- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04600830
Evaluation of the Effectiveness of Dry Needling Versus Foam Roller
May 10, 2021 updated by: Fundación Universidad Católica de Valencia San Vicente Mártir
Evaluation of the Effectiveness of Dry Needling Against Foam Roller in the Short Term, Healthy Athletes With Reduced Mobility of the Ankle Joint
To compare the effects of dry needling and Foam roller in myofascial trigger points.
Needling has been shown to decrease pain in the short term; however, its effects on muscle force production are unclear.
There are differences between dry needling and foam roller after treatment?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Background: It has been shown that the decrease of the range of motion in the ankle, due to the presence of latent trigger points in the gastro-sole complex, can affect performance, as well as being a predisposing factor to injury.
Objective: To compare the effects of Dry Needling and Foam roller in healthy athletes with limited dorsal ankle flexion by the presence of latent trigger points.
Material and methods: This is a clinical trial, single-blind experimental study.
The sample will have a total of 44 students, volunteers, healthy of the degree of physiotherapy of the the investigator's university (UCV).
Participants who meet the inclusion criteria will be randomly assigned in two groups: Group 1 or Dry Needling (N = 22) and Group 2 or Foam Roller (N = 22).
The range of motion of ankle will be assessed through the Leg Motion system (Check Your Motion®, Albacete, Spain).
Assessed thought Ankle Test (post-intervention and 24 hours later).
The reference values to consider the decreased ankle ROM will be <11.5 cm, <35º measured with Easy Angle® digital goniometer (Meloq AB, Sweden) and/or if it has a difference of 1.5 cm between both extremities.
Thus, the effect on previous activity performance will be assessed thought the Counter Movement Jump.
Data analysis: Once the distribution of the sample is determined, a descriptive analysis of the data will be carried out and an ANOVA of repeated measures.
Will be used to compare the data found in the two groups that make up the study taking into account a 95% CI and an error less than 0.05.
Study Type
Interventional
Enrollment (Actual)
45
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
-
-
-
Valencia, Spain, 46021
- Juan Vicente Mampel
-
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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 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Students of physiotherapy degree of the university
- All participants who present restriction on active ankle dorsiflexion (<35º).
- They must be diagnosed through manual therapy of latent PG in the gastro-soleus complex.
Exclusion Criteria:
- Subjects suffering from belonephobia
- Pathology of connective tissue
- Coagulation problems
- Lymphatic disorders
- Diabetes
- Surgical history in the lower limb (last 12 months)
- Prior treatment with dry needling (last 6 months)
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dry Needling Group
Dry needling will be applied to the myofascial trigger points of the gastrocnemius muscle.
With the dry needle (0.3 x 40 mm.
Myofib, Toledo, Spain).
Thus, insert the needle until you get the first twitch response.
Once the first twitch response is obtained, the needle will move about 2-3 mm vertically quickly.
Twenty-five insertions without leaving the skin.
The approximate frequency of 1 Hz for 25 to 30 seconds.
|
Intervention with deep dry needling on latent myofascial trigger points (MTrPs) in gastrocnemius muscle.
|
Active Comparator: Foam Roller Group
The myofascial self-release technique with the FR Black Roll PRO (Bottighogen, Switzerland).
The subject will move his body in the same direction as the muscle fibers, using his hands to propel and get the roller to slide back and forth.
The device will only be applied at the muscular level, avoid the area of the Achilles tendon.
It will be repeated on the contralateral leg.
A total of three 60-second steps is executed on each leg and a 30-second break between both.
|
Intervention with deep dry needling on latent myofascial trigger points (MTrPs) in gastrocnemius muscle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Range of motion (ROM)
Time Frame: 48 hours
|
Range of motion (ROM) is a key measurement to help in detecting and diagnosing musculoskeletal deficits, monitoring treatment progression, and guiding the treatment plan.
Measurement of ROM is a relevant point and an important item of the joint evaluation process when using any ankle scoring system as part of the ankle and ankle joint evaluation.
ROM of ankle joint in load PRE, POST treatment and POST 24 hours after of intervention.
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lunge / Ankle Test Test
Time Frame: 48 hours
|
he Weight-bearing lunge test (WBLT) or Dorsiflexion Lunge Test (DFT) is used to assess the dorsiflexion range of movement (DROM) at the ankle joint.
Participants are instructed to lunge forward until their knee touches the wall (vertical line).
The heel is required to remain in contact with the floor at all times.
The foot is moved away from the wall to the point where the knee can only make slight contact with the Wall.
|
48 hours
|
Counter Movement Jump (CMJ)
Time Frame: 48 hours
|
The countermovement jump (CMJ) is a simple, practical, valid, and very reliable measure of lower-body power.
This suggests that performances in the CMJ are linked with maximal speed, maximal strength, and explosive-strength.
When the CMJ is performed using the arm-swing, performances can be ≥10% higher than when they include no arm-swing.
Contact mats, force platforms, accelerometers, high-speed cameras, and infrared platforms have all been shown to provide a valid and reliable measure of CMJ performance - though force platforms are considered as the 'gold-standard'.
|
48 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Juan Vicente, Fundacion UCV
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.
General Publications
- Calatayud J, Martin F, Gargallo P, Garcia-Redondo J, Colado JC, Marin PJ. The validity and reliability of a new instrumented device for measuring ankle dorsiflexion range of motion. Int J Sports Phys Ther. 2015 Apr;10(2):197-202.
- Grieve R, Clark J, Pearson E, Bullock S, Boyer C, Jarrett A. The immediate effect of soleus trigger point pressure release on restricted ankle joint dorsiflexion: A pilot randomised controlled trial. J Bodyw Mov Ther. 2011 Jan;15(1):42-9. doi: 10.1016/j.jbmt.2010.02.005. Epub 2010 Mar 23.
- Gerwin RD. A review of myofascial pain and fibromyalgia--factors that promote their persistence. Acupunct Med. 2005 Sep;23(3):121-34. doi: 10.1136/aim.23.3.121.
- de Benito AM, Valldecabres R, Ceca D, Richards J, Barrachina Igual J, Pablos A. Effect of vibration vs non-vibration foam rolling techniques on flexibility, dynamic balance and perceived joint stability after fatigue. PeerJ. 2019 Nov 26;7:e8000. doi: 10.7717/peerj.8000. eCollection 2019.
- Grieve R, Goodwin F, Alfaki M, Bourton AJ, Jeffries C, Scott H. The immediate effect of bilateral self myofascial release on the plantar surface of the feet on hamstring and lumbar spine flexibility: A pilot randomised controlled trial. J Bodyw Mov Ther. 2015 Jul;19(3):544-52. doi: 10.1016/j.jbmt.2014.12.004. Epub 2014 Dec 18.
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)
May 1, 2020
Primary Completion (Actual)
May 15, 2020
Study Completion (Actual)
May 10, 2021
Study Registration Dates
First Submitted
October 19, 2020
First Submitted That Met QC Criteria
October 22, 2020
First Posted (Actual)
October 23, 2020
Study Record Updates
Last Update Posted (Actual)
May 11, 2021
Last Update Submitted That Met QC Criteria
May 10, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UCV/2019 - 2020/062
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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