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Completed

NCT Number: NCT06023823

The Role of Dry Needling in Hallux Valgus

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.

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Key information

Conditions

Hallux Valgus Foot Deformities Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndrome Myofascial Pain Syndromes

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Training and Resarch Hospital

Istanbul, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Toe spread out

Other

toe-spread-out exercise.

Dry needling+Toe spread out

Other

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.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 5, 2023
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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