Clinical trial NCT06284993: Acupuncture of Different Treatment Frequency in Chronic Plantar Fasciitis
Official title: Acupuncture of Different Treatment Frequency in Chronic Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Plantar Fasciitis, Chronic
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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, we 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.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with chonic PF should have a disease course of ≥ 6 months;
* The most painful heel pain in the morning is VAS≥ 40mm;
* Patients must be aged between 18 and 75;
* Recruited patients should be conscious, free from mental disorders, and without serious heart, liver, or kidney diseases;
* 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 (high arched feet, flat feet, foot valgus);
* Systemic diseases (obligatory spondylitis, rheumatoid arthritis, seronegative arthritis, tumors, diabetes);
* Pregnant women; patients with severe combined cardiac, hepatic, renal, haematopoietic, and autoimmune system diseases, and patients with severe poor general nutritional status;
* Cognitive impairment, inability to understand the content of the scale evaluation; patients with cardiac pacemakers;
* Topical steroid injection or oral use in the past 6 months;
* Patients with known fear of acupuncture or who have been treated with acupuncture in the past 8 weeks;

Primary outcomes:
measure: The response rate
timeFrame: At the end of weeks 4
Secondary outcomes:
measure: The response rate
timeFrame: At the end of weeks 8, and 16
measure: Change from baseline in the VAS score for worst pain intensity during the first steps in the morning
timeFrame: At the end of weeks 4, 8, and 16
measure: Change from baseline in the VAS score for mean pain intensity during the day
timeFrame: At the end of weeks 4, 8, and 16
measure: Change from baseline in the duration of heel pain during the day
timeFrame: At the end of weeks 4, 8, and 16
measure: Change from baseline in heel pressure pain threshold (PPT)
timeFrame: At the end of weeks 4, 8, and 16
measure: Change from baseline in ankle range of motion (AROM)
timeFrame: At the end of weeks 4, 8, and 16
measure: Change from baseline in Foot and Ankle Ability Measure (FAAM) total score and subscale scores
timeFrame: At the end of weeks 4, 8, and 16
measure: Participant global assessment of improvement
timeFrame: At the end of weeks 4, 8 and 16
Other outcomes:
measure: Participants' expectation towards acupuncture
timeFrame: At baseline
measure: Safety assessment
timeFrame: During weeks 1-4, weeks 5-8 and weeks 9-16
measure: Adherence assessment
timeFrame: Weeks 1-4
measure: Number of cases and number of times painkillers and other treatments
timeFrame: At baseline and at the end of weeks 4, 8 and 16
Locations:
city: Beijing
country: China
facility: Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Weiming Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: