NCT06023823

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2023

Completed
Last Updated

October 3, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

August 26, 2023

Last Update Submit

September 30, 2023

Conditions

Hallux ValgusMyofascial Pain Syndrome

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Toe spread out treatment

ACTIVE COMPARATOR
Other: Toe spread outOther: Dry needling+Toe spread out

Dry needling

ACTIVE COMPARATOR
Other: Dry needling+Toe spread out

Interventions

Toe spread outOTHER

toe-spread-out exercise.

Toe spread out treatment
Dry needling+Toe spread outOTHER

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.

Dry needlingToe spread out treatment

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Training and Resarch Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hallux ValgusMyofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal DiseasesMuscular Diseases

Study Officials

  • Burak Tayyip Dede

    İstanbul Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

August 26, 2023

First Posted

September 5, 2023

Study Start

May 1, 2023

Primary Completion

September 15, 2023

Study Completion

September 25, 2023

Last Updated

October 3, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

Locations

TU(1)