Critical review and research proposal for the management of Claws toe deformity in the RA patient, age group (old/adult)

In Patients with Osteoarthritis of the First Metatarsophalangeal Joint or Hallux Rigidus, How Effective are Shoe Modifications and Foot Orthoses in Relieving Pain Compared to Standard Footwear? Student Name Affiliation Course Number: Course Name Instructor Name Due Date Section 1: Structured Literature Review Background Hallux rigidus (HR) can be defined as an increasingly painful condition linked to the first meta-tarsophalangeal (MTP1) joint in a patient with degenerative arthritis, and the condition typically results in proliferative bony response and constant dorsiflexion loss, culminating in increased joint bulk (Colo et al., 2023). Anderson et al. (2023) noted that osteoarthritis of the first metatarsophalangeal joint (MTP), also known as HR, is a common source of foot pain in adults. Although the terms hallux limitus (HL) and HR are often used interchangeably, it is vital to make a distinction between the two to set the pace for this critical appraisal of literature and avoid confusion. HR is normally defined as the pain which emanates from ankylotic and arthritic joint with complete loss of locomotion, whereas HL is delineated as the functional pain linked to tension in soft tissue (that is, gastrocnemius contracture) or an increasingly elevated and long first metatarsal (Colo et al., 2023). Now, considering the initial definition of HR outlined in this section, it should be noted that patients struggling with HL normally experienced heightened MTP1 bending, or rather dorsiflexion in the foot, especially following plantarflexion examination, as such eliminates restricting factor and releases gastrocnemius tightness (Colo et al. 2023). HR pathology affects roughly 2.5 percent of individuals aged 50 years and above and has significant implications on the patients’ quality of life and ability to perform daily-life activities (Lam et al., 2017). The aetiology of HR is not well-established. Researchers hold that trauma is one of the leading causes of HR affecting only one toe (Robinson et al., 2016; Lam et al., 2017; Colo et al., 2023). The condition’s impact on both big toes could be linked to the female gender and family history. HR is more prevalent in individuals assigned the female gender at birth. Females are twofold as likely to be diagnosed with HR as compared to their male counterparts (Patel & Swords, 2023), although the rationale for this is not well explained in existing scholarly evidence (Robinson et al., 2016). However, this assertion could be attributed to foot structure, footwear choices, and higher stress incidence on foot joints from joint wear and tear and body mechanics (Puszczałowska-Lizis et al., 2019). Concerning family history, being related to someone with HR implies that one has a higher probability of developing the condition. This could be due to the related persons having the same foot gait or structure. Lam et al. (2017) noted that metatarsal bone variations could heighten the probability of an individual developing foot problems, including HR. Management strategies for HR depend on the aetiology and severity of the clinical manifestations. Whereas there is no best management approach for HR, different therapies can be combined to help reduce pain as well as other symptoms. A healthcare provider can recommend footwear changes to reduce MTP joint pressure. This might involve recommending that the patient avoid high heels and consider stiff soles. Orthotics and inserts are additional footwear options for the management of HR symptoms to provide extra cushioning and arch support (Robinson et al., 2016). It should be noted that inserts are typically placed inside the shoes to enhance comfort, but they cannot correct HR and related foot problems. Over-the-counter pain relievers can also be prescribed to manage HR symptoms, including topical and oral non-steroid anti-inflammatory drugs (NSAIDS) like ibuprofen and naproxen to reduce swelling and ease pain. While NSAIDS can effectively reduce pain, joint stiffness, and inflammation linked to HR (NHS, 2022), these medications cannot cure the condition, and thus, other strategies should be incorporated into the care plan. In contexts where nonsurgical strategies cannot relieve pain and manage HR symptoms, the healthcare provider can suggest surgery. Some surgical procedures could reduce the patient’s ability to bend the toe, but they assist in locomotion and performing activities of daily living without discomfort and pain. According to Lam et al. (2017), cheilectomy is highly successful for individuals struggling with early phases of HR, while arthrodesis remains the gold standard surgical intervention for end-phase HR. Since HR is a progressive condition that often worsens over time, the nonsurgical interventions discussed in this section can help manage symptoms, reduce pain, and decelerate its progression. Since surgical interventions should only be recommended in severe cases of HR or when conservative strategies have proved ineffective in alleviating the symptoms (NICE, 2024), the health provider should first consider nonsurgical (i.e., conservative) treatments like NSAIDs, injections, orthotics, and footwear modifications before proceeding to other strategies in cases where the symptoms persist. Caravelli et al. (2018) noted that there is no scholarly consensus concerning whether conservative management approaches are effective in stopping the clinical progression of HR. However, Lam et al. (2017) suggested that orthotics and shoe modifications could reduce symptoms and decelerate the worsening of the condition over time. Moreover, research indicates that the usage of modified footwear is more effective in relieving pain compared to NSAIDs (Becker & Childress, 2018). These findings justify the present structured literature review, which focuses on investigating the effectiveness of shoe modifications and foot orthoses compared to standard footwear in relieving pain among patients diagnosed with HR or HL. HR is the most common source of foot pain in the adult population (Anderson et al., 2023), and thus, the condition is best suited when investigating the effectiveness of shoe modifications and foot orthoses in reducing pain. Search Strategies, Databases, Prisma Flowchart The researcher followed the PRISMA checklist's quality standards in the execution and reporting of this research project. PRISMA is a standardized methodology that enhances the quality assurance of the review and replication process. A search was performed in PubMed of studies examining the outcomes of shoe modifications and foot orthoses as interventions for pain in patients with osteoarthritis of the first metatarsophalangeal joint or hallux rigidus. The following keywords and MeSH terms were used: ‘hallux rigidus’, ‘first metatarsophalangeal joint osteoarthritis’, ‘foot orthoses’, ‘shoe modifications’, ‘footwear’ and ‘pain’. Boolean operators (AND/OR) were utilized to combine the terms such as: (“hallux rigidus” OR “1st MTP joint OA”) AND (“FOs” OR “shoe modifications”) AND “pain.” Filters were added to include English language and human studies. Four articles were included for full-text after reviewing the titles and abstracts and ensuring the inclusion criteria were satisfied. The inclusion criteria for this literature review included: * Randomized controlled trials (RCTs), cohort studies (CSs), proof-of-concept (POC) studies, and controlled clinical trials (CCTs). POC studies shed light on future RCTs that are more rigorous and thus warrant inclusion in the present scholarly endeavor. * Studies qualifying as authentic study protocols for RCTs, CSs, or CCTs. * Participants diagnosed with HR, HL, or MTP1 joint osteoarthritis. * Studies comparing the efficacy or effectiveness of shoe modifications versus standard footwear. * Studies incorporating validated pain scales to measure pain improvement as an outcome. * Studies that are published in English. The exclusion criteria included: * Systematic reviews, meta-analyses, reviews, and case reports. * Studies focusing on participants with conditions other than MTP1 joint osteoarthritis. * Studies focusing on pharmacological or surgical interventions, without focusing solely on shoe-related modifications. * Studies not focusing on pain as a key outcome measure * Studies not published in English. Figure 1 Article Selection: PRISMA Selection Process PICO Table Study ID Population (P) Intervention (I) Comparison (C) Outcome (O) Study 1 - Munteanu et al. (2021). The trial participants were men and women aged from 24 to 82 years and struggling with first MTP joint pain rated at least 30 on the 100 mm visual analogue scale (VAS). The mean age of the 100 randomized participants was 57.5. The intervention entailed full-length shoe-stiffening inserts. The point of comparison in this study was the control group, which was allocated sham inserts that did not have any effects on the dorsiflexion of the first MTP joint. The Foot Health Status Questionnaire (FHSQ) pain domain constituted the primary outcome measure in this trial. Pain severity at the first MTP joint was conceived as one of the secondary measures. Study 2 - Munteanu et al. (2017). The population was comprised of 90 participants who had to be at least 18 years old and have reported pain in the MTP1 joint and pain rated at least 30 mm on the VAS. The intervention was full-length shoe-stiffening inserts, which were allocated at the baseline assessment. The point of comparison comprised the control group, which was allocated sham inserts that did not impact MTP1 joint dorsiflexion. The primary outcome was the foot pain domain of the FHSQ. One of the secondary outcomes was pain severity in the MTP1 joint as reported via the VAS tool. Study 3 - Jerilyn et al. (2016). The population comprised of 31 participants with MTP1 joint osteoarthritis, aged at least 18 years. The intervention entailed full-length shoe-stiffening inserts that were prescribed during the baseline assessment. The point of comparison entailed performing outcome measures at one and three months following the execution of baseline intervention to establish any change in MTP1 joint pain. The FHSQ pain domain constituted the primary outcome measure. The study also incorporates a relevant secondary outcome involving the use of a five-point Likert scale to assess the comfort of the shoe insert(s), which could point to the intensity of the pain felt. Study 4 - Paterson et al. (2022). The population comprises patients aged 45 years and above who had MTP1 joint pain and with a pain score of at least three on the eleven-point numerical rating scale. The intervention in this case was contoured foot orthoses. The point of comparison in this study is the control measure, which entailed participants using sham flat insoles. The study incorporates both primary and secondary outcomes that are relevant to the present study. It has only one primary outcome, which is the MTP1 joint pain when walking as measured using an 11-point numerical rating scale (NRS). It also incorporates different secondary outcome measures, of which two are relevant to the present study: (a) foot pain as measured using the FHSQ tool and (b) overall MTP1 joint pain based on the eleven-point NRS. Critical Appraisal of Articles and Identified Gaps Four studies were identified as relevant to the present scholarly endeavor, and thus, a critical appraisal is necessary to establish the soundness of the used articles. An assessment of the methodological quality of each of the studies is necessary in order to establish some gaps necessary to refine or improve the research topic. Munteanu et al. (2017) designed a study protocol for an RCT where both the assessor and participants were to be blinded in order to compare the effectiveness of shoe-stiffening inserts with sham inserts in reducing pain linked to MTP1 joint osteoarthritis. By designing a study protocol for an RCT, Munteanu et al. (2017) specified a clear roadmap for researchers examining the same research question to follow and thus prevent possible limitations and biases in future study results. For instance, the authors purposed to use the FHSQ tool as the primary measure for foot pain associated with MPT1 joint because it provides a holistic evaluation of the health of the patient’s foot, including pain, footwear, function, as well as overall foot wellness. The tool also demonstrates high responsiveness to alterations for foot health conditions and is increasingly employed as a validated tool in clinical trials focusing on different disorders of the foot. The only limitation in this study protocol is the failure of the researchers to completely blind the participants to the intervention, particularly due to glaring differences that participants could see in sham inserts and shoe-stiffening inserts. The visible variations in the design of the intervention and control inserts might introduce bias among the participants as they can point out which ones are meant for the treatment group. The significance of the study protocol cannot be underestimated, as the FHSQ tool is also employed as an outcome measure in the studies by Munteanu et al. (2021), Jerilyn et al. (2016), and Paterson et al. (2022), thus demonstrating similar benefits. VAS tool was only used as part of the inclusion criteria for participants in the study protocol by Munteanu et al. (2017), and the same inclusion criteria was also used for participants considered in the Munteanu et al. (2021) study. However, it should be noted that the VAS tool is more preferred over the FHSQ pain domain measure in RCTs because it is easy to use, sensitive to insignificant alterations in pain intensity, and simpler. FHSQ offers a comprehensive measure for different aspects of foot health (Munteanu et al., 2021; Paterson et al., 2022; Jerilyn et al., 2016). On the other hand, the VAS tool offers a more practical and quantifiable measure for pain intensity and thus is more recommended for use in detecting intervention effects (Da-Costa et al., 2021). Munteanu et al.’s (2021) study employed a randomized controlled trial (RCT) where both the participants and assessors were “blinded” to the intervention that was allocated to the partakers. The purpose of the trial was to assess the efficacy of carbon-fibre shoe-stiffening inserts in persons struggling with MTP1 joint osteoarthritis. The researchers found that both the intervention and control groups showed improvements within the FHSQ pain domain at the respective follow-up periods, with a significant difference between groups that favored the group that used shoe-stiffening inserts (adjusted mean difference of 6.66 points, 95% CI 0.65 to 12.67, P = 0.030). Blinding both the participants and investigators reduced bias and ensured the results’ validity by preventing the parties from influencing the procedures, data gathering, and findings interpretation either consciously or subconsciously. Having prior or current knowledge about the intervention could result in a biased assessment or motivate the participants to change their behaviors. Additionally, both studies incorporate well-defined study protocol as the authors detailed each study’s purpose, design, and methodology, as well as ethical considerations. The key strengths in Munteanu et al. (2021) include a rigorous research design that blinded the participants, adequate statistical power, as well as excellent retention over a comparatively extended follow-up period. Nevertheless, the results should be interpreted with respect to specific limitations that can be pointed out. First, the control intervention could not be conceived as genuinely inert, as is the status quo for all mechanical device/intervention trials. So, the control intervention is ideally a sham instead of a placebo. Second, research staff allocating the participants with shoe inserts were not blinded, thus undermining the study’s validity because of possible bias. Ultimately, participants recruited for this trial might not reflect the real patients that are likely to visit a primary care unit seeking treatment for MTP1 joint pain osteoarthritis. This undermines the validity of the study results because the researchers sought to investigate a condition that is commonly reported in primary care settings. The limitation also creates room for skewed findings and constrained generalizability in diverse patient populaces. Jerilyn et al. (2016) conducted a proof-of-concept (PoC) study to establish the potential of shoe stiffening inserts in reducing pain associated with MTP1 osteoarthritis. The researchers found statistically significant relief in foot pain as well as foot-associated disability, particularly at one and three months (mean discrepancy at 3 months: foot pain = 18.8, 95% CI, 13.3-24.3; foot function = 11.8, 95% CI, 4.3-17.3). The observations indicated the promise of full-length shoe-s...