The Role of Dry Needling in Hallux Valgus

• ClinicalTrials.gov Identifier: NCT06023823
• Recruitment Status: Completed
• First Posted: September 5, 2023
• Last Update Posted: October 3, 2023
• Sponsor: Istanbul Training and Research Hospital
• Information provided by (Responsible Party): Burak Tayyip Dede, Istanbul Training and Research Hospital

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Hallux Valgus; Myofascial Pain Syndrome	Other: Toe spread out; Other: Dry needling+Toe spread out	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Dry Needling of the Abductor Hallucis Muscle in the Management of Hallux Valgus; Effect on Pain, Function and Valgus Angle
• Actual Study Start Date: May 1, 2023
• Actual Primary Completion Date: September 15, 2023
• Actual Study Completion Date: September 25, 2023

Arms and Interventions

Arm	Intervention/treatment
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.
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.

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 25 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Turkey

Istanbul Training and Resarch Hospital

Istanbul, Turkey

Sponsors and Collaborators

Istanbul Training and Research Hospital

Investigators

• Principal Investigator: Burak Tayyip Dede; İstanbul Training and Research Hospital

More Information

• Responsible Party: Burak Tayyip Dede, Medical Doctor, Istanbul Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT06023823
• Other Study ID Numbers: 07/04/2023; 2011-KAEK-50;88
• First Posted: September 5, 2023
• Last Update Posted: October 3, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Myofascial Pain Syndromes; Fibromyalgia; Hallux Valgus; Bunion; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Foot Deformities; Foot Deformities, Acquired