Massage Therapy versus Simple Touch to Improve Pain and Mood in Patients with Advanced Cancer

Context Some patients nearing death seek pain relief with massage, but little is known about the effectiveness of massage in managing pain in palliative care settings. Contribution In this randomized trial in 380 patients with advanced cancer, improvement in pain and mood immediately after treatment was greater with massage than with simple touch. Unfortunately, there were no sustained differences in pain, quality of life, or analgesic use during 3 weeks. Adverse effects were infrequent and similar in both groups. Implication Massage may offer some immediate relief for patients with advanced cancer, but the absence of sustained effects demonstrates the need for more effective strategies to manage pain at the end of life. The Editors Symptom relief is central to end-of-life care; however, many terminally ill individuals experience serious pain and other physical and emotional symptoms (14). Studies examining the efficacy of therapies that may mediate these symptoms deserve the highest priority. The Institute of Medicine and the National Institutes of Health recommend research directed at improving end-of-life care (5, 6). Pain associated with advanced cancer can cause physical and emotional distress, leading to decreased functional ability and quality of life. Massage may interrupt the cycle of distress through the therapist's intention (presence, communication, and desire to produce a therapeutic response), induction of a relaxation response, increased blood and lymphatic circulation, potentiation of analgesic effects, decreased inflammation and edema, manual release of muscle spasms, increased endogenous endorphin release, and competing sensory stimuli that override pain signals (711). Despite theoretical bases supporting the use and growing acceptance of massage therapy, few randomized clinical trials have assessed its efficacy. Large trials have been difficult to design and carry out; challenges include frailty of patients with late-stage cancer and reluctance of health care providers to refer patients because of the possibility of randomization to nonmassage therapy control (12). Therapeutic massage can reduce pain and improve symptom distress and quality of life for patients with cancer at the end of life. The purpose of the REST (Reducing End-of-Life Symptoms with Touch) study was to evaluate the efficacy of massage compared with an exposure controlling for time, attention, and touch. We hypothesized that massage would decrease pain and explored effects on quality of life, physical and emotional symptom distress, and analgesic medicine use. Methods Design Overview We conducted this prospective, 2-group, randomized, single-blind trial between November 2003 and October 2006. After we evaluated patients for inclusion and exclusion criteria, patients provided written informed consent. Then we randomly assigned patients to a treatment group (massage) or control exposure (simple touch). Figure 1 depicts the timing of the study procedures for a hypothetical participant. We collected individual characteristics, disease, pain characteristics, symptom distress, quality of life, functional status (Karnofsky Performance Scale score) (13), expected helpfulness of massage for pain, and concurrent interventions (pharmacologic and nonpharmacologic) at baseline (within 72 hours of study enrollment) and at 3 subsequent weekly visits over the 3 to 4 weeks of participation (sustained outcomes). Final data collection occurred approximately 1 week after the final treatment. Data collectors were blinded to treatment assignment. Participants received up to six 30-minute treatments over 2 weeks, with at least 24 hours between treatment sessions. The initial treatment session occurred within 48 hours of baseline data collection. The treatment provider and patient determined the scheduling of treatment sessions. Treatment providers who were not blinded to treatment assignment obtained the immediate outcomes just before and after every treatment session. All participants received routine care in addition to the specified interventions. The Colorado Multiple Institutional Review Board and, where applicable, site-specific institutional review boards approved the study. Figure 1. Study overview: timing of study procedures. Setting and Participants Study sites included 15 U.S. hospices that are members of the Population-based Palliative Care Research Network (PoPCRN) (14) and the University of Colorado Cancer Center, Aurora, Colorado. Eligible participants were English-speaking adults with advanced cancer (stage III or IV, all cancer types, any care setting) who had at least moderate pain (score 4 on a 0- to 10-point scale) in the week before enrollment, an anticipated life expectancy of at least 3 weeks, and the ability to consent. Exclusion criteria included receipt of professional massage within 1 month of enrollment, anticoagulant therapy, known platelet count less than 10109 cells/L, or known unstable spine. Randomization and Interventions Verification of eligibility was forwarded by a study coordinator from each study site to the University of Colorado researchers. Two designated investigators randomly assigned patients; assignments were transmitted back to the requesting site. All study personnel other than the on-site study coordinators and these 2 designated investigators were blinded to the randomization sequence. An SAS software program (SAS Institute, Cary, North Carolina) generated the randomization sequence by producing a randomized block design stratified by study site. Block size randomly varied among 2, 4, and 6 so that it was not possible to predict the next assignment. To minimize the likelihood that potential participants would decline enrollment because of reluctance to be randomly assigned, we offered massage after study completion to those assigned to the control group. Experimental Treatment: Massage Therapy The massage intervention included gentle effleurage, petrissage, and myofascial trigger point release. Effleurage is a smooth, gliding stroke; petrissage is squeezing, rolling, and kneading the muscles; and trigger point release provides concentrated finger pressure to painful localized areas in muscles to break cycles of spasm and pain (15). Individual therapist judgment dictated the frequency of rhythm, rate, or stroke; sequence or mix of strokes; time spent in each stroke; stroke length; and body area massaged (16). Massage therapists spent 65% of the time in effleurage and 35% in petrissage. The most frequently massaged areas of the body were the neck and upper back (about 80% of the time) and arms, hands, lower legs, and feet (about 75% of the time). Other areas, such as the chest, abdomen, buttocks, back of the thighs, and forehead were massaged less than 50% of the time. Therapists appropriately modified massage in persons with skin fragility, postural limitations, edema, osteoporosis, or bone metastasis. Therapists avoided sites of inflammation or infection, hyperesthesias, injury, surgery, ports, catheters, deep venous thrombosis, and tumors. Therapists identified and treated up to 3 myofascial trigger points per session (located 15% to 25% of the time in the neck, upper trapezius, and lower trapezius regions). One half of the sessions were provided with the patient supine, 25% seated, and the remainder split between side-lying and prone positions. Temperature and level of privacy varied with setting. Fewer than 25% of participants were unclothed during treatments. Massage was performed by licensed massage therapists who had at least 6 months of experience treating patients with advanced cancer or hospice patients and completed a minimum 500-hour program of study in massage from an institution recognized by their state as a vocational school. Control Exposure We designed the control exposure, simple touch, to control for the time, attention, touch, and healing intent components of the intervention (17). The control consisted of placement of both hands on the participant for 3 minutes at each of the following locations bilaterally: base of neck, shoulder blades, lower back, calves, heels, clavicles, lower arms, hands, patellae, and feet. Pressure was light and consistent, with no side-to-side hand movement. Control therapy providers interrupted conscious healing intention by silently counting backward from 100 by 7, reciting nursery rhymes, or planning their day's activities (18, 19). The control treatments were provided by individuals with no past body or energy work experience. All treatment providers participated in standardized hands-on training, received a study manual and training video, and were evaluated for competency in study procedures. We monitored adherence to study protocols during twice-yearly site visits. Treatment providers in both groups used Biotone hypoallergenic unscented massage cream (Biotone, San Diego, California). For the purposes of standardization and to mediate the presence of intervening variables, we did not permit music, essential oils, or energy work and instructed treatment providers to limit their communication to providing instructions or responding to therapy-related questions. To minimize variation by treatment provider, 1 primary massage therapist or simple-touch provider per participant at each study site administered study treatments. Outcomes and Follow-up We used face-to-face, interviewer-administered questionnaires to collect all study data. We measured neuropathic pain at baseline only by the Neuropathy Pain Scale (0- to 10-point scale), which is sensitive to pain qualities most common to neuropathic pain syndromes (20, 21). Presence of neuropathic pain was defined as a Neuropathy Pain Scale summary score greater than 3. Primary Outcomes: Immediate and Sustained Change in Pain The immediate effect was measured by the pain intensity scale of the Memorial Pain Assessment Card (MPAC) (0 to 10 points; 10 = worst pain) (22). The sustained effect was measured b