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Myofascial Pain SyndromesNCT04600830

Evaluation of the Effectiveness of Dry Needling Versus Foam Roller

A study testing Dry needling in people with Myofascial Pain Syndromes and Dry Needling, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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? Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Myofascial Pain Syndromes, Dry Needling
What is being tested?
Dry needling
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSpain
Study dates
1 May 2020to 10 May 2021
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 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Juan Vicente Mampel

    Valencia, 46021

Other trials in Spain

About this study

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

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?

Read the 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.

Being tested
Dry needling
Keywords
Dry needling, Myofascial pain syndromes, Ankle joint
Medical subject headings
Myofascial Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry needlingProcedure or surgery

    Intervention with deep dry needling on latent myofascial trigger points (MTrPs) in gastrocnemius muscle.

Study groups in NCT04600830
Study groupRoleWhat they receive
Dry Needling GroupExperimentalDry 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.
Receives: Procedure: Dry needling
Foam Roller GroupActive comparatorThe 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.
Receives: Procedure: Dry needling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 48 hours

Secondary outcomes (2)

  1. 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.

    Measured: 48 hours

  2. 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'.

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2020
  2. Study start1 May 2020
  3. Primary completion15 May 2020
  4. Study completion10 May 2021

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04600830
Sponsor's protocol ID
UCV/2019 - 2020/062
Status last verified
May 2021
First submitted
19 Oct 2020
Last updated
11 May 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21147417

  • 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.

    PubMed 16259310

  • 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.

    PubMed 31788353

  • 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.

    PubMed 25883868

  • 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.

    PubMed 26118527

  • Vicente-Mampel J, Bautista IJ, Lopez-Soler J, Torregrosa-Valls J, Falaguera-Vera F, Gargallo P, Baraja-Vegas L. Acute effects of self-myofascial release compared to dry needling on myofascial pain syndrome related outcomes: Range of motion, muscle soreness and performance. A randomized controlled trial. J Bodyw Mov Ther. 2024 Oct;40:632-639. doi: 10.1016/j.jbmt.2024.04.005. Epub 2024 Apr 10.

    PubMed 39593656

Questions about this trial

What is this clinical trial studying?

A study testing Dry needling in people with Myofascial Pain Syndromes and Dry Needling, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.

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 7 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 11 May 2021. 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 Spain. 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?

Range of motion (ROM) (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04600830, which also lists 6 linked publications.

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 11 May 2021.

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