Hallux rigidus: are only injections worth it?—a systematic review

Introduction

Hallux rigidus is the most common disorder affecting the first metatarsophalangeal joint and may be more debilitating than hallux valgus because of the significant limitations in ambulation observed in severe cases (1).

While the clinical signs and symptoms suggest that hallux rigidus often presents with bilateral involvement, surgical outcome studies have predominantly focused on unilateral cases. However, with extended follow-up, bilateral symptoms have been reported in 80% or more of patients (2). A higher prevalence of hallux rigidus was observed in males over the aged >30 years who presented with related complaints (3). In contrast, studies of patients undergoing surgical intervention have consistently reported a significantly higher incidence in females (2).

The term hallux rigidus describes the painful condition of the metatarsophalangeal joint of the great toe, characterized by restricted motion, mainly dorsiflexion and proliferative osteophytosis.

Initially, hallux rigidus presents with pain, swelling, and synovitis of the first metatarsophalangeal (MTP) joint, with restricted dorsiflexion being a hallmark feature. As the degenerative process progresses, bony osteophytes typically develop on the dorsal and dorsolateral aspects of the first metatarsal head, forming a prominent bony ledge, against which the proximal phalanx impinges.

Alternative terms, such as hallux limitus, dorsal bunion, hallux dolorosus, hallux malleus, and metatarsus primus elevatus, have been proposed (4). The terms “hallux rigidus” and “hallux limitus” are often used interchangeably; however, some authors differentiate between them, with hallux limitus referring to a restricted range of dorsiflexion and hallux rigidus denoting a complete absence of motion (5).

Several clinical and/or radiographic classifications have been reported in the literature; the most cited and complete classifications were described by Coughlin and Shurnas in 2003 (2). This classification is based on clinical (pain intensity, range of motion, positive grinding test) and/or radiological parameters (osteophyte size and localization and osteoarthritic changes). Four grades were defined: Grade 0, minimal symptoms and no radiographic changes; Grade 1, mild pain with activity and dorsal osteophytes; Grade 2, moderate pain, joint space narrowing, and perimetral osteophytes; Grade 3, significant pain, marked joint space narrowing, and subchondral sclerosis; Grade 4, end-stage, including constant pain, severely limited motion, and nearly complete joint degeneration.

Conservative management of hallux rigidus is guided by the clinical severity of the condition. In the early stages, treatment typically involves the use of nonsteroidal anti-inflammatory drugs (NSAIDs) and insoles designed to limit motion at the MTP joint. For more advanced cases, footwear with a low heel and spacious upper is recommended to accommodate the enlarged MTP joint and minimize pressure on dorsal exostosis. In certain cases, a carefully administered intra-articular steroid injection may offer temporary relief. However, repeated injections are discouraged, as they may accelerate the degenerative process (2,5).

Concerning hallux rigidus, literature is lacking: only a few studies have reported results on injections as conservative treatment, and many of them focus on patients who have previously undergone surgical intervention (5-8). Therefore, these studies do not allow for a clear understanding of the true efficacy of injections only for hallux rigidus, as their effectiveness is confounded by biases, such as concomitant surgical interventions. Therefore, a systematic review of the literature is needed to minimize bias through transparent and reproducible methods.

For this reason, we aimed to address four questions about the use of injection for hallux rigidus as a conservative treatment: (I) what injection treatment options are available for hallux rigidus? (II) What are the success rates and outcomes of these treatments? (III) Which factors influence the outcomes? (IV) How long have the effects of the injection lasted? We present this article in accordance with the PRISMA reporting checklist (9) (available at https://asj.amegroups.com/article/view/10.21037/asj-25-21/rc).

Methods

Search strategy and criteria

As mentioned above, the purpose of this review was to evaluate the efficiency of injections for hallux rigidus.

Traditionally, terms “hallux rigidus” and “hallux limitus” are often used interchangeably in literature, even if some authors used to refer “hallux limitus” to a restricted range of dorsiflexion and “hallux rigidus” to a complete absence of motion (4). Therefore, both terms were included in the present study. Simultaneously, we considered the most popular substances injected into the foot/ankle joints: steroids, hyaluronic acid, and platelet-rich plasma (PRP).

For this systematic review we searched the electronic databases PubMed, Scopus, and Embase using the search terms: “hallux rigidus” or “hallux limitus” and “injection” or “steroid” or “hyaluronic” or “Platelet-Rich Plasma” (Table 1). As this review is an internal project with no anticipated publication, the protocol was not submitted to a protocol registry.

The research questions and inclusion and exclusion criteria were determined a priori. The inclusion criteria were human studies published in English and studies on the treatment of hallux rigidus/limitus with injections. The exclusion criteria were as follows: descriptive reports on hallux diseases and treatment; injections involving other joints (knee, temporomandibular, ankle, hip); systematic review; studies on animals/cadavers; epidemiologic studies; and injection after hallux surgery. This last criterion is fundamental, as it allows us to truly understand whether injections for the hallux rigidus are effective.

Study screening

All the aforementioned electronic databases were consulted on January 15, 2025, by two independent reviewers (L.M. and A.P.).

After excluding duplicates, the titles, abstracts, and full texts of each study, disagreements were resolved through discussion after a full-text evaluation. The reference lists of the studies were manually searched for other publications, which may have excluded the initial search (Table 2).

Assessment of study quality

Two reviewers (L.M. and A.P.) independently evaluated the quality of each included study.

For this systematic review, the Methodological Index for Non-randomized Studies (MINORS) questionnaire was used (22). For CAse REport studies, the CAse REport (CARE) Guidelines Checklist was used (23). A methodological approach for the quality of healthcare systems (MARQulS) was used to assess the quality of healthcare audits (24). The ROBINS-I was used to assess the risk of bias in each report (25).

Data collection

The data from each study included the number of patients, sex, age, follow-up, type and number of injections, success rate, outcomes, and complications (Tables 3,4).

The factors that may have influenced the success rate are reported in Table 5.

Results

A total of 114 articles were retrieved for preliminary evaluation (Figure 1). Reported studies range from 1950 to 2024.

Figure 1 Flowchart of the study.

After duplicates were eliminated, 68 original articles remained. Three authors (L.M., A.P., and G.R.) reviewed the titles: thirty-five studies were excluded because they did not meet the inclusion criteria. After reviewing the abstracts, 17 studies were excluded because they did not meet the inclusion criteria. Of the remaining 16 articles, five were excluded after evaluation of the full text and two because published in a language other than English. Four articles were added to the nine eligible studies based on their references; thus, a total of 13 studies were included in the final analysis and quality assessment.

The studies included in the final analysis are summarized in Table 2. The mean MINORS score was 12/16 (range, 7–16); the mean CARE Checklist was 15.3/16 (range, 15–15.5). The MARQuIS was 15/21 only for audit reports. Most studies showed a moderate risk of bias after ROBINS-I evaluation.

Different types of studies were included: three single-blind randomized controlled studies, two double-blind randomized controlled studies, one observational study, two case reports, one observational prospective multicenter pilot study, one cross-sectional observational study, one clinical audit study, and two retrospective studies (Table 2). The sample size, mean age, mean weight, sex, sex, classification, and type of injection details from each study are presented in Table 3.

All 13 (100.0%) studies reported data on treatment by injection for hallux rigidus (first question) and on success rates and outcomes (second research question); eight studies (61.5%) reported data on factors influencing outcomes (third research question), and six studies (46.2%) reported data on duration of effects (fourth research question).

Significant variability was observed in the procedural techniques and injection protocols used in the included studies.

Types of injection

The selected studies reported the injection of different substances into the hallux rigidus. Three typologies were used: steroids (methylprednisolone, triamcinolone acetonide) with the addition of an anesthetic (bupivacaine 0.5%, lidocaine 1%) in six studies (46%) (7,11,14,17,19,20), hyaluronic acid in seven studies (54%) (7,10-12,15,16,21), and autologous adipose-derived stem in one study (0.8%) (13). Pons used both hyaluronic acid and steroids (11).

Outcomes

The outcomes and complications are summarized in Table 4. Multiple studies have demonstrated significant improvements in pain and function following hallux rigidus injections. The reduction in visual analogic score (VAS) scores after injection was statistically significant, regardless of the substance used in most studies (P<0.05) (11,12,15,24,25). Some authors have reported exceptionally high pain relief rates ranging from 84% to 92% (7,17). Post-injection VAS scores showed significant reductions at rest, during dorsiflexion/plantarflexion, with local palpation, tip-toe tests, and walking (P<0.05) (10,11,18). Galois also observed a decreased need for pain medication in patients (15).

Functional improvements have been highlighted in different studies, and the AOFAS-Hallux score showed a significant increase after injection (P<0.01) (11,13,14). However, Razavi noted that although these increases were statistically significant, they may not be clinically meaningful (14). The range of motion also significantly and progressively improved following injections (P<0.009) (18).

Factors influencing outcomes

The influencing factors are presented in Table 5. The studies analyzed did not extensively address the factors that may influence clinical outcomes. Among these, the severity of hallux osteoarthritis appears to play a critical role. Several studies have indicated that the therapeutic efficacy of injections diminishes in patients with severe degenerative changes (P=0.02) (7,12,15,16,19). Specifically, Solan observed more favorable outcomes following injections in cases classified as Coughlin-Shurnas grade 1 or grade 2, a finding corroborated by Galois (15,19). Grice and Solan collectively suggested that hallux rigidus injections should be primarily reserved for patients with mild arthritis (7,19).

The use of imaging guidance during injections has also been investigated. Ali emphasizes that fluoroscopy may be warranted in cases where concerns about surrounding soft tissues arise (17). Additionally, Razavi and Grice demonstrated that ultrasound-guided injections enhance both the accuracy and therapeutic efficacy of the intervention (7,14). However, Conrozier found no significant correlation between pain relief after injection and the use of imaging guidance (P=0.02) (12). Furthermore, Galois reported that imaging guidance was not associated with injection-related side effects (P=0.81) (15).

Regarding the injected substance, Pons observed no initial differences in pain relief or functional improvement between hyaluronic acid and corticosteroids. However, follow-up results demonstrated a statistically significant advantage in favor of hyaluronic acid (11).

Duration of effects

The duration of symptomatic benefit following intra-articular injections varied significantly across studies. Maher reported pain relief in 23% of the patients at one month, 23% at 3 months, and 46% at 6 months (16). Petrella observed a significant reduction in pain and improved dorsiflexion at 9 months (18). Conversely, Ali noted that 81.8% of patients (9 out of 11) experienced no pain relief for 3 months (17).

The rate of subsequent surgical intervention following the injection also showed considerable variability. Maher reported a 50% surgery rate at 6 months (16), while Pons documented a rate of 52.9% at 1 year (11). Petrella et al. reported a markedly lower rate of 4% at 1 year (18). In contrast, Grice observed a surgery rate of 55% at 2 years, and Ali reported a rate of 20% at 6 months (7,17). Solan noted a one-year surgical rate of 66% in patients with grade-2 Karasick severity and 100% in those with grade-3 severity (19).

Complications

No authors have reported any serious, unexpected, or systemic adverse events related to intra-articular injections. However, transient joint discomfort at the injection site was observed in 22% of patients (12,15). These side effects include pain, irritation, and swelling of the hallux, typically occurring within hours after injection and lasting for 3 to 7 days (11,12,15,16). All cases resolved spontaneously within 1 week (10,15,16).

A single case of cellulitis at the injection site was reported by Munteanu, which resolved after a 12-day course of antibiotic therapy (21).

Discussion

Hallux rigidus is the most common disorder affecting the first metatarsophalangeal joint and may be debilitating.

Conservative management of hallux rigidus is guided by the clinical severity of the condition: in certain cases, a carefully administered intra-articular steroid injection may offer temporary relief; however, repeated injections are discouraged, as they may accelerate the degenerative process.

However, the literature reveals a significant gap in information regarding the effectiveness of intra-articular injections. Despite their longstanding and widespread use, there remains a lack of robust evidence to guide clinical decision making. This paucity of data is reflected in the considerable variation observed in clinical practice (20).

To minimize bias in evaluating the efficacy of intra-articular injections for hallux rigidus, we excluded studies in which patients received these treatments postoperatively.

The findings of this review indicate that intra-articular injections of hallux rigidus are effective, with demonstrated improvements in both pain and function (2-10,22-25). Pain relief was significant at rest, during dorsiflexion and plantarflexion, with local palpation, tip-toe tests, and while walking (10,11,18). Functional improvements following injections have also been significant in multiple studies (10,11,18). These results were consistent with those reported by Butler (30). This treatment is highly safe, with side effects limited to local and transient discomfort including pain, swelling, and irritation, which typically resolve within a few days (2,11,12,15). To avoid infections, the following standard aseptic techniques certainly minimize risk, as suggested by Maher (16).

However, patients should be informed that the duration of symptomatic relief from intra-articular injections is limited, with benefits lasting no more than 12 months in 50% of the cases (16-18). The efficacy of intra-articular injections is further highlighted by the rate of subsequent surgical intervention. At 6 months, Maher reported that 50% of patients required surgery, compared to 20% reported by Ali (16,17). At one year, Pons documented a surgery rate of 52.9%, while Solan reported a rate of 66% in patients with grade-2 Karasick severity and 100% in those with grade-3 severity (11,19). In contrast, Grice observed a surgery rate of 55% at 2 years (7).

The effectiveness of intra-articular injections and their duration of effects depend on the severity of hallux osteoarthritis, and the therapeutic efficacy diminishes in patients with severe degenerative changes (7,12,15,16,19). Therefore, Grice and Solan suggested that injections for hallux rigidus should be primarily reserved for patients with mild arthritis (7,19). However, the studies included in this review use different radiological classifications of hallux osteoarthritis: Coughlin-Shurnas, Regnauld, Karasick-Wapner, Hattrup-Johnson, Menz. This may have led to a biased comparison among the results (7,26-29).

The use of imaging guidance during injections has been debated; inaccurate placement of joint injections has been well documented in the literature, raising concerns that extra-articular placement may lead to local tissue damage, including soft tissue and fat atrophy (31). Although evidence specific to the foot and ankle is limited, imaging guidance has been shown to enhance the accuracy of injection placement in other joints. However, its impact on clinical outcomes remains unclear (20).

Ali is the only author emphasizing that fluoroscopy may be warranted in cases where concerns about surrounding soft tissues arise (17). Nonetheless, they concluded that fluoroscopy may not be essential when injections are used solely for therapeutic purposes (17). This perspective aligns with Kirk’s findings, which suggest that experienced surgeons can achieve a 97% accuracy rate for intra-articular injections in a normal posterior subtalar joint without fluoroscopy (32). In our view, the availability of US guidance may further reduce the need for fluoroscopy for hallux injection.

US guidance has been shown to improve the accuracy and therapeutic efficacy of injections (7,14). However, other authors have reported that imaging guidance does not appear to influence the occurrence of injection-related side effects, with similar findings observed by Ekeberg for shoulder injections (10,15,33). These results suggest that accurate placement may not be crucial for symptom relief, raising questions regarding whether the additional cost of imaging guidance is justified.

Regarding the substance injected, our results indicate that both hyaluronic acid and corticosteroids are effective in improving pain relief and range of motion (7,10-17).

Strengths and limitation

This review presents the first comprehensive and methodologically rigorous synthesis of available evidence on intra-articular injections for conservative treatment of hallux rigidus. By adhering to PRISMA guidelines and employing validated tools for quality assessment, including MINORS, MARQulS, and ROBINS-I, this study ensured a transparent and reproducible approach to evidence synthesis. A notable strength is the strict exclusion of studies involving postsurgical injections, which allowed for a more accurate assessment of the isolated efficacy of intra-articular therapies. Furthermore, the review encompassed a broad range of injection types (steroids, hyaluronic acid, and adipose-derived cells), providing a well-rounded overview of the available treatment options. The analysis also addresses outcomes and success rates, as well as factors influencing therapeutic efficacy and duration of relief, offering valuable clinical insight for personalized patient management.

Despite its methodological rigor, this review had some limitations. First, the overall quality of the included studies was moderate, with most showing a non-negligible risk of bias as reflected in the ROBINS-I assessments. Heterogeneity in study design, patient populations, and outcome measures limits the comparability of the results across studies. Moreover, significant variability was observed in the classification systems used to grade hallux rigidus, complicating the interpretation of efficacy relative to disease severity. Another key limitation was the lack of long-term follow-up data. The use and impact of imaging guidance during injections remains inconclusive, and the cost-effectiveness of such practices is yet to be fully determined. Finally, while the review includes a broad range of substances, the limited number of randomized controlled trials constrains the strength of the recommendations that can be made.

Conclusions

Intra-articular injections of hallux rigidus are effective and safe for conservative treatment of hallux rigidus, particularly in the early stages of osteoarthritis. Efficacy is limited to one year, but pain relief and restoration of range of motion are significant. The usefulness of imaging guidance is debated: even if imaging guidance has been shown to enhance the accuracy of injection, its impact on clinical outcomes remains unclear.

Acknowledgments

None.

Footnote

Reporting Checklist: The authors have completed the PRISMA reporting checklist. Available at https://asj.amegroups.com/article/view/10.21037/asj-25-21/rc

Peer Review File: Available at https://asj.amegroups.com/article/view/10.21037/asj-25-21/prf

Funding: None.

Conflicts of Interest: All authors have completed the ICMJE uniform disclosure form (available at https://asj.amegroups.com/article/view/10.21037/asj-25-21/coif). The authors have no conflicts of interest to declare.

Ethical Statement: The authors are accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Open Access Statement: This is an Open Access article distributed in accordance with the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 International License (CC BY-NC-ND 4.0), which permits the non-commercial replication and distribution of the article with the strict proviso that no changes or edits are made and the original work is properly cited (including links to both the formal publication through the relevant DOI and the license). See: https://creativecommons.org/licenses/by-nc-nd/4.0/.

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