Plantar FasciitisNCT04185259
Acupuncture vs Sham Acupuncture or Waitlist Control for Patients With Chronic Planter Fasciitis
A study testing Acupuncture in people with Plantar Fasciitis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plantar Fasciitis
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences Guang'anmen Hospital
Beijing
Zilin Long, MD
About this study
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
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.
- Conditions
- Plantar Fasciitis
- Being tested
- Acupuncture, Sham acupuncture
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
The investigators will apply two Ashi points (the two most severe tender points in the most sensitive area over the anteromedial aspect of the heels), Chengshan (BL57), Taixi (KI3) and Kunlun (BL60) in this trial. With the patient in a prone position, the local skin will be routinely sterilized followed by a 10mm diameter and 5mm thick sterile adhesive pad pasting onto each selected acupoint. Ashi points will be perpendicularly inserted through the pad to the plantar fascia layer with a depth of approximately 15-20mm depending on the location. BL57, KI3 and BL60 will be punched perpendicularly 10-15mm deep into the skin through the pad. All needles except Ashi points will be manually stimulated by small, equal manipulations of lifting, thrusting, twirling and rotating to achieve De qi. Needles will be retained for 30 minutes per treatment. During each treatment, every needle will be manipulated three times every 10 minutes.
Sham acupunctureOther
Sham Ashi (0.5 cun away from Ashi, one 'cun' is equivalent to the greatest width of the individual patients' thumb, ~1.5 cm), sham BL57 (0.5 cun lateral to true BL57 horizontally), sham KI3 (midway between true KI3 and heel tendon) and sham BL60 (midway between true BL60 and heel tendon) will be used. Treatment protocol will be similar to that of the acupuncture group. The Hwato-brand disposable blunt-tipped needles (size 0.30 × 25 mm) will be inserted at sham points through adhesive pads to the skin without skin penetration. The needles will then be lifted, thrusted, twirled, and rotated evenly three times every ten minutes. No specific de qi response will be elicited.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | Not described Receives: Other: Acupuncture |
| Sham acupuncture | Sham comparator | Not described Receives: Other: Sham acupuncture |
| Waitlist control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with treatment response 4 weeks after randomization
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.
Measured: at week 4
Secondary outcomes (8)
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
Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.
Measured: 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
Pain intensity will be measured using a 0-100 VAS, with 0 indicating no pain and 100 indicating maximal pain.
Measured: at week 4, week 8 and week 16
Changes in the pressure pain threshold (PPT) at the most painful area from baseline to 4 weeks, 8 weeks and 16 weeks after randomization
Pressure pain threshold (PPT) is defined as the minimum pressure detected when the sensation of pressure changes to a first sensation of pain, PPT will be tested with a pressure algometer (Fabrication Enterprises, Inc., White Plains, NY; from 1 kg/cm2 to 5 kg/cm2) involved a metal probe with a 0.5 cm2 rubber disc by a trained researcher.
Measured: 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
The examiner will measure the AROM including plantar dorsiflexion and plantar flexion using a digital goniometer (Tangxia Electronic Instrument Factory, Dongguan, from 0° to 360°).
Measured: 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
The Foot and Ankle Ability Measure has a maximum potential score (116 total, 84 ADL, and 32 Sport subscales). The obtained score (total score, ADL, and sport subscale scores) is divided by the maximum potential score and multiplied by 100 to get a percentage.
Measured: at week 4, week 8 and week 16
Change in plantar fascia thickness (PFT) from baseline to 4 weeks after randomization
Plantar fascia thickness (PFT) will be measured at the thickest point closest to the calcaneal insertion in its medial portion using ultrasound
Measured: at week 4
Participant global assessment of improvement
Participants will be asked to rate his/her global improvement using a 7-point scale. The improvement will be scale from 1(complete recovery) to 7(vastly worse), with 2 being obvious improvement, 3 being a little improvement, 4 being no change, 5 being a little worse and 6 being obvious worse.
Measured: 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
The proportion of patients using rescue medicine and the mean frequency of using rescue medicine per week will be compared among three groups during weeks 1-4, and weeks 5-16.
Measured: weeks 1-4, and weeks 5-16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Dec 2020
- Primary completionJun 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plantar FasciitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, weiming wang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Zhishun Liu, MD, PhD, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04185259
- Sponsor's protocol ID
- ZZ13-YQ-019
- Status last verified
- Mar 2022
- First submitted
- 30 Nov 2019
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32978188
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04185259
- Acronym / sponsor ID
- ZZ13-YQ-019
- Conditions
- Plantar Fasciitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 4 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: Acupuncture |
| Sham acupuncture | Sham comparator | Other: Sham acupuncture |
| Waitlist control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureThe investigators will apply two Ashi points (the two most severe tender points in the most sensitive area over the anteromedial aspect of the heels), Chengshan (BL57), Taixi (KI3) and Kunlun (BL60) in this trial. With the patient in a prone position, the local skin will be routinely sterilized followed by a 10mm diameter and 5mm thick sterile adhesive pad pasting onto each selected acupoint. Ashi points will be perpendicularly inserted through the pad to the plantar fascia layer with a depth of approximately 15-20mm depending on the location. BL57, KI3 and BL60 will be punched perpendicularly 10-15mm deep into the skin through the pad. All needles except Ashi points will be manually stimulated by small, equal manipulations of lifting, thrusting, twirling and rotating to achieve De qi. Needles will be retained for 30 minutes per treatment. During each treatment, every needle will be manipulated three times every 10 minutes. | Other | Acupuncture group |
| Sham acupunctureSham Ashi (0.5 cun away from Ashi, one 'cun' is equivalent to the greatest width of the individual patients' thumb, ~1.5 cm), sham BL57 (0.5 cun lateral to true BL57 horizontally), sham KI3 (midway between true KI3 and heel tendon) and sham BL60 (midway between true BL60 and heel tendon) will be used. Treatment protocol will be similar to that of the acupuncture group. The Hwato-brand disposable blunt-tipped needles (size 0.30 × 25 mm) will be inserted at sham points through adhesive pads to the skin without skin penetration. The needles will then be lifted, thrusted, twirled, and rotated evenly three times every ten minutes. No specific de qi response will be elicited. | Other | Sham acupuncture |
Primary outcome
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.
8 secondary outcomes
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
Time frame: 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
Time frame: at week 4, week 8 and week 16
Changes in the pressure pain threshold (PPT) at the most painful area from baseline to 4 weeks, 8 weeks and 16 weeks after randomization
Time frame: 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
Time frame: 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
Time frame: at week 4, week 8 and week 16
Change in plantar fascia thickness (PFT) from baseline to 4 weeks after randomization
Time frame: at week 4
Participant global assessment of improvement
Time frame: 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
Time frame: weeks 1-4, and weeks 5-16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Derived from this study: PubMed 32978188Wang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhishun Liu, MD, PhD principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Plantar Fasciitis, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiming Wang, MD, PhD (010-88001241, wangweiming1a1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of participants with treatment response 4 weeks after randomization (time frame: at week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04185259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.