Δ at visit 1 | −1.24 (3.49) | +0.16 (1.92) | 0.93 (−0.21 to 2.06), 0.11 | −3.29 (3.15)c | −1.74 (2.56)c | 0.64 (−0.11 to 1.39), 0.09 |
| Δ at visit 2 | −1.33 (2.99) | +0.05 (2.53) | −3.19 (3.04)c | −2.06 (2.53)c | ||
| Δ at visit 3 | −1.60 (3.23)c | −0.78 (2.67) | −2.50 (2.98)c | −2.28 (2.47)c | ||
| Relaxation | ||||||
| Baseline (screen pretest) | 4.14 (2.92) | 4.84 (2.14) | 4.14 (2.92) | 4.84 (2.14) | ||
| Δ at visit 1 | −0.14 (3.40) | −1.00 (2.67) | −0.24 (−1.37 to 0.88), 0.66 | +4.67 (3.02)c | +3.47 (2.52)c | −0.17 (−1.01 to 0.66), 0.68 |
| Δ at visit 2 | +1.38 (3.22) | +0.21 (2.64) | +4.62 (3.40)c | +3.56 (2.36)c | ||
| Δ at visit 3 | +0.85 (3.15) | +0.72 (2.08) | +4.25 (3.16)c | +4.00 (2.11)c | ||
| Nausea | ||||||
| Baseline (screen pretest) | 0.57 (1.57) | 0.16 (0.69) | 0.57 (1.57) | 0.16 (0.69) | ||
| Δ at visit 1 | +1.43 (2.87)c | +1.63 (2.34)c | −0.66 (−1.65 to 0.34), 0.19 | −0.10 (1.58) | +0.89 (2.14) | −0.19 (−0.81 to 0.43), 0.53 |
| Δ at visit 2 | +1.81 (2.56)c | +0.95 (1.99) | +0.81 (2.73) | +0.33 (1.28) | ||
| Δ at visit 3 | +1.00 (2.20) | +0.39 (1.20) | −0.05 (1.70) | −0.06 (0.80) | ||
| Fatigue | ||||||
| Baseline (screen pretest) | 3.76 (3.24) | 3.74 (1.52) | 3.76 (3.24) | 3.74 (1.52) | ||
| Δ at visit 1 | +2.62 (3.76)c | +2.95 (2.93)c | 0.17 (−1.11 to 1.46), 0.79 | +0.71 (4.52) | +0.84 (2.24) | 0.17 (−1.32 to 1.67), 0.81 |
| Δ at visit 2 | +1.52 (3.79) | +1.84 (2.67)c | +0.19 (4.49) | +0.83 (2.64) | ||
| Δ at visit 3 | +1.10 (2.53) | +1.44 (3.15) | −0.80 (3.50) | −0.33 (2.57) | ||
| Pain | ||||||
| Baseline (screen pretest) | 1.71 (2.39) | 1.00 (1.33) | 1.71 (2.39) | 1.00 (1.33) | ||
| Δ at visit 1 | +3.05 (2.46)c | +3.95 (1.68)c | −0.19 (−1.14 to 0.75), 0.68 | +1.14 (2.29)c | +1.63 (2.11)c | −0.76 (−1.52 to 0.003), 0.05 |
| Δ at visit 2 | +2.43 (3.20)c | +2.74 (2.13)c | +0.81 (3.52) | +0.72 (1.84) | ||
| Δ at visit 3 | +1.75 (2.22)c | +1.56 (2.04)c | +0.90 (2.59) | +0.06 (1.51) | ||
| Mood | ||||||
| Baseline (screen pretest) | 7.19 (2.38) | 7.21 (2.04) | 7.19 (2.38) | 7.21 (2.04) | ||
| Δ at visit 1 | −1.05 (2.52) | −0.63 (1.83) | 0.48 (−0.42 to 1.38), 0.29 | +0.81 (2.58) | +0.28 (1.96) | −0.06 (−0.85 to 0.72), 0.87 |
| Δ at visit 2 | −0.86 (2.35) | −0.84 (1.50)c | +0.62 (2.54) | +0.50 (1.58) | ||
| Δ at visit 3 | −0.90 (2.53) | −0.06 (2.07) | +0.50 (2.61) | +1.00 (1.60)c | ||
One participant did not complete visit 3 in the Massage-Only Group. In the Massage+Acupuncture Group, one participant did not complete the acupuncture portion in visit 3 and one participant did not complete acupuncture in visit 2 or any treatment in visit 3.
Data were analyzed with use of a linear mixed model with an autoregressive covariance structure to account for the repeated-measures study design. In all cases, the independent variable was study group (Massage+Acupuncture Group vs. Massage-Only Group); the baseline value of the screening pretest score was included as a covariate. The effect estimate corresponds to the estimated difference between study groups (Massage+Acupuncture minus Massage Only).
p < 0.05 for two-sided paired t test of visit compared with baseline.
Δ, change; CI, confidence interval; SD, standard deviation; VAS, visual analog scale.
From the repeated measures analysis, which included preintervention data from all three treatment visits, stress was the only item that differed significantly between the two treatment groups. The effect estimate was 1.13 (95% CI 0.10–2.16), indicating significantly higher stress for the Massage+Acupuncture Group than the Massage-Only Group. The repeated measures analysis of postintervention VAS scores also showed a significant difference in stress between the two groups: The Massage+Acupuncture Group had higher stress than the Massage-Only Group (effect estimate 0.7; 95% CI 0.02–1.36). Although stress decreased from baseline for both groups at every visit posttreatment, the Massage-Only Group had a greater decrease than the Massage+Acupuncture Group (p = 0.04). Five participants reported adverse events as being related to the assigned treatment: headaches (Massage-Only Group, n = 2), neck soreness (Massage-Only Group, n = 1), nausea (Massage-Only Group, n = 1), and nausea and headache (Massage+Acupuncture Group, n = 1 for each). All adverse events were reported as mild.
The WIWI questionnaire collected satisfaction data from participants after treatment completion. Two individuals in the Massage-Only Group did not respond to the survey. When asked whether they felt the study was worthwhile to their participation, 100% (19/19) of the Massage-Only Group and 89% (16/18) of the Massage+Acupuncture Group said yes (p = 0.23) (Table 3). Asked whether they would participate in the study again, 100% (19/19) of the Massage-Only Group and 94% (17/18) of the Massage+Acupuncture Group said yes (p = 0.49). Asked whether they would recommend the study to others, 100% (19/19) of the Massage-Only Group and 94% (17/18) of the Massage+Acupuncture Group responded yes (p = 0.49).
Table 3.
Was It Worth It Survey and Satisfaction Questions
| Question | Massage-only group (n = 21), n (%) | Massage+Acupuncture group (n = 19), n (%) | pa |
|---|---|---|---|
| Worthwhile to participate | 19 (100)b | 16 (89)c | 0.23 |
| Would you do it again | 19 (100)b | 17 (94)c | 0.49 |
| Would you recommend to others | 19 (100)b | 17 (94)c | 0.49 |
| Quality of life | |||
| Improved | 11 (61)b,c | 15 (83)c | 0.32 |
| Stayed the same | 6 (33)b,c | 2 (6)c | |
| Got worse | 1 (6)b,c | 1 (6)c | |
| Overall experience | 0.85 | ||
| Better than expected | 14 (74)b | 12 (67)c | |
| Same as expected | 4 (21)b | 5 (28)c | |
| Worse than expected | 1 (5)b | 1 (6)c | |
| Level of satisfaction with treatment | 0.18 | ||
| 0–6 | 0 (0)c | 0 (0)c | |
| 7 | 0 (0)c | 4 (22)c | |
| 8 | 2 (10)c | 1 (6)c | |
| 9 | 6 (30)c | 5 (28)c | |
| 10 | 12 (60)c | 8 (44)c | |
Fisher exact test.
Two participants did not respond to follow-up call.
One participant did not answer question: (Chauhan et al., unpublished data).
Discussion
This pilot study shows that both massage therapy and massage with acupuncture treatment have favorable effects on various symptoms of patients recovering from ATR surgery after mastectomy for breast cancer. Although both massage therapy alone and acupuncture plus massage therapy showed reduced stress, massage therapy alone had a greater effect.
Other studies have found a beneficial association of massage in fatigue reduction for cancer patients.25 Drackley et al.13 reported significant reductions in pain, stress, and muscle tension and increases in relaxation for patients who received massage after mastectomy on postoperative day 1. One of the authors' previous studies26 evaluated the effect of massage therapy alone and in combination with meditation for a similar breast cancer population undergoing reconstructive surgery. That study reported that scores for anxiety, stress, mood, relaxation, fatigue, tension, pain, and energy improved significantly after massage therapy.
In the present study, the addition of acupuncture had no observed additional beneficial effect on stress, anxiety, mood, relaxation, nausea, pain, and fatigue. In addition, the Massage+Acupuncture Group was more anxious at baseline before the intervention than the Massage-Only Group, which could be attributed to the patients' anxiety about getting treated with needles or receiving a treatment with which they were not familiar, or both. Both treatments significantly reduced stress, reduced anxiety, and increased relaxation scores at every visit compared with the baseline score.
These findings are somewhat disappointing. They also are in contrast to a report by Mallory et al.,17 a study that did daily acupuncture intervention for breast cancer patients after they had undergone mastectomy or breast reconstruction, or both, starting on postoperative day 1 and running through the postoperative hospital stay. In addition to observing a significant decrease in pain (p = 0.023), Mallory et al. noted a significant decrease in the anxiety (p = 0.006) and in tension/muscular discomfort (p < 0.001). The relationship between acupuncture and relaxation was not statistically significant (p = 0.053). However, acupuncture has been reported to be of value in stress management for students and staff at a large urban university, an effect that persisted for at least 3 months after treatment completion.27
Mehling et al.28 evaluated the combination treatment of massage and acupuncture in addition to usual care versus usual care alone for cancer patients in the postoperative setting. The investigators randomly assigned the cancer patients to receive either treatment postoperatively. Patients were observed over 3 days. The addition of massage and acupuncture to usual care resulted in decreased pain and decreased depressed mood between these two patient groups. However, this study did not identify the individual contribution of symptom improvement of these two integrative approaches.
A small study of patients with temporomandibular joint disorders compared the therapeutic effect of massage and electroacupuncture pulse stimulation therapy with that of electroacupuncture pulse stimulation therapy alone.29 The investigators observed that the combination was more effective, especially for patients at an early stage of myofascial pain.
Although the small sample size is acceptable for a pilot study, it limits the ability to detect statistically significant differences between the two groups. The open-label design limits their study because of patient selection bias,30 participant retention bias,31 participant performance bias,32 response bias,33 and treatment selection bias34 to the study questions. Some participants eligible for the study decided not to participate, knowing there was a chance that they would not receive their preferred treatment. In addition, the authors did not include details of the individualized therapy session in the data analysis past the randomized assignment. Another limitation was that the total duration of the treatment in the two treatment intervention groups differed. Patients who received massage and acupuncture had a total of 40 min of exposure with a provider. By comparison, the massage group had only a 20-min interaction, which could have an effect on the patients' experience. A massage session of 40 min would most likely have led to a different result.
In summary, sound evidence shows that massage therapy provides temporary benefit for various postoperative symptoms. Massage alone and massage and acupuncture both showed a significant increase in relaxation from baseline, but the increases were not significantly different between the two groups. Both treatments significantly reduced anxiety and reduced stress from baseline after treatment, but no significant difference was observed between the overall effects of the two groups. Although both treatments decreased stress, massage alone had a significantly greater reduction overall in stress than massage and acupuncture combined.
Conclusion
In the present pilot study, the addition of acupuncture to postoperative massage did not show additional beneficial effects in patients' overall postoperative symptom management. No additive beneficial effects were observed with the addition of acupuncture to massage for pain, anxiety, relaxation, nausea, fatigue, and mood. The combined treatment of massage and acupuncture was not as effective in reducing stress as massage alone, although both groups had significant stress reduction. These findings indicate the need for larger studies to explore these therapies further.
Acknowledgments
The study team thanks Jennifer L. Hauschulz, Nikol E. Dreyer, and Alexander Do, LAc, the massage therapists, and licensed acupuncturist who were able to fill in at the last minute. The authors thank the exceptional research staff of the Mayo Clinic Department of Medicine Clinical Research Office, Bonnie J. Donelan Dunlap, CCRP, Donna F. Rasmussen, RN, CCRP, and Sarah L. Gifford, CCRP, for their patience, persistence, hard work, and dedication in helping to collect, compile, and organize these data. The study team thanks Katrina A. Croghan, MS, CCRP, for her hard work and dedication in the protocol development and study start-up, including all regulatory approvals. Last but not least, they thank the patients who participated in this clinical trial. Without them, this project would not have been possible.
Ethics and Consent to Participate
In accordance with the Declaration of Helsinki, the Mayo Clinic Institutional Review Board reviewed and approved this study (ID 16-004817). The board-approved written informed consent was obtained for all patients before study participation.
Data Sharing
Additional details can be sought by contacting the corresponding author, Ivana T. Croghan, PhD (croghan.ivana@mayo.edu). Deidentified participant data that underlie the reported results in this article (i.e., text, tables, and figures) can be made available beginning at 9 months and ending at 36 months after article publication for individual participant data meta-analysis, if the proposed use has been approved by an independent review committee. Proposals should be directed to Ivana T. Croghan, PhD (croghan.ivana@mayo.edu). To gain access, data requestors will need to sign a data access agreement.
Author Disclosure Statement
No competing financial interests exist.
Funding Information
REDCap was the data entry system for this trial. This project was supported, in part, by the Center for Clinical and Translational Science Grant Number UL1 TR000135 from the National Center for Advancing Translational Sciences (NCATS). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Institutes of Health. This study also was supported, in part, by the Mayo Clinic Department of Medicine Division of General Internal Medicine and Clinical Research Office. The Division of General Internal Medicine provided funding in part for the study. The Clinical Research Office provided oversight of the clinical trial; provided input in study design and data collection; and aided in data interpretation.
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