- Original Research Article
- Open access
- Published:
Effect of extracorporeal shockwave on gait parameters in patients with plantar fascitis: a randomized controlled trial
Bulletin of Faculty of Physical Therapy volume 29, Article number: 64 (2024)
Abstract
Background
Plantar fasciitis (PF) is the most common cause of heel pain affecting both young active patients and older sedentary individuals. It most often arises as a result of degenerative changes in the proximal plantar fascia.
Aim
The purpose of this study was to investigate the effect of extracorporeal shockwave on gait parameters in patients with plantar fasciitis.
Design
A randomized controlled clinical trial.
Setting
The outpatient physiotherapy clinic of the teaching hospital Shibin El Kom.
Methods
Participants were randomly divided into two equal groups. Group (A) (study group): received extracorporeal shockwave therapy one session per week and traditional treatment (ultrasound, stretching exercises, and strengthening exercises) three sessions per week for 4 weeks. Group (B)(the control group): received traditional treatment (ultrasound, stretching exercises, and strengthening exercises) 3 sessions per week for 4 weeks. The pre- and post-treatment development of the patients was evaluated by visual analog scale (VAS) to measure pain, foot function index (FFI) to measure foot function, and Kinovea software to analyze gait parameters (stride length, stride time, walking speed, and cadence).
Results
Both groups showed improvement in all study variables, but the study group showed more improvement. There was a statistically significant decrease in VAS (p = 0.001), a significant decrease in FFI (p = 0.001), a significant increase in stride length (p = 0.001), a significant decrease in stride time (p = 0.001), a significant increase in walking speed (p = 0.001), and a significant increase in cadence (p = 0.01) post-treatment compared to group (B).
Conclusion
Extracorporeal shockwave treatment is regarded as a useful treatment for improving gait parameters in patients with plantar fasciitis.
Clinical rehabilitation impact
Extracorporeal shockwave therapy improved gait parameters in patients with plantar fasciitis as it increases stride length, walking speed, cadence, and decreases stride time. So, it is recommended to be included in the rehabilitation program for patients with plantar fasciitis and gait disabilities.
Introduction
A persistent musculoskeletal disorder known as plantar fasciitis (PF) or plantar heel pain (PHP) is the most prevalent source of knife-like pain, usually at the fascia's enthesis at the heel’s medial plantar location [1]. It is estimated that 10% of the general population may also suffer from PF, with 83% of patients being employed people between the ages of 25 and 65 [2].
Plantar fasciitis is caused by recurrent strain on the plantar fascia at the calcaneus medial tubercle where it originates. It is the outcome of the plantar fascia’s ongoing overload. Overuse, as observed in obese people (body mass index > 30 kg/m2), sedentary people, and people who stand for extended periods of time may be the cause [3].
In 70% of cases of plantar fasciitis, pain is frequently unilateral and acute. Heel discomfort gets worse when a person bears weight on heels after a long period of rest. People who have plantar fasciitis frequently claim that their symptoms are worse during their initial steps after getting out of bed or after spending long periods of time sitting still. Walking regularly usually helps with symptoms. Though uncommon symptoms such as tingling, numbness, swelling, or radiating pain have been described [4].
Significant reductions in cadence, walking speed, stride length, and stride time are observed in PF patients. Additionally, those with PF who are in the chronic phase or suffer from a non-painful episode may exhibit the antalgic gait adaptation mechanism [5]. To prevent or reduce pain, people with plantar fasciitis (PF) typically move more slowly than people in a healthy state [6].
The absence of walking or other weight-bearing exercises may lead to an increase in body weight, a reduction in muscle strength and flexibility, and a sedentary lifestyle. Treatment for PF is therefore required to maintain quality of life and avoid other potential complications [7].
In the fields of orthopedics and traumatology, extracorporeal shockwave therapy (ESWT) is a non-invasive therapeutic approach used to treat a variety of musculoskeletal conditions. The basic concept underlying this method is the action of shockwaves, which are energetic acoustic waves that propagate quickly through tissues and transfer energy causing therapeutic effects [8].
ESWT may have a reflexive analgesic effect by inducing axon excitability, eliminating unmyelinated sensory fibers, and promoting neovascularization and collagen synthesis in degenerative tissues. According to a number of recent studies, ESWT may cause the creation of nitric oxide, which is essential for inhibiting the inflammatory process [9].
ESWT has been described as a safe and efficient treatment for those with long-term musculoskeletal conditions such as tennis elbow, plantar fasciitis, and chordae tendinitis [10]. As mentioned in the literature people with plantar fasciitis have gait difficulties and to the best of our knowledge, no randomized control trial has been conducted to investigate how extracorporeal shockwave affects gait parameters in plantar fasciitis patients. This encourages us to conduct this study to fill the gap in the literature and help in the rehabilitation program of those patients with plantar fasciitis.
Materials and methods
Sample size
Before the trial began, the G*Power program (version 3.0.10) was used to determine the sample size. The choice was F-test MANOVA within and between interaction effects. Taking into consideration a power of 0.80, an α level of 0.05 (2-tailed), and an effect size of 0.4; with two groups and two numbers of measures, for this investigation, a minimum sample size of about 42 participants was recommended. A 20% increase in the recommended sample size was made to account for the drop-off, resulting in 52 patients making up the study sample.
Randomization
The subjects were randomized into two groups using a computer-generated randomization block. The four and eight-block sizes were chosen to prevent bias and guarantee group balance. The randomization codes were kept in opaque, sealed envelopes with sequential numbers to guarantee the allocation’s security. The opaque, sealed package was opened by the researcher, who was blinded before giving the treatment. A randomized strategy was applied by the blinded researcher, who was not involved in the data collection process.
The data was collected by the blinded researcher without their knowledge of the allocation stage. After that, the blinded researcher examined and interpreted the information. This research trial's flow chart is shown in (Fig. 1). Fifty-two participants were recruited and randomly assigned to two groups (A and B), with 26 participants in each group. Ten participants were excluded from the study because they did not meet the inclusion criteria.
Participants
A single-blinded randomized controlled clinical trial was followed. This trial, which was conducted at the physical therapy clinic of the Shibin El Kom teaching hospital from September 29th, 2023, to March 3rd, 2024, involved 52 female patients between the ages of 18 and 40 years.
Participants who met the study’s inclusion criteria were female patients with unilateral chronic plantar fasciitis lasting longer than 3 months, BMI of 18 to 25 kg/m2, pain in the morning or after prolonged sitting, localized discomfort at the heel's fascia attachment point that worsens after prolonged walking or standing for more than 15 min, a history of 6 months of trying but failing with conservative treatment, and at least 4 weeks without therapy before referral.
Individuals who were receiving other therapies that would have an impact on the results, like plantar fasciitis medication or other types of physical therapy, were not allowed to participate in the study. In addition, those with bilateral plantar fasciitis, patients who were taking part in any other interventional clinical research trial, those with foot or ankle dysfunction (such as instability), patients with foot arthrosis or foot arthritis, patients with cancer or infections affecting the lower extremities, anomalies of the nervous system and trapping of nerves (tarsal tunnel syndrome, for example), abnormalities of the veins (such as significant varicosities or persistent ischemia), surgical intervention for heel spur, anticoagulant medication, diabetes, pregnancy, trauma, prior surgery, inflammatory diseases, and rheumatoid arthritis patients were also excluded.
Outcome measures
The outcomes of the study were collected 4 weeks after the intervention and before the treatment program began. The outcome measurements included gait parameters measured by Kinovea software, foot function determined by foot function index (FFI), and pain intensity measured by visual analog scale (VAS).
Assessment of pain
Visual analog scale (VAS) is one instrument used to measure pain levels. It is a reliable and valid clinical pain evaluation measure. It is frequently used to assess the frequency or severity of particular symptoms in epidemiologic and clinical research. VAS is a straight horizontal line with a predetermined length, often measuring 100 mm. It measures the amount of pain that a patient feels which ranges across a continuum from none reflecting no pain (0 mm) to an extreme amount of pain (100 mm) [11].
Assessment of foot function
To assess foot function regarding pain, disability, and activity restriction, a valid and reliable Egyptian Arabic version of FFI was used [12].
Assessment of gait parameters
Parameters of gait (stride length, stride time, walking speed, and cadence) were measured using the free 2D motion analysis Kinovea program. Kinovea software is a valid, reliable, accessible, affordable, and free program that is used to assess gait parameters [13] (Fig. 2).
Procedures
Assessment
-
➢
The study was conducted at Shibin El Kom teaching hospital. Each patient was requested to fill out an informed consent form. An explanation of the study and a study number were provided to each participant.
-
➢
Each patient provided the following information: name, age, sex, height, weight, BMI, and occupation.
Assessment of pain intensity
For assessment of pain, the patient was asked to mark points on the VAS continuum to indicate the degree of pain, and the distance measured from zero end to 100 mm end to reflect the pain severity [14].
No pain (0–4 mm), mild pain (5–44 mm), moderate pain (45–74 mm), and severe pain (75–100 mm). Pain intensity was categorized by VAS values as none, mild, moderate, or severe [11].
Assessment of foot function
The 23 self-reported components of the FFI are divided into three subcategories: activity, disability, and pain, based on patient values. The participants were asked to rate their foot’s discomfort and difficulty on a scale of 0 (no pain or difficulty) to 10 (worst pain imaginable or so bad it demands help) for each question [12].
Nine items in the disability subcategory evaluate how difficult it is to carry out various functional tasks because of foot problems such as climbing stairs. The five items in the activity limitation subcategory indicate activities that are restricted due to foot problems such as spending the entire day in bed. Higher ratings indicate worse pain. The scores are recorded using the visual analog scale (VAS), which has a range of 0 to 100 mm [12].
The patient was asked to determine how much each item represented her foot function on a scale ranging from 0 (no pain or difficulty) to 10 (worst pain imaginable or so severe it required help) [12].
Assessment of gait parameters
Kinovea software was used to assess spatiotemporal gait parameters (stride length, stride time, walking speed, and cadence).
Study setting
The study area was a five-meter-long hallway in a simulated laboratory. Important sites, including the camera position, the start and end points for walking, etc., were marked with signs and markers. This aimed to ensure that, on the day and at any time throughout the capture, every subject was in the same posture. The stride was recorded using a high-speed digital video camera (Sony HXRNX5U NXCAM; Sony Corp., Minato, Tokyo, Japan) [13] (Fig. 3).
Parameters and experimental protocol
The camera was positioned on a level tripod, perpendicular to the pathway’s center, at a distance of 2.43 m (8 ft.) and roughly 0.3048 m (1 ft) above the floor for the preset field of view, and this proved to be the ideal camera position and angle (Fig. 4). With this configuration, the subject’s lower leg was covered by the calibration region [13].
Experimental protocol
Every participant received spoken instructions and a thorough description of the study’s objectives and methodology as previously indicated in [13] (Fig. 2).
A marker was applied to the lower limb at the pre-determined location. The foot’s lateral malleolus received a reflective marking application. It is significant to remember that, despite the fact that the Sony Camera-Kinovea system is thought of as a marker-less motion capture system, the markers offer a useful focal point when motion tracking (or playing back videos) is being done using Kinovea. All subjects were instructed to walk on the predetermined track at their usual pace [13] (Fig. 3).
Five repetitions of the walking procedure were conducted and a Sony camera was used to record the action while concentrating on the gait. Generally speaking, for a single person, the entire experiment, including the placement of the markings, took about 20 min [13].
Motion tracking (video analysis)
All videos from the Sony video camera were recovered using a freeware motion analysis program called Kinovea (version 0.9.5), which is an open-source program. To check for any obvious errors, all of the recorded videos were first downloaded to a computer and then played backward. Moreover, low-quality captures were discarded. The primary marker for each approved video was identified and tracked using Kinovea throughout the entire recording, including the walking stride (Fig. 5).
The necessary locations of the walking surfaces such as the beginning point and midpoint were highlighted on the software using various tools. To adjust for the beginning and fatigue, the first and last phases of the gait were not analyzed. As a result, only the intermediate (2–4) cycles needed to be examined. The gait spatiotemporal parameters (stride length, stride time, walking speed, and cadence) were measured and recorded using the software capabilities after the program completed the video tracking. They were then exported using the command “Export to spreadsheet” (Fig. 6).
Interventions
The study group (A) received extracorporeal shock wave therapy once a week for 4 weeks, along with three sessions of conventional treatment (ultrasound, stretching exercises, and strengthening exercises) for plantar fasciitis. Conversely, the control group (B) received three weekly sessions of traditional treatment, which included stretching exercises, strengthening exercises, and ultrasound.
Extracorporeal shockwave therapy
The therapist placed the patient in the prone position and found the point of greatest tenderness. The treatment area was prepped using coupling gel to minimize shockwave therapy loss at the skin-applicator tip interface. For 4 weeks, each patient received 2000 impulses, 3 bar energy, and a 15-mm depth applicator at a frequency of 10 Hz per session [15] (Fig. 7).
Ultrasound
For 5 min, participants received treatment with therapeutic ultrasound at a frequency of one MHz and continuous current at a pulse intensity of 1.8 W/cm2. The therapist adjusted the intensity when the patient was injured during the process due to excessive sensitivity [16] (Fig. 8).
Stretching exercises
Pain and soreness in the muscles can be alleviated by stretching the calf muscles. Prior to stretching, each participant was advised to take a warm bath or a few minutes of cardiovascular exercise [17, 18].
Heel raise
The patient was instructed to place the balls of her feet on the bottom of the step edge. Gently and slowly, the patient was advised to descend her heels just below the step edge, leaving them hanging over the edge. Her calf muscles might feel stretched. Then the patient ascended gradually onto her balls of feet. This exercise was repeated ten times for two sets once a day [19] Fig. 9 (A and B).
Toe towel scrunches
The patient was instructed to spread her toes and stand upright with one foot supported by a towel ten times, curl her toes into a scrunch, and then pull the towel toward her. This exercise was performed for two sets once a day [19] Fig. 10 (A and B).
Seated plantar fascia stretch
The patient was instructed to sit in a chair with her ankle resting on top of her other leg by crossing one leg over the other knee. Using one hand to support her ankle and the other to grasp her toes, gradually, she pulled her toes back until she felt a stretch in the bottom of her foot. The patient was instructed to maintain this posture for 20 s, then switch to both feet and repeat three times. This workout was performed once a day [19] (Fig. 11).
Wall-facing calf stretch
The patient was instructed to place her hands flat on the wall while standing erect and facing an arm’s length away from her. With both feet flat on the floor, the patient was instructed to bend her front leg straight backward until she felt a stretch in her calf for 20 s. This workout was repeated three times once a day [19] (Fig. 12).
Strengthening exercises
Many muscles such as the toe flexors (flexor hallucis longus and brevis, flexor digitorum longus, and brevis), ankle evertors (peroneus brevis and longus), and intrinsic and extrinsic foot muscles were weak in patients with plantar fasciitis [20].
The exercises included in the strengthening program were heel raises, toe curls, ankle invertor exercises, and ankle evertors. The physical therapist assessed the beginning point of each exercise after assessing each participant’s degree of performance [21] (Figs. 13 (A and B), 14 (A and B), 15, 16, and 17).
Statistical analysis
The Shapiro–Wilk test was used to determine whether the data was normally distributed. Levene’s test for homogeneity of variances was applied to assess the homogeneity between groups. Using the unpaired t-test, subject characteristics were compared between groups. Mixed MANOVA was utilized to determine the effect of the therapy on VAS, FFI, stride length, stride time, walking speed, and cadence. Later on, additional comparisons were conducted using post-hoc testing and the Bonferroni adjustment. At a significance threshold of p < 0.05, all statistical tests were performed. All statistical analysis was performed using IBM SPSS, Chicago, IL, USA’s version 25 of the statistical software for social research (SPSS).
Results
Subject characteristics
Table 1 presents the subject characteristics of both groups (A) and (B). There were no statistically significant differences in age, weight, height, or BMI between the groups (p > 0.05).
Effect of treatment on VAS, FFI, stride length, stride time, walking speed, and cadence
Using mixed MANOVA, it was possible to find a statistically significant interaction effect between treatment and time (F = 48.38, p = 0.001, and partial eta squared = 0.86). A statistically significant main effect of time was found (F = 901.58, p = 0.001, and partial eta squared = 0.99). A statistically significant main impact was seen with treatment (F = 30.72, p = 0.001, and partial eta squared = 0.79).
Within group comparison
Following therapy, both groups’ VAS and FFI showed a statistically significant decrease from the starting point (p > 0.001). After treatment, there was a statistically significant increase in stride length, walking speed, and cadence in both groups compared to pretreatment and a statistically significant decrease in stride time (p < 0.001) (Table 2).
Between-group comparison
There was no statistically significant difference (p > 0.05) between the groups before treatment. Following the treatment, a comparison of the groups showed that group (A) had a statistically significant drop in VAS, FFI, and stride time and significantly increased stride length, walking speed, and cadence compared to group (B) (p < 0.01) (Table 2).
Discussion
ESWT is a safe and effective treatment for individuals suffering from chronic musculoskeletal conditions like tennis elbow, plantar fasciitis, and chordae tendinitis. Patients with plantar fasciitis have heel pain which affects function and pattern of gait leading to a significant decrease in stride length, stride time, walking speed, and cadence [10]. Additionally, the antalgic gait adaptation mechanism can be seen in people with PF who are in the chronic phase or are experiencing a pain-free period [5]. To prevent or reduce pain, people with PF typically move more slowly than people in good health [6]. This study was conducted to examine the effect of extracorporeal shockwave therapy on gait parameters (stride length, stride time, walking speed, and cadence) in patients with plantar fasciitis.
According to the study findings, there was a statistically significant difference in both groups regarding pain intensity, foot function, and gait parameters (stride length, stride time, walking speed, and cadence) with the superiority for the study group that received both extracorporeal shock wave therapy and conventional treatment (US, stretching exercises, and strengthening exercises). Following the treatment, a comparison of the groups showed that group A had a more statistically significant decrease in VAS (p = 0.001), FFI (p = 0.001), and stride time (p = 0.001), and a more statistically significant increase in stride length (p = 0.001), walking speed, and cadence (p = 0.01) than group (B). This could be due to the fact that extracorporeal shock wave therapy (ESWT) passes through muscle and adipose tissue and releases energy at the boundary of the bone causing a therapeutic effect [22]. Additionally, ESWT may cause a reflexive analgesic effect by eliminating unmyelinated sensory fibers and increasing axon excitability [23].
Nitric oxide generation is crucial for inhibiting the inflammatory process, and it may be induced by ESWT [24]. For individuals with plantar fasciitis, ESWT may be a significant alternative to current treatment options in terms of improving gait parameters, which may enhance patients’ quality of life and gait patterns [10]. The experimental findings confirm that ESWT decreases the expression of high levels of inflammatory mediators (matrix metalloproteinases and interleukins). Consequently, ESWT has a tissue-repairing and regenerative effect on musculoskeletal tissues [25]. As a result of the analgesic and inflammatory effects of extracorporeal shock wave, the level of pain decreases and therefore foot function improves leading to enhancement of gait pattern in patients with plantar fasciitis.
The results of our study matched with a study conducted by Krishnan A et al. [26], who examined the therapeutic effects of extracorporeal shockwave therapy in resistant plantar fasciitis. They concluded that the average VAS scores were significantly decreased suggesting that plantar fasciitis can be successfully treated with ESWT, there were no serious adverse effects, and none of the patients needed further shock wave therapy or any other type of medical intervention.
The findings of this investigation agreed with a previous study conducted by Fariba Eslamian et al. [23], who examined the effect of extracorporeal shock wave therapy versus local corticosteroid injection in the treatment of chronic plantar fasciitis. They found that patients who received sessions of ESWT or single steroid injection had changes in the VAS scores in the morning and during the day and the FFI throughout the study period was significant in both groups. The ESWT group showed more improvement in FFI and a greater decrease in VAS in the morning. Additionally, Dastgir N [27] examined the effectiveness of extracorporeal shockwave therapy for treating plantar fasciitis and found a significant improvement in both pain and functional scores, as well as a significant decrease in pain on the visual analog scale. Also, there was a noticeable increase in comfortable walking distance. Also, Yoo SD et al. [5] conducted a study using a gait analysis system with a pressure sensor to analyze biomechanical factors in plantar fasciitis, which aligned with our study findings. They discovered that during arch-building gait, the subjects with unilateral PF had significantly decreased foot rotation, step length, and step time. These measurements were made using the Zebris gait analysis system, which provided numerical data for kinetic and kinematic gait parameters. Similar to our investigation, Akınoğlu B and Köse N [28] studied a comparison of the acute effects of extracorporeal shockwave therapy, ultrasound therapy, and exercise therapy on plantar fasciitis. They found that pain and fatigue levels decreased following the therapies in groups, which were measured by a visual analog scale and a 6-min walking test, respectively. They also found that heel rise test scores increased, which was assessed by the 6-min walking test. The 20-m walking speed increased in the US and ESWT groups following the therapies and there was no difference found in the exercise therapy group. So, the study showed that the combination of exercise therapy, ESWT, and US was an effective way to reduce pain and enhance walking distance, walking speed, and foot function.
In the same line, Kai Sun et al. [29], investigated the effect of extracorporeal shock wave therapy versus other therapeutic methods for chronic plantar fasciitis. According to their findings, individuals treated with ESWT responded better than those treated with other therapies, had fewer problems, and had better success or improvement rates in the modified Roles and Maudsley (RM) score. Also, they found a reduction in pain scales, a return-to-work time, and fewer complications than the other therapeutic methods. On the other hand, Grecco MV et al. [30], conducted a follow-up study to examine the effect of shockwave versus conventional physiotherapy. According to their findings, morning pain measured using VAS before the treatment showed scores greater than or equal to 5 for all the patients. After the treatment, 33 of all 40 patients had VAS scores of less than 2, showing that both treatments were effective for pain reduction. They found that shockwave therapy was not more helpful than traditional physiotherapy in terms of reducing pain and enhancing functional abilities in patients with plantar fasciitis.
Limitation
The current study has some limitations, even though it presents objective data with statistically significant differences; the study included only female patients, and the sample size was small. So, further studies are needed to be conducted on both gender and larger sample sizes. Also, more studies are done to find out the long-term impact of extracorporeal shock wave therapy on gait characteristics in individuals with plantar fasciitis.
Conclusion
Extracorporeal shock wave therapy has a noticeable significant effect on pain level, foot function, and gait parameters including cadence, walking speed, stride length, and stride time in patients with plantar fasciitis.
Availability of data and materials
Upon a reasonable request, the datasets used and/or analyzed for this study may be obtained from the corresponding author.
Abbreviations
- ESWT:
-
Extracorporeal shock wave therapy
- FFI:
-
Foot function index
- PF:
-
Plantar fasciitis
- US:
-
Ultrasound
- VAS:
-
Visual analog scale
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AMS and SAA had a hand in the article’s conception or creation. The data for the article was acquired, analyzed, and/or interpreted in part by AMS, SAA, ASD, and EME. AMS, SAA, and EME wrote the article or made significant critical revisions for intellectual content. The authors have read and approved the final manuscript.
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The study was accepted by the Research Ethics Committee of Cairo University’s Faculty of Physical Therapy, and it was given a unique ethical number (P.T.REC/012/004468). An additional unique number comes from the Clinical Trials Registry, which is designated by the Registry ID: NCT06310122.
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Saleh, A.M., ELNaggar, E.M., El Sayed, A.S. et al. Effect of extracorporeal shockwave on gait parameters in patients with plantar fascitis: a randomized controlled trial. Bull Fac Phys Ther 29, 64 (2024). https://doi.org/10.1186/s43161-024-00227-1
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DOI: https://doi.org/10.1186/s43161-024-00227-1