Plantar FascitisNCT05588349
Effectiveness of Trigger Point Dry Needling on Plantar Fasciitis
A study testing Dry needling and Stretching exercise in people with Plantar Fascitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Plantar fasciitis could lead to pain, disability and impaired balance. Dry needling that targets myofascial trigger points (MTrPs) has been shown to be beneficial in reducing pain, improving range of motion and function in patients with musculoskeletal conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- Dry needling and Stretching exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Feb 2023to 31 May 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 18-65 years
- Clinical diagnosis of plantar fasciitis in accordance with the clinical guidelines of the Orthopaedic Section of the American Physical Therapy Association (APTA)
- Pain intensity of a minimum score of 5 on 11-point NPRS
- Presence of trigger points of the gastrocnemius or soleus muscles or both
- History of plantar heel pain for over 1 month
Who cannot join
- Needle allergy or phobia
- Bleeding disorders or severe vascular disease
- Pregnancy
- Cancer
- Fracture or surgery in the foot region or leg
- Infection
Show all 10Show fewer
- Dermatological disease in the area of needling
- History of injection therapy in the heel during the previous three months
- Cognitive impairment
- Neurological disorders affecting balance
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Our Lady of Maryknoll Hospital
Hong Kong
Wong
About this study
Official title: Effectiveness of Trigger Point Dry Needling on Plantar Fasciitis: a Randomized Controlled Trial
Plantar fasciitis could lead to pain, disability and impaired balance. Dry needling that targets myofascial trigger points (MTrPs) has been shown to be beneficial in reducing pain, improving range of motion and function in patients with musculoskeletal conditions. Previous systematic review suggested a positive effect of dry needling on improving pain intensity and pain-related disability in patients with plantar heel pain (Llurda-Almuzara et al., 2021). However, the generalisability of the result is limited by small number of trials and heterogenicity in the dry needling application. Also, there is currently no evidence on its effect on dynamic balance and ankle dorsiflexion range of motion. This randomized controlled trial is designed to investigate the effectiveness of dry needling on pain, pain-related disability, dynamic balance and ankle dorsiflexion range of motion in patients with plantar fasciitis.
Read the detailed description
Twenty participants aged 18 - 65 years with plantar fasciitis will be recruited and randomized to (1) dry needing and stretching exercise group or (2) stretching exercise group, receiving three treatment sessions over three weeks. The primary outcome measure will be numeric pain rating scale (NPRS) and the secondary outcome measures will be Chinese Foot and Ankle Outcome Score (FAOS), modified Star Excursion Balance Test (mSEBT) and weight bearing lunge test (WBLT) measured at baseline and week 4.
- Conditions
- Plantar Fascitis
- Being tested
- Dry needling, Stretching exercise
- Keywords
- Plantar fasciitis, Dry needling
- Medical subject headings
- Fasciitis, Plantar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry needlingOther
Dry needling + stretching exercise
Stretching exerciseOther
Stretching exercise only
| Study group | Role | What they receive |
|---|---|---|
| Dry needling + stretching exercise | Experimental | After locating the MTrPs, hand hygiene of the physiotherapist will be done and the needling site will be disinfected with alcohol swab. 0.30 x 50 mm disposable stainless-steel needles (DongBang Acupuncture Inc., Boryeong, Korea) will be used. The needle will be inserted into the muscle and pistoned in an up-and-down fashion using the "fast in and fast out" technique in order to provoke the local twitch response (LTR). This will be repeated until either the LTRs are exhausted, or the participant's tolerance threshold is met. If the participant is sensitive to the needle stimulation, the manipulation will be reduced. The needle will be left in situ for five minutes (Cotchett et al., 2011). Participants will receive dry needling once per week for three weeks. Plantar fascia and calf stretching exercise will be taught Receives: Other: Dry needling |
| Stretching exercise | Active comparator | Plantar fascia stretching exercise:
Participants will be instructed to sit with the affected foot placed on the contralateral thigh with the toes being grasped and pulled into extension until a stretch is felt in the plantar fascia.
Calf stretching exercise:
To focus on stretching the gastrocnemius, participants will be taught to stand with both hands holding onto the wall and keep the affected leg back with knee straightened and heel in contact with the floor. Slowly lean forward to the wall until a stretch is felt in the calf. To focus on stretching the soleus, the same procedures will be taught except with the affected knee being bent. Receives: Other: Stretching exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in first-step pain intensity
The change in first-step pain intensity will be measured by the numeric pain rating scale (NPRS), which is a 11-point scale ranging from 0 ("no pain") to 10 ("the worst pain imaginable").
Measured: Baseline to 4 weeks
Secondary outcomes (3)
Change in pain-related disability
The change in pain-related disability will be measured by the Chinese Foot and Ankle Outcome Score (FAOS), which is a 42-item patient-reported outcome measure with a normalized score ranging from 0 to 100. A score of 100 resembling no symptoms and 0 resembling severe symptoms.
Measured: Baseline to 4 weeks
Change in dynamic balance
The change in dynamic balance will be measured by the modified Star Excursion Balance Test (mSEBT). Participants stand on the leg to be tested and attempt to reach as far as possible with the reaching foot in 3 directions (anterior, posteromedial and posterolateral). The maximal distance reached along each direction (in centimeters) will be recorded. Greater reaching distance indicates better performance in dynamic balance.
Measured: Baseline to 4 weeks
Change in weight bearing ankle dorsiflexion range of motion
The change in weight bearing ankle dorsiflexion range of motion will be measured by weight bearing lunge test (WBLT). Participants lunge forward until the knee could only make a slight contact with the wall with the heel remain in contact with the ground. The maximal distance (in centimeters) from the wall to the tip of the great toe is recorded. Greater distance indicates greater ankle dorsiflexion range of motion.
Measured: Baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Feb 2023
- Primary completion30 Apr 2023 (estimated)
- Study completion31 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Plantar FascitisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Dry needling plus stretching exercise versus stretching exercise alone
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wong Wing Sze, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588349
- Sponsor's protocol ID
- ChineseUHK2022
- Status last verified
- Feb 2023
- First submitted
- 15 Oct 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Llurda-Almuzara L, Labata-Lezaun N, Meca-Rivera T, Navarro-Santana MJ, Cleland JA, Fernandez-de-Las-Penas C, Perez-Bellmunt A. Is Dry Needling Effective for the Management of Plantar Heel Pain or Plantar Fasciitis? An Updated Systematic Review and Meta-Analysis. Pain Med. 2021 Jul 25;22(7):1630-1641. doi: 10.1093/pm/pnab114.
PubMed 33760098Cotchett MP, Landorf KB, Munteanu SE, Raspovic AM. Consensus for dry needling for plantar heel pain (plantar fasciitis): a modified Delphi study. Acupunct Med. 2011 Sep;29(3):193-202. doi: 10.1136/aim.2010.003145. Epub 2011 Apr 18.
PubMed 21504939
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Trigger Point Dry Needling on Plantar Fasciitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05588349
- Acronym / sponsor ID
- ChineseUHK2022
- Conditions
- Plantar Fascitis
- Keywords
- Plantar fasciitis, Dry needling
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 20 Oct 2022 (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 could lead to pain, disability and impaired balance. Dry needling that targets myofascial trigger points (MTrPs) has been shown to be beneficial in reducing pain, improving range of motion and function in patients with musculoskeletal conditions. Previous systematic review suggested a positive effect of dry needling on improving pain intensity and pain-related disability in patients with plantar heel pain (Llurda-Almuzara et al., 2021). However, the generalisability of the result is limited by small number of trials and heterogenicity in the dry needling application. Also, there is currently no evidence on its effect on dynamic balance and ankle dorsiflexion range of motion. This randomized controlled trial is designed to investigate the effectiveness of dry needling on pain, pain-related disability, dynamic balance and ankle dorsiflexion range of motion in patients with plantar fasciitis.
Detailed description
Twenty participants aged 18 - 65 years with plantar fasciitis will be recruited and randomized to (1) dry needing and stretching exercise group or (2) stretching exercise group, receiving three treatment sessions over three weeks. The primary outcome measure will be numeric pain rating scale (NPRS) and the secondary outcome measures will be Chinese Foot and Ankle Outcome Score (FAOS), modified Star Excursion Balance Test (mSEBT) and weight bearing lunge test (WBLT) measured at baseline and week 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Dry needling plus stretching exercise versus stretching exercise alone
| Arm | Type | Receives |
|---|---|---|
| Dry needling + stretching exercise | Experimental | Other: Dry needlingAfter locating the MTrPs, hand hygiene of the physiotherapist will be done and the needling site will be disinfected with alcohol swab. 0.30 x 50 mm disposable stainless-steel needles (DongBang Acupuncture Inc., Boryeong, Korea) will be used. The needle will be inserted into the muscle and pistoned in an up-and-down fashion using the "fast in and fast out" technique in order to provoke the local twitch response (LTR). This will be repeated until either the LTRs are exhausted, or the participant's tolerance threshold is met. If the participant is sensitive to the needle stimulation, the manipulation will be reduced. The needle will be left in situ for five minutes (Cotchett et al., 2011). Participants will receive dry needling once per week for three weeks. Plantar fascia and calf stretching exercise will be taught |
| Stretching exercise | Active comparator | Other: Stretching exercisePlantar fascia stretching exercise: Participants will be instructed to sit with the affected foot placed on the contralateral thigh with the toes being grasped and pulled into extension until a stretch is felt in the plantar fascia. Calf stretching exercise: To focus on stretching the gastrocnemius, participants will be taught to stand with both hands holding onto the wall and keep the affected leg back with knee straightened and heel in contact with the floor. Slowly lean forward to the wall until a stretch is felt in the calf. To focus on stretching the soleus, the same procedures will be taught except with the affected knee being bent. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 18-65 years
- Clinical diagnosis of plantar fasciitis in accordance with the clinical guidelines of the Orthopaedic Section of the American Physical Therapy Association (APTA)
- Pain intensity of a minimum score of 5 on 11-point NPRS
- Presence of trigger points of the gastrocnemius or soleus muscles or both
- History of plantar heel pain for over 1 month
Key exclusion criteria (10 listed)
- Needle allergy or phobia
- Bleeding disorders or severe vascular disease
- Pregnancy
- Cancer
- Fracture or surgery in the foot region or leg
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 |
|---|---|---|
| Dry needlingDry needling + stretching exercise | Other | Dry needling + stretching exercise |
| Stretching exerciseStretching exercise only | Other | Stretching exercise |
Primary outcome
Change in first-step pain intensity
Time frame: Baseline to 4 weeks
The change in first-step pain intensity will be measured by the numeric pain rating scale (NPRS), which is a 11-point scale ranging from 0 ("no pain") to 10 ("the worst pain imaginable").
3 secondary outcomes
Change in pain-related disability
Time frame: Baseline to 4 weeks
Change in dynamic balance
Time frame: Baseline to 4 weeks
Change in weight bearing ankle dorsiflexion range of motion
Time frame: Baseline to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Background: PubMed 33760098Llurda-Almuzara L, Labata-Lezaun N, Meca-Rivera T, Navarro-Santana MJ, Cleland JA, Fernandez-de-Las-Penas C, Perez-Bellmunt A. Is Dry Needling Effective for the Management of Plantar Heel Pain or Plantar Fasciitis? An Updated Systematic Review and Meta-Analysis. Pain Med. 2021 Jul 25;22(7):1630-1641. doi: 10.1093/pm/pnab114.
- Background: PubMed 21504939Cotchett MP, Landorf KB, Munteanu SE, Raspovic AM. Consensus for dry needling for plantar heel pain (plantar fasciitis): a modified Delphi study. Acupunct Med. 2011 Sep;29(3):193-202. doi: 10.1136/aim.2010.003145. Epub 2011 Apr 18.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry needling and Stretching exercise in people with Plantar Fascitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 10 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 14 Feb 2023. 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 Hong Kong. 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. 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 Wong (64323868, 1155168950@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in first-step pain intensity (time frame: Baseline to 4 weeks). 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 NCT05588349, which also lists 2 linked publications.
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 14 Feb 2023.