Effectiveness of Trigger Point Dry Needling on Plantar Fasciitis

February 12, 2023 updated by: Wong Wing Sze, Chinese University of Hong Kong

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Our Lady of Maryknoll Hospital
        • Contact:
          • Wong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dry needling + stretching exercise
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
Other: Dry needling
Dry needling + stretching exercise
ACTIVE_COMPARATOR: Stretching exercise

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.
Other: Stretching exercise
Stretching exercise only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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").
Baseline to 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain-related disability
Time Frame: Baseline to 4 weeks
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
Change in dynamic balance
Time Frame: Baseline to 4 weeks
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
Change in weight bearing ankle dorsiflexion range of motion
Time Frame: Baseline to 4 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2023

Primary Completion (ANTICIPATED)

April 30, 2023

Study Completion (ANTICIPATED)

May 31, 2023

Study Registration Dates

First Submitted

October 15, 2022

First Submitted That Met QC Criteria

October 18, 2022

First Posted (ACTUAL)

October 20, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 12, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChineseUHK2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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