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

Tracking Information

• First Submitted Date: August 26, 2023
• First Posted Date: September 5, 2023
• Last Update Posted Date: October 3, 2023
• Actual Study Start Date: May 1, 2023
• Actual Primary Completion Date: September 15, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 3, 2023)

• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Hallux Valgus
• Myofascial Pain Syndrome

Intervention

• 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.

Study Arms

• Active Comparator: Toe spread out treatment
  Interventions:

  • Other: Toe spread out
  • Other: Dry needling+Toe spread out
• Active Comparator: Dry needling
  Intervention: Other: Dry needling+Toe spread out

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 30, 2023): 31
• Original Estimated Enrollment (submitted: September 3, 2023): 40
• Actual Study Completion Date: September 25, 2023
• Actual Primary Completion Date: September 15, 2023 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT06023823
• Other Study ID Numbers: 07/04/2023; 2011-KAEK-50;88
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Yes

• Current Responsible Party: Burak Tayyip Dede, Istanbul Training and Research Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Istanbul Training and Research Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Istanbul Training and Research Hospital
• Verification Date: September 2023