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Abstract

Objective:

Determine if adding an acupuncture protocol with electrostimulation to a standard exercise program improves pain and function in adult patients with plantar fasciopathy more than a standard exercise program alone.

Intervention:

In this randomized, multisite controlled study, patients were randomized to either receive a local electroacupuncture protocol plus home exercise program or a home exercise program alone. Acupuncture treatments were performed every 2 weeks for 6 weeks with a 6-week follow-up for a total study period of 12 weeks. The home exercise program included stretching and strengthening exercises over a 5-week period.

Main Outcome and Measure:

The primary outcome was change in the patients’ reported Defense and Veterans Pain Rating Scale (DVPRS) scores. The secondary outcome was change in the Revised Foot Function Index–Revised (FFI-R) Short Form questionnaire.

Results:

Seventy-two subjects were enrolled, with 37 randomized into the acupuncture plus exercise group (58 feet) and 35 randomized into the exercise group alone (59 feet). Demographics were similar between the two groups. Significantly stronger declines over time were observed in the intervention group for both DVPRS pain scores (12 week decline of 2.17 compared with 1.62 in the comparison group, interaction coefficient of −0.07, 95% confidence interval [CI]: −0.13, −0.01) and FFI-R scores (12 week decline of 19.5 compared with 12.9 in the comparison group, interaction coefficient of −0.65, 95% CI: −1.20, −0.10). Overall, 23 out of 25 subjects in the acupuncture plus exercise group reported that they were satisfied with their acupuncture treatment.

Conclusions and Relevance:

Acupuncture with electrostimulation plus prescribed exercise decreases pain and improves function in both the short and long term in adult patients with plantar fasciopathy, more than exercise alone. These findings add to evidence that acupuncture is an important adjunctive treatment option in the management of common outpatient clinic problems.

Trial Registration: NCT04243343.

Keywords

plantar fasciitis acupuncture electroacupuncture

CME available online at www.medicalacupuncture.org/cme Questions on page 52.

INTRODUCTION

Plantar fasciopathy is a common condition that affects the heel and sole of the foot, significantly impacting quality of life, functionality, and ability to return to work or sports. About 10% of the general population will experience plantar fasciopathy at some point, more in physically active populations, such as active military members and athletes.^1–4 The primary symptom is pain in the heel and sole of the foot. The pain can be severe with initial steps upon waking or after a period of rest and can limit physical activity, thereby negatively impacting quality of life. The condition is caused by degeneration of the plantar fascia, a thick band of connective tissue that runs along the bottom of the foot from the heel to the toes. Overuse, injury, and improper foot mechanics can all contribute to the development of plantar fasciopathy.^2,4,5 A physical examination will demonstrate pain with palpation of the medial calcaneal tubercle, the site of the plantar fascia origin.²

Although plantar fasciopathy will generally resolve within 6–12 months without interventions, it can impact quality of life and physical function during a period of prolonged symptoms.^2,4,5 Management of plantar fasciopathy focuses on stretching and strengthening of the associated structures to include the plantar fascia and gastroc-soleus complex.^6,7 However, typical mechanical rehabilitation protocols often take weeks or months to provide clinically meaningful relief. Support for adjunctive modalities is limited, given that most studies are performed in conjunction with other treatments, and there is no clear evidence to support one treatment modality over the other.⁸ Even treatments as simple and widespread as foot orthoses and night splints show no real benefit to plantar fasciopathy resolution.^6,9 There is evidence supporting the use of injection therapies such as dehydrated amniotic membrane, corticosteroid, platelet-rich plasma, and OnabotulinumtoxinA (BOTOX), but these have limited availability, often offer only short-term relief, and are costly.^7,10,11

Acupuncture is a promising nonpharmacologic treatment approach for plantar fasciopathy.^12–14 Acupuncture has been proven to reduce pain acutely in plantar fasciopathy, but there is a knowledge gap in terms of specific acupuncture points used in treatment, as well as uniformity of research and long-term effectiveness.^12,15,16 Previous studies utilized daily acupuncture therapies lasting 30 min, making these treatments more difficult to perform in the primary care setting.^13,17

Given the potential benefits of acupuncture for plantar fasciopathy, there is a need for rigorous studies to investigate the efficacy of acupuncture and to develop evidence-based treatment protocols that can be implemented in primary care settings.

METHODS

This study was approved by the Wilford Hall Ambulatory Surgical Center’s Institutional Review Board as FWH20200060H on March 24, 2020. Written consent was obtained from subjects. All study personnel performing the acupuncture procedure were allopathic or osteopathic family physicians with 200–300 h of training in medical acupuncture and were practicing medical acupuncturists.

Randomization and Masking

The aim of this study was to determine if the addition of a specific acupuncture protocol, with electrostimulation, to a standard exercise program is more effective at improving pain and function in adult patients with plantar fasciosis than a standard exercise program alone. This was a randomized, nonblinded, multisite controlled study of active duty and Department of Defense (DoD) beneficiaries, 18 years or older, with a diagnosis of plantar fasciosis. A designated research coordinator, otherwise uninvolved in the study, tracked and implemented randomization using a random number generator with blocks of 6, informing study coordinators and investigators of subject allocation after a subject signed written informed consent. Patients were randomized to either receive a deep ankle local acupuncture protocol along with a home exercise program versus a home exercise program alone.

Demographic characteristics, including gender, ethnicity, foot injury history, and prior acupuncture treatments, were recorded. Acupuncture treatments were performed every 2 weeks for 6 weeks (four treatments) by 11 medical acupuncturists, followed by a 6-week follow-up period for a total of a 12-week study period. The home exercise program included daily stretching and every other day strengthening exercises over a 6-week period.

Acupuncture Protocol

The Deep Ankle Local Protocol points (Fig. 1) were used as the treatment points. The rationale for this treatment was based on the clinical experience of the authors. Deep Ankle Local Protocol points are based on specific acupuncture points as taught in the Helms Medical Institute’s Medical Acupuncture for Physicians course. Of note, two points in the protocol include a single apostrophe after the numbered location. In the training course noted above, this is referred to as “prime,” for example, gallbladder 39 prime. These are points specific to that training course and are described in detail below.¹⁸ Gallbladder (GB)-39 is located on the lateral side of the leg 3 cun (in traditional acupuncture one cun is equal to the width of the subjects thumb at the knuckle, usually 1.5–2.0 cm) superior to the most prominent part of the lateral malleolus in a depression between the posterior border of the fibula and the tendons of peroneus muscles. Bladder (BL) 62′ is located on the lateral side of the foot in line with the tip of the lateral malleolus, just anterior to the lateral process of the tuberosity of the calcaneus, at the dorsal–plantar skin junction. Spleen (SP) 6 is located on the medial side of the leg, posterior to the medial margin of the tibia, in a notch 3 cuns above the medial malleolus prominence. Kidney (KI) 6′ is located on the medial side of the foot, directly inferior to the distal tip of the medial malleolus, in a depression at the dorsal–plantar skin junction, just below the lower border of the calcaneus. The needles used were Seirin® and Hwato® 40–75 mm acupuncture needles. A total of four needles were inserted in the affected foot in the locations corresponding to GB 39, BL 62′, SP 6, and KI 6′. Needles inserted at BL 62′ and KI 6′ were placed at a depth as close to the plantar fascia as possible. The needles were connected with electrostimulation leads from the ITO® ES-130 3 channel electrostimulation unit, with GB 39 (positive electrode) attached to KI 6′ (negative electrode) and SP 6 (positive electrode) attached to BL 62′ (negative electrode) (Fig. 1). A frequency of 30 Hz was run at an intensity as directed by patient tolerance for a total of 20 min.

FIG. 1.

Deep Ankle Protocol. (1) The needles used were Seirin® and Hwato® 40–75 mm. A total of four needles were inserted (as shown below) in the locations corresponding to GB 39, BL 62′, SP 6, and KI 6′. Needles inserted at BL 62′ and KI 6′ were placed at a depth as close to the plantar fascia as possible. (2) The needles were connected with electrostimulation leads, with GB 39 attached to KI 6′ and SP 6 attached to BL 62′ (see below diagram showing that the electricity from the leads crossed over the ankle from BL 62′ to SP6 and KI 6′ to GB 39). (3) The electrostimulation device was set to a frequency of 30 Hz, and the intensity of the stimulation was gradually increased to a level tolerable by the patient. (4) The treatment ran for a total of 20 min. (5) The needles were removed after the treatment was complete. GB, gallbladder; BL, bladder; SP, spleen; KI, kidney.

Home Exercise Program

The standard of care prescribed home exercise program was a combination of stretching and strengthening exercises that patients were asked to perform and was based on an evidence-based plantar fasciitis-specific high-load training program.⁵ Two stretching exercises were prescribed three times daily for 6 weeks (holding each stretch for 30–60 s). The strengthening exercises were prescribed every other day (three sets of 12 reps). A research coordinator distributed a handout to subjects that contained instructions, descriptions, figures, and photos of the stretches and exercises. Subjects were also asked to demonstrate the stretches and exercises to ensure understanding. Subjects were given a diary to record adherence to the exercises.

Inclusion/Exclusion

Subjects were recruited from three Air Force military treatment facilities at Nellis, Scott, and Eglin Air Force Bases. Inclusion criteria were male and female active-duty members and DoD beneficiaries, aged 18–74 years, diagnosed with plantar fasciosis (in one or both of their feet) or subjects meeting criteria of pain in the bottom of the foot or heel with first steps in the morning and tenderness to palpation over the medial calcaneal tubercle (where the plantar fascia inserts). Patients who were pregnant were excluded. Other exclusions were active cellulitis of the lower extremity, prior surgery for plantar fasciosis, steroid injections within 12 weeks of the study for plantar fasciosis, any prior acupuncture for plantar fasciosis using the defined Deep Ankle Local points, any regenerative therapy to include proliferation therapy or platelet-rich plasma therapy within 12 weeks of the study for plantar fasciosis, or botulinum toxin injections for plantar fasciosis within 12 weeks of the study for plantar fasciosis.

Outcome Measures

The primary outcome was change in the patients’ reported Defense and Veterans Pain Rating Scale (DVPRS) scores. The DVPRS is a validated 11-point (0–10) Visual Analog Pain Scale (VAS) routinely used in the Veterans Affairs and DoD health care systems.¹⁷ Each pain level is associated with cartoon facial expressions and a written description of the pain level to ensure consistency across visits (e.g., pain level 4 is described as “distracts me, can do usual activities”). Higher scores indicate worse pain. Pre- and posttreatment DVPRS scores for individual study visits were only obtained for acupuncture subjects, whereas a single DVPRS score was obtained at each visit for the exercise-only group.

The secondary outcome was change in the Revised Foot Function Index–Revised (FFI-R) Short Form questionnaire, which is a 34-item self-reported foot function questionnaire that addresses function based on pain level, stiffness, difficulty, activity limitation, and social issues.¹⁹ Higher scores indicate worse symptoms.

STATISTICAL ANALYSIS

The treatment (exercise plus acupuncture) and comparison (exercise only) groups were described and compared with respect to sociodemographic attributes, foot injury history, DVPRS (baseline pain) and FFI-R (function), standard care adherence, and exclusion from comparative analyses. Sociodemographic variables assessed included age, height, weight, body mass index (BMI), gender, and race/ethnicity. Standard care (exercise) adherence was assessed using continuous variables for the total number of exercises performed, the number of stretches performed, and the number of strengthening exercises performed. Descriptive analyses included numbers/percents for categorical variables and means/standard deviations for continuous variables. Statistical testing for differences between the intervention and comparison groups was conducted using chi-square test for categorical variables and t-test for continuous variables.

In the assessment of changes in DVPRS and FFI-R over time, feet were excluded if the baseline value was missing and/or if there were no follow-up measures. The mean outcomes for each time point were described by treatment group, and the mean change in score was calculated as compared with baseline. DVPRS and FFI-R over time by group were plotted. Differential changes in DVPRS and FFI-R were assessed using multivariable random-effects regression models with random intercepts to account for the lack of independence of data within patients for whom both feet were assessed and repeated measurements over time. Models included a term for treatment group, weeks postbaseline, and an interaction between those variables. The interaction term is used to assess differential changes over time by treatment group. Candidate covariates for model adjustment included age, gender, race/ethnicity, BMI, and a history of foot injury. Final models were selected by assessing Akaike information criterion (AIC) for each possible model and using the model with the best fit (i.e., the lowest AIC). The final model for DVPRS was adjusted for race/ethnicity and BMI. The final model for FFI-R was adjusted for gender, race/ethnicity, BMI, and history of foot injury.

A priori power analysis for DVPRS indicated a minimum of 28 subjects in each treatment group, for a total sample size of 56, would have a power of 0.80 to detect the minimal clinically important difference at alpha = 0.05. Using FFI-R indicated a minimum of 28 subjects in each treatment group, for a total sample size of 56, would have a power of 0.81 to detect the minimal clinically important difference at alpha = 0.05. We recruited a total of 72 subjects, which was inclusive of a 30% dropout rate.

RESULTS

Of the 72 people enrolled in the study, 37 (58 feet) were assigned to the treatment group, and 35 (59 feet) were assigned to the comparison group (Fig. 2). Twenty-one of the treatment group participants and 24 of the comparison group participants reported data for both feet. Seven feet in the treatment group were excluded from analysis due to having only baseline data. Thirteen (for FFI-R) and 15 (for DVPRS) feet were excluded from the comparison group due to having only baseline data or missing baseline data (Fig. 2).

FIG. 2.

Participant enrollment, group allocation, and exclusions.

No differences in sociodemographic, foot injury history, baseline DVPRS or FFI-R, standard care adherence, or exclusions from analysis were observed when comparing the treatment and comparison groups (all p-values were 0.1276 and higher, Table 1). Mean changes in DVPRS at 12 weeks as compared with baseline were −2.17 in the treatment group and −1.62 in the comparison group (Table 2, Fig. 3). Mean changes in FFI-R at 12 weeks as compared with baseline were −19.5 in the treatment group and −12.9 in the comparison group (Table 2, Fig. 4). The intervention group reported greater decline than the comparison group (Table 3) in DVPRS (regression coefficient −0.07, 95% CI: −0.13 to −0.01, p = .0250) and FFI-R (regression coefficient −0.65, 95% CI: −1.20 to −0.10, p = 0.0202).

Table 1.

Sociodemographic Attributes, Baseline Defense and Veterans Pain Rating Scale (Pain) and Foot Function Index–Revised (Function), Exercise Adherence, and Exclusion from Analysis by Study Group, All Participants (n = 72 People)

	Acupuncture + exercise	Exercise only	p-value^*
Sociodemographic attributes and injury history
Age, mean (SD)	46.2 (11.9)	46.1 (10.8)	0.9702
Height, mean (SD)	66.8 (6.8)	66.6 (3.7)	0.8862
Weight, mean (SD)	197.9 (37.2)	186.9 (35.1)	0.2039
BMI, mean (SD)	30.4 (5.7)	29.5 (4.5)	0.4666
Gender, N (%)
Female	16 (43.2%)	18 (51.4%)	0.6461
Male	21 (56.8%)	17 (48.6%)	0.6461
Race/ethnicity, N (%)
Asian	2 (5.4%)	2 (5.7%)	0.7784
Black/African American	9 (24.3%)	10 (28.6%)
Hispanic, Latin, or Mediterranean	4 (10.8%)	1 (2.9%)
Pacific Islander/American Indian/Alaskan Native	1 (2.7%)	1 (2.9%)
White	20 (54.1%)	18 (51.4%)
Other/undefined	0	1 (2.9%)
Missing	1 (2.7%)	2 (5.7%)
Foot injury history, N (%)	11 (29.7%)	9 (25.7%)	0.9069
Baseline pain and function
Pain score/DVPRS, mean (SD)	4.1 (1.7)	4.8 (1.8)	0.1374
Function/FFI-R, mean (SD)	66.2 (17.6)	72.3 (16.1)	0.1276
Standard care (exercise) adherence
Total number of exercises performed, mean (SD)	150.4 (96.0)	139.6 (87.6)	0.6504
Number of stretches performed, mean (SD)	99.5 (63.2)	92.3 (59.1)	0.6483
Number of strengthening exercises performed, mean (SD)	50.9 (37.4)	47.3 (31.2)	0.6900
Exclusion from analysis
DVPRS	4 (10.8%)	8 (22.9%)	0.2917
FFI-R	4 (10.8%)	7 (20.0%)	0.4499

p-value calculated by Welch’s two-sample t-test for continuous outcomes and Pearson’s chi-square test for categorical variables.

DVPRS, Defense and Veterans Pain Rating Scale; FFI-R, Foot Function Index–Revised; SD, standard deviation.

Table 2.

Descriptive Statistics for Defense and Veterans Pain Rating Scale (Pain) and Foot Function Index–Revised (Function) Scores by Time Point and Study Group

	Baseline	2 weeks	4 weeks	6 weeks	12 weeks
DVPRS, acupuncture + exercise
Mean (SD)	4.37 (1.75)	4.06 (1.55)	3.09 (1.56)	2.87 (1.56)	2.15 (1.90)
Mean change in score		−0.31	−1.24	−1.46	−2.17
DVPRS, exercise only
Mean (SD)	4.50 (1.85)	3.98 (2.28)	3.90 (2.31)	3.58 (2.06)	3.08 (2.19)
Mean change in score		−0.52	−0.74	−0.97	−1.62
FFI-R, acupuncture + exercise
Mean (SD)	70.08 (16.76)	64.39 (19.17)	57.94 (17.05)	56.48 (16.71)	52.11 (19.01)
Mean change in score		−5.7	−13.3	−15.2	−19.5
FFI-R, exercise only
Mean (SD)	70.41 (18.50)	64.57 (18.75)	61.29 (22.37)	64.32 (21.61)	58.36 (18.22)
Mean change in score		−5.8	−9.5	−6.3	−12.9

FIG. 3.

Mean pain scores (Defense and Veterans Pain Rating Scale) by time point and study group, n = 95 feet. Note: The second data value at each interval (baseline, 2 weeks, 6 weeks, and 12 weeks) for the exercise plus acupuncture group shows values immediately posttreatment.

FIG. 4.

Mean function scores (Foot Function Index–Revised) by time point and study group, n = 97 feet.

Table 3.

Assessment of Differential Trends in Pain and Function Scores by Study Group Over Time

	Regression coefficient (95% CI)	p-value
DVPRS
Weeks postbaseline	−0.13 (−0.17, −0.08)	<0.0001
Exercise + acupuncture (reference = exercise only)	−0.27 (−1.17, 0.62)	0.5428
Interaction between time and exercise + acupuncture	−0.07 (−0.13, −0.01)	0.0250
FFI-R
Time (weeks)	−0.94 (−1.33, −0.55)	<0.0001
Exercise + acupuncture (reference = exercise only)	−4.26 (−13.82, 5.30)	0.3752
Interaction between time and exercise + acupuncture	−0.65 (−1.20, −0.10)	0.0202

Sample size for DVPRS n = 87 (exercise + acupuncture n = 47, exercise only n = 40); sample size for FFI-R n = 89 (exercise + acupuncture n = 47, exercise only n = 42); regression coefficients and p-values from a random-effects regression model assessing the trend in DVPRS/FFI-R scores over the course of either standard treatment (exercise only) or acupuncture in addition to standard treatment to assess the interaction (differential trends by treatment condition). Random intercepts were included in the models to account for the lack of independence of data within patients for whom both feet were assessed and repeated measurements. Models adjusted for sociodemographic covariates based on AIC/model fit: DVPRS was adjusted for race/ethnicity and BMI, and FFI-R was adjusted for gender, race/ethnicity, BMI, and history of foot injury.

AIC, Akaike information criterion; BMI, body mass index; CI, confidence interval.

DISCUSSION

This study demonstrates that a Deep Ankle acupuncture protocol with electrostimulation plus prescribed exercise is more effective than exercise alone at decreasing pain and improving function in both the short and long term in adult patients with plantar fasciopathy. These findings add to the body of evidence that acupuncture is an effective adjunctive treatment option in the management of common outpatient clinic problems. Evidence has shown that repeat treatments with acupuncture can have a cumulative effect.^20–23 More research is needed to delineate whether there are optimal interval and total duration of treatments to maximize the utility of acupuncture therapy such as Deep Ankle Protocol.

This study’s protocol was designed for practical implementation in a busy primary care medical acupuncture setting, allowing for feasible follow-ups for both physicians and patients. Most patients with plantar fasciopathy initially consult primary care clinicians; therefore, managing the condition through acupuncture in the primary care setting can reduce the need for referrals, which saves patients time and money and has the potential to reduce overall cost to the health care system.

The utilization of acupuncture to alleviate pain and enhance function in patients with plantar fasciopathy holds promising implications for their return to work and sports activities. By effectively reducing pain, acupuncture enables patients to experience relief and regain mobility in the affected foot. This reduction in pain levels can enhance individuals’ ability to perform work-related duties without discomfort or limitations. It can also facilitate a smoother return to their regular physical activities, which is crucial for overall physical and mental well-being. Similarly, in sports or military settings, the ability to participate without discomfort or limitations can improve performance, overall satisfaction, and motivation to engage in physical activities. Although further studies are still needed to evaluate the effect of acupuncture treatment on athletic or military-specific performance, this study adds to previous reports of the beneficial effect of acupuncture on the treatment of plantar fasciopathy.

Acupuncture itself is a safe and effective procedure that avoids some of the risks seen with other injection techniques for treating plantar fasciopathy. For example, corticosteroid injections pose risks such as plantar fascia rupture and fat pad atrophy, which can occur in about 2.4% of individuals receiving multiple injections.²⁴ Other injection treatments, such as BOTOX, prolotherapy, platelet-rich plasma, or stem cell injections, can be costly and painful. In contrast, adverse effects from acupuncture are temporary and resolve upon discontinuation of needling.

Limitations of the study include missing data collection time points and losses to follow-up. Some participants were excluded due to missing baseline or all follow-ups: 22 feet (19% for DVPRS) and 20 feet (17% for FFI-R). We found no significant difference in exclusions when comparing study groups. Among those included in the analysis, 82 feet (86% for DVPRS and 85% for FFI-R) had data for all five time points. Missing follow-up data were treated as missing at random in statistical models.

The lack of blinding in acupuncture treatment research presents another limitation to this study. Blinding is difficult to achieve in acupuncture treatment research. Acupuncture needling produces a characteristic sensation that is difficult to replicate with a placebo. And although sham acupuncture protocols may not be entirely inert and can still produce some therapeutic effects, a sham acupuncture arm in our study was considered unnecessary based on previous research.^25–31

Future research utilizing this study could consider comparing different frequencies of acupuncture treatment (such as weekly vs. monthly intervals between treatments) as well as assessing pain and function over a longer follow-up time frame (6 and 12 months). It will also be valuable to study comparative effects of differing acupuncture treatments to this protocol to see if a best practice emerges.

CONCLUSIONS

Acupuncture with electrostimulation plus prescribed exercise is an effective treatment for plantar fasciopathy. Our findings support the use of acupuncture as a complementary therapy for the management of this common and often debilitating condition. Acupuncture provided immediate pain reduction as well as decreased pain and improved function over a 12-week period. Acupuncture should be considered as an adjunct therapy for the management of this condition, especially for patients who are not responding to conventional treatments or who prefer less invasive approaches.

AUTHORS’ CONTRIBUTIONS

D.M.: Conceptualization; methodology; acquisition, analysis, validation, and interpretation of data; investigation; writing—original draft; writing—review and editing; formal statistical analysis; project administration; and supervision. B.R.: Conceptualization; methodology; acquisition, analysis, validation, and interpretation of data; investigation; writing—original draft; and project administration. W.W.: Acquisition, analysis, validation, and interpretation of data; writing—original draft; writing—review and editing; and formal statistical analysis. P.C.: Conceptualization; methodology; acquisition, analysis, validation, and interpretation of data; investigation; writing—original draft; writing—review and editing; formal statistical analysis; project administration; and supervision.

Footnotes

ACKNOWLEDGMENT

The authors wish to thank Amanda Crawford for her assistance in preparing this article.

AUTHOR DISCLOSURE STATEMENT

The authors have no conflicts of interest to declare, financial or otherwise.

FUNDING INFORMATION

This project was supported by funding from the Nellis Clinical Investigations Program. The funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the article; and decision to submit the article for publication.

DATA AVAILABILITY STATEMENT

D.M. had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

DISCLAIMER

The opinions and assertions expressed herein are those of the authors and do not necessarily reflect the official policy or position of the Uniformed Services University, the U.S. Air Force, or the Department of Defense.

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