Actively Recruiting
Acupuncture of Different Treatment Frequency in Chronic Plantar Fasciitis
Led by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Updated on 2025-07-16
80
Participants Needed
1
Research Sites
136 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Plantar fasciitis (PF) is one of the most common causes of heel pain, typically characterized by a sharp pain in the plantar aponeurosis, specifically near the insertion site close to the medial process of the calcaneal tuberosity. It has been reported that 1 in 10 people are expected to be affected by PF in their lifetime. A comprehensive internet-panel survey conducted among the adult United States population revealed the population-based prevalence of self-reported PF with pain in the last month was 0.85 percent. Approximately 1 million patients are diagnosed with this disease each year in the United States. PF was believed to be an acute inflammatory disease, but patient samples show it is actually a chronic degenerative process caused by various factors such as repetitive stresses, vascular and metabolic disorders, excess free radicals, high temperatures, genetic factors, and conditions like rheumatoid arthritis and spondyloarthropathies. PF may be associated with impaired health-related quality of life, including reduced life functioning, poor perceived health status and social isolation. Additionally, a recent study indicates that the annual cost associated with PF is $284 million. The first-line treatments recommended by guidelines for PF encompass physical therapy (including manual therapy, stretching, and others), pharmacological therapy (involving corticosteroids or platelet-rich plasma), and surgical treatment. However, the definite effects of physical therapy still require confirmation. Pharmacological treatments, such as local corticosteroid injections, exhibit a short maintenance period. Some studies indicate that the relief provided by corticosteroid injections lasts up to one month, yet its efficacy diminishes after 6 months. Surgical treatment is generally advised 6 to 12 months after unsuccessful conservative treatment, albeit with the drawback of higher costs, post-surgery recovery time, and patient apprehension. Acupuncture is one of the most common complementary alternative therapy for the treatment of pain-related diseases such as musculoskeletal muscle, and recent guidelines recommend dry needling as a treatment for relief of plantar fasciitis, with a level of evidence of B. Dry acupuncture is different from acupuncture in terms of theoretical basis, therapeutic apparatus, technical operation and scope of indications, however, the American Alliance for Professional Acupuncture Safety also believes that dry needling falls under the umbrella of acupuncture, but under a different name. In addition, there are systematic evaluations that suggest acupuncture can be a safe and effective treatment for PF, and most of the trials in the systematic evaluations used 4-week treatment courses. Our prior study demonstrated that a 4-week intervention of both electroacupuncture and manual acupuncture resulted in improved pain outcomes among patients with PF. The frequency of acupuncture stands as a crucial factor influencing its efficacy. A study revealed that needling trials with negative results had a significantly lower frequency compared to those yielding positive results. Furthermore, several studies indicate that acupuncture once a week can be help in conditions such as simple obesity, functional dyspepsia, and overactive bladder in women. There is no universally accepted standard of frequency of treatment for many conditions, including PF. In China, patients with chronic diseases usually receive 3-5 acupuncture treatments per week. However, in most previous trials, individuals with chronic diseases received 1-2 needling sessions per week. An increase in the frequency of acupuncture means an increase in the pain, time, and financial investment associated with the acupuncture process. Therefore, it is critical to optimize the frequency of acupuncture to ensure the effectiveness and feasibility of the treatment while avoiding increasing the burden on the patient. Accordingly, the investigators designed the current trial to compare the effects of different acupuncture sessions (1 session per week versus 3 sessions per week) in a randomized controlled trial (RCT) of chronic PF. The hypothesis is that 1 session per week compared with 3 sessions per week of electroacupuncture treatment over a total of 4 weeks of treatment will provide a similar effect on pain relief in chronic PF.
CONDITIONS
Official Title
Acupuncture of Different Treatment Frequency in Chronic Plantar Fasciitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic plantar fasciitis with symptoms lasting 6 months or more
- Most painful heel pain in the morning rated 40 or higher on a 100 mm Visual Analogue Scale
- Age between 18 and 75 years
- Conscious and free from mental disorders
- No serious heart, liver, or kidney diseases
- Willing to sign informed consent form
You will not qualify if you...
- History of calcaneal tuberosity fracture, stress fracture, contusion, or plantar fascia rupture
- History of ankle or foot surgery
- Achilles tendon enthesis lesion, tarsal tunnel syndrome, medial calcaneal nerve entrapment, or nerve injury
- Systemic or local infection, severe cracked heel, or foot deformity such as high arched feet, flat feet, or foot valgus
- Systemic diseases including spondylitis, rheumatoid arthritis, autoimmune diseases, tumors, diabetes, or other conditions unsuitable for the trial
- Pregnant women or severe combined cardiac, hepatic, renal, hematopoietic diseases, patients with cardiac pacemakers, or poor nutritional status
- Cognitive impairment preventing understanding of study evaluations
- Use of topical steroids or oral steroids in past 6 months
- Known fear of acupuncture or acupuncture treatment within past 8 weeks
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital
Beijing, China
Actively Recruiting
Research Team
W
Weiming Wang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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