NCT05588349

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

October 15, 2022

Last Update Submit

February 12, 2023

Conditions

Keywords

Plantar fasciitisDry needling

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in pain-related disability

    Baseline to 4 weeks

  • Change in dynamic balance

    Baseline to 4 weeks

  • Change in weight bearing ankle dorsiflexion range of motion

    Baseline to 4 weeks

Study Arms (2)

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

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.

Other: Stretching exercise

Interventions

Dry needling + stretching exercise

Dry needling + stretching exercise

Stretching exercise only

Stretching exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Our Lady of Maryknoll Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (2)

  • 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.

    PMID: 33760098BACKGROUND
  • 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.

    PMID: 21504939BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar

Interventions

Dry NeedlingMuscle Stretching Exercises

Condition Hierarchy (Ancestors)

FasciitisMusculoskeletal DiseasesFoot Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesExercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Dry needling plus stretching exercise versus stretching exercise alone
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Student

Study Record Dates

First Submitted

October 15, 2022

First Posted

October 20, 2022

Study Start

February 1, 2023

Primary Completion

April 30, 2023

Study Completion

May 31, 2023

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations