Soden, et al. 2004(3535 Soden K, Vicent K, Craske S, Lucas C, Asheley S. A randomized controlled trial of aromatherapy massage in a hospice setting. Palliat Med. 2004 Mar 10;18(2):87-92. doi: 10.1191/0269216304pm874oa
https://doi.org/10.1191/0269216304pm874o...
)
United Kingdom |
To compare the effects of a 4-week aromatherapy massage and massage only on physical and psychological symptoms in patients with advanced cancer |
Randomization: The treatment allocation was concealed by a numbered opaque envelope and opened after the initial evaluation was completed
Blinding: The researchers who analyzed the data were blinded to the interventions. The patients who received the massages were not informed about the oils used |
The two experimental groups (EGs) (aromatherapy group and massage group) received a 30-minute back massage weekly for four weeks. Lavender essential oil (LEO) was chosen due to its sedative and analgesic effects The LEO was mixed with sweet almond oil (an inert carrier oil) for a 1% dilution. The patients in the Control Group (CG) completed the assessment scales weekly during the study period, but did not receive any massage |
- EG1) Aromatherapy Group (n=16): massage with LEO and an inert carrier oil
- EG2) Massage Group (n=13): massage only with an inert carrier oil |
- CG (n=13): patients who did not receive any massage |
- VAS
- Modified Tursky Pain Descriptors Scale
- VSH Sleep Scale
- HADS
- RSCL
|
Changes in the VAS scores for pain, from the baseline to the final assessment |
Sleep; depression and anxiety |
There was a statistically significant reduction in the VAS pain scores in the aromatherapy (p = 0.03) and combined massage (p = 0.01) groups after the second treatment. There were no significant changes in the scale of the pain descriptors, and no cumulative analgesic effect over time |
Kutner, et al. 2009(3636 Kurtner JS, Smith MC, Corbin L, Hemphill L, Benton K, Mellis BK, et al. Massage therapy versus simple touch to improve pain and mood in patients with advanced cancer: a randomized trial. Ann Intern Med. 2008 Sep 16;149(6):369-79. doi: 10.7326/0003-4819-149-6-200809160-00003
https://doi.org/10.7326/0003-4819-149-6-...
)
USA |
To assess the efficacy of the massage in reducing pain and suffering symptoms in order to improve the quality of life of patients with advanced cancer |
Randomization: The individuals were randomized from a central unit by two researchers. The randomization sequence was stratified in blocks and generated by the SAS computer program
Blinding: The data collectors were blinded to the interventions. The entire study team, except the study coordinators at the study locus and the two researchers at the center, were blinded to the randomization sequence |
- EG: The massage intervention included light/smooth effleurage (65% of the time), petrissage and release of myofascial trigger point (35% of the time). The most massaged areas of the body were the neck and upper back (nearly 80% of the time) and the arms, hands, legs, and feet (nearly 75% of the time) Inflammation/Infection, hyperesthesia, injury, surgery, catheters, deep vein thrombosis and tumors were avoided. 50% of the sessions were held with the patient in the supine position; 25% in a seated position, and 25% were divided between lying and prone positions. The massage was performed by massage therapists, with at least 6 months of experience in treating patients with advanced cancer
- The CG received "simple touch", which consisted of placing both hands on the participant for 3 minutes: neck base, scapulas, lumbar region, gastrocnemius, heels, clavicles, arms, hands, patellas, and feet. The pressure was light and consistent, with no hand movements from side to side. The control treatments were provided by individuals with no previous experience |
- EG: Massage Therapy Group (n=188): Patients receiving massage therapy |
- CG (n=192): Patients receiving simple touch |
- MPAC
- BPI
- MQOL
- MSAS
|
Immediate and sustained change in pain levels |
Immediate secondary outcomes included mood, heart rate, and respiratory rate. Sustained effects included quality of life, physical and emotional distress, and use of painkillers |
Both groups showed an immediate improvement in pain (EG = -1.87 points
(CI: -2.07; -1.67),
CG= -0.97 points (CI: -1,18; -0,76); immediate mood improvement (EG = 1.58 points (CI: 1.40; 1.76), CG = 0.97 points (CI: 0.78; 1.16). The EG obtained a higher score for pain and mood outcomes (p < 0.001). There were no differences between the means of the groups over time in pain (Mean BPI = 0.07 (CI: -0.23; 0.37), quality of life (general
QoL = 0.08 (CI: -0,37; 0.53), distress of the symptoms (MSAS Index=-0.002 (CI: -0,12; 0.12)
or use of analgesics = -0.10
(CI: -0.25; 0.05) |
Lopez-Sendín, et al. 2011(3737 López-Sendín N, Alburquerque-Sendín F, Cleland JA, Fernández-de-las-Peñas C. Effects of physical therapy on pain and mood in patients with terminal cancer: a pilot randomized clinical trial. J Altern Complement Med. 2012 May 10;18(5):480-6. doi: 10.1089/acm.2011.0277
https://doi.org/10.1089/acm.2011.0277...
)
Spain |
To determine the effects of physical therapy, including massage therapy and exercise, on pain and mood in patients with advanced terminal cancer |
Randomization: A table of random numbers was generated by computer, created before the study started
Blinding: A therapist who collected all the study results was blinded to the group interventions |
- The physiotherapy intervention in the EG consisted of several different massage techniques: Effleurage, petrissage, and strain/counterstrain techniques over the sensitive points. The patients received passive mobilization, active assistance or resistance exercises, and local and global resistance exercises, in addition to proprioceptive neuromuscular facilitation applied to the tense/painful joints and muscles
- The CG received a "simple touch" (ideal condition for false control), which was applied to areas of pain and maintained for the same period as in the EG. The treated areas included the lower cervical area, shoulder, interscapular area, heels, dorsal region of the foot, and gastrocnemius. In both groups, the risk areas (location of tumors, catheters, surgery) were avoided. All the patients received 6 sessions lasting 30 to 35 minutes over a period of two weeks |
EG= Intervention group (n=12): Patients receiving physical therapy, including massage therapy and exercises |
CG (n=12): Patients receiving simple manual touch |
- BPI
- MPAC
- MSAS
|
Changes in pain levels |
Differences in mood levels in the pre-/post-intervention |
A significant group x time interaction was found with improvements in the EG for the BPI index (F = 13.2, p<0.001), and for the psychological MSAS (F = 8.480, p = 0.001). In summary, the present study demonstrated that the combination of massage and exercise can reduce pain and improve mood in patients with terminal cancer |
Lam, et al., 2017(3838 Lam TY, Lu LM, Ling WM, Lin LZ. A pilot randomized controlled trial of acupuncture at the Si Guan Xue for cancer pain. BMC Complement Altern Med. 2017 Jun 26;17(1):335. doi: 10.1186/s12906-017-1838-5
https://doi.org/10.1186/s12906-017-1838-...
)
China and Hong Kong |
To test the safety of si guanxue acupuncture for cancer pain management |
Randomization: A computer program was used to randomize the participants. The study coordinator allocated the randomization codes that indicated the study arms in the numbered and sealed envelopes. These envelopes were sealed for the investigators
Blinding: neither the researchers nor the participants were blinded. Only those who conducted the analyses were blinded |
The EG1 only used si guanxue, while the EG2 used si guanxue in combination with a set of commonly used acupuncture points: Neiguan (PC6), Zusanli (ST36), and Sanyinjiao (SP6)
These points also constituted the CG. Disposable acupuncture needles (0.25 x 25 mm or 0.30 x 40 mm) were inserted under the skin at a vertical depth of 10 to 20 mm. Afterwards, a reinforcement reduction method was used to activate the Qi until the sensation of the arrival of the Qi (numbness, fullness, and weight) was reported by the patients. The patients were kept in dorsal supine with the needles left in place for 30 minutes. The acupuncture treatment consisted of 7 sessions, performed daily or on alternate days |
EG1) Treatment Arm 1 (n=14): si guan xue
EG2) Treatment Arm 2 (n=14): si guan xue plus the commonly used acupuncture points (PC6; ST36; SP6) |
CG (n=14): Patients receiving acupuncture at the commonly used points (PC6; ST36; SP6) |
- NRS
- PGIC
- EORTC QLQ-C30
- KPS
|
Relief of cancer pain and subjective improvement of the patients |
Quality of Life |
The analysis showed that the reduction in cancer pain in the EG2 was more prominent on day 5 when compared to the control arm (p<0.05). There was no difference in the PGIC, EORTC QLQ-C30 or KPS scores among the three groups (p>0.05). In addition, no serious adverse events were observed. The use and addition of si guanxue in the acupuncture treatment for cancer pain was also considered feasible and manageable |
Kim, et al. 2018(3939 Kim K, Lee S. Intradermal acupuncture along with analgesics for pain control in advanced cancer cases: a pilot, randomized, patient-assessor-blinded, controlled trial. Integr Cancer Ther. 2018 Dec 7;17(4):1137-43. doi: 10.1177/1534735418786797
https://doi.org/10.1177/1534735418786797...
)
Republic of Korea |
To determine the viability and to evaluate the effects and safety of intradermal acupuncture (IA) in patients who were receiving analgesics for cancer pain |
Randomization: The block randomization method was used by a statistician to generate random numbers, using the R program. Opaque envelopes numbered and containing the randomization sequences were kept in a safe place
Blinding: Only the clinician who administered the IA therapy was not blinded to the interventions. The subjects, the outcome evaluators, and the statistician who performed data analysis were blindedto the allocation of the treatment throughout the study |
- In the EG, the patients received IA treatment for 3 weeks at the specified acupuncture points (CV12, bilateral ST25, LI4, LR3, PC06, and additionally 0-3 Ashi points). The acupuncture points were selected by consensus of a committee of specialists composed of professors/researchers specialized in traditional Korean Medicine. Disposable, sterile, stainless steel IA needles, measuring 0.18 x 1.3 x 1.5 mm, were fixed with adhesive tape. Each IA needle was kept in the skin for 48 to 72 hours, and all the patients were instructed to press all locations on the needle with their hands 2x/day
- In the CG (Sham IA), all the interventions were the same as for the EG, including issuing the same instructions. However, the tip of the needle has been bent so as to cause a stinging sensation, imitating real acupuncture, without actually piercing the skin. The EG and CG interventions were performed by Korean physicians with at least 3 years of clinical experience |
EG= IA treatment (n=15): Patients receiving AI |
CG=Sham IA Treatment (n=15): Patients receiving Sham IA |
- NRS
- EORTC
QLQ-C30
|
Change in the grade and dosage of analgesics for cancer pain between baseline assessments and after the treatment |
Pain intensity and quality of life |
Nine patients (64%) in the EG (IA) and 5 (38%) in the CG (Sham IA) responded to the three-week intervention. Self-reported pain decreased by -1.54 ± 1.45 and by -1.15 ± 1.57 in the IA and Sham IA groups, respectively, with a reported improvement in quality of life (p = 0.017) |
De Paolis, et al. 2019(4040 De Paolis G, Naccarato A, Cibelli F, D'Alete A, Mastroianni C, Surdo L, et al. The effectiveness of progressive muscle relaxation and interactive guided imagery as a pain-reducing intervention in advanced cancer patients: a multicenter randomized controlled non- pharmacological trial. Complement Ther Clin Pract. 2019 Feb 2;34:280-7. doi: 10.1016/j.ctcp.2018.12.014
https://doi.org/10.1016/j.ctcp.2018.12.0...
)
Italy |
To assess the adjuvant effect of PMR-IGI in pain relief in a sample of terminal cancer patients in palliative care |
Randomization: The patients were allocated using a stratified randomization procedure based on their baseline pain score, which was associated with a randomization list placed in a sealed envelope which was opened by the clinical research nurse (CRN)
Blinding: There was no blinding |
The study had 4 phases: T0, T1, T2 and T3:
- T0 (patient registration): Patients admitted to the hospital for at least 48 hours; examined by some CRN
- T1 (within 24 hours from T0): Collecting information at the baseline. The EG patients (group A) were scheduled to an individual PMR-IGI session. The CG (group B) received the usual care
- T2 (within 1h from T1): Each PMR-IGI lasted 20 minutes. In the first 4 minutes, a state of psychophysical relaxation was induced by prolonged deep breathing and relaxation of the main muscle groups. The patient was invited by the professional to focus on their voice, tone and volume
- T3 (within 2h from the intervention): The patients were reassessed by the ESAS-r
- the number of acute pain episodes that occurred in the 24-hour period after the intervention and the administration of rescue analgesics were recorded in the CRF
|
EG=Group A (n=46): Patients receiving intervention (PMR-IGI) |
CG=Group B (n=45): Patients receiving standard care (without intervention) |
- ESAS-r
- TSDS
|
The primary endpoint was a Pain Intensity Difference (PID) score, i.e., a difference in the pain reported before and after the intervention ≥ 1 |
- Total score for distress, anxiety, and depression;
- Number of acute pain episodes reported within 24 hours after the PMR-IGI session;
- Need for rescue painkillers |
The Pain Intensity Difference (NRS at T3-NRS at T1) was 1.83 in the EG (group A) and 0.55 in the CG (group B), having statistical significance (p<0.0001). The mean total distress score decreased by 8.83 in the EG, and by 1.84 in the CG. The mean difference in the ESAS-r emotional scores (anxiety and depression) was 2.93 in the EG (p<0.0001) and 0.07 in the CG (p>0.05) |
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