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25 May 2024: Clinical Research  

Comparative Efficacy of Micro-Needle-Knife Therapy and Acupuncture in Acute Ankle Sprains: A Randomized Controlled Trial

Sen-wei Lu1ABCDEFG*, Bo-xu Lang2ABC, Jia-na Liu1ABC, Xiao-xiao Ma1ABD, Tang-tang Li1BCD, Xin Du1BCF, Mao-liang Zhang1BC

DOI: 10.12659/MSM.944157

Med Sci Monit 2024; 30:e944157

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Abstract

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BACKGROUND: Micro-needle knife (MNK) therapy releases the superficial fascia to alleviate pain and improve joint function in patients with acute ankle sprains (AAS). We aimed to evaluate the efficacy and safety of MNK therapy vs that of acupuncture.

MATERIAL AND METHODS: This blinded assessor, randomized controlled trial allocated 80 patients with AAS to 2 parallel groups in a 1: 1 ratio. The experimental group received MNK therapy; the control group underwent conventional acupuncture treatment at specified acupoints. Clinical efficacy differences between the 2 groups before (time-point 1 [TP1]) and after treatment (TP2) were evaluated using the visual analogue scale (VAS) and Kofoed ankle score. Safety records and evaluations of adverse events were documented. One-month follow-up after treatment (TP3) was conducted to assess the intervention scheme’s reliability.

RESULTS: VAS and Kofoed ankle scores significantly improved in both groups. No patients dropped due to adverse events. At TP1, there were no significant differences between the 2 groups in terms of VAS and Kofoed scores (P>0.05). However, at TP2, efficacy of MNK therapy in releasing the superficial fascia was significantly superior to that of acupuncture treatment (P<0.001). At TP3, no significant differences in scores existed between the groups (P>0.05).

CONCLUSIONS: This study demonstrates that 6 sessions of MNK therapy to release the superficial fascia safely and effectively alleviated pain and enhanced ankle joint function in patients with AAS, surpassing the efficacy of conventional acupuncture treatment. Future studies should increase the sample size and introduce additional control groups to further validate the superior clinical efficacy of this intervention.

Keywords: Ankle Injuries, Biopsy, Fine-Needle, Fascia, Randomized controlled trial

Introduction

Acute ankle sprain (AAS) is one of the most prevalent conditions in sports medicine, leading the spectrum of joint and ligament injuries [1,2]. It accounts for approximately 16% to 40% of all sports-related injuries [3,4]. Clinically, AAS is characterized by ankle pain and functional impairment, noted for its sudden onset, intense pain, and significant impact on daily activities [5–7]. The ankle, being one of the body’s crucial weight-bearing joints, with a complex anatomical structure and relatively fragile muscles and tendons, is highly susceptible to injury in everyday life [8]. Moreover, it can afflict individuals across all age groups and demographics [9–11], carrying a high risk of recurrence [12].

The management of AAS embraces a variety of principles, with the PRICE (protection, rest, ice, compression, and elevation) guideline being the most frequently used [13]. These measures aim to mitigate swelling and pain, prevent further injury, and facilitate tissue repair [14]. However, systematic reviews [15] incorporating analyses from 11 studies indicate that most patients require additional supervision to ensure compliance. Surveys [16] have also highlighted that 78% of physicians believe patient expectations influence the adherence to rehabilitation guidelines, hence affecting recovery outcomes and potentially leading to chronic ankle sprains [17,18]. Patients often prefer more physician-led interventions to self-administered management approaches [19–21]. Moreover, the rest and immobilization strategies central to the PRICE principle can result in a temporary loss of joint function, with the immobilization causing adhesions in the joint’s synovial folds and superficial fascial layers [22]. Research indicates that the muscles, ligaments, and joint capsules surrounding the ankle all belong to the superficial fascial system, where adhesions typically develop [23–25]. Studies have shown that in patients with AAS, the superficial fascia around the ankle is thicker compared with that in healthy individuals, suggesting the presence of adhesive responses [26,27]. These findings corroborate the rationale and necessity for addressing adhesions within the superficial fascial system to effectively manage and rectify the core issues associated with AAS.

Micro-needle knife (MNK) therapy, primarily for soft tissue injuries, operates on the principle of inserting the MNK into the lesion site to perform gentle cutting, peeling, and loosening procedures [28,29]. This approach aims to eliminate muscle fascia adhesions, contractures, and scars, restoring normal biomechanics, alleviating inflammation and pain, and promoting tissue repair [30,31]. Its advantages include simplicity, minimal invasiveness, no need for suturing, absence of adverse reactions, rapid efficacy, short treatment duration, and broad applicability. Numerous clinical studies have underscored the significant therapeutic outcomes of MNK in addressing acute or chronic soft tissue injuries. For instance, Zhu et al [32] treated 31 patients with painful knee osteoarthritis, applying MNK to release the superficial fascia at various sites such as the quadriceps tendon of the knee, peripatellar joint capsule, tendons, and ligaments, fibular and tibial collateral ligaments, and tender points (trigger points) at the lateral and medial heads of the gastrocnemius muscle, as well as the biceps femoris attachment points, markedly improving pain and clinical questionnaire scores. Guo et al [33] treated 38 patients with periarthritis of the shoulder, using MNK to release the superficial fascia at critical sites, including the coracoid (attachment point of the short head of the biceps), small tubercles (subscapularis attachment points), intertubercular sulcus (long head of the biceps attachment point), subacromial bursa (supraspinatus attachment point), and the greater tubercle of the humerus (teres minor attachment point), resulting in enhanced shoulder function and reduced coracohumeral ligament thickness. Sun et al [34] presented a pathological report on a patient with carpal tunnel syndrome, noting that MNK release of the fibrotic superficial fascia within the carpal tunnel improved finger mobility and pain after just 1 treatment. Moreover, 2 systematic reviews and meta-analyses have respectively evaluated the evidence for MNK treatment of plantar fasciitis [35] and post-herpetic neuralgia [36], both endorsing its clinical safety and superior efficacy in treating acute or chronic soft tissue traumatic diseases. However, to the best of our knowledge, no studies have definitively reported on the clinical safety and superior efficacy of MNK in treating AAS.

This study is predicated on our clinical observations showing that MNK therapy can bring about substantial therapeutic benefits for patients with AAS. Hence, we have designed this evaluator-blinded randomized controlled trial to authenticate the clinical efficacy and safety of MNK, aiming to provide a basis for decision-making by clinicians and patients with AAS. Given the robust validation of acupuncture in treating AAS through extensive, multicenter randomized controlled trials [37], we have selected acupuncture as the positive control to ascertain the reliability of our study outcomes.

Material and Methods

PARTICIPANTS:

Eighty patients, all diagnosed with AAS and meeting the inclusion criteria, were recruited from the Department of Tuina at the Affiliated Dongyang Hospital of Wenzhou Medical University. They were randomly allocated into 2 groups using a random number table method, with 40 patients in each group. The experimental group (group 1) underwent MNK therapy to release the superficial fascia, while the control group (group 2) received conventional acupuncture treatment. The recruitment period was from January 2023 to January 2024. The detailed recruitment flowchart is shown in Figure 1.

SAMPLE SIZE CALCULATION:

To ascertain the sample size required for this study, we used G*Power 3.1 (https://gpower.software.informer.com/3.1/) software for calculation [38]. n represents the required sample size for each group, essential to ensure the study had sufficient statistical power to detect a difference between 2 independent sample means. α denotes the probability of making a type I error, the risk of incorrectly rejecting the null hypothesis. In this study, this value was set to 0.05, indicating a willingness to accept a 5% risk of drawing an incorrect conclusion. Z1-a2 is the critical value from the standard normal distribution at 1-α/2 for a 2-tailed test. With α=0.05, it represents the Z-value when leaving 2.5% in each tail of the normal distribution. β represents the probability of a type II error, the risk of failing to detect an effect that actually exists. In this study, β was set to 0.2, indicating a willingness to accept a 20% risk of not detecting an actual effect. corresponds to the critical value from the standard normal distribution for power (1-β). In this context, it signifies an 80% probability of detecting the effect if it truly exists. E denotes the effect size, calculated here as 0.65, based on preliminary experimental outcomes, representing the minimum significant effect size anticipated by the study, in standard deviation units.

With the aforementioned parameters, the preliminary calculated sample size was 38 participants per group to meet the requirements for statistical power. To account for potential participant dropout, an additional proportion of participants was planned to compensate for potential losses. Assuming an anticipated dropout rate of 5%, each group aimed to recruit 40 participants (38 multiplied by 1.05) to ensure that, even with dropouts, the necessary sample size would be maintained. This resulted in a total sample size of 80 participants for the study (40 in each group).

RANDOMIZATION AND BLINDING:

This study used an evaluator-blinded randomized controlled trial methodology. In this approach, the evaluators were unaware of which participants received the experimental intervention and which were assigned to the control group while assessing the study outcomes. This strategy minimizes the potential for evaluators’ expectations or prior knowledge to influence their judgments, thereby enhancing the objectivity and reliability of the research.

Group randomization was conducted using a random digit table. An investigator who was not involved in the intervention steps randomly assigned enrolled participants to groups. Each enrolled participant was assigned a number generated randomly by IBM SPSS Statistics version 26.0 (https://www.ibm.com/support/pages/downloading-ibm-spss-statistics-26). Each generated number corresponded to 1 of 2 treatment groups. The investigator then randomly allocated each participant to the respective treatment group based on this number. During this process, the investigator did not have access to any other personal information of the participants. A total of 80 random numbers were generated for 80 participants, with 40 individuals per group.

INCLUSION CRITERIA:

The inclusion criteria were as follows: age of 16 to 55 years; injury occurred less than 72 h before the assessment at the clinic [39]; presence of localized swelling, pain, bruising, and limping symptoms in the ankle joint; pain in the ankle joint upon resistance; no accompanying fractures; diagnosis of acute ankle injury according to the “Diagnostic and Therapeutic Criteria of Traditional Chinese Medicine”; no prior treatment before participating in this therapy; and willingness to participate in this study and sign the informed consent form.

EXCLUSION CRITERIA:

The exclusion criteria were as follows: patients with clear indications for surgery; other conditions, including gout, rheumatoid arthritis, joint tuberculosis, and joint tumors; pregnant or breastfeeding women; serious primary diseases of the cardiovascular, liver, kidney, brain, and hematopoietic systems; local skin lesions or skin diseases; injury mechanisms inconsistent with ligament sprain (eg, direct impact); inability to comply with the time-intensive study protocol; plans to seek physical therapy outside the study protocol [39]; coagulation dysfunction; severe fear of needles; and patients unwilling to comply with the treatment regimen.

CASE ELIMINATION AND DROPOUT CRITERIA:

The following criteria led to case elimination or dropout: patients included that did not meet the inclusion criteria; patients who do not follow medical advice, affecting the assessment of efficacy or safety; patients who were unwilling to continue with the observation or treatment; and patients who experienced adverse reactions, making it inappropriate to continue the experiment. Patients with adverse reactions were to be included in the analysis of adverse reactions. Those who self-withdrew from the study more than twice due to ineffectiveness of the treatment were to be included in the efficacy analysis.

ETHICAL REVIEW AND PROTOCOL REGISTRATION:

The Institutional Review Board at Dongyang People’s Hospital approved this study protocol (No. 2023-YX-080). This protocol was registered on ClinicalTrials.gov (NCT06266520). Additionally, it was conducted in accordance with the Declaration of Helsinki. All patients provided written informed consent.

INTERVENTION PROCEDURE:

Group 1 underwent MNK therapy for superficial fascia release. The MNK, manufactured by Ma’anshan Bond Medical Instrument Co., Ltd., measured 0.40×40 mm, with a blade width of 0.4 mm, and adhered to the product standard LJ3525R. The procedure was designed to address the superficial fascia of several key anatomical structures in the ankle and lower leg: the peroneus brevis (Figure 2A), peroneus longus (Figure 2B), superior extensor retinaculum (Figure 2C), and peroneus tertius (Figure 2D). By targeting these specific areas, the treatment aimed to alleviate tension and restrictions within the fascia, promoting improved function and reducing discomfort in these integral components of the ankle’s musculoskeletal framework. The patient, positioned supine and wearing shorts for full lower limb exposure, underwent layered palpation by the practitioner at the procedure points, with identification of tender nodules and swelling in superficial fascia and muscles, followed by disinfection with an iodophor cotton swab. The practitioner, wearing sterile latex gloves, held the MNK between the thumb and index finger of the right hand, inserting it parallel to the body’s longitudinal axis, while the left thumb pressed and held the cord-like nodules for parallel incisions, with a maximum insertion depth of 5 mm, performing lifting and cutting motions. Depending on the nodule size, 1 to 3 incisions were made. After the procedure, any bruising or tissue fluid was expelled by massaging from distal to proximal around the incision. The area was then compressed with dry sterile gauze until bleeding ceased. Treatments were administered every other day, totaling 6 sessions.

Group 2 received acupuncture treatment, with needles produced by Suzhou Medical Supplies Factory Co., Ltd., with specifications of 0.30×40 mm and conforming to standard GB2024-1994. Patients, positioned prone or laterally with exposed lower limbs below the knee, were disinfected with an iodophor cotton swab. Acupuncture points selected included GB39, BL60, BL40, ST41, KI9, and KI6. The practitioner applied pressure to the points with the left hand and swiftly inserted the needle with the right hand, using a disposable sterile acupuncture needle measuring 0.30×40 mm, penetrating the skin about 1.25 cm to 2.0 cm. After achieving deqi, the needle was twisted and thrust several times and then left in place for 30 min. Upon removal, the needle site was compressed with a dry cotton swab until bleeding stopped. Treatments occurred every other day, totaling 6 sessions (Figure 3).

All clinical procedures for MNK therapy and acupuncture were conducted by the same rehabilitation expert, LSW, who had 18 years of expertise, thereby ensuring standardized quality control of the intervention protocols.

OUTCOMES:

Clinical questionnaire data were collected from all AAS patients at 3 time points: prior to intervention (TP1), immediately after intervention (TP2), and 1 month after intervention (TP3). The visual analogue scale (VAS) [40] and Kofoed ankle scores [41] were used to assess the pain levels and functional recovery of the ankle joint in AAS patients, respectively.

The VAS [42] is used to assess the degree of pain experienced by the patient. Patients select an appropriate number (0 to 10) based on their perceived pain intensity: 0 indicates no pain and a normal state; 1 to 3 signifies mild pain that is tolerable and does not interfere with daily activities; 4 to 6 represents moderate pain that is noticeable and tolerable but affects daily life and sleep; 7 to 10 indicates severe pain that is intolerable.

The Kofoed ankle score [43] is a clinical metric designed to assess the recuperation of ankle joint function following treatment, with the evaluation performed by medical professionals. This scale yields essential data concerning the intensity of pain, capacity for daily activities, and functional condition of the ankle joint. It has a maximum score of 100 points, with scores ranging from 85 to 100 categorized as excellent, 75 to 85 as good, 70 to 74 as fair, and any score below 70 considered poor.

SAFETY EVALUATION:

Accurate records were maintained for adverse events, including any exacerbation of pain symptoms, complications, syncope, and arrhythmias, that might arise during the treatment process, alongside an analysis of their causes to assess the safety of MNK therapy in treating acute ankle sprains. In the experiment, if there was an aggravation of the condition, serious complications, or adverse reactions deemed to be induced by the experimental intervention, the treatment was to be immediately discontinued, appropriate corrective measures implemented, and detailed records taken. In this study, no adverse reactions were reported.

PATIENT COMPLIANCE EVALUATION:

A questionnaire survey was designed to record the responses of patients in each group during the treatment process, including fear, discomfort after the procedure, increased pain, attendance rate, and reasons for dropping out, if any. This facilitated an analysis of compliance with the 2 treatment regimens. In this study, there were no instances of patient attrition.

STATISTICAL ANALYSIS:

Data analysis in this study was conducted using SPSS software (version 26.0). Initially, we assessed the distribution characteristics of various metrics at baseline. Specifically, for data adhering to a normal distribution, we described it using mean±standard deviation (x±s) and used independent sample t tests to compare differences between groups. For data not following a normal distribution, we described it using the median and interquartile range [M (P25, P75)] and used the Mann-Whitney U test (also known as the rank-sum test) and chi-square test to evaluate intergroup differences. In all analyses, a P value of less than 0.05 was considered statistically significant.

For the clinical scale evaluation of the ankle joint, we used Python 3.0 (https://www.python.org/downloads/) for statistical analysis. The specific process included initially testing the data for normality to determine the appropriate statistical methods. For data conforming to a normal distribution, we used independent sample t tests to assess differences between groups and paired sample t tests to analyze variations within the same group across different time points. Such an analytical process ensured that our statistical methods were both scientific and appropriate, accurately reflecting the true outcomes of the research.

Results

BASELINE DATA:

Between January 2023 and January 2024, this study meticulously adhered to inclusion and exclusion criteria to enroll a total of 80 patients with AAS, who were then divided into 2 groups via a randomized digital table method (group 1, n=40; group 2, n=40). Group 1 underwent MNK therapy aimed at alleviating the superficial fascia, while group 2 was treated with acupuncture. Throughout the treatment period, no adverse events were reported, nor was there any attrition among the patients. We analyzed the baseline data between the 2 cohorts, which revealed no significant statistical difference in sex distribution (M/F: group 1: 23/17 vs group 2: 25/15, χ2=0.052, P=0.819), or age distribution (group 1: 31.575±7.164 vs group 2: 31.825±6.641, t=−0.162, P=0.872) (Table 1).

CHANGES OF VAS AND KOFOED ANKLE SCORES:

Upon comparing the distinct interventions administered to group 1 and group 2, we found significant enhancements in both the VAS and Kofoed ankle scores after treatment (TP2 vs TP1), as demonstrated by paired t tests. The improvements are highlighted in Figures 4, 5, and Table 2, where P<0.001. Furthermore, clinical questionnaire data were collected at 3 different times: before intervention (TP1), immediately after intervention (TP2), and 1 month after intervention (TP3), to ascertain the differential efficacy between the 2 groups using independent sample t tests. At the initial time point (TP1), there were no statistically significant differences between the 2 groups regarding the VAS and Kofoed score of the ankle (P>0.05). However, at TP2, the efficacy of MNK therapy in releasing the superficial fascia was significantly superior to that of acupuncture treatment (P<0.001). Moreover, at TP3, there were no statistically significant differences between the groups in terms of VAS and Kofoed ankle scores (P>0.05) (Figures 6, 7).

Discussion

LIMITATIONS:

This study had several limitations. First, the patient cohort was sourced from a single hospital, potentially creating selection bias. Future studies should pursue multi-center, large-sample randomized controlled trials across various regions to address this issue. Second, the number of control groups was limited. Our analysis compared the efficacy differences solely with acupuncture; future studies should incorporate additional positive control groups, such as interventions involving surgery or other physical therapies, for a more comprehensive comparison. Third, the follow-up period was relatively short. It would be prudent for future research to extend the follow-up duration, such as conducting clinical questionnaire surveys 3 months after treatment, to account for patients potentially experiencing recurrent ankle sprains. Lastly, the intervention sites chosen for MNK therapy to release the superficial fascia were based on anatomical foundations and specialized knowledge of superficial fascia, lacking objective, visual techniques to monitor whether MNK therapy precisely targeted the intended superficial fasciae. Future work should utilize technologies such as ultrasonography or histological imaging to aid in accurately directing MNK therapy for the precise release of targeted superficial fascia locations.

Conclusions

The findings of this study showed that MNK therapy, aimed at releasing the superficial fascia, effectively reduced pain levels and enhanced the functionality of the ankle joint in patients with AAS, surpassing the therapeutic efficacy of acupuncture. Future investigations should endeavor to increase the sample size and incorporate additional control groups to further substantiate the superior clinical effectiveness of this intervention.

Data Availability

The data that support the findings of this study are available from the corresponding author upon reasonable request. The Python code used for the study’s statistical analysis has been made available as open-source data at https://github.com/LuSenwei/MNK-for-AAS_code.git.

Figures

Recruitment flowchart.Figure 1. Recruitment flowchart. Operation diagram of micro-needle knife (MNK) therapy for superficial fascia release. (A) Peroneus brevis superficial fascia. (B) Peroneus longus superficial fascia. (C) Superior extensor retinaculum superficial fascia. (D) Peroneus tertius superficial fascia.Figure 2. Operation diagram of micro-needle knife (MNK) therapy for superficial fascia release. (A) Peroneus brevis superficial fascia. (B) Peroneus longus superficial fascia. (C) Superior extensor retinaculum superficial fascia. (D) Peroneus tertius superficial fascia. Operation diagram of acupuncture treatment. GB39 – Gallbladder 39 acupuncture point; BL60 – Bladder 60 acupuncture point; BL40 – Bladder 40 acupuncture point; ST41 – Stomach 41 acupuncture point; KI9 – Kidney 9 acupuncture point; KI6 – Kidney 6 acupuncture point.Figure 3. Operation diagram of acupuncture treatment. GB39 – Gallbladder 39 acupuncture point; BL60 – Bladder 60 acupuncture point; BL40 – Bladder 40 acupuncture point; ST41 – Stomach 41 acupuncture point; KI9 – Kidney 9 acupuncture point; KI6 – Kidney 6 acupuncture point. Comparison of visual analogue scale scores before and after treatment. Paired t test; TP1 – before treatment; TP2 – after treatment; TP3 – follow-up 1 month after treatment. This figure was produced using Python Statistical Software version 3.0 (Python Software Foundation).Figure 4. Comparison of visual analogue scale scores before and after treatment. Paired t test; TP1 – before treatment; TP2 – after treatment; TP3 – follow-up 1 month after treatment. This figure was produced using Python Statistical Software version 3.0 (Python Software Foundation). Comparison of Kofoed ankle scores before and after treatment. Paired t test; TP1 – before treatment; TP2 – after treatment; TP3 – follow-up 1 month after treatment. This figure was produced using Python Statistical Software version 3.0 (Python Software Foundation).Figure 5. Comparison of Kofoed ankle scores before and after treatment. Paired t test; TP1 – before treatment; TP2 – after treatment; TP3 – follow-up 1 month after treatment. This figure was produced using Python Statistical Software version 3.0 (Python Software Foundation). Comparison of 2 groups of visual analogue scale at each time point. 2-sample t test; TP1 – before treatment; TP2 – after treatment; TP3 – follow-up 1 month after treatment. This figure was produced using Python Statistical Software version 3.0 (Python Software Foundation).Figure 6. Comparison of 2 groups of visual analogue scale at each time point. 2-sample t test; TP1 – before treatment; TP2 – after treatment; TP3 – follow-up 1 month after treatment. This figure was produced using Python Statistical Software version 3.0 (Python Software Foundation). Comparison of 2 groups of Kofoed ankle scores at each time point. 2-sample t test; TP1 – before treatment; TP2 – after treatment; TP3 – follow-up 1 month after treatment. This figure was produced using Python Statistical Software version 3.0 (Python Software Foundation).Figure 7. Comparison of 2 groups of Kofoed ankle scores at each time point. 2-sample t test; TP1 – before treatment; TP2 – after treatment; TP3 – follow-up 1 month after treatment. This figure was produced using Python Statistical Software version 3.0 (Python Software Foundation).

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Figures

Figure 1. Recruitment flowchart.Figure 2. Operation diagram of micro-needle knife (MNK) therapy for superficial fascia release. (A) Peroneus brevis superficial fascia. (B) Peroneus longus superficial fascia. (C) Superior extensor retinaculum superficial fascia. (D) Peroneus tertius superficial fascia.Figure 3. Operation diagram of acupuncture treatment. GB39 – Gallbladder 39 acupuncture point; BL60 – Bladder 60 acupuncture point; BL40 – Bladder 40 acupuncture point; ST41 – Stomach 41 acupuncture point; KI9 – Kidney 9 acupuncture point; KI6 – Kidney 6 acupuncture point.Figure 4. Comparison of visual analogue scale scores before and after treatment. Paired t test; TP1 – before treatment; TP2 – after treatment; TP3 – follow-up 1 month after treatment. This figure was produced using Python Statistical Software version 3.0 (Python Software Foundation).Figure 5. Comparison of Kofoed ankle scores before and after treatment. Paired t test; TP1 – before treatment; TP2 – after treatment; TP3 – follow-up 1 month after treatment. This figure was produced using Python Statistical Software version 3.0 (Python Software Foundation).Figure 6. Comparison of 2 groups of visual analogue scale at each time point. 2-sample t test; TP1 – before treatment; TP2 – after treatment; TP3 – follow-up 1 month after treatment. This figure was produced using Python Statistical Software version 3.0 (Python Software Foundation).Figure 7. Comparison of 2 groups of Kofoed ankle scores at each time point. 2-sample t test; TP1 – before treatment; TP2 – after treatment; TP3 – follow-up 1 month after treatment. This figure was produced using Python Statistical Software version 3.0 (Python Software Foundation).

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