- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03273985
Effectiveness of Dry Needling in Shortened Triceps Surae Muscle (DN-TS)
December 6, 2017 updated by: César Calvo Lobo, Universidad de León
Effectiveness of Deep Dry Needling in Subjects With Shortened Triceps Surae Originated by Myofascial Pain Syndrome
To date, there are not studies about the effectiveness of dry needling versus ischemic compression in the triceps surae trigger points.
A randomized clinical trial is carried out.
A sample of 30 subjects are recruited and allocated into dry needling (n = 15) and ischemic compression (n = 15).
Outcome measurements such as dorsal flexion range of motion, plantar pressures, temperature, superficial muscle activity and trigger points pressure pain threshold are measured immediately before and after treatment.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Madrid
-
Fuenlabrada, Madrid, Spain, 28943
- Fisiofuenla
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Myofascial pain syndrome in the triceps surae muscle, limitation of ankle dorsal flexion range of motion.
Exclusion Criteria:
- Neurologic disorders, pharmacologic treatment (within the previous 3 months), cognitive impairment, prosthesis in the lower limb, systemic or infectious diseases, autoimmune diseases, fibromyalgia, hypothyroidism, anticoagulants or antiplatelet agents, and fear of needles.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dry needling
|
Trigger point deep dry needling
|
Experimental: Ischemic compression
|
Trigger point ischemic compression
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of motion
Time Frame: Change from Baseline Range of motion at 25 minutes
|
Ankle dorsal flexion by means of the goniometer
|
Change from Baseline Range of motion at 25 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plantar pressures
Time Frame: Change from Baseline Plantar pressures at 25 minutes
|
Plantar pressures platform
|
Change from Baseline Plantar pressures at 25 minutes
|
Temperature
Time Frame: Change from Baseline Temperature at 25 minutes
|
Thermal imaging
|
Change from Baseline Temperature at 25 minutes
|
Superficial muscle activity
Time Frame: Change from Baseline Superficial muscle activity at 25 minutes
|
Electromyography
|
Change from Baseline Superficial muscle activity at 25 minutes
|
Pressure pain threshold
Time Frame: Change from Baseline Pressure pain threshold at 25 minutes
|
Algometer
|
Change from Baseline Pressure pain threshold at 25 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2017
Primary Completion (Actual)
December 6, 2017
Study Completion (Actual)
December 6, 2017
Study Registration Dates
First Submitted
September 1, 2017
First Submitted That Met QC Criteria
September 2, 2017
First Posted (Actual)
September 6, 2017
Study Record Updates
Last Update Posted (Actual)
December 8, 2017
Last Update Submitted That Met QC Criteria
December 6, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DN-TS-UCM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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