Alternative treatments in pain management and medication therapy

¶ … MacPherson, Thorpe, and Thomas (2006) reported an interesting qualitative study on the use of acupuncture in the treatment of low back pain. They report the results of a qualitative study nested within a large quantitative study (there were actually tow qualitative studies performed but the current study only addresses one of them). The quantitative study design was one of a large randomized controlled trial that compared acupuncture against typical general practitioner care. The study was carried out York between the years 1999 and 2003. The acupuncture treatment for the study was founded on the principles of Traditional Chinese Medicine (TCM) using six acupuncturists who all had a minimum of three years of post-qualification clinical experience. The acupuncturists were encouraged by the researchers to provide their typical treatment so that the study would evaluate the effect of routine care for lower back pain, each acupuncturist making meticulous notes of the aspects of the diagnoses and of the treatments each provided.

The study had 241 patients with 160 randomized to the acupuncture group. The acupuncture treatment was composed of up to 10 treatment sessions which were provided over a three-month time period. When the data was analyzed comparing the acupuncture group to the control group it was found that the clinical benefits of the acupuncture treatment increased between three and twelve months and then again between 12 and 24 months post-treatment. Using an analysis of covariance, adjusting for baseline pain scores, the findings indicated a modest reduction effect of 5.6 points on a standardized measure of pain in favor of the acupuncture treatment group compared to the control (physician) group at 12 months. The benefits of acupuncture continued over time and the difference increased to a statistically significant difference of eight points at 24 months suggesting that the treatment continued to pay benefits.

The researchers were also interested in understanding the process of acupuncture and an understanding of how the acupuncturists worked and the acupuncturists' experiences of delivering care in the framework of a clinical trial. In order to accomplish this goal MacPherson et al. also conducted a nested qualitative study within the qualitative clinical trial by interviewing all of the participating acupuncturists. The qualitative aspect of the study was undertaken in order to understand the acupuncturists' thoughts, reasoning processes, provide insights into acupuncture from the experiences of the treatment provider, and to understand the process of acupuncture treatment from this perspective by looking at the manner in which the acupuncturists attempted to elicit benefits to their patients' health. The other aspect of the qualitative study involved interviews with 12 of the patients themselves, but this aspect of the study was not reported in the current paper.

For this aspect of the qualitative portion of the study each of the acupuncturists were interviewed by two interviewers: one interviewer was one of the participating acupuncturists in the study in addition to being a coauthor of the paper (MacPherson), and the other was one of the researchers/coauthors who was not an acupuncturist. When he was interviewed by one of the other acupuncturists and the same coauthor. These interviews were accomplished at the particular acupuncturist's office/place of work with each interview lasting approximately one hour in duration. The questions for the interviews were taken from a pre-prepared topic guide (not referenced) that queried the acupuncturists to think back on and to discuss their experiences of treating their patients with respect to five general areas:

1. Acupuncture diagnosis.

2. The actual acupuncture treatment.

3. The patient -- practitioner relationship.

4. Issues regarding providing treatment within the constraints of a clinical trial.

5. The potential for creating a flexible trial treatment protocol.

Each interview was tape-recorded then transcribed verbatim and double-checked for accuracy. The data analysis was performed by means a thematic "framework" approach used in other qualitative studies. After understanding the coding processes the researchers developed an index designed to investigate the goals and processes of treatment not concerned with aspects of treatment related to the specific techniques of "needling." Then the interview data were coded using the Atlas/Ti software and entered into a spreadsheet across the acupuncturists, across the a priori themes listed above, as well as across the emergent themes that appeared as a result of the interviews. Coding the data in this manner allowed the researchers to look at the data by subject and by theme as well. The researchers discussed their findings related to the relevant themes that were deemed to be important.

The first theme discussed is the importance of the therapeutic relationship in acupuncture treatment. The importance of establishing a positive relationship was emphasized in the interviews in order that the patient feels safe and trusts the acupuncturist. The methods that the acupuncturists used to build relationships with their patients were varied and included such strategies. For instance acupuncturists mentioned that establishing rapport was important. This strategy as described by the participants appeared to have much in common with therapeutic encounters in general by being open and honest with patients, encouraging two-way dialogue, and "connecting" with patients so that the typical power structure between clinician as all-knowing and patient as subject is relaxed somewhat. An interesting strategy discussed by one acupuncturist was "meeting with the patient where they are" in terms of individualizing the treatment (discussed more below) as a means to develop a positive relationship. Other areas mentioned that fostered the therapeutic relationship included making sense of the patient's condition or explaining it to them in a different light (via a TCM view), nonverbal communications, capitalizing on immediate treatment effects, and inviting and sharing information between patient and clinician.

A second emergent theme discussed by the researchers was that of individualizing the treatment, which is a core feature of TCM. From the interviews it appears that this begins with the history and examining the individual aspects related to the patient's pain. Each practitioner appeared to have an individualized approach within this theme. Still, general themes also emerged such as the use of palpation to find the source of pain, whether the pain was acute or chronic, etc. In order to assist with the diagnosis. Acupuncturists feel for the patient's style and needs and adjust their intervention accordingly as different patients have different needs, expectations, and willingness to develop a close therapeutic relationship. The resulting mixture of the acupuncturists' clinical and personal style along with the patients' responsiveness lead to a distinctive set of descriptors for every treatment session. There are a number of considerations (variables) that lead to each patient and interaction being unique such as the location of the pain, the selection of points, the number of needles, the depth of insertion, the strength of needle stimulation, and the option of auxiliary interventions. All of these factors make acupuncture treatment a multifaceted and personalized intervention.

Another strong emergent theme was the one of the acupuncturist facilitating the involvement of the patient in their treatment and recovery. The researchers identified two main themes here. The first was the attempt to connect with the patient regarding their attitudes towards their pain. For instance, some patients do not see that they have any personal responsibility for getting better. This can range from patient believing nothing will help them to being committed to working with the acupuncturist. Acupuncturists in this study seemed to also almost be acting as psychotherapists in this manner. This included "spiritual issues" and the second theme, the facilitation of changes in the patient's lifestyle and attitudes to help reduce relapse. Some did not mention spiritual issues using the spirit word, but addressed them in a more benign manner

Finally, the experience of being in a clinical trial was discussed. First it appeared that the acupuncturists believed that their practice in the trial was equivalent to their practice methods outside the trial with the exception of a limit on the number of sessions in the clinical trials. Some did feel the patients were different, especially in their willingness to accept responsibility and more focused on their pain reduction. All of the participants felt the experience would improve the quality of their future treatments.

The researchers conclude by stating that despite individual differences in their styles of treating patients and relating to patients the acupuncturists basically described a pattern of patient-centered care based on a partnership model of interface between the acupuncturist and the patient:

1. Building a positive therapeutic relationship.

2. Tailoring the treatment to the individual patient

3. Actively working to engage patients in their recovery during the treatment and beyond.

The interviews with the acupuncturists indicated the significance of three elements of successful acupuncture treatment that went well beyond the needling features of acupuncture. All three of these elements were believed to be important contributors to long-term positive treatment outcomes. The researchers also apply their findings to clinical trials with acupuncture in treating chronic conditions. The researchers suggest that there should be a differentiation between acupuncture clinical trials for short-term outcomes and more complex interventions set forth in the UK Medical Research Council's guidelines for such interventions. This type of research concerning acupuncture's effectiveness could be designed around a depiction of the treatment that transcends just the process of needling and incorporates the associated diagnostic, treatment, and the therapeutic relationship components that are specific to acupuncture as it is commonly practiced by acupuncturists. Thus, the use of one standardized treatment is not supported by the data (even needling treatment was changed from patient to patient over the course of the study).

An additional point the researchers draw attention to is the nature of the specific and nonspecific treatments in acupuncture. The researchers believe that that the specific and nonspecific effects of acupuncture treatment are not easily separated, and the desire to do so stems from an essentially reductionist agenda (a bad word for some) that require proof of a specific effect. The researchers say that their qualitative study has raised questions about what exactly is "specific" and what is "nonspecific" in acupuncture treatment and that the therapeutic relationship has both specific and nonspecific dimensions.

Finally, the researchers report that measures of long-term care and follow-up are needed for acupuncture treatment as suggested by the qualitative and quantitative aspects of the study. Clinical trials should measure change over 12 or preferably 24-month periods.

The idea of performing a qualitative study nested within a quantitative one is interesting, basically because doing qualitative research on aspects of treatment not confirmed by quantitative research is like trying to explain how a member of the flat earth society views his potential fear of falling off the world if he sails too far out to sea. The two types of research should compliment each other, and in this case they do. The best parts of this particular study are the quotes from the interviews with the participants. These quotations give the reader a real feel into the process and thinking that the acupuncturist does when dealing with a patient. However, there are several major flaws in the design of the study and in the conclusions of the authors.

First, having one of the researchers as a dual role in as a participant violates research protocol. There is a wide possibility of experimenter bias when this situation is created; especially in a qualitative study where semi-structured interviews are given (not to mention the complications and bias that can occur in the quantitative section). The potential for bias is so great that this condition detracts from the legitimacy of the study and it is surprising that the reviewers let it pass. Moreover, from what we can deduce from the methods, interviews were transcribed and coded by the interviewers, another potential area of bias.

Next, much is made of the therapeutic relationship in acupuncture and how this facilitates treatment. Based on the a priori assumptions of the researchers, it would be surprising if their interviews, transcriptions, and coding did not produce the three areas of focus that they did. The assumptions of the interviewers guided the overall findings in the study. Perhaps somewhere within the questioning a little more freedom for the participants would have gotten some other perspectives on what was important during the treatment.