Medical Research>> Research projects on back disorders>> Projects on treatments>> Effectiveness and Efficiency of Neuroreflexotherapy in the National Health System.

EFFECTIVENESS AND EFFICIENCY OF NEUROREFLEXOTHERAPY IN THE NATIONAL HEALTH SYSTEM

Title.

Effectiveness and efficiency of neuroreflexotherapy (NRT) for the management of non-specific low back pain in primary care. A randomized community trial.

Background.

Back pain represents one of the leading causes for doctor consultations and work absenteeism in industrialized countries. It is estimated that the cost it represents to the public coffers equals approximately 1.7% of the Gross Domestic Product.

Many procedures are used to treat it, but few have been rigorously evaluated and only a small part of them have been shown to be effective, especially in those cases in which the pain is prolonged. In fact, acute cases have a good prognosis and tend to cure themselves spontaneously, but chronic cases (in which the pain lasts more than 90 days) have a poor prognosis and while they represent a minority of patients, they generate the immense majority of the costs derived from these ailments.

Neuroreflexotherapy (NRT) consists of the very superficial implantation of surgical material on the nerve endings of the skin without breaking it. This stimulation prompts a neurological mechanism that could improve certain illnesses. All of the surgical material is sterile and used only once and is left implanted between 14 and 90 days. Its implantation is practically painless, does not require anesthesia and is performed on an outpatient basis.

It should be pointed out that, while this kind of treatment is often confused with acupuncture, available scientific studies show that they are not related. The territories stimulated in NRT are defined exclusively by the nerve fibers found in them. They do not coincide with the locations of the acupuncture points nor do they reveal the electric and radioactive characteristics that define them.

Available data show that this technology is safe for the treatment of subacute and chronic back pain (see page 40) and its efficacy was shown in two controlled, randomized, double-blind clinical trials carried out by different researchers in different care and geographical settings (see pages 42 and 44).

For that reason, after the National Health System co funded along with the Kovacs Foundation two studies to evaluate the efficacy of this technology, and these studies provided positive results, it became essential to also evaluate its effectiveness (that is to say, the effect of its application in ordinary health care conditions and not in the context of an experimental study) as well as its efficiency (that is to say, the relationship between the cost of applying it and the outcome obtained). Thus, the objective of this study was not centered on determining whether the technology had an intrinsic effect or not, since that had already been demonstrated, but rather on evaluating its effectiveness and its efficiency in order to situate it as the most appropriate treatment for the health of patients and the profitable use of public funds.

Objectives.

To determine the clinical and economic effects entailed in including referral for neuroreflexotherapy in the usual scheme of treatment for back pain in the National Health System, evaluating:

1. The clinical evolution of referred patients, in comparison to those who are treated with the usual treatment scheme (and defining "clinical evolution" as that the evolution of pain, disability and quality of life).

2. The direct and indirect costs generated by the NRT referral patients in comparison to those who are not.

3. The efficiency (relationship between cost and effect) of adding the NRT referral to the usual treatment scheme in the National Health System, comparing the relation between cost and effectiveness in the group in which it is performed and that in which it is not.
   

Methodology.

It was a randomized, controlled, clinical trial with blinding in the randomization and in the analysis of the results, in which the doctors were randomized and in which the patients were followed for one year.

The study was carried out at Primary Care centers of the National Health System in Mallorca. Physicians at those centers were offered to participate in the study and those that accepted were randomly assigned to one of two groups. In the control group, the physicians treated the patients according to the customary scheme of treatment of the National Health System (medical advice, medication, and assessment of prescription of diagnostic tests or referrals to specialists, physiotherapy or rehabilitation). In the intervention group, the doctors were also allowed to refer those patients in whom it was indicated for neuroreflexotherapy.

The doctors included patients in the study between 18 and 65 years old who consulted them for low back pain ("non-specific low back pain" defined by the standard diagnoses accepted by the international scientific community), resistant to 14 days of pharmacological treatment and in whom there was no indication for urgent surgery.

The patient's clinical situation was appraised obligatorily in the moment he or she was included in the study, at 14, 60 and 365 days. Additionally, all of the visits the patient voluntarily requested with the doctor for his or her low back pain or complications from the treatment were considered additional controls and their outcomes were considered.

To follow the patients' clinical evolution, essentially pain intensity (local and radiated to the leg), measured independently on the Visual Analog Scale, degree of disability due to pain, measured on the Roland-Morris scale and quality of life, measured by means of the EuroQol questionnaire. Also appraised were: sick leave, other treatments the patients required (medications of different kinds, physiotherapeutic or rehabilitation treatments, surgery, etc.) and the diagnostic tests that were indicated during the follow-up year. Also appraised were the direct and indirect costs generated by each patient throughout that year for low back pain and the treatment of possible complications from the tests or treatments they received.

When the study was concluded, the results referring to the patients' clinical evolution were analyzed by a team of Spanish statisticians, who did not know which group (intervention or control) each patient belonged to. The analysis strategy and the results were later supervised by a team of independent analysts.

Finally, another independent team of analysts made the analysis referring to costs and efficiency. Obviously this team had to know which patients belonged to one group or another (control or intervention), since it had to assign the costs of the neuroreflexotherapy to the group in which it was carried out.

Participants, along with the Foundation's Science Department.

Research Unit in Health Services of the Carlos III Institute, and Research Units of: INSALUD Primary Care of the Balearic Islands, the 12th of October Hospital and Ramón y Cajal Hospital: Department of Bio-Statistics of Emory University (Atlanta, USA), Health Centers of: Inca, A. Bennassar, Coll d'en Rebassa, S´Escorxador, Santa Catalina, Son Serra/La Vileta, and Valldargent.

Funded in entirety by the Kovacs Foundation.

Status.

The study has concluded and its results have been published. Spine 2002; 27:1149-1159.

In short, its results show that including NRT in the usual treatment plan for back pain entails:

Once the study was published, an independent team of analysts requested the data to reanalyze them from an essentially economic point of view, using new methods of analysis ("multilevel analysis"). The corresponding article was sent to an internationally distributed journal.

On the other hand, it should be noted that the scheme of successive evaluations on safety, efficacy, effectiveness and efficiency that have been applied in the case of neuroreflexotherapy is the standard recommended by the international scientific community for evaluating a new technology, since it is the only way of ensuring the efficacy and safety of the treatments applied to the public and the profitable use of public funds spent on health care. However, unfortunately very few technologies-including those currently applied in the National Health System-have been evaluated in a similar manner.