ClinicalTrials.gg
CompletedNCT06023823Updated Oct 3, 2023

The Role of Dry Needling in Hallux Valgus

An interventional study of Toe spread out and Dry needling+Toe spread out in Hallux Valgus and Myofascial Pain Syndrome, sponsored by Istanbul Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-10-03.

Sponsored by Istanbul Training and Research Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled May 2023, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 11 studies in Hallux Valgus with a site in Turkey — 4 open to participants now, 4 under way, none of them phase 3. Hallux Valgus · Turkey.

Started
2023
with 1 other
No phase
7 of 11
3 open now
Registered
3rd of 11
by date
Lead sponsor
1 of 11
Istanbul Training and Research Hospital

Among the 11 studies in Hallux Valgus with a site in Turkey, this one is one of 2 that started in 2023, is one of 7 with no phase, and was the 3rd registered.

Hallux Valgus

157 studies on the registry are indexed under Hallux Valgus; 36 are open to participants now.

Browse Hallux Valgus studies →

Open to participants now

4 of the 11 studies in Hallux Valgus with a site in Turkey are open now. Recruiting first, the newest first:

All 4 open studies →

A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →

Who these studies take

Of the 21 Hallux Valgus studies recruiting now, 10 (48%) set no upper age limit and 7 (33%) stop at 75 or younger; 3 take children under 18; 4 take healthy volunteers.

This study: 25 Years to 65 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Hallux Valgus with a site in Turkey, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Hallux Valgus
  • Myofascial Pain Syndrome
04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
31 participants (actual)

Study arms

  • Active comparator
    Toe spread out treatment

    Other: Toe spread out · Other: Dry needling+Toe spread out

  • Active comparator
    Dry needling

    Other: Dry needling+Toe spread out

Interventions

  • OtherToe spread out

    toe-spread-out exercise.

  • OtherDry 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 3 week, 7 week

  2. 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.

    Time frame: Baseline, 3 week, 7 week

  3. 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.

    Time frame: Baseline, 7 week

07

Study locations

1 site
  • Istanbul Training and Resarch Hospital
    Istanbul, Turkey
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2023 to primary completion in Sep 2023, 4 months.

Of 51 non-industry interventional studies with no phase under Hallux Valgus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 55. This study's 4 months is below that.

Counting every sponsor, half of 56 studies reached it within 26 months; a quarter within 11 and three quarters within 55.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2023
First posted
Sep 5, 2023
StartActual
May 1, 2023
Primary completionActual
Sep 15, 2023
CompletionActual
Sep 25, 2023
Last update
Oct 3, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06023823
Lead sponsor
Istanbul Training and Research Hospital
Responsible party
Burak Tayyip Dede (Medical Doctor, Istanbul Training and Research Hospital) — Principal investigator
First posted
Sep 5, 2023
Start date
May 1, 2023
Primary completion
Sep 15, 2023
Completion
Sep 25, 2023
Last update
Oct 3, 2023

Study contacts

Burak Tayyip Dede
principal investigator · İstanbul Training and Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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