Acupuncture of Different Treatment Frequency in Chronic Plantar Fasciitis

Not Applicable

Recruiting

• Conditions: Plantar Fasciitis, Chronic

• Registration Number: NCT06284993
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-17
• Study First Submitted QC: 2024-02-22
• Study First Posted: 2024-02-29
• Study Start: 2024-05-21
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-13
• Last Update Posted: 2025-07-16
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients with a diagnosis of chronic PF with a disease course of ≥ 6 months;
• The most painful heel pain in the morning is Visual Analogue Scale (VAS; 0 indicating no pain and 100 indicating maximal pain) ≥ 40 mm on a 100 mm VAS;
• Patients between the ages of 18 and 75 years;
• Patients should be conscious, free from mental disorders, and without serious heart, liver, or kidney diseases; and
• Willing to sign the informed consent form.

Exclusion Criteria

• History of calcaneal tuberosity fracture/calcaneal stress fracture/calcaneal contusion/plantar fascia rupture;
• History of ankle or foot surgery;
• Achilles tendon enthesis lesion/tarsal tunnel syndrome/medial calcaneal nerve entrapment/nerve injury;
• Systemic or local infection, severe cracked heel, foot deformity (e.g., high arched feet, flat feet, foot valgus);
• Systemic diseases (e.g., obligatory spondylitis, rheumatoid arthritis, seronegative arthritis, autoimmune system diseases, tumors, diabetes ) and other situations judged by the investigators not to be suitable for the clinical trial;
• Pregnant women; patients with severe combined cardiac, hepatic, renal, hematopoietic, and patients with cardiac pacemakers , and patients with severe poor general nutritional status;
• Cognitive impairment, inability to understand the content of the scale evaluation;
• Topical steroid injection or oral use in the past 6 months;
• Patients with a known fear of acupuncture or who have been treated with acupuncture in the past 8 weeks.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The response rate	At the end of weeks 4	Defined as a minimum of 50% improvement in the worst pain intensity during the first morning steps compared with the baseline. This trial will be analyzed using the mean of the worst pain level VAS from the previous three days. Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain. Participants who must resort to additional treatments other than the permitted rescue medication will be classified as non-responders.

Secondary Outcome Measures

Name	Time	Method
The response rate	At the end of weeks 8, and 16	Defined as a minimum of 50% improvement in the worst pain intensity during the first morning steps compared with the baseline. This trial will be analyzed using the mean of the worst pain level VAS from the previous three days. Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain. Participants who must resort to additional treatments other than the permitted rescue medication will be classified as non-responders.
Change from baseline in the VAS score for worst pain intensity during the first morning steps	At the end of weeks 4, 8, and 16	A 100-mm VAS ranging from 0 mm (no pain) to 100 mm (maximal pain), with varying degrees of pain in between will be used. Patients will indicate their pain intensity on the VAS by marking a point, and the distance from 0 mm to this point will determine the pain score. The mean of the worst pain intensity during the first morning steps during the previous three days will be determined.
Change from baseline in the VAS score for mean pain intensity during the day	At the end of weeks 4, 8, and 16	A 100-mm VAS ranges from 0 mm (no pain) to 100 mm (maximal pain), with varying degrees of pain in between will be used. The average VAS score of daily heel pain over the past three days will be assessed.
Change from baseline in the duration of heel pain during the day	At the end of weeks 4, 8, and 16	The study will measure the average number of hours of daytime heel pain over the last three days while participants maintain their normal daily activities.
Change from baseline in heel pressure pain threshold (PPT)	At the end of weeks 4, 8, and 16	PPT is defined as the minimum pressure detected when the sensation of pressure first changes to a sensation of pain. PPT will be tested with a pressure algometer (Fabrication Enterprises, White Plains, NY; from 1 kg/cm2 to 5 kg/cm2) using a metal probe with a 0.5 cm2 rubber disc, performed by a trained researcher. PPT will be measured with the participant lying supine in a relaxed position with the affected foot hanging over the edge of the bed. When measuring the PPT, the rubber disc will be placed perpendicularly on the painful spot, and pressure will be applied at a rate of approximately 0.1 kg/cm2/s through the metal probe of the pressure algometer. Participants will be asked to report when the initial pain sensation occurs, and the readings of the algometer will be recorded. The score will be determined by averaging three repeated measurements with 30 s between each trial. All values below 1 kg/cm2 will be reported as 0.5 kg/cm2.
Change from baseline in ankle range of motion (AROM)	At the end of weeks 4, 8, and 16	The examiner will measure the AROM, including dorsiflexion and plantar flexion with the knee extended, using a digital goniometer (Tangxia Electronic Instrument Factory, Dongguan, from 0° to 360°). For the extended-knee assessment, the participant will be seated on a treatment table with the knees fully extended (0°) and the feet hanging off the end of the table. The axis of the goniometer will be placed at the lateral malleolus. The stationary arm will be placed parallel to the center of the fibular head and the moving arm placed parallel to the fifth metatarsal. The ankle will be passively moved from a neutral starting position into dorsiflexion and plantar flexion until a firm end feel is elicited, and the readings of the goniometer will be recorded. The mean score of three trials, with 10s between each examination, will be calculated and used for analysis.
Change from baseline in Foot and Ankle Ability Measure (FAAM) total score and subscale scores	At the end of weeks 4, 8, and 16	The FAAM is a self-reported outcome instrument designed to assess physical functioning in patients with foot and ankle-related injuries, and consists of a 29-item questionnaire divided into two subscales: a 21-item Activities of Daily Living (ADL) subscale, and an eight-item exercise subscale. Each item is scored on a 0-4 point Likert scale ranging from zero (unable to do) to four (no difficulty at all), with higher total scores indicating a higher level of function. The FAAM has a maximum potential score of 116 (84 ADL and 32 sport subscales). The score obtained (total, ADL, and sport subscale scores) is divided by the maximum potential score and multiplied by 100 to obtain a percentage. If the patient does not respond to a question, that specific question will be left blank and not be a part of the final value of the questionnaire. In this trial, we will use the previously validated Chinese version of the FAAM.
Participant global assessment of improvement	At the end of weeks 4, 8 and 16	The evaluation of overall clinical impact from the participants' perspective will be divided into seven grades, assessed by patients at three timepoints: the end of the four-week treatment, and at eight and 16 weeks of follow-up. The improvement will be scaled from one (complete recovery) to seven (vastly worse), with two being obvious improvement, three being a little improvement, four being no change, five being a little worse and six being obviously worse. Although the scale's validity has not been verified in patients with PF, it has been shown to provide credible validity in some musculoskeletal disorders including osteoarthritis, rheumatoid arthritis, inflammatory synovitis.

Trial Locations

Locations (1)

Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital; 🇨🇳 Beijing, China