Effectiveness of Trigger Point Dry Needling on Plantar Fasciitis

Plantar Fascitis Clinical Trial

Official title:

Effectiveness of Trigger Point Dry Needling on Plantar Fasciitis: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05588349
• Other study ID #: ChineseUHK2022
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: February 2023
• Source: Chinese University of Hong Kong
• Contact: Wong
• Phone: 64323868
• Email: 1155168950[@]link.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 31, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Needle allergy or phobia
• Bleeding disorders or severe vascular disease
• Pregnancy
• Cancer
• Fracture or surgery in the foot region or leg
• Infection
• 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

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fascitis

Intervention

Other:
• Dry needling
Dry needling + stretching exercise
• Stretching exercise
Stretching exercise only

Locations

Country	Name	City	State
Hong Kong	Our Lady of Maryknoll Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

Cotchett 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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").	Baseline to 4 weeks
Secondary	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.	Baseline to 4 weeks
Secondary	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.	Baseline to 4 weeks
Secondary	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.	Baseline to 4 weeks