Hallux ValgusNCT06023823
The Role of Dry Needling in Hallux Valgus
A study testing Toe spread out and Dry needling+Toe spread out in people with Hallux Valgus and Myofascial Pain Syndrome, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Hallux Valgus, Myofascial Pain Syndrome
- What is being tested?
- Toe spread out and Dry needling+Toe spread out
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 25 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 25-65 years old with pain for more than 4 weeks
- Hallux valgus angle between 16-40 degrees
- Activity VAS value above 4
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Training and Resarch Hospital
Istanbul
About this study
Official title: Dry Needling of the Abductor Hallucis Muscle in the Management of Hallux Valgus; Effect on Pain, Function and Valgus Angle
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.
- Conditions
- Hallux Valgus, Myofascial Pain Syndrome
- Being tested
- Toe spread out, Dry needling+Toe spread out
- Medical subject headings
- Hallux Valgus, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toe spread outOther
toe-spread-out exercise.
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.
| Study group | Role | What they receive |
|---|---|---|
| Toe spread out treatment | Active comparator | Not described Receives: Other: Toe spread out; Other: Dry needling+Toe spread out |
| Dry needling | Active comparator | Not described Receives: Other: Dry needling+Toe spread out |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 7 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2023
- Study start1 May 2023
- Primary completion15 Sep 2023
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Burak Tayyip Dede, Istanbul Training and Research Hospital
- Investigators
- Burak Tayyip Dede, Principal investigator, İstanbul Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06023823
- Sponsor's protocol ID
- 07/04/2023; 2011-KAEK-50;88
- Status last verified
- Sep 2023
- First submitted
- 26 Aug 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling of the Abductor Hallucis Muscle in the Management of Hallux Valgus; Effect on Pain, Function and Valgus Angle
- ClinicalTrials.gov ID
- NCT06023823
- Acronym / sponsor ID
- 07/04/2023; 2011-KAEK-50;88
- Conditions
- Hallux Valgus, Myofascial Pain Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Istanbul Training and Research HospitalOther government
- Study start
- 1 May 2023 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 5 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toe spread out treatment | Active comparator | Other: Toe spread out, Other: Dry needling+Toe spread out |
| Dry needling | Active comparator | Other: Dry needling+Toe spread out |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 25-65 years old with pain for more than 4 weeks
- Hallux valgus angle between 16-40 degrees
- Activity VAS value above 4
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toe spread outtoe-spread-out exercise. | Other | Toe spread out treatment |
| Dry needling+Toe spread outThe 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. | Other | Dry needling, Toe spread out treatment |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Burak Tayyip Dede principal investigator
İstanbul Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toe spread out and Dry needling+Toe spread out in people with Hallux Valgus and Myofascial Pain Syndrome, run by Istanbul Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.