Limited DorsiflexionNCT02087969
Triceps Surae Trigger Point Size and Muscle Extensibility
A study testing Dry Needling and Stretching in people with Limited Dorsiflexion and Limited Ankle Range of Motion, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of dry needling in improving ankle range of motion and functional outcomes. There have been an increasing number of studies on dry needling as an intervention for pain but none thus far that have studied functional outcome measures of the ankle. Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Limited Dorsiflexion, Limited Ankle Range of Motion
- What is being tested?
- Dry Needling and Stretching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Jan 2015
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 18-30 Years Old
- No history of ankle surgery
- No current ankle injuries
Who cannot join
- hypothyroidism
- fibromyalgia
- connective tissue disorders
- chronic pain
- bleeding disorders including use of anti-coagulants
- vitamin D and B12 deficiencies
Show all 12Show fewer
- active sites of cancer
- local or systemic infections
- local skin lesions, local lymphedema
- peripheral vascular disease including varicose veins
- compromised immune system
- needle phobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Dry Needling to Decrease Trigger Point Size and Increase Soft Tissue Extensibility in the Triceps Surae Muscle as Measured Via Musculoskeletal Ultrasound
The purpose of this study is to determine the effectiveness of dry needling in improving ankle range of motion and functional outcomes. There have been an increasing number of studies on dry needling as an intervention for pain but none thus far that have studied functional outcome measures of the ankle. The study will include healthy male subjects between the ages of 18-30 years old randomized in to 3 intervention groups of: dry needling of the triceps surae, triceps surae stretching only, dry needling and stretching. The subjects who receive dry needling as an intervention will have the trigger point identified and dry needling performed while under musculoskeletal ultrasound visualization. The subjects will undergo pre and post intervention testing including Lower Quarter Y-Balance test, passive ankle dorsiflexion, closed chain half kneeling dorsiflexion, standing dorsiflexion, deep squat, multisegmental flexion as well as Marx Activity Level Scale. There will be 3 days between the initial testing/intervention and follow up. These outcomes will be the primary variables of interest. Ultrasound, Y balance testing, self stretching, and range of motion measurements are safe and pose no risk to the subject. Dry Needling has been found to be very safe and effective in the hands of physical therapists with a calculated risk of adverse events to be less than 0.04%.
- Being tested
- Dry Needling, Stretching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingProcedure or surgery
StretchingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Dry Needling | Experimental | Dry Needling to Triceps Surae Receives: Procedure: Dry Needling |
| Stretching | Experimental | Subjects will be given a home exercise program of stretches which are commonly prescribed to improve ankle dorsiflexion. Receives: Procedure: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Ankle Dorsiflexion Range Of Motion
Ankle range of motion measures will be record before and immediately after the intervention.
Measured: Baseline and 10 Minutes
Change in Ankle Dorsiflexion Range of Motion
Ankle dorsiflexion will again be measured at three days after the intervention to determine short term effectiveness of results.
Measured: Baseline and 3 Days
Secondary outcomes (2)
Change in Y-Balance Test for the Lower Quarter
Test of balance and functional performance of lower extremities.
Measured: Baseline and 20 Minutes
Change in Y Balance Test for the Lower Quarter
Y Balance Test for the Lower Quarter will be assessed again at 3 days after the intervention to assess short term effectiveness.
Measured: Baseline and 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Limited DorsiflexionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad Cook, PhD, PT, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087969
- Sponsor's protocol ID
- Pro00052299
- Status last verified
- Mar 2015
- First submitted
- 7 Mar 2014
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Dry Needling to Decrease Trigger Point Size and Increase Soft Tissue Extensibility in the Triceps Surae Muscle as Measured Via Musculoskeletal Ultrasound
- ClinicalTrials.gov ID
- NCT02087969
- Acronym / sponsor ID
- Pro00052299
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 14 Mar 2014 (estimated)
- 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.
The purpose of this study is to determine the effectiveness of dry needling in improving ankle range of motion and functional outcomes. There have been an increasing number of studies on dry needling as an intervention for pain but none thus far that have studied functional outcome measures of the ankle. The study will include healthy male subjects between the ages of 18-30 years old randomized in to 3 intervention groups of: dry needling of the triceps surae, triceps surae stretching only, dry needling and stretching. The subjects who receive dry needling as an intervention will have the trigger point identified and dry needling performed while under musculoskeletal ultrasound visualization. The subjects will undergo pre and post intervention testing including Lower Quarter Y-Balance test, passive ankle dorsiflexion, closed chain half kneeling dorsiflexion, standing dorsiflexion, deep squat, multisegmental flexion as well as Marx Activity Level Scale. There will be 3 days between the initial testing/intervention and follow up. These outcomes will be the primary variables of interest. Ultrasound, Y balance testing, self stretching, and range of motion measurements are safe and pose no risk to the subject. Dry Needling has been found to be very safe and effective in the hands of physical therapists with a calculated risk of adverse events to be less than 0.04%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Needling | Experimental | Procedure: Dry NeedlingDry Needling to Triceps Surae |
| Stretching | Experimental | Procedure: StretchingSubjects will be given a home exercise program of stretches which are commonly prescribed to improve ankle dorsiflexion. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- 18-30 Years Old
- No history of ankle surgery
- No current ankle injuries
Key exclusion criteria (12 listed)
- hypothyroidism
- fibromyalgia
- connective tissue disorders
- chronic pain
- bleeding disorders including use of anti-coagulants
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 |
|---|---|---|
| Dry Needling | Procedure or surgery | Dry Needling |
| Stretching | Procedure or surgery | Stretching |
Primary outcome
Change of Ankle Dorsiflexion Range Of Motion
Time frame: Baseline and 10 Minutes
Ankle range of motion measures will be record before and immediately after the intervention.
Change in Ankle Dorsiflexion Range of Motion
Time frame: Baseline and 3 Days
Ankle dorsiflexion will again be measured at three days after the intervention to determine short term effectiveness of results.
2 secondary outcomes
Change in Y-Balance Test for the Lower Quarter
Time frame: Baseline and 20 Minutes
Change in Y Balance Test for the Lower Quarter
Time frame: Baseline and 3 Days
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 15 Dec 2017.
Related trials for Limited Dorsiflexion
Recruiting
Limited Ankle Dorsiflexion and Effect on Single Limb Squats in Individuals With Patellofemoral Pain
Patellofemoral Pain
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.
Chad Cook, PhD, PT principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Needling and Stretching in people with Limited Dorsiflexion and Limited Ankle Range of Motion, run by Duke University at 1 site in United States.
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 4 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 15 Dec 2017. 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 United States. 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?
Change of Ankle Dorsiflexion Range Of Motion (time frame: Baseline and 10 Minutes). The study lists 2 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 15 Dec 2017.