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Effectiveness of Trigger Point Dry Needling on Plantar Fasciitis

Primary Purpose

Plantar Fascitis

Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Dry needling
Stretching exercise
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Plantar Fascitis focused on measuring Plantar fasciitis, Dry needling

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Our Lady of Maryknoll HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry needling + stretching exercise

Stretching exercise

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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").

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 15, 2022
Last Updated
February 12, 2023
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05588349
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascitis
Keywords
Plantar fasciitis, Dry needling

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Dry needling plus stretching exercise versus stretching exercise alone
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dry needling + stretching exercise
Arm Type
Experimental
Arm Description
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
Arm Title
Stretching exercise
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
Dry needling + stretching exercise
Intervention Type
Other
Intervention Name(s)
Stretching exercise
Intervention Description
Stretching exercise only
Primary Outcome Measure Information:
Title
Change in first-step pain intensity
Description
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").
Time Frame
Baseline to 4 weeks
Secondary Outcome Measure Information:
Title
Change in pain-related disability
Description
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.
Time Frame
Baseline to 4 weeks
Title
Change in dynamic balance
Description
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.
Time Frame
Baseline to 4 weeks
Title
Change in weight bearing ankle dorsiflexion range of motion
Description
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.
Time Frame
Baseline to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wong
Phone
64323868
Email
1155168950@link.cuhk.edu.hk
Facility Information:
Facility Name
Our Lady of Maryknoll Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wong

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33760098
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.
Results Reference
background
PubMed Identifier
21504939
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.
Results Reference
background

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Effectiveness of Trigger Point Dry Needling on Plantar Fasciitis

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