“Research is creating new knowledge, more options and more hope”

Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes.⁽¹⁾ It follows a pre-defined plan or protocol to evaluate the effects of medical or behavioral intervention on health outcomes.

Clinical trials may compare a new medical approach to a standard one that is already available, placebo which contains no active ingredients, or to no intervention.

What is the importance of research in physiotherapy?

Physical therapy mainly addresses the injuries and disorders which hampers the daily living and quality of life of the people.

Clinical studies will help establish and promote innovative practice patterns by providing evidence-based care and testing new modes of treatment. This will translate the results of research into practice and meet the community needs in an effective manner. This helps the physiotherapy practitioner keep updated with the latest practical methods, technology and opportunities.

Objectives for conducting clinical studies for Physiotherapists-

Designed to add to medical knowledge related to the treatment.
Evaluating one or more interventions for treating the condition, syndrome and disorder.
Finding ways to primordial prevention of a particular disease or disorder through lifestyle changes.
Examining methods for identifying a condition or risk factors for that condition.
Exploring and measuring ways to improve the comfort and quality of life through supportive care for people with a chronic illness.

Types of clinical studies-

Observational studies observe people in normal clinical settings. Often involves recruitment of patients and the interaction of the investigators with subjects to obtain natural history data. Researchers may collect data through medical exams, tests, or questionnaires and these studies may help identify new possibilities for clinical trials.
Clinical trials are studies performed in people that are aimed at evaluating the medical, surgical or behavioral intervention. They are the primary way that researchers find out if a new treatment is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.

Phases of clinical studies-

Clinical trials are broken down into four phases-

Phase 1 trials. These trials are conducted on a small group of people and are designed to see if a treatment technique is safe.
Phase 2 trials. After the treatment technique is considered safe, it is evaluated to see if the technique or therapy is effective. This study is carried on people with the same medical condition for example- patients with mechanical low back pain.
Phase 3 trials. If a treatment is found safe and effective, it is then evaluated to see if it is more effective than the available standard methods of treatments.
Phase 4 trials. Can be declared as a new mode of effective treatment.

Steps of conducting clinical studies-

Deciding the aim or purpose for conducting the study
How useful is the study in clinical practice?
Review the literature and find out if anyone has conducted a similar study.
who may participate in the study (The eligibility criteria)
Develop an inclusion and exclusion criteria.
Sample size
Methodology or the trial protocol.
The length of the study.
Take written consent from the patients
Measure the outcomes.
Analyse the data using appropriate statistical methods
Conclusion and clinical implication.

I hope that after reading this blog, you must be excited to conduct some research in your clinical practice and participate in accelerating the process of rehab!

Stay tuned!