Acupuncture of Different Treatment Frequency in Chronic Plantar Fasciitis

NCT06284993 | Recruiting

• 1 other identifier: 2023-214-KY
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Plantar Fasciitis, Chronic

Outcome Measures

Primary Outcomes (1)

• The response rate

  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.

  At the end of weeks 4

Secondary Outcomes (8)

• The response rate

  At the end of weeks 8, and 16

• 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

• Change from baseline in the VAS score for mean pain intensity during the day

  At the end of weeks 4, 8, and 16

• Change from baseline in the duration of heel pain during the day

  At the end of weeks 4, 8, and 16

• Change from baseline in heel pressure pain threshold (PPT)

  At the end of weeks 4, 8, and 16

Other Outcomes (4)

• Participants' expectation towards acupuncture

  At baseline

• Safety assessment

  During weeks 1-4, weeks 5-8 and weeks 9-16

• Adherence assessment

  Weeks 1-4

Study Arms (2)

The more frequent acupuncture treatment group (Group M)

EXPERIMENTAL

The more frequent acupuncture treatment group (Group M)

Procedure: electroacupuncture(more frequent)

The less frequent acupuncture treatment group (Group L)

EXPERIMENTAL

The less frequent acupuncture treatment group (Group L)

Procedure: electroacupuncture(less frequent)

Interventions

electroacupuncture(more frequent) PROCEDURE

With the patient in a prone position, the local skin will be routinely sterilized, Ashi points will be perpendicularly inserted into the plantar fascia layer with a depth of approximately 15-20 mm depending on the location. BL57, KI3, and BL60 will be punched perpendicularly 10-15 mm deep into the skin. All needles except the Ashi points will be manually stimulated with small, equal manipulations of lifting, thrusting, twirling, and rotating to achieve De qi (a sensation including soreness, numbness, distention, and heaviness), and the practitioner has a feeling of needle sinking and tightness. The electroacupuncture instrument is connected to the needle handle of BL57 and BL60 respectively. During the needle retention period, except for BL57 and BL60, which are connected to the electroacupuncture instrument, Ashi points and KI3 perform a small and uniform twisting technique three times every 10 min, and a total of 3 times within 30min.

The more frequent acupuncture treatment group (Group M)

electroacupuncture(less frequent) PROCEDURE

The intervention is the same as Group M except that the frequency of acupuncture will be once per week acupuncture. During the treatment period, in addition to acupuncture, patients will be visited twice a week for a total of 8 visits by telephone or in person. If the content of the visit aligns with the established efficacy evaluation visit in the program, it will be carried out as planned. If not, the patient will be inquired about the progress of their condition since the previous treatment, any rescue medication taken, and other relevant information. Visits that do not involve improvement in relevant indicators of study concern do not need to be recorded. The electroacupuncture will last for 30 min and will be performed three sessions per week or one session per week for a total of 12 or 4 sessions in four consecutive weeks. Participants in both groups will be treated and (or) evaluated separately.

The less frequent acupuncture treatment group (Group L)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital

Beijing, China

RECRUITING

Related Publications (1)

• Shi J, Jiao R, Liu Y, Liu X, Sun Y, Shi H, Gao N, Liu Z, Liang J, Wang W. Comparing different session regimens of electroacupuncture for chronic plantar fasciitis: Study protocol for a randomized clinical trial. Contemp Clin Trials Commun. 2024 Aug 24;41:101355. doi: 10.1016/j.conctc.2024.101355. eCollection 2024 Oct.

  PMID: 39280785 DERIVED

MeSH Terms

Conditions

Fasciitis, Plantar

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases

Study Officials

• Weiming Wang, Ph.D

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiming Wang, Ph.D

CONTACT

+8613426424993; wangweiming1a1@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2024
• First Posted: February 29, 2024
• Study Start: May 21, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: It depends
• Access Criteria: It depends

Locations

CN (1)