Control groups in clinical trials of non-pharmacological interventions for cancer pain: a meta-research study
DOI:
https://doi.org/10.15343/0104-7809.202650e18042025IKeywords:
Cancer Pain, Complementary Therapeutic Methods, Holistic HealthAbstract
Cancer pain is a common challenge in patients with cancer, arising from tumor progression or adverse effects of treatment. For its management, non-pharmacological interventions have been investigated through randomized controlled trials (RCTs), which require appropriate comparative strategies (placebo or sham) to isolate the effects of the intervention. However, limitations in blinding inherent to this type of intervention may influence the interpretation of results. The objective of this study was to identify the strategies used in the control groups of randomized controlled trials evaluating non-pharmacological interventions for cancer pain. This is a meta-research study (research on how science is produced) conducted in the MEDLINE and LILACS databases, using MeSH/DeCS descriptors and free-text terms related to “Cancer pain” and “Complementary therapies,” with no restrictions on language or year of publication. Non-randomized studies and those involving surgical interventions were excluded. Study selection and data extraction were performed in duplicate. Information on the type of blinding and the strategies used in the control groups was extracted. The search retrieved 311 articles; 52 were included after screening, of which 22 had full-text availability. Of these, 15 were single-blind, 6 were open-label, 1 was described as double-blind, and 12 discussed the impact of performance bias. The most frequently evaluated interventions included acupuncture, therapeutic massage, and music therapy. Control groups varied between usual care, placebo, no intervention, and sham procedures. It is concluded that there is substantial variability in control strategies and that the absence of discussion regarding performance bias may compromise the interpretation of results and clinical decision-making.
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This article is a translation in English of the article:
Grupos controle de ensaios clínicos sobre intervenções não medicamentosas para dor oncológica: uma meta-pesquisa
References
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Ruela LO, Iunes DH, Nogueira DA, Stefanello J, Gradim CVC. Efetividade da acupuntura auricular no tratamento da dor oncológica: ensaio clínico randomizado. Rev Bras Enferm. 2017;70(4):807–13. doi:10.1590/S1980-220X2017040503402.
Weinrich SP, Weinrich MC. The effect of massage on pain in cancer patients. Appl Nurs Res. 1990;3(4):140–5.
Carson JW, Carson KM, Olsen MK, Sanders L, Westbrook K, Keefe FJ, et al. Yoga practice predicts improvements in day-to-day pain in women with metastatic breast cancer. J Pain Symptom Manage. 2021;61(6):1227–33.
Bandeira MD. Mascaramento em ensaios clínicos [Internet]. EME – Estudantes para Melhores Evidências; 2021 [citado 2025 maio 28]. Disponível em: https://eme.cochrane.org/mascaramento-em-ensaios-clinicos/
Johnson MI, Goebel A. Sham controls in device trials for chronic pain: tricky in practice. Pain Manag. 2023;13(6):423–6. doi:10.2217/pmt-2023-0032. Disponível em: https://pmc.ncbi.nlm.nih.gov/articles/PMC10474149/
Ioannidis JPA. Meta-research: why research on research matters. PLoS Biol. 2018;16(3):e2005468.
Lefebvre C, Glanville J, Briscoe S, Featherstone R, Littlewood A, Metzendorf MI, et al. Chapter 4: Searching for and selecting studies, section 4.4.3. In: Higgins JPT, Thomas J, Chandler J, Cumpston M, Li T, Page MJ, et al., editors. Cochrane Handbook for Systematic Reviews of Interventions. Version 6.5. London: Cochrane; 2024. Disponível em: https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04#section-4-4-3.
Ouzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan: a web and mobile app for systematic reviews. Syst Rev. 2016;5:210. doi:10.1186/ s13643-016-0384-4.
Syrjala KL, Cummings C, Donaldson GW. Hypnosis or cognitive behavioral training for reduction of pain and nausea during cancer treatment: a controlled clinical trial. Pain. 1992;48(2):137–46. doi:10.1016/0304-3959(92)90049-H.
Ferrell-Torry AT, Glick OJ. The use of therapeutic massage as a nursing intervention to modify anxiety and perception of cancer pain. Cancer Nurs. 1993;16(2):93–101.
Syrjala KL, Donaldson GW, Davis MW, Kippes ME, Carr JE. Relaxation and imagery and cognitive-behavioral training reduce pain during cancer treatment: a controlled clinical trial. Pain. 1995;63(2):189–98. doi:10.1016/0304-3959(95)00039-U.
Reinhardt U. Untersuchungen zur Synchronisation von Herzfrequenz und musikalischem Rhythmus im Rahmen einer Entspannungstherapie bei Patienten mit tumorbedingten Schmerzen. Forsch Komplementarmed. 1999;6(3):135–41. doi:10.1159/000021235.
Wilkie DJ, Kampbell J, Cutshall S, Halabisky H, Harmon H, Johnson LP, et al. Effects of massage on pain intensity, analgesics, and quality of life in cancer pain: pilot randomized clinical trial conducted within hospice care delivery. Hosp J. 2000;15(3):31–53.
Olson K, Hanson J, Michaud M. A phase II trial of Reiki for management of pain in advanced cancer patients. J Pain Symptom Manage. 2003;26(5):990 7. doi:10.1016/s0885-3924(03)00334-8.
Alimi D, Rubino C, Pichard-Léandri E, Fermand-Brulé S, Dubreuil-Lemaire ML, Hill C. Analgesic effect of auricular acupuncture for cancer pain: randomized controlled trial. J Clin Oncol. 2003;21(22):4120–6. doi:10.1200/JCO.2003.09.011.
Siedliecki SL, Good M. Effect of music on power, pain, depression and disability. J Adv Nurs. 2006;54(5):553–62. doi:10.1111/j.1365-2648.2006.03860.x.
Zhang T, Ma SL, Xie GR, Deng QH, Tang ZZ, Pan XC, et al. Clinical research on nourishing yin and unblocking meridians recipe combined with opioid analgesics in cancer pain management. Chin J Integr Med. 2006;12(3):180–4. doi:10.1007/BF02836518.
Stephenson NL, Swanson M, Dalton J, Keefe FJ, Engelke M. Partner-delivered reflexology: effects on cancer pain and anxiety. Oncol Nurs Forum. 2007;34(1):127–32. doi:10.1188/07.ONF.127-132.
Tsai PS, Chen PL, Lai YL, Lee MB, Lin CC. Electromyography biofeedback-assisted relaxation on pain in advanced cancer patients in palliative care. Cancer Nurs. 2007;30(5):347–53. doi:10.1097/01.NCC.0000290805.38335.7b.
Chen ZJ, Guo YP, Wu ZC. Observation on therapeutic effect of acupuncture at pain points on cancer pain. Zhongguo Zhen Jiu. 2008;28(4):251–3.
Kwekkeboom KL, Wanta B, Bumpus M. Individual difference variables and effects of progressive muscle relaxation and analgesic imagery on cancer pain. J Pain Symptom Manage. 2008;36(6):604–15. doi:10.1016/j.jpainsymman.2007.12.011.
Butler LD, Koopman C, Neri E, Giese-Davis J, Palesh O, Thorne-Yocam KA, et al. Effects of supportive-expressive group therapy on pain in metastatic breast cancer. Health Psychol. 2009;28(5):579–87. doi:10.1037/a0016124.
Huang ST, Good M, Zauszniewski JA. Effectiveness of music in relieving pain in cancer patients. Int J Nurs Stud. 2010;47(11):1354–62. doi:10.1016/j. ijnurstu.2010.03.008.
Jane SW, Chen SL, Wilkie DJ, Lin YC, Foreman SW, Beaton RD, et al. Effects of massage on pain, mood, relaxation, and sleep in Taiwanese patients with metastatic bone pain. Pain. 2011;152(10):2432–42. doi:10.1016/j.pain.2011.06.021.
Chen H, Liu TY, Kuai L, Zhu J, Wu CJ, Liu LM. Electroacupuncture for pancreatic cancer pain: randomized controlled trial. Pancreatology. 2013;13(6):594–7. doi:10.1016/j.pan.2013.10.007.
Lee J, Yoon SW. Moxibustion for pain in metastatic cancer: pilot randomized single-blind trial. Integr Cancer Ther. 2014;13(3):211–6. doi:10.1177/1534735413510025.
Warth M, Keßler J, Hillecke TK, Bardenheuer HJ. Music therapy in palliative care. Dtsch Arztebl Int. 2015;112(46):788–94. doi:10.3238/ arztebl.2015.0788.
Sharif Nia H, Sharif SP, Yaghoobzadeh A, Yeoh KK, Goudarzian AH, Soleimani MA, et al. Effect of acupressure on pain in leukemia. Int J Nurs Pract. 2017;23(2):e12513. doi:10.1111/ijn.12513.
Uysal N, Kutlutürkan S, Uğur I. Effects of foot massage on symptom control in colorectal cancer. Int J Nurs Pract. 2017;23(3):e12532. doi:10.1111/ ijn.12532.
Lam TY, Lu LM, Ling WM, Lin LZ. Acupuncture at Si Guan Xue for cancer pain: pilot randomized controlled trial. BMC Complement Altern Med. 2017;17(1):335. doi:10.1186/s12906-017-1838-5.
Mendoza ME, Capafons A, Gralow JR, Syrjala KL, Suárez-Rodríguez JM, Fann JR, et al. Waking hypnosis plus CBT for pain, fatigue and sleep: randomized trial. Psychooncology. 2017;26(11):1832–8. doi:10.1002/pon.4232.
Xu L, Wan Y, Huang J, Xu F. Electroacupuncture and multiple acupoint stimulation for cancer pain in hepatocellular carcinoma. J Cancer Res Ther. 2018;14(1):99–102. doi:10.4103/jcrt.JCRT_736_17.
Eyigor S, Uslu R, Apaydın S, Caramat I, Yesil H. Yoga for shoulder/arm pain and QoL in breast cancer: randomized trial. Complement Ther Clin Pract. 2018;32:40–5. doi:10.1016/j.ctcp.2018.04.010.
Kim K, Lee S. Intradermal acupuncture plus analgesics for pain in advanced cancer. Integr Cancer Ther. 2018;17(4):1137–43. doi:10.1177/1534735418786797.
Liang Y, Bao G, Gong L, Zhou J, Kong X, Ran R, et al. TEAS + opioids for cancer pain: study protocol RCT. Trials. 2019;20(1):40. doi:10.1186/s13063 018-3145-y.
De Paolis G, Naccarato A, Cibelli F, D’Alete A, Mastroianni C, Surdo L, et al. Progressive muscle relaxation + imagery for cancer pain: multicentre RCT. Complement Ther Clin Pract. 2019;34:280–7. doi:10.1016/j.ctcp.2018.12.014.
Hsieh FC, Miao NF, Tseng IJ, Chiu HL, Kao CC, Liu D, et al. Music intervention vs ambient music in breast cancer survivors: feasibility study. Eur J Cancer Care. 2019;28(4):e13064. doi:10.1111/ecc.13064.
He Y, May BH, Zhang AL, Guo X, Liu Y, Qu Y, et al. Acupuncture for cancer pain: pilot RCT protocol. BMJ Open. 2019;9(7):e025564. doi:10.1136/ bmjopen-2018-025564.
Wu QL, Cao W, Wang W, Jiang ZY, Chen L, Li LL. Wrist-ankle needle + opioids for refractory cancer pain: RCT. Zhongguo Zhen Jiu. 2019;39(10):1051 4. doi:10.13703/j.0255-2930.2019.10.005.
Rambod M, Pasyar N, Shamsadini M. Foot reflexology for fatigue, pain and sleep in lymphoma: clinical trial. Eur J Oncol Nurs. 2019;43:101678. doi:10.1016/j.ejon.2019.101678.
Li D, Sun RR, Li QL, et al. Acupuncture + opioids for moderate/severe cancer pain: RCT. Zhongguo Zhen Jiu. 2020;40(3):257–61. doi:10.13703/ j.0255-2930.20190311-k0001.
Lei Y, Duan Y, Wang J, Yu X, Deng S, Liu R, et al. Acupuncture + therapy for prostate cancer pain: protocol. Medicine (Baltimore). 2020;99(14):e19609. doi:10.1097/MD.0000000000019609.
Xu LP, Yang SL, Su SQ, Huang BX, Lan XM, Yao RJ. Wrist-ankle + auricular acupuncture: four-arm RCT. Complement Ther Clin Pract. 2020;39:101170. doi:10.1016/j.ctcp.2020.101170.
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2026-01-16
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Gurman, N., Maruyama, A. T., Castagna, C., Moraes, R. C. G. de, Santos, S. S., Frederico, Y., & Latorraca, C. de O. C. (2026). Control groups in clinical trials of non-pharmacological interventions for cancer pain: a meta-research study. O Mundo Da Saúde, 50. https://doi.org/10.15343/0104-7809.202650e18042025I
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