Clinical trial NCT04185259: Acupuncture vs Sham Acupuncture or Waitlist Control for Patients With Chronic Planter Fasciitis
Official title: Efficacy of Acupuncture vs Sham Acupuncture or Waitlist Control for Patients With Chronic Planter Fasciitis: Study Protocol for a 2-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plantar Fasciitis
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to acupuncture group, sham acupuncture group, or waitlist (no acupuncture) group at a ratio of 2:1:1 using simple randomization.
Primary purpose: TREATMENT

Brief summary: Plantar fasciitis (PF) predominantly affects elderly and middle-aged individuals and is more frequent in runners or those whose employment requires standing. The available treatment options of PF mainly included non-operative treatments (e.g., plantar fascia and gastrocnemiussoleus muscle stretching, heel cups, arch supports, night splints, nonsteroidal antiinflammatory drugs (NSAIDs), local corticosteroid injections) and operative management. However, no consensus has been reached regarding the most beneficial treatment method for PF.

Acupuncture has been used in the management of PF and the other musculoskeletal pain-related conditions for thousands of years. Recent two systematic reviews have found that acupuncture may reduce pain intensity and improve plantar function for patients with PF. However, there are methodological problems with small sample size, or not controlled with a placebo/waitlist group, or not account for the confounding effects of patients who experienced combination treatments in the design of the included acupuncture literature. Therefore, the placebo effect of acupuncture and a possible spontaneous remission for PF cannot be excluded and the beneficial effects of acupuncture for PF remained need to more assessment.

The investigators designed a randomized controlled trial to evaluate the efficacy of Traditional Chinese acupuncture (TCA), compared with sham acupuncture (SA) or being on a waitlist control group (no acupuncture treatment), for patients with chronic PF for ≥ 6 months. The hypothesis was that combined acupuncture and sham acupuncture will result in larger improvements in heel pain more than no acupuncture treatment in patients with chronic PF. Secondary hypotheses examined whether acupuncture reduce heel pain intensity more effectively than sham acupuncture or no acupuncture.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years and ≤75 years;
2. History of planter medial heel pain for at least 6 months before enrolment;
3. Reported an average worst pain intensity at first steps in the morning over the last 7 days of at least 50mm on a 100-mm visual analog scale (VAS) before enrolment;
4. Failure to respond to conservative treatment for ≥ 1 months, including any of the following modalities: stretching exercises, nonsteroidal anti-inflammatory drugs, orthotics;
5. Ability to comply with the study protocol, understand the medical information forms as well as having signed informed consent.

Exclusion Criteria:

1. History of calcaneus fracture, calcaneal bone tumor or cyst, plantar fascia rupture， or have a significant foot deformity(clubfoot, pes cavus, or pes calcaneovalgus);
2. Previous injection (corticosteroid, platelet-rich plasma, lidocaine needling), or radiation, or surgery to plantar fascia within 6 months preceding enrollment;
3. Radiculopathy or peripheral neuropathy around the ankle joint such as nerve entrapment tarsal tunnel syndrome or Achilles tendinopathy;
4. Systemic disorders like rheumatoid arthritis, gout, Reiter syndrome, type 1 or 2 diabetes mellitus, osteoporosis, spondyloarthritis, or osteomyelitis;
5. Joint, bone, or skin infection in the affected foot;
6. Clinically significant cardiovascular disorder, severe hepatic/renal insufficiency or coagulation disorder at baseline as determined by the investigator;
7. Known phobic to acupuncture or received acupuncture treatment within 4 weeks prior to enrollment.

Primary outcomes:
measure: The proportion of participants with treatment response 4 weeks after randomization
timeFrame: at week 4
Secondary outcomes:
measure: Changes in VAS score for worst pain intensity during the first steps in the morning from baseline to 4 weeks, 8 weeks and 16 weeks after randomization
timeFrame: at week 4, week 8 and week 16
measure: Changes in VAS score for mean pain intensity during the day from baseline to 4 weeks, 8 weeks and 16 weeks after randomization
timeFrame: at week 4, week 8 and week 16
measure: Changes in the pressure pain threshold (PPT) at the most painful area from baseline to 4 weeks, 8 weeks and 16 weeks after randomization
timeFrame: at week 4, week 8 and week 16
measure: Changes in ankle range of motion (AROM) from baseline to 4 weeks, 8 weeks and 16 weeks after randomization
timeFrame: at week 4, week 8 and week 16
measure: Changes in Foot and Ankle Ability Measure (FAAM) total score and subscale scores from baseline to 4 weeks, 8 weeks and 16 weeks after randomization
timeFrame: at week 4, week 8 and week 16
measure: Change in plantar fascia thickness (PFT) from baseline to 4 weeks after randomization
timeFrame: at week 4
measure: Participant global assessment of improvement
timeFrame: at week 4, week 8 and week 16
measure: The proportion of patients using rescue medicine and the mean frequency of rescue medicine use per week during weeks 1-4 and weeks 5-16
timeFrame: weeks 1-4, and weeks 5-16
Other outcomes:
measure: Participants'expectation towards acupuncture
timeFrame: at baseline
measure: The proportion of participants who have maintained blinding during treatment in acupuncture and SA groups
timeFrame: at week 4
measure: Incidence of adverse events
timeFrame: weeks 1-16
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: Zhishun Liu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang W, Liu S, Liu Y, Zang Z, Zhang W, Li L, Liu Z. Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial. BMJ Open. 2020 Sep 25;10(9):e036773. doi: 10.1136/bmjopen-2020-036773.