The Role of Dry Needling in Hallux Valgus

Dry Needling of the Abductor Hallucis Muscle in the Management of Hallux Valgus; Effect on Pain, Function and Valgus Angle

Forty Hallux valgus patients between the ages of 25-65 years, who are admitted to the Physical Medicine and Rehabilitation clinic with the complaint of 1st Metatarsophalangeal (MTF) pain and who meet the inclusion and exclusion criteria will be included. Hallux valgus (HV) angles will be measured by dorsoplantar radiography before the patients start the study. The HV angle was measured as the angle between the bisection line of the first metatarsal bone and the first proximal phalanx. Demographic data (age, gender, body mass index) will be recorded at the beginning of the study. Then, the initial Foot Functional Index (FFI) and Visual Analog Scale (VAS) scales were completed. The 1st MTF joint angle was also measured with a goniometer and recorded before starting the study. The patients were divided into two groups. The first group will be given 3 sessions of dry needling with Seirin branded 0.6*50 mm acupuncture needles for trigger point in the abductor hallucis muscle and toe-spread-out exercise. The second group will receive only toe-spread-out exercises. After starting the treatment, FFI and VAS scores and 1st MTF angles will be measured and recorded weekly with a goniometer. At the end of the 3-week treatment, the FFI and VAS scores of the participants will be re-evaluated after 1 week and 1 month, and the participants will be re-evaluated with a goniometer. The hallux valgus angle will be re-evaluated with X-ray 4 weeks after the end of the treatment.

Study Overview

• Status: Completed
• Conditions: Myofascial Pain Syndrome; Hallux Valgus
• Intervention / Treatment: Other: Toe spread out; Other: Dry needling+Toe spread out

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul Training and Resarch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 25-65 years old with pain for more than 4 weeks
• Hallux valgus angle between 16-40 degrees
• Activity VAS value above 4

Exclusion Criteria:

• Patients diagnosed with rheumatologic diseases
• Those diagnosed with Diabetes Mellitus (DM), those with chronic liver and kidney failure
• Those who received anti-inflammatory-analgesic treatment in the last 1 week
• Diagnosed with inflammatory rheumatic disease
• Those with a history of foot surgery
• Those with mid or hindfoot deformity
• Those with 1st MTF joint problems other than hallux valgus
• Those with a history of orthotic use
• Previous history of central or peripheral nerve damage, lower extremity neuropathy
• Those diagnosed with Diabetes Mellitus
• Those with cognitive impairment
• Unassisted mobilization

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dry needling	Other: Dry needling+Toe spread out; The group will be given 3 sessions of dry needling with Seirin branded 0.6*50 mm acupuncture needles for trigger pointe in the abductor hallucis muscle and additionally toe-spread-out exercise.
Active Comparator: Toe spread out treatment	Other: Toe spread out; toe-spread-out exercise.; Other: Dry needling+Toe spread out; The group will be given 3 sessions of dry needling with Seirin branded 0.6*50 mm acupuncture needles for trigger pointe in the abductor hallucis muscle and additionally toe-spread-out exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Does dry needling make an additional contribution to the spread out exercise in the pain management of hallux valgus?	Pain assessment was performed with (Visual Analog Scale) VAS score at baseline, 3.w and 8.w.	Baseline, 3 week, 7 week
Does dry needling make an additional contribution to the spread out exercise in the functional management of hallux valgus?	Function assessment was performed with (Foot Functional INdex) FFI score at baseline, 3.w and 8.w.	Baseline, 3 week, 7 week
Does dry needling provide an additional contribution to the spread out exercise in the hallux valgus angle?	The hallux valgus angle will be measured at baseline and 7.w on direct radiographs.	Baseline, 7 week

Collaborators and Investigators

• Sponsor: Istanbul Training and Research Hospital
• Investigators: Principal Investigator: Burak Tayyip Dede, Istanbul Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2023
• Primary Completion (Actual): September 15, 2023
• Study Completion (Actual): September 25, 2023

Study Registration Dates

• First Submitted: August 26, 2023
• First Submitted That Met QC Criteria: September 3, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 30, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Foot Deformities; Foot Deformities, Acquired; Fibromyalgia; Myofascial Pain Syndromes; Hallux Valgus; Bunion
• Other Study ID Numbers: 07/04/2023; 2011-KAEK-50;88

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No