Clinical trial NCT05588349: Effectiveness of Trigger Point Dry Needling on Plantar Fasciitis
Official title: Effectiveness of Trigger Point Dry Needling on Plantar Fasciitis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plantar Fascitis
Keywords: Plantar fasciitis
Dry needling
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Dry needling plus stretching exercise versus stretching exercise alone
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in first-step pain intensity
timeFrame: Baseline to 4 weeks
Secondary outcomes:
measure: Change in pain-related disability
timeFrame: Baseline to 4 weeks
measure: Change in dynamic balance
timeFrame: Baseline to 4 weeks
measure: Change in weight bearing ankle dorsiflexion range of motion
timeFrame: Baseline to 4 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Our Lady of Maryknoll Hospital
Study officials:
References:
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.
citation: 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.