What does it take to demonstrate the value of aquatic therapies?

People have been 'taking the waters' since ancient times.  In fact, many so-called complementary and alternative (CAM) treatments, including water-based ones, have been practiced for a long time.  A prevailing view is that, without scientific evidence, people using such treatments could be at risk or using treatments that are ineffective.

For some recent insights see this post on Andrea Salzman's blog (Aquatic Resources Network): Question: Why would aquatic therapy have to be "better" than land-based therapy? 'Eavesdrop on some of the recent decisions which addressed whether aquatic therapy is medically necessary.'

In a series of posts on this  blog, I have been asking if an overwhelming emphasis on scientific validation (e.g. evidence-based medicine) may lead to 'throwing the baby out with the bath water' for CAM aquatic therapies, including two practices that particularly interest me - Watsu and Ai Chi.  These two examples are increasingly popular in both spa and clinic settings.

I am also suggesting that it is helpful for any aquatics practitioner who wishes to make claims about the therapeutic benefits of their work to have some understanding of: (1) what it takes to provide evidence of specific benefits; (2) why some aspects of therapy do not lend themselves to this (see above). 

This post looks at what it takes to provide what is considered good evidence for the effectiveness of aquatic therapy.

You'll see in the next post that, judging by a recent review (Jan. 2010) of relevent international scientific literature, evidence-based research demonstrating the effectiveness of aquatic therapy in general (exercise or bathing) appears thin on the ground and not very encouraging. 

Meanwhile, a recent discussion on the ATRI e-list about the benefits of Ai Chi for people with fibromyalgia indicates that much of the therapy is 'poorly described'.  Yet, subjective and anecdotal reports of experiences  with Ai Chi over long periods of time appear positive and very individual.

This might well not impress anyone evaluating aquatics from a scientific perspective alone.

Read more about both these examples in the next two posts:
Is immersion in warm water beneficial?
Keeping a balanced perspective in aquatics: Ai Chi as an example

My purpose here is to suggest that, even if you are not a scientist or clinician doing a formal research project, keeping comprehensive and careful records of your aquatic sessions over the long-run can only be a helpful resource in demonstrating the value of your therapeutic work, and might eventually contribute to appropriate validating studies.

Here are some basic things to know about the scientific approach ...

Why are clinical trials used?

Clinical trials are research studies in which the safety and efficacy of treatments and therapies are tested in people to try to determine which treatments work, which do not, and why. Note that these trials can only be as helpful as the questions they set out to answer are.

The US  National Center for Complementary and Alternative Medicine (NCCAM) provides a fact sheet on how such trials are conducted. Download NCCAM-Clinical trials

Ideally, researchers do clinical trials in the hope of finding answers to questions such as:

• Does it work?
• If so, how does it work?
• For which diseases and conditions does it work?
• What are the adverse effects?
• How should it be given?
• Are there situations in which it might be harmful?
• Can it be used safely with other forms of treatment?
• Is it better than, or a useful option compared with, other treatments that are available?

There are clinical trials for healthy people (preventive treatments) and trials for many different types and stages of diseases and conditions.  Even if you are working in a spa setting and not focused on treating people for ailments, your observations and findings could provide a starting point for future research.

Before a clinical trial can begin, there has to be some evidence that the therapy is likely to work.  This can come either from previous laboratory research studies or from reports on the therapy's use by people.  The latter source is one that all practitioners of aquatic modalities could provide - if they kept records.

Clinical trials take place in three phases, the first of which (see Phase I below) could be done in almost any setting, if appropriate records were kept of treatment sessions.  Phases II and III take quite a bit more organization and coordination but they always start with a pilot study I.

I'm particularly interested in encouraging aquatics practitioners working in non-clinical settings to keep records, providing a place to gather and share resulting data, and seeking positive ways to use the information are needed though.  But I need to know if there is support for this.

Establishing clear objectives for any studies, identifying appropriate participants, and obtaining informed consent for the use of any data gathered, are important parts of good practice that might be overlooked in non-clinical or non-research oriented settings.

It would also be essential that non-clinical practitioners of aquatic therapies, who were interested in keeping records of their sessions, did so in a form (or forms) that would provide the kinds of information useful to researchers conducting more extensive studies. 

Write to me here < Email > if you are an aquatics practitioner interested in collaborating in developing a way of encouraging the keeping of records, and the gathering, sharing and further development of such records, particularly in settings currently deemed non-clinical such as spas, community pools, and private practices.

Below are some more things to know about conventional studies.  Please note that these methods do not suit all aspects of the healing processes that some alternative practitioners use and consider important parts of what they offer.  For more on this, see my article written for the Aquatic Therapy and Rehabilitation Institute (ATRI) last year  Download Documentation and research for alternative aquatics (S. Firman)

More about clinical trials

Phases of a clinical trial

Phase I: researchers test the treatment in a small group of people, focusing on safety, adverse effects, and sometimes dosage and schedule of administration. (See earlier comment about this Phase.)

Phase II: the treatment is given to a larger number of people to determine potential usefulness and to further evaluate its safety and adverse effects. This phase can last several years.

Phase III: the treatment is usually given to several hundred or more people to confirm its efficacy and more fully define any adverse effects. Phase III trials often compare the treatment with standard treatments.

Standard elements of clinical trials

Randomized: each participant is assigned by chance to an investigational group or a control group. Randomization is used in all Phase III studies and some Phase II studies. It helps ensure that results are attributable to the treatment and not to unrelated factors.

Double blind: neither the researchers nor the participants know who has been assigned to which group. Blinding is another way to help minimize the chance of bias influencing the trial results.

Eligibility criteria: these identify appropriate participants, based on what is being studied and the questions the researchers hope to answer.

Informed consent: this protects people who are considering taking part in a clinical trial.  They are made aware of:

• Who is sponsoring and conducting the research
• Who has reviewed and approved the study
• What the researchers want to learn
• How the research team will monitor participants' health and safety
• What participants will be required to do during the trial, and for how long
• Possible benefits and risks of participating
• Other treatments that are available for the disease or condition
• How the privacy of participants' medical records will be protected.

If you're interested in this topic, please comment below, Email me, or join in the discussion in my Group Aquatic Research on AquaticNing.

Also useful is the ARN Tip Sheet #301: Performing Aquatic Therapy Research available to members of the Aquatic Resources Network.

For an outline of all the posts in this series see Faith and Facts in Aquatics: A digest