Effects of Diacutaneous Fibrolysis Over Neuromuscular Response

• Sponsor: Universitat Internacional de Catalunya (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03963674
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 3.9
• Patients Per Site Per Month: 7.6

Study Details

Study Description

Brief Summary

The study consists in evaluating the neuromuscular response of the gastrocnemious muscles before and after a diacutaneous fibrolysis over the gastrocnemious muscles.

Condition or Disease	Intervention/Treatment	Phase
Myofascial Pain Syndrome; Contraction	Other: Diacutaneous fibrolysis	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Diacutaneous Fibrolysis Over the Gastrocnemious Neuromuscular Response
• Actual Study Start Date: Feb 5, 2019
• Actual Primary Completion Date: Feb 5, 2019
• Anticipated Study Completion Date: Jun 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diacutaneous fibrolysis	Other: Diacutaneous fibrolysis; Diacutaneous fibrolysis over the gastrocnemious muscles
No Intervention: Control

Outcome Measures

Primary Outcome Measures

1. Delay time change [4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later]

   Time between an electric impulse and 10% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).

2. Contraction time change [4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later]

   Time between 10% and 90% of the contraction of the muscle that is being excited with an electric impulse, using an electromyography test (miliseconds).

3. Sustain time change [4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later]

   time between 50% of the contraction and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).

4. Relaxation time change [4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later]

   time between 90% and 50% of the relaxation of the muscle after being impulsed with an electric impulse, using an electromyography test (miliseconds).

5. Maximal displacement change [4 minutes before the intervention, 5 minutes after the intervention and 30 minutes later]

   Maximal displacement of the muscle after being excited with an electric impulse, using an electromyography test (miliseconds).

6. Stiffness change [2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later]

   Resistance to an external force that deforms its initial shape, using a "Myoton" (Newtons/metre).

7. Elasticity change [2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later]

   Capacity to recover its initial shape after the removal of the external force that lead to its deformation, using a "Myoton" (logarithmic decrement of a tissue's natural oscillation).

8. Relaxation change [2 minutes before the intervention, 7 minutes after the intervention and 30 minutes later]

   Time for a muscle to recover its shape from deformation after the removal of an external force, using a "Myoton" (miliseconds).

Secondary Outcome Measures

1. Gastrocnemious strength change [8 minutes before the intervention, 1 minute after the intervention and 30 minutes later]

   Isometric strength of the gastrocnemious muscles using a handheld dynamometer "microFET 2" (newtons).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Exclusion Criteria:

• Muscle injury in the last two months

• To not understand the study orders

• Suffer a musculoskeletal disorder that doesn't allow the subject to do the study protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Albert Pérez-Bellmunt	Sant Cugat del Vallès	Barcelona	Spain	08017

Sponsors and Collaborators

• Universitat Internacional de Catalunya

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Albert Pérez Bellmunt, Principal investigator, Universitat Internacional de Catalunya
• ClinicalTrials.gov Identifier: NCT03963674
• Other Study ID Numbers: Protocol 5
• First Posted: May 28, 2019
• Last Update Posted: May 28, 2019
• Last Verified: Feb 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Albert Pérez Bellmunt, Principal investigator, Universitat Internacional de Catalunya: Neuromuscular response; diacutaneous fibrolysis
• Additional relevant MeSH terms: Myofascial Pain Syndromes; Fibromyalgia

Study Results

No Results Posted as of May 28, 2019