Musculoskeletal pain studies in humans

Christian Ariel Mista Bioethics 2011

Defining the problem
Pain is considered one of the most important factors that have a strong effect on the motor control and the motor variability. Experimentally induced muscle pain produce changes in the muscle activity, and these alterations are related with the motor task and the strategies of the motor system to recruit the muscles to perform these actions. The assessment of adaptations in the motor control during painful condition is important not only in sport science and rehabilitation, but it is also significant to the understanding the quality of the patient s life. In addition, treatments could be improved based on results obtained from investigations, and new techniques can provided solutions to patients that suffer different type of muscle pain. Nowadays the capacity to perform accurately forces is playing an important role in daily life. Submaximal force levels and during precision tasks are the most common tasks required in daily living, and indeed these types of contractions are those that present higher force fluctuations under pain effects. Therefore, further investigations are needed in order to fully understand the motor control adaptations due to the presence of muscle pain. The relationship of these adaptations with biomechanics variables, such as force and torque, is also essential in the investigation of the human performance during different motor tasks. The primary objective on this kind of investigations is to arrive to a solution to patients that suffer musculoskeletal pain. However, several issues could be found through the progress of the investigations. For instance, pathological conditions are related with diverse kind of processes that may result in the final dysfunction of the tissue or organ, and the individual study of each of these mechanisms becomes highly complex. Nevertheless, the study of the different factors involved in pathologies can be study individually using specific techniques. For example, different pain models applied to healthy subjects can be used to simulate pathological pain conditions, reducing the amount of intervening factors in the process: the cause and the effects of these models are known.

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One technique generally used to induce musculoskeletal pain in healthy subjects is the intramuscular injection of hypertonic saline solution, an extensively described and established model. Hypertonic saline induce pain often reported as deep, moderately severe. The pain usually disappears after 10-15 minutes, and leaves no lasting damage. In this type of stimulation, activation of groups III and IV nociceptive afferents is achieved. The quality of the induced pain is comparable to acute clinical muscle pain and it shows localized and referred pain characteristics. In addition, a more natural and endogenous activation of pain receptors, called delayed onset muscle soreness (DOMS), may be induced by series of eccentric muscle contractions. The soreness usually lasts for one or more days after exercise.

Identifying Relevant Moral Issues

A standard approach to biomedical ethics, developed by Beauchamp and Childress in Principles of Biomedical Ethics, resolves ethical issues in terms of four ethical principles: y y y Autonomy Beneficence & non-maleficence Justice

Two of these principles, nonmaleficence and beneficence are focus to avoid doing harm and to act in the best interests of the patient. The principle of nonmaleficence prohibits the infliction of harm to subjects, although chronic untreated pain inflicts both physical and psychological harm to the patient. From Beauchamp and Childress point of view is not ethic to induce harm or pain in healthy subjects, and leaves patients that suffer pain is not ethical correct. Therefore, can we induce pain in healthy subjects in order to improve treatments or only to gain more information about a disease? In order to obtain an answer is needed to perform a meticulous analysis of the stakeholders and the solution proposed.

Stakeholders/interested parties
Several stakeholders are interest in the investigation of human muscle pain. For example, patients that suffer chronic pain and they are waiting a solution to relief their condition, researchers and groups of scientific communities that investigate pain and pathologies, governments and health insurance companies that investing a lot of resource in medical

Christian Mista- Bioethics 2011

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systems due to treatments provided to chronic pain patients, pharmacologic industry and companies manufacturers of pain killers. Patients put pressure on the scientific community not only to accelerate the new investigations on pain or pathologies, but also to avoid some legal steps and get the solutions to their conditions as soon as possible. Researchers have to be aware of the vulnerability of the patients since desperate nature of pain makes them trying anything. Additionally, governments and health insurance companies are interest in reduce medical costs with new treatments and provide a better coverage. For instance, it has been pointed out that disabling chronic pain costs in American people billions of dollars annually. A great part of these costs is caused by musculoskeletal pain, and it can be prevented through new findings obtained from investigations. On the other hand, the pharmacologic companies and the manufacturers of pain killers try to sustain their own business, for this cause they are more interested in treat the symptoms than in obtain a cure or solution to chronic pain patients. Probably that is the reason why they focus their investigations in new analgesic agent than to develop new techniques to prevent chronic pain. Apart from that, researchers and scientific community have to confront different interest of each part, and generally they stand to their own ethical principles. For example, the International Association for the Study of Pain (ISAP), one of the biggest association related to the study of pain, has established to follow the next agreements: the World Medical Association's Declaration of Helsinki, Recommendations Guiding Doctors in Clinical Research (1964, revised 1975), the Ethic Principles of the American Psychological Association (1973), the Declaration of Lisbon, the Rights of the Patient (1981), the proposed International Guidelines for Biomedical Research Involving Human Subjects, and Council for International Organizations of Medical Sciences (1982). The ISAP establish in their guideline The goal of pain research is to acquire new knowledge on the mechanisms, pathogenesis, diagnosis, and treatment of pain. This requires research on humans and animals. Human research may be undertaken on both healthy persons and patients. This research may involve painful stimuli or delaying pain relief in patients ; therefore, they approve the study on humans in order to obtain more information. Nevertheless, they point out that The primary intention is to advance knowledge so that patients in general may benefit; the individual patient may or may not benefit directly . The position of the ISAP can be in some way defined as utilitarism point of view, where actions are done in order to maximize the overall "happiness".

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Solutions to the problem

Musculoskeletal human pain research seems to be a dilemma with a complex solution. However, studies involving pain in humans occur commonly nowadays. On the other hand, have we other possibility to avoid involve human in pain studies? For instance, can we use animals or human models instead of persons in the investigations? As mention before, several investigations are conducted using humans as participant through the regulation of ethical organisms on every study. Therefore, before conducting a research that involves humans, the researchers must receive approval from a Human Research Ethics Committee. In general, the Ethic committees require some ethical rules in the experiments. Some of these items are listed below. y Potential participants should be informed fully about the goals, procedures and risks of the study before giving their consent. Healthy subjects and patients must be able to decline, or to terminate, participation at any stage without risk or penalty whatsoever. Written consent must be obtained to indicate that the subject understands the nature and purpose of the proposed study. There is a duty to protect those who may be incapable of giving fully informed and voluntary consent. These include children, the elderly, the mentally handicapped, prisoners and those very ill with other disease. Such persons should not be used for medical research unless they are essential for the goals of the proposed research. In any pain research, stimuli should never exceed a subject's tolerance limit and subjects should be able to escape or terminate a painful stimulus at will. The minimal intensity of noxious stimulus necessary to achieve goals of the study should be established and not exceeded. In all circumstances, including studies that employ placebo and sham treatment methods, an effective, accepted method of pain relief must be provided on request of the patient or subject.

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Prioritizing solutions
Taking into consideration the health, safety and dignity of human subjects have always been the highest priority in pain research. It can be argue that the rights and safety of the subjects is guaranteed. Moreover, the investigators are personally responsible for the conduct of research and its effects on the experimental subject at all times, even though the patients have given their consent to participate. Therefore, this puts legal barrier over researchers to prevent medical negligence caused by external interests to speed up the investigations. On the other hand, animals have been used in medical research for a long time although some medical aspects cannot be study using animals as subjects. In the hypothetic case that animals can be used for all the pain studies, one question is rising from the moral side, are the human ethics rights more important than the animals rights? Why animals are not equal to Human Beings? The majority would probably decide that the claims of human suffering take precedence over that of animals; but a minority would doubtless voice the opposite view, and the issue would be inconclusive. The remaining solution is to modeling the human being using computational models, and obtains the information through different simulations. However, the models required for such process cannot be attained with the models developed in the present days. New models more advanced, in order to cover all the aspects of the pain mechanisms, are needed. Therefore, we have to wait more progress in the computational science before to decide to use virtual subject instead of human beings.

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