Research study design principles and methods

Orthotic Devices

Orthoses are a clinically successful podiatric intervention

Foot pain is a problem that can affect lives, making it difficult to perform everyday tasks. Many underlying foot conditions result in pain including plantar fasciitis, overpronation, Achilles tendonitis, and metatarsalgia. The most common treatment for these and similar conditions include orthoses designed to provide support to the portion of the foot where it is needed. Orthoses provide a simple solution to the problem in many cases. There are many types of orthoses available on the market. Some are hard and some are soft. Many types are available over the counter, but many require prescriptions. There are also specific types available based on the type of walking or activity that at person engages in on a daily basis.

Literature regarding the efficacy of foot orthoses, particularly those that alter biomechanical processes, are generally positive (Landorf & Keenan, 2000). One of the key problems with the assessment of the effectiveness of orthoses is that few controlled studies have been performed (Landorf & Keenan, 2000). The biomechanical rationale for the development of orthoses is well supported. However, a gap exists that supports the efficacy of orthoses in clinically-based trials. This research will support the hypothesis that orthoses are a clinically successful podiatric intervention.

Literature Review

Self-reporting questionnaires are used in many explorations of patient satisfaction in those who wear orthoses to relieve an underlying condition. Landorf, Keenan, & Herbert (2006) compared the efficacy of pre-fabricated orthotic devices with custom devices in patients with plantar fasciitis. This study found that both types of devices had similar effectiveness in reducing the symptoms associated with plantar fasciitis. However, the benefits were short-term and did not result in long-term reduction in symptoms.

Patellofemoral pain syndrome is one of the most prominent conditions that are treated with orthotics. A number of orthotic devices are used to the treat this condition including tape, braces, straps, sleeves, or inlay soles (D'hondt, Struijs, & Kerkhoffs et al., 2004). The results of a study involving evaluation of various treatment strategies for this syndrome were inconclusive, as not enough information on any of the orthotics used were available to ascertain that the devices were effective in relieving pain caused by patellofemoral syndrome (D'hondt, Struijs, & Kerkhoffs et al., 2004). The results of this study support the need for further studies regarding the efficacy of various orthotic devices in the ability to relieve certain conditions.

The most prominent aspect of the literature is the lack of valid studies. Orthotics are often the first intervention attempted before more drastic measures, such as surgery, are used. Yet, only a handful of academic studies exist that address the efficacy of orthotic devices in the treatment of specific conditions. This gap in research must be addressed if orthopedists can be expected to make the best choices in treatment for their patients. This study is based on the need to fill the existing knowledge gap that exists regarding the use of orthotic devices to treat various foot conditions.

Methods

One of the key concerns discovered during the literature review was the need to develop a valid measure for assessing patient pain levels and success. Pain is subjective and there are a number of factors that can affect the perception of pain and the effectiveness of treatments in various patients. One of the key challenges of this study will be the development of a research instrument that accurately and consistently can assess the pain level and discomfort of the patient. The following examines the research design that will be employed for the conduct of this study.

Development of the Research Instrument

Research into the efficacy of orthotic devices has many aspects. Pain is recognized to have many dimensional aspects including sensory, affective, and cognitive dimensions (Rowan, 2001). These dimensions were used in the development of the ROwan Foot Pain Assessment Questionnaire (ROFPAQ). This instrument allows clinicians to understand which dimensions of foot pain are most relevant to the patient (Rowan, 2001). Bennett, Patterson, Wearing, & Baglioni, (1998) conducted a survey of orthoses users, with the intention of developing a reliable research instrument for the evaluation of the effectiveness of orthotic devices. This instrument will be used in the conduct of this study, as reliability and validity data can be easily obtained. Budiman-Mak, Conrad, & Roach (1991) developed a similar scale to measure foot pathology in terms of pain, disability, and restriction of activity. This scale will also be administered to assess the degree of disability associated with foot pathology. This instrument demonstrated high construct validity and is considered a reliable indice of function.

These research instruments will be used in conjunction with each other in order to provide the most comprehensive information regarding pain and disability before use of an orthotic device and again after three months of treatment. Use of these three scales in combination will allow the research to explore many aspects of pain and disability, as opposed to focusing on only one aspect of the symptoms.

Data Collection Methods

This study will use a pre-treatment/post-treatment format on the sample population. The research instrument, consisting of three scales, will be administered to a selected group of patients presenting symptoms of plantar fasciitis. The ROFPAQ will be used to measure the sensory, affective, and cognitive dimensions of pain. The scale developed by Bennett, Patterson, Wearing, & Baglioni, (1998) will provide a subjective assessment of the condition. The Budiman-Mak, Conrad, & Roach scale will be used to measure the pain, disability and restriction of activity caused by the condition. It is believed that all of these aspects are necessary in order to understand how the patient's plantar fasciitis affects their life.

The sample population for the study will consist of 100 subjects between the ages of 20-45, who have recently diagnosed with plantar fasciitis. They will be both male and female and will not have had a previous experience with the condition. For all patients, this will be their first experience with the diagnosis.

Patients will be administered the three mentioned research instruments prior to use of orthotic devices. The group of patients will use the devices, as prescribed by the physician, for a period of three months. The patients will then re-take the three research instruments to assess aspects of their pain and disability after use of the orthotic device. A time of three months was chosen as a result of the study conducted by Landorf, Keenan, & Herbert (2006), which indicated that the greatest relief occurred in the first three months of treatment.

Results

The results of the study will be derived through the analysis of the three research instruments and the comparison of pre-treatment and post-treatment answers. The data will consist of two sets of data from the same subject. These results will be compared and analyzed using regression analysis, descriptive statistical techniques, and correlative measures. Results from the three research instruments will be compared.