Posted: June 24th, 2015
A comparative study investigating the effectiveness of THE EFFECT OF CUSTOM ORTHOTICS and stretching exercises AS A FIRST LINE OF TREATMENT FOR PLANTAR FASCIITIS
Abstract
Title: The effect of custom orthotics as first treatment of Plantar Fasciitis.
Aim: This paper is a proposal for conducting a research project that will determine the effectiveness of custom orthotics as the first treatment of plantar fasciitis.
Background: Mechanical interventions such as foot orthotics and stretching exercises have been shown to be effective in minimizing pain from plantar fasciitis. There is, however a deficiency of controlled trials to validate what has been shown clinically. Studies on the effects of foot orthotic and stretching exercises, in prospective and randomized trials, will be conducted with a one year follow up.
Methods: Sixty participants between the ages of twenty and sixty, both men and women with plantar fasciitis will be randomized to receive foot orthotics (n=30) and stretching exercises (n=30). Functional limitations, pain and quality of life will be evaluated with the Foot and Ankle Outcome Score.
Data analysis: Non-parametric statistics will be used. Post-treatment changes across all times will be assessed by Friedman’s test. If this test will be significant, post-treatment changes at six, twelve, twenty-six and fifty-two weeks compared to baseline will be assessed by Wilcoxon’s signed rank test. The Mann-Whitney U-test will be used when comparing the two treatment groups and the Chi-square test will be used for comparison of proportions.
Results: Data gathered over time will be analyzed using the most appropriate test as specified above in data analysis, in order to come up with reliable results.
Table of Contents
Abstract………………………………………………………………………………………………………………. 4
1.0 CHAPTER ONE: INTRODUCTION…………………………………………………………………………….6
1.1 Background to the Study…………………………………………………………………………………………6
1.2 Statement of the Problem…………………………………………………………………………………………6
1.3 Research Questions……………………………………………………………………………………………….7
1.4 Aims and Objectives of the Study…………………………………………………………………………………8
1.5 Significance of the Study…………………………………………………………………………………………8
2.0 CHAPTER TWO: LITERATURE REVIEW………………………………………………………………………9
2.1 Introduction ………………………………………………………………………………………………………9
2.2 What is Plantar Fascia…………………………………………………………………………………………………………………………10
2.3 Functions of a Plantar Fascia. The Windlass Mechanism………………………………………………………11
2.4 Previous Treatment Methods of Plantar Fasciitis……………………………………………………………….12
2.5 The Role of Custom orthotics in Treatment of Plantar Fasciitis…………………………………………………13
2.6 Interpretation and Hypothesis……………………………………………………………………………………15
CHAPTER THREE METHODOLOGY AND RESEARCH DESIGN………………………………………………16
3.1 The Research Design……………………………………………………………………………………………16
3.2 The Target Population……………………………………………………………………………………………16
3.3 Sample and Sampling strategy…………………………………………………………………………………..17
3.4 Inclusion and Exclusion Criteria…………………………………………………………………………………17
3.5 Data Collection Instruments……………………………………………………………………………………..17
3.6 Data Collection Methods………………………………………………………………………………………..18
3.7 Data Analysis……………………………………………………………………………………………………19
3.8 Ethical Issues…………………………………………………………………………………………………….19
3.9 Reliability Test…………………………………………………………………………………………………..20
3.10 Cross Tabulations and Inferential Statistics……………………………………………………………………20
3.11 Conclusions…………………………………………………………………………………………………….20
References…………………………………………………………………………………………………………….22
1.0 CHAPTER ONE: INTRODUCTION
Plantar Fasciitis refers to inflammation of the plantar fascia tissue leading to heel pain (Jain & Jain 2014). Approximately 0.6 million people suffer from this condition and have to visit outpatient facilities in search for medical attention (Covey & Mulder 2013). Plantar fasciitis affects different people in various working backgrounds based on certain risk factors (Beeson 2014). Postmen are likely to suffer from this condition if they run or walk on surfaces that are poorly cushioned. Prolonged heavy weight bearing may result in plantar fasciitis among people such as gym instructors (Rathleff et al. 2014). People whose occupations do not facilitate the physical exercise of the body are likely to become obese, thus subjecting their plantar fascia on excess body weight (Beeson 2014). Eventually, heel pains may develop, and this is likely to degenerate into plantar fasciitis (Wapner & Parekh 2011).
Excessive or prolonged walking may cause damage to the plantar fascia tissue and may result in heel pain unless precautionary measures are taken (Taunton 2012). Aging may also lead to the development of this condition, as wear and tear on the plantar fascia does not recover quickly, due to low cell production rates (Cheung et al 2006). These risk factors ideally suggest that anyone can get the condition, either avoidably or unavoidably (Rathleff et al. 2014).
Plantar fasciitis occurs mostly in adults and is characterized by heel pain. In the majority of the cases, the disorder manifests itself early in the morning when the patient feels intense pain on the heel after taking few steps. For many years, planter fasciitis has been on the rise as reported by different sources including websites and scholars doing research related to plantar fasciitis. Nothing much has been done, and the increasing number of cases of plantar fasciitis does not seem to change for the better. Most of the information has been a repetition of what has been researched many years ago, and this has not added anything to the pandemic. Plantar fasciitis is a stubborn disease (Rathleff et al. 2014). In addition, the symptoms of this disease most of the time resolve faster especially when the interval between onset of symptoms and treatment are shorter. Current treatments include rest, strengthening, arch supports, change of shoes, surgery and anti-inflammatory agents. However, plantar fasciitis can be successfully facilitated by treatment to ones’ risk factors as well as preferences.
Podiatrists excel in diagnosing and treating such disorders, although treatment of this condition may take up to 2 years of close monitoring for the patient to recover fully (Bharti and Rami 2004). Additionally, treatment and surgery of the plantar fascia is not only delicate but also expensive as well (Bharti & Rami 2004). This makes plantar fasciitis not only a medical condition for the patients, but also a financial dilemma. Considering the large of patients suffering from this condition and the constant appointments they have to for, it is clear that PF poses as a great burden to those suffering from it. Consequently, this will translate to stress for the patients thus affecting their normal functioning. The problem we have as podiatrist is……….You need to clearly state here that we have all f these treatments but non seem to be definitive. We commonly as a profession use orthoses and stretching exercises as first line treatment but which is better? The purpose of this review is to explore the evidence to support the treatment strategies commonly used by podiatrist and to develop a proposal to test the effectiveness of the possible first line
2.0 CHAPTER TWO: LITERATURE REVIEW
2.1 Search Strategy (Use a table as your paragraph below does not make sense)
| Plantar fasciitis,
windlass mechanism, heel spur, orthotic, orthosis, orthoses insole. |
Introduction Your introduction is the piece of work above this is now the focu of your literature review
2.2 What is Plantar Fascia?
2.4 Previous Treatment Methods of Plantar Fasciitis
Different conservative treatments have been applied in the relief of plantar fasciitis (Covey & Mulder 2013). Laser irradiation is very efficient in pain reduction and in healing soft tissues through increased levels of protein syntheses and cellular metabolisms (Lafuente Guijosaet al. 2007) However, research by Lori and Terry (2004) found out that laser irradiation was ineffective in the treatment of musculoskeletal conditions such as the plantar fasciitis. In the study that sought to find out if ultrasound could help in the relief of plantar fasciitis, due to its perceived ability to energize and increase chemical activity of the body tissues, the researcher never came to a conclusive judgment because only two participants enrolled for the treatment.
Other previous treatment methods include the use of extracorporeal shockwave therapy. In this procedure, high-energy shockwave impulses stimulate the healing process in plantar tissue that has been damaged. This procedure has not shown consistent results and thus it is not commonly performed. The use of physical therapy which focuses on exercise programs that stretch the calf muscles and plantar fascia is also one of the treatments for PF. It may also involve specialized massages, ice treatments and medication to decrease inflammation.
Other conservative treatments include stretching, taping, and night splints. Surgical treatments of plantar fasciitis have been used to treat patients with acute conditions that are not responsive to the conservative treatments. Though still controversial, the method is not popular due to the perceived highs costs of treatment (McNally & Shetty 2010).
Kogler showed that a wedge under the lateral aspect of the foot greatly minimized the strain on the plantar aponeurosis, and ended up suggesting that this may be effective for treating plantar fasciitis. The following studies provide additional weight to the fact that treatment with pre-fabricated or custom orthotics is effective.
A study by Pfeffer (1999) compared the effectiveness of stretching in combination with one of three different shoe inserts with stretching alone in the treatment of plantar fasciitis. Shoe inserts included two pre-fabricated pads and custom foot orthoses. Though the conclusion was clear that pre-fabs in combination with stretching are more effective than custom orthoses, a keen analysis of the statistics reveals that all the treatment groups had an improvement in pain scales, without significant difference between the treatment groups in the lessening of overall pain scores after eight weeks of treatment. The misleading conclusion prompted an in depth analysis of the details to determine why the researchers would have made a conclusion that was not supported by their data.
2.5 The Role of custom orthotics in Treatment of Plantar Fasciitis
External causes of plantar fasciitis relate to use of inappropriately designed custom orthotics (Bharti & Rami 2004). Many shoes manufacturers use shortcuts aimed at reducing their costs of production. An ideal example is the scoring technique used for the fixing of the innersoles for standard shoes, which does not allow for sufficient support causing indentation of the foot during pronation (Bharti & Rami 2004). Plantar fasciitis quickly develops from the indentation of the foot, which exerts stress on the fascia while negotiating for a balance during pronation (Cheung & Ng 2008). Additionally, rocker sole shoes with extremely thicker soles than normal and rounded heels have been observed to augment on the problem (Fong et al. 2012).
(Walther et al. 2013) categorized custom orthotics into supportive foam (FO), non-supportive orthotic (NO), and self-supporting plastic (PO). For each of these orthotic inserts, the degree of customization and the mechanism of foot support are very important. In a study conducted by (Fong et al. 2012), participants with custom orthotics inserted with supportive foam (FO) reported a reduction in heel pain within two weeks, those with non-supportive orthotics (NO) showed no significant improvement after use, and those with self –supporting plastic (PO) improved within one week.
Custom orthotic inserts are mould to fit different foot requirements, which include the angle of pronation and the shape of the heel pad (Bharti & Rime 2004). This type of orthotics is designed specifically to support the hallux, forefoot, heel, and the mid foot (Baldassin & Beraldo 2009). Compared to the pre-fabricated device, a custom orthotic alleviates heel pain much more quickly(Cleland et al.2009). Another inherent advantage of the custom orthotic is that it works in tandem with the biomechanics of the plantar fascia during gait cycle because the orthotic reduces pressure at the various regions of the foot to reduce chances of injury (Beeson 2014). This enables persons with plantar fasciitis to engage and exercise in different physical activities and contained heel pains. Further, a reduction in pain does not only make the patients to be comfortable, but also ensures that they go through normal procedures comfortably, while being provided with medical care (Bharti & Rami 2004). You need to conclude here what you have found out about CMO treating PF such as best materials/density and prescription as this will help you to make the descion about you will prescribe to your group.
You also need a section here on the role of streatching exercises in the treatment of PF with a conclusion about the best type of exercises combination and regime again this will inform you of what you will give to your control group
2.6Hypothesis
- The use of appropriate custom orthotics in day to day activities will reduce the pain level more than the stretching exercises.
- The use of appropriate custom orthotics in day to day activities will reduce the pain at the same level as performing stretching exercises.
- The use of appropriate custom orthotics in day to day activities will have no effect on reducing the pain level.
3.0 CHAPTER THREE: METHODOLOGY AND RESEARCH DESIGN
The proposed study will be a randomized controlled trial This is because the study will begin by exploring plantar fasciitis in detail as the research problem and then use of appropriate custom orthotics as the interventional strategy compared to a control group where stetching will be used and comparisons can be drawn. After selecting an appropriate custom orthotic based upon evidence drawn from the literature review as an ideal interventional strategy, the researcher in the proposed study will implement it and observe how the research participants will respond.. The reason for selecting this research design is that it will help the researcher to find a solution for plantar fasciitis by testing the solution practically and also minimize on biasness.
The proposed study will rely on postmen as the target population. The reason for selecting this category of participants is that they work indoors and outdoors, sorting and delivering mail which would subject them to rigorous physical activities typical for easy development of plantar fasciitis. The postmen will be obtained from their operating centre, where they have their main offices.
3.3 Sample and Sampling Strategy
The study will utilize a randomized sampling method for obtaining its participants. The participants will be categorized into two treatment group namely, the custom made orthotics group and the stretching exercise group. Participants, who will fulfill the written inclusion criteria, will be referred to an examiner, a physical therapist that is not involved in the evaluation or intervention of the study, who will randomize the participants by pulling out an envelope from a box holding sixty why have you chosen 60? What is the justification for this number? You should also conseder adding 10% more people than you need to make the results significant to accommodate for anyone who drops out randomly ordered envelopes, thirty for each treatment group. The examiner will also do a clinical examination and verify the diagnosis. Why use a physio to do this and not a podiatrist?
3.4 Inclusion and Exclusion Criteria
Postmen thirty years age and over seeking treatment of plantar fasciitis will be the candidates for inclusion in the study.
Table 1: Inclusion criteria
| Criteria | Justification |
| Exhibited over pronation | More than 6 of pronation lead to development of plantar fasciitis if engaged in psychical exercises (Golightly et al 2014). |
| Being heavy weight but apparently low height (high Body mass index) | A high BMI correlates with being obese. Obesity is a mechanical cause of plantar fasciitis (Beeson 2014). |
| Very high or very low arched foot | Having either a high very low arched foot increases the risk of catching plantar fasciitis when engaged in physical activities (Taunton 2012; Lori & Terry 2004). |
| Aged 30 years above
|
Aging leads to the degeneration of the fascial connection between the Achilles tendon and the plantar fascia, hence may lead to plantar fasciitis (Cheung et al 2006). |
| Has been previously diagnosed with plantar fasciitis | A Previous diagnosis of plantar fasciitis means that it could still be present in the participant, This is because the condition takes up to 2 years to heal fully (Bharti & Rami 2004). |
Table 2: The Exclusion criteria
| Criteria | Justification |
| A history of systemic lupus erythematosus (SLE) and rheumatoid arthritis | With these two conditions, a patient may catch plantar fasciitis due to internal inflammation of the fascial tissue (Bouysset et al 2011; Cherian et al 2011). |
3.5 Data Collection Instruments
Data collection instruments will involve the use of participant-administered questionnaires that will be provided at baseline and at 6, 12, 26 and 52 weeks after the initiation of both treatments. There will be the use of foot and ankle outcome score which evaluates the functions, symptoms, and foot and ankle-related quality of life. This will be mailed to the participants for completion and they will be supplied with a stamped and addressed envelope for them to return it to the researcher. Foot and Ankle Outcome Score (FAOS) is an adaptation of the Knee Injury and Osteoarthritis Outcome Score (KOOS) and normally assess outcomes that are relevant to the patient in five different subscales: activities of daily living, pain, other symptoms, foot and ankle related quality of life, and sport and recreation function. Pain will be considered as the main outcome. A percentage score of zero to a hundred will be calculated for each subscale, a hundred to represent the best possible score. If the Knee Injury and Osteoarthritis Outcome Score will considered, then a ten point score change will indicate a clinical change. Has this outcome score being used for PF before if so reference please
The data will be collected over a range of weeks namely, at six, twelve, twenty-six and fifty-two weeks after the initiation of both treatments. To determine compliance with the treatments and possible adverse side effects, the participants will be asked to maintain daily logs that should be returned by mail at six and twelve weeks. Compliance will be assessed on weekly basis. Daily use of the custom orthotic will be recommended. Good compliance will be defined as using the orthotic at least seventy-five percent, for example five days a week.
Stretching exercises will be recommended to be done seven days a week. Similarly, good compliance will be defined as undertaking the stretching exercises at least seventy-five percent, for example five nights a week. Side effects will also be evaluated on a weekly basis; they may include pressure-related pain. Difficulty during the stretching exercises will be assessed on a five point scale (no, mild, moderate, severe and extreme). The answers will be categorized into none or minor difficulty and moderate to extreme difficulty.
To ensure safety in dealing with protocol violation such as cross-over between treatments and non-compliance to treatments, the analysis will be based on the groups as randomize, for example, intention to treat analysis will be used. Non-parametric statistics will be used. Post-treatment changes across all times will be assessed by Friedman’s test. If this test will be significant, post-treatment changes at six, twelve, twenty-six and fifty-two weeks compared to baseline will be assessed by Wilcoxon’s signed rank test. The Mann-Whitney U-test will be used when comparing the two treatment groups and the Chi-square test will be used for comparison of proportions.
The manager responsible for overlooking of the postmen activities will be approached and consent will be obtained before proceeding with any other activity. The researcher will approach the participants one by one and request their approval to participate in the study. Clearance will be sought from the university before proceeding with the study. Before proceeding with data collection, the purpose of the study will be explained in detail to all potential participants who will be recruited after voluntarily signing the consent form. The participants will be assured that their identity will remain confidential. No names will be entered on the questionnaire and that the information obtained will only be used for study purposes. Where will the data be stored and what happens to partially collected data, for example what if at 6 weeks some withdraws from the study, will you still use that data? Have you considered reporting adverse events? What if someone injures themselves doing the streathching exercises or the insole causes a problem e.g. blisters or an additional MSK injury?
3.9 Reliability Test
This will be calculated using Cronbach’s reliability test to determine if the three variables will actually measure what they are intended to measure (Cooper et al 2009). In total, 3 reliability tests will be conducted. The first test will be performed on the variable of the subscales assessed by Foot and Ankle Outcome Score as discussed earlier, which are given a percentage of zero to a hundred each. The second test will be undertaken on the same subscales which will be assessed by the Knee injury and Osteoarthritis Outcome Score, which normally has a ten point score change. The third test will be conducted on the variable of plantar fasciitis in order to test if the 0-10 pain scale actually measures the effectiveness of the two treatment methods. Since each variable will have one entry in the questionnaire, the single item will be used in Cronbach’s reliability test. A Cronbach’s alpha of 0.7 and more will mean that a viable actually measures what is intended to measure (Cooper et al 2009).
3.10 Cross Tabulations and Inferential Statistics
This research will use the cross tabulation technique to show the distribution of responses across variables. Then, Chi-square test will be used as the inferential statistics for the proposed study in order to deduce whether the observed distributions are due to chance or actually represent the real conduction about the research problem (Cooper et al 2009), which is whether pain is reduced greater using custom made orthotics or stretching exercises.
This proposal expects that appropriate custom orthotics would play a role in the treatment of plantar fasciitis when under physical activity. The proposed methodology is quality enough to verifying whether the claim is true or not. However, the researcher is likely to encounter challenges, such as locating participants and making follow-ups. This will require a lot of resources and time, which might not be under the capability of the researcher.
Beeson, P. 2014. Plantar fasciopathy: Revisiting the risk factors. Foot and Ankle Surgery, 20(3), pp.160-165.
Benjamin, M. 2009.The fascia of the limbs and back – a review. Journal of Anatomy, 214(1), pp.1-18.
Bouysset, M. et al 2011. Calcaneal involvement in rheumatoid arthritis and in a control group (X-ray study).. Médecine et chirurgie du pied, 27(2), pp. 52-56.
Cheng, H., Lin, C., Wang, H. & Chou, S 2008. Finite element analysis of plantar fascia under stretch—the relative contribution of windlass mechanism and Achilles tendon force. Journal of biomechanics, 41(9), pp. 1937-1944.
Cherian, J. et al 2011. A 26‐year‐old white man with a systemic lupus erythematosus flare and acute multiorgan ischemia: Vasculitis or thrombosis?. Arthritis care & research, 63(5), pp. 766-774.
Cheung, M., Zhang, M. & An, K 2006. Effect of Achilles tendon loading on plantar fascia tension in the standing foot. Clinical Biomechanics, 21(2), pp. 194-203.
Cheung, R. & Ng, G 2008. Influence of different footwear on force of landing during running. Physical therapy, 88(5), pp. 620-628..
Cooper, H., Hedges, L. & Valentine, C 2009. The handbook of research synthesis and meta-analysis. s.l.:Russell Sage Foundation.
Covey, C. & Mulder, M 2013. Plantar Fasciitis: How best to treat?. The Journal of Family Practice, 62(9), pp. 466-471.
Donatelli, R. et al 1999. Relationship between static and dynamic foot postures in professional baseball players. J Orthop Sports Phys Ther, Volume 29, p. 316–330.
Fong, D. T.-P. et al 2012. Evaluation of combined prescription of rocker sole shoes and custom-made foot orthoses for the treatment of plantar fasciitis. Clinical Biomechanics, Volume 27, p. 1072–1077.
Golightly, Y. et al 2014. Foot Disorders Associated With Overpronated and Oversupinated Foot Function The Johnston County Osteoarthritis Project. Foot & Ankle International, Issue 1071100714543907.
Hamming, M., Shah, R. & Parekh, S 2012. Plantar Heel Pain. Foot and Ankle Surgery. s.l.:s.n.
Jain-S. & Jain-R 2014. Plantar fasciitis, calcium, calcitriol, heel pain.. role of calcium, calcitriol and intralesion corticosteroid for heel pain management in women, p. 5238.
Lori, A. B. & Terry, R 2004. Plantar Fasciitis and the Windlass Mechanism: A Biomechanical Link to Clinical Practice. The Journal of Athletic training, 39(1), pp. 77-82.
Martinelli, N. et al 2013. Platelet-rich plasma injections for chronic plantar fasciitis. International orthopaedics, 37(5), pp. 839-842.
McNally, E. & Shetty, S 2010. Plantar fascia: imaging diagnosis and guided treatment.. In Seminars in musculoskeletal radiology, 14(3), p. 334.
Rajput, B. and Abboud, R. 2004. Common ignorance, major problem: the role of footwear in plantar fasciitis. The Foot, 14(4), pp.214-218.
Rathleff, M. S. M. C. M. et al 2014. High‐load strength training improves outcome in patients with plantar fasciitis: A randomized controlled trial with 12‐month follow‐up. Scandinavian journal of medicine & science in sports, 1(1), pp. 1-9.
Reason, P. & Bradbury, H 2013. The SAGE handbook of action research: Participative inquiry and practice. London: Sage.
Taunton, J 2012. A Clinical Trial of a Multi-Element Exercise Program for Plantar Fasciopathy in Workers Required to Stand for Prolonged Periods of Time.. s.l.:s.n.
Wapner, KL and Parekh SG 2011.Heel pain. In: DeLee JC, Drez D Jr, Miller MD, eds. DeLee
and Drez’sOrthopaedic Sports Medicine. 3rd ed. Philadelphia, Pa: Saunders Elsevier;
Section F.
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