Research Project with Chronic Pain 07/14/2005
This Research, tracking the reduction of pain medication with Aquatic Bodywork, has protocals that can be replicated. Prospective observational study of Aquatic Bodywork in patients suffering from chronic pain

Context:
Pain is a complex phenomenon that happens to our body as well as to our soul. The treatment of pain with modern pain therapy methods offers a variety of different approaches. Some of those approaches are based on very different fundamental assumptions. Normally, the origin of pain is supposed to be eliminated or reduced by using any of these healing methods, which are surgery, analgetics, and spasmolytics, drugs that cause muscle relaxation, calcium antagonists and therapeutic local anaesthesia. However, these “conventional” methods often do not have a satisfactory therapeutic effect. It is therefore often patients who are considered to be “resistant to therapy” who turn more often to out-patient clinics for pain treatment. Besides the approaches of orthodox medicine, pain clinics often also use methods of complementary medicine. For several years, they have been increasingly using movement therapy in warm water to treat pain.
The following theories about Aquatic Bodywork are being looked at from different angles in this study:
1.Supported by the warm water and held and moved rhythmically by the therapist in time to his/her breathing in an Aquatic Bodywork Session, the patients have the chance to get rid of their body’s old posture and movement patterns, which are often helping maintain the pain-related illness. The patients body can learn physiological movement patterns again.
2.Through the profound relaxation state and the flow of movements during the water session the patients can work on a new way of being in their body and dealing with its limitations.
3.The feelings of profound trust (in themselves, in the water, the therapist, in life itself) repeatedly experienced during the water sessions can be carried into everyday life and enable patients to face everyday life in a new (more active) way.

This Aquatic Bodywork research project lookes mainly at two key questions:

In patients participating in the project:
can a permanent reduction in the consumption of pain reducing drugs be reached to at least half of the previous amount?
In how far is there a permanent improvement in the patient’s quality of life?

This Prospective observational study includes 100 – 200 patients at the pain clinic of the Herdecke Community Hospital that is a co-operating hospital of Witten/Herdecke university, Germany and other co-operating pain clinics.

Procedure:
Patients: Pain clinic patients of the Herdecke Community Hospital and other co-operating pain clinics of both sexes will receive an aquatic treatment session once a week. Children who are on a stage comparable with stage III of the cronification of pain according to Gerbershagen will also be treated if their parents agree. At the same time drug consumption, pain intensity and quality of life will be recorded. It is planned that 100 – 200 patients take part in the study within a two-year period. The patients will be divided into several groups and will be looked after at the Herdecke Community Hospital as well as at other places in Germany and abroad. Each group will go through three phases: One month of preparation and documentation time, four months of treatment, and three months of post-treatment observation.


6.1. Criteria for participation

In-patients and out-patients who suffer from chronic pain and who are on stage III of the Cronification of pain according to Gebershagen. The patients mentioned must be receiving treatment at the pain clinic of the Herdecke Community Hospital or at other places. The patients must agree to participate in the study.
The origin of the pain is irrelevant.

6.2. Criteria that exclude participation

Serious cardiac insufficiency
Large open wounds or sutures that cannot take 45 minutes contact with water
Vital capacity below 1500 ml
Arterial occlusive disease
Acute herniated vertebral disc including deficits
Acute psychosis
Acute venous thrombosis
Patients who are not able to answer questions in a sensible way
Patients who are allergic to disinfectants that are used in the swimming pool of the Herdecke Community hospital (chlorine base 0.3 – 0.6 mg/l and ozone)
Fever above 38°
Withdrawal of agreement

In the case of temporary criteria that prevent participation in the study, the patients must rest until they are fully recovered. However, during that time they will continue their documentation in the usual way.


Preparation: Before starting the treatment phase, the patients document their pain level by using a visual analogous scale and their daily drug consumption every day for one month. This documentation is recorded in the so-called day sheet. The results serve as a baseline, a basic value which can be referred to at any time during the study. Furthermore, each patient’s expectations of the therapy will be recorded once with regard to the effect of Aquatic Bodywork on their personal pain level and on their own important parameters in life (personal therapy goal).


Treatment phase: While continuing the other therapies as usual the patients will receive one therapy session every week for 4 months by either Ms Caspers herself or one of her fellow Aquatic Bodyworkers. The patients will also adapt their drug consumption to their needs. This phase will be documented in the following way:
Day sheet: Visual analogous scale of pain sensation and documentation of drug consumption
Observation form: Before the weekly aquatic therapy session, the patient will fill in the sheet showing the course of treatment together with the therapist or another person who has been engaged by the therapist.
Quality of life sheet (SF 36): monthly
Scale of pain sensation (SES) (Mc Gill): monthly
The first documentation phase of the second group of patients will already start during the post-treatment observation phase of the first group of patients, i.e. after the first group of patients has finished four months of treatment.

Post-treatment observation phase: After four months of treatment with Aquatic Bodywork the following will be documented in the subsequent three months:
Day sheet (pain level with the visual analogous scale as well as changes in the daily drug consumption)
Monthly quality of life sheet SF 36 and SES scale of pain sensation Mc Gill
In a further examination after a total of 8 months of study (1 + 4 + 3), the basic data of each patient will be compared in relation to the data of the therapy phase and the post-treatment observation phase.

Evaluation:
The success (outcome) of Aquatic Bodywork can be seen as an improvement in the results of the scale of pain sensation (Mc Gill) as well as in the quality of life questionnaire (SF 36) as well as in the reduction of drug consumption. Since, up to now, no quantitative results are available on Aquatic Bodywork, the success of this method is specified in the so-called powers of effect (Cohen). The powers of effect indicate the difference in average values by the sizes of (pooled) deviations from the standard. A value that is higher than 0.5 indicates that the therapy has had a medium effect and a value higher than 0.8 indicates a high effect. Additionally, the final results of the pain sensation on the visual analogous scale will be compared with the patient’s expectations of the therapy ascertained in the baseline. By means of descriptive statistical methods, patients who achieved their previously fixed goal will be compared with those patients who were not able to achieve their goal. For all final parameters the local dispersion units and confidence intervals usually taken for studies will be given within the scope of explorative statistics.

Risks and side effects of Aquatic Bodywork
Because of the vascular dilatation in warm water, people with low blood pressure might feel dizzy, and at worst might feel sick. (especially if they are on strong medicine that alter their bodies compensation mechanisms) However, this will be discussed beforehand with the participants. They will be encouraged to drink enough before entering the water. Because of some circular movements during a water treatment session, people who suffer easily from seasickness might feel sick. The participants will be asked about this disposition at their first check-up so that circular movements during the water treatment session can be avoided accordingly. Taking into account the contraindications (please see brief description) and the criteria that allow or exclude participation in the study, there are no further risks or side effects of Aquatic Bodywork known among therapists up to now.
Aquatic Bodywork is a well established method of therapy and up to now no serious events have been reported. In the case of noticeably adverse effects on a patient, his/her participation in the study can be stopped at any time. In the case of serious side effects on several patients in this study as well as on patients of international practitioners, it is also possible to stop the whole study.




Persons leading the study:
Academic Director: Prof. Peter F. Matthiessen, MD, Chair of Medical Theory and Complementary Medicine at Witten/Herdecke University, Gerhard-Kienle-Weg 4, 58313 Herdecke; Phone: +49 - (0) 2330/62 3935
Medical Director: Karla Caspers, assistant surgeon in the emergency unit of Herdecke Community hospital and research assistant at the Institute for Medical Theory and Complementary Medicine at Witten/Herdecke University, Gerhard-Kienle-Weg 4; 58313 Herdecke; Phone: +49 – (0) 02330/62 39 27 or 62 38 66; e-mail: karlacaspers@gmx.de


- accepted by the ethics committee of Witten/Herdecke University -







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