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Evaluation of the Effectiveness of Dry Needling Versus Foam Roller

Primary Purpose

Myofascial Pain Syndromes, Dry Needling

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Sponsored by
Fundación Universidad Católica de Valencia San Vicente Mártir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myofascial Pain Syndromes focused on measuring Dry needling, Myofascial pain syndromes, Ankle joint

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Juan Vicente Mampel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry Needling Group

Foam Roller Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Range of motion (ROM)
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.

Secondary Outcome Measures

Lunge / Ankle Test Test
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.
Counter Movement Jump (CMJ)
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'.

Full Information

First Posted
October 19, 2020
Last Updated
May 10, 2021
Sponsor
Fundación Universidad Católica de Valencia San Vicente Mártir
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1. Study Identification

Unique Protocol Identification Number
NCT04600830
Brief Title
Evaluation of the Effectiveness of Dry Needling Versus Foam Roller
Official Title
Evaluation of the Effectiveness of Dry Needling Against Foam Roller in the Short Term, Healthy Athletes With Reduced Mobility of the Ankle Joint
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
May 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Universidad Católica de Valencia San Vicente Mártir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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?
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pain Syndromes, Dry Needling
Keywords
Dry needling, Myofascial pain syndromes, Ankle joint

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
A simple blind masking will be carried out to reduce biases in the interpretation of the results. The researchers responsible for the observation, measurement of the ankle ROM and Counter Movement Jump, will not be informed of the treatment performed at the time of immediate post-treatment and post-treatment at 24 hours.
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry Needling Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Foam Roller Group
Arm Type
Active Comparator
Arm Description
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 Type
Procedure
Intervention Name(s)
Dry needling
Intervention Description
Intervention with deep dry needling on latent myofascial trigger points (MTrPs) in gastrocnemius muscle.
Primary Outcome Measure Information:
Title
Range of motion (ROM)
Description
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.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Lunge / Ankle Test Test
Description
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.
Time Frame
48 hours
Title
Counter Movement Jump (CMJ)
Description
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'.
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Vicente
Organizational Affiliation
Fundacion UCV
Official's Role
Principal Investigator
Facility Information:
Facility Name
Juan Vicente Mampel
City
Valencia
ZIP/Postal Code
46021
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21147417
Citation
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.
Results Reference
background
PubMed Identifier
16259310
Citation
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.
Results Reference
background
PubMed Identifier
31788353
Citation
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.
Results Reference
background
PubMed Identifier
25883868
Citation
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.
Results Reference
background
PubMed Identifier
26118527
Citation
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.
Results Reference
background

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Evaluation of the Effectiveness of Dry Needling Versus Foam Roller

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