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The Role of Dry Needling in Hallux Valgus

Primary Purpose

Hallux Valgus, Myofascial Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Toe spread out
Dry needling+Toe spread out
Sponsored by
Istanbul Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hallux Valgus

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Training and Resarch Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Toe spread out treatment

Dry needling

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 26, 2023
Last Updated
September 30, 2023
Sponsor
Istanbul Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06023823
Brief Title
The Role of Dry Needling in Hallux Valgus
Official Title
Dry Needling of the Abductor Hallucis Muscle in the Management of Hallux Valgus; Effect on Pain, Function and Valgus Angle
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
September 15, 2023 (Actual)
Study Completion Date
September 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus, Myofascial Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Toe spread out treatment
Arm Type
Active Comparator
Arm Title
Dry needling
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Toe spread out
Intervention Description
toe-spread-out exercise.
Intervention Type
Other
Intervention Name(s)
Dry needling+Toe spread out
Intervention Description
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 Outcome Measure Information:
Title
Does dry needling make an additional contribution to the spread out exercise in the pain management of hallux valgus?
Description
Pain assessment was performed with (Visual Analog Scale) VAS score at baseline, 3.w and 8.w.
Time Frame
Baseline, 3 week, 7 week
Title
Does dry needling make an additional contribution to the spread out exercise in the functional management of hallux valgus?
Description
Function assessment was performed with (Foot Functional INdex) FFI score at baseline, 3.w and 8.w.
Time Frame
Baseline, 3 week, 7 week
Title
Does dry needling provide an additional contribution to the spread out exercise in the hallux valgus angle?
Description
The hallux valgus angle will be measured at baseline and 7.w on direct radiographs.
Time Frame
Baseline, 7 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Burak Tayyip Dede
Organizational Affiliation
İstanbul Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Training and Resarch Hospital
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

The Role of Dry Needling in Hallux Valgus

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