Group CBT did not achieve the expected change in the primary outcome measure as a significant number did not achieve scores within the normal range post-intervention. The treatment did not return a significant number of subjects to within the normal range on this domain; however, significant improvements were evident in some areas. Group CBT was effective in treating symptoms of fatigue, mood and physical fitness in CFS/ME. It was found to be as effective as trials using individual therapy in these domains. However, it did not bring about improvement in cognitive function or quality of life. There was also evidence of improvement in the EAS group, which indicates that there is limited value in the non-specific effects of therapy. Further research is needed to develop better outcome measures, assessments of the broader costs of the illness and a clearer picture of the characteristics best fitted to this type of intervention.

The findings indicate that evaluating TENS using a unidimensional pain scale is likely to overlook potential benefits. The complex pattern of TENS usage, as well as multiple direct and indirect outcomes, indicates that TENS could be considered as a complex intervention.

The negative themes may help explain the negative outcomes from rehabilitation reported by previous patient surveys. The negative themes indicate rehabilitation processes which contradict the NICE (National Institute for Health and Clinical Excellence) Guideline advice regarding GET, indicating that some clinical encounters were not implementing these. These findings suggest areas for improving therapist training, and for developing quality criteria for rehabilitation in CFS/ME. Implications for Rehabilitation The insensitive delivery of rehabilitation support for people with CFS/ME can explain negative outcomes reported in patient surveys. Therapist-patient collaboration, establishing a sustainable baseline and agreeing a setback plan are all examples of higher quality rehabilitation indicated by this research. Greater awareness of the positive and negative experiences of rehabilitation therapies should enable avoidance of the potential pitfalls identified in this research. Positive experiences of rehabilitation therapies include supportive communication with a therapist, treatment which included routines and goals, and value attached to baselines and controlled pacing. By contrast, factors leading to negative experiences include poor communication and support, conflict in beliefs about CFS/ME and rehabilitation, pressure to comply with treatment, worsening of symptoms, baselines experienced as unsustainable, and feeling blamed for rehabilitation not working.

The findings indicated that a pragmatic TENS evaluation may need to incorporate a learning phase to allow patients to optimize this complex pattern of TENS usage, and evaluation may need to be sensitive to the outcomes of strategic use. These findings also have implications for clinical practice.

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Background and objectives: There is a lack of good quality evidence regarding the effectiveness of transcutaneous electrical nerve stimulation (TENS) for chronic musculoskeletal pain, including chronic low back pain. High quality randomised controlled trials (RCTs) have been called for to establish effectiveness over and above placebo and some guidance has already been offered regarding the design of such trials. This article expands the discussion regarding the design of future TENS trials. There is qualitative evidence of the complexity of TENS as an intervention which should be considered in future TENS evaluations. This complexity includes multiple benefits reported by patients, depending on their chosen contexts of TENS use. The ideal content and delivery of support for patients to optimise TENS use also lacks consensus. There is no evidence that a TENS education package has been designed to support the complex set of behaviours and choices which experienced users suggest are required to optimise TENS benefits. Finally, clinical and research outcomes have not been contextualised and related to the specific strategies of use. Conclusions: We suggest that research is required to develop consensus about the content and delivery of training in TENS use for patients who live with pain, informed by the experience of patients, clinicians, and researchers. Once a consensus about the content of TENS training has been reached, there is then a need to develop a TENS training course (TTC) based on this content. An effective and acceptable TTC is needed to develop the knowledge and skills required to optimise TENS use, supporting patients to build confidence in using TENS in everyday life situations with the aim of reducing the impact of chronic pain on function and quality of life. Further research is required to extend the evidence base regarding appropriate, contextualised TENS patient-reported outcomes.

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