Efficacy of Acupuncture vs Sham Acupuncture or Waitlist Control for Patients With Chronic Planter Fasciitis: Study Protocol for a 2-center Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- The proportion of participants with treatment response 4 weeks after randomization
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Participants in acupuncture group and sham acupuncture group, together with efficacy evaluators and data analysts will be blinded to the group assignments. Participants in the waitlist control group and acupuncturists will not be blinded.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥18 years and ≤75 years;
- •History of planter medial heel pain for at least 6 months before enrolment;
- •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;
- •Failure to respond to conservative treatment for ≥ 1 months, including any of the following modalities: stretching exercises, nonsteroidal anti-inflammatory drugs, orthotics;
- •Ability to comply with the study protocol, understand the medical information forms as well as having signed informed consent.
Exclusion Criteria
- •History of calcaneus fracture, calcaneal bone tumor or cyst, plantar fascia rupture， or have a significant foot deformity(clubfoot, pes cavus, or pes calcaneovalgus);
- •Previous injection (corticosteroid, platelet-rich plasma, lidocaine needling), or radiation, or surgery to plantar fascia within 6 months preceding enrollment;
- •Radiculopathy or peripheral neuropathy around the ankle joint such as nerve entrapment tarsal tunnel syndrome or Achilles tendinopathy;
- •Systemic disorders like rheumatoid arthritis, gout, Reiter syndrome, type 1 or 2 diabetes mellitus, osteoporosis, spondyloarthritis, or osteomyelitis;
- •Joint, bone, or skin infection in the affected foot;
- •Clinically significant cardiovascular disorder, severe hepatic/renal insufficiency or coagulation disorder at baseline as determined by the investigator;
- •Known phobic to acupuncture or received acupuncture treatment within 4 weeks prior to enrollment.
Arms & Interventions
Acupuncture group
Intervention: Acupuncture (Other)
Sham acupuncture
Intervention: Sham acupuncture (Other)
Waitlist control group
Participants will receive no treatment for their heel pain for a period of 16 weeks after randomization, and subsequently have the option of 4 weeks (12 sessions) of acupuncture with free of charge at the end of follow-up.
Outcomes
Primary Outcomes
The proportion of participants with treatment response 4 weeks after randomization
Time Frame: at week 4
A treatment responder is defined as a participant having a minimum of 50% improvement in the worst pain intensity during the first steps in the morning compared with baseline.
Secondary Outcomes
- Change in plantar fascia thickness (PFT) from baseline to 4 weeks after randomization(at week 4)
- Changes in the pressure pain threshold (PPT) at the most painful area from baseline to 4 weeks, 8 weeks and 16 weeks after randomization(at week 4, week 8 and week 16)
- Changes in ankle range of motion (AROM) from baseline to 4 weeks, 8 weeks and 16 weeks after randomization(at week 4, week 8 and week 16)
- 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(weeks 1-4, and weeks 5-16)
- 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(at week 4, week 8 and week 16)
- Changes in VAS score for mean pain intensity during the day from baseline to 4 weeks, 8 weeks and 16 weeks after randomization(at week 4, week 8 and week 16)
- 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(at week 4, week 8 and week 16)
- Participant global assessment of improvement(at week 4, week 8 and week 16)
Investigators
weiming wang
Principal Investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences