Exploring integrative medicine for back and neck pain : On the integration of manual and complementary therapies in Swedish primary care

Sammanfattning: Background and aims: The integration of complementary therapies (CTs) with an emerging evidence base into conventional care services is common, despite limited evidence as to the clinical effectiveness of comprehensive models delivering such care, i.e. integrative medicine (IM). Low back and neck pain (LBP/NP) are two of the most common reasons for people to use CTs. The objectives of this thesis were to develop, implement and explore the relevance of IM as a potential health service option in Swedish primary care. Methods: Acknowledging IM as a complex health care intervention, both qualitative and quantitative research approaches were used in this thesis. During the development of the IM model, an action research approach with focus groups and key informant meetings with multiple conventional and CT stakeholders was utilised. The development progressed through iterative cycles of data collection, analysis, refinement of strategies and actions following research group consensus, followed by further data collection (immersion/crystallisation). Perceived facilitators, barriers and strategies were identified and findings were categorised within a public health science framework of IM model structures, processes and outcomes. The feasibility and comparative effectiveness of IM vs. conventional primary care was investigated in a pragmatic pilot randomised clinical trial (RCT) of 80 patients with LBP/NP. Parametric and nonparametric statistics were used to explore outcome changes between groups after four months: SF-36 (main); self-rated disability, stress and well-being (0-10 scales), days in pain and the use of health care resources including analgesics, conventional care and CTs. Perspectives on receiving care were explored through focus group discussions with patients from the RCT and analysed by content analysis. A health economic evaluation was conducted alongside the RCT to explore the likelihood of the IM model being a cost-effective health service option. Results: The developed IM model adhered to standard clinical practice procedures and involved active partnership between a gatekeeping general practitioner collaborating with a team of certified/licensed CT providers (Swedish massage therapy, manipulative therapy/naprapathy, shiatsu, acupuncture and qigong) in a consensus case conference model of care. The implementation of the IM model was feasible and most patients were women with chronic (?3 months) LBP/NP. The conventional care mainly consisted of pain management advice (stay active) and analgesics, occasionally complemented by short-term sick leave or a physiotherapy referral. In addition to this, the IM model integrated seven sessions of two different CTs over 10 weeks on average. It was found that the pilot RCT was underpowered to detect statistically significant differences between groups, and that a full-scale RCT would require a minimum of 120 patients. However, the trend in the clinical quantitative results with an increase in the SF-36 domain Vitality and a decrease in the use of analgesics favoured IM. In addition, the qualitative findings indicated that the interviewed patients valued the IM combination of conventional biomedical diagnostic procedures with empowering CT self-help strategies. There was a conservative likelihood (67%) of the IM model being cost-effective at a threshold of EUR 50,000 per quality-adjusted life year gained. Conclusion: Identification of IM facilitators, barriers and strategies by the different stakeholders contributed to feasible implementation within Swedish primary care. Triangulation of the various results suggests that IM is at least as effective as conventional care, with potential clinical benefits including empowerment and reduced need for analgesics. To verify the relevance of IM in Swedish primary care, future research should prioritise larger trials considering large variability, chronic pain duration, small to moderate effects, indirect costs and longer-term follow-up while adopting a mixed methods approach considering both general and disease-specific outcomes.