The Role of Dry Needling in Hallux Valgus

Hallux Valgus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06023823
• Other study ID #: 07/04/2023; 2011-KAEK-50;88
• Status: Completed
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: September 25, 2023

Study information

• Verified date: September 2023
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 25, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bunion
• Fibromyalgia
• Hallux Valgus
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes

Intervention

Other:
• Toe spread out
toe-spread-out exercise.
• 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.

Locations

Country	Name	City	State
Turkey	Istanbul Training and Resarch Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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