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Effectiveness of Dry Needling of the Gastrocnemius Muscle VS Electrolysis in Subjects With Achilles Tendinopathy

Primary Purpose

Achilles Tendinopathy, Pain

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
Electrolysis
Sponsored by
Universidad Católica de Ávila
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Achilles Tendinopathy focused on measuring achilles tendon, electrolysis, tendinopathy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signing of informed consent both to participate in the study and to undergo invasive in the study, as well as to undergo invasive physiotherapy techniques. physiotherapy techniques. Presence of symptoms (swelling or pain) for at least 3 months. Positive Achilles tendon palpation test. Males and females over 18 years of age. Presence of MMP in the gastrocnemius muscle, meeting at least three of the following criteria diagnostic criteria described by Travell and Simons: Presence of palpable tight band. Local pain on pressure at the nodule of the tense band. Recognition by the patient as his usual pain after mechanical after mechanical stimulation of the sensitive nodule. Limitation of range of motion. Exclusion Criteria: Any related acute or chronic musculoskeletal disease that may related chronic musculoskeletal disease, which may affect the results of the study

Sites / Locations

  • Jorge Velázquez SaornilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Dry needling+eccentric exercises

Electrolysis+eccentric exercises

Arm Description

Application of dry needling on the hyperalgesic trigger points of the gastrocnemius muscle and subsequent inclusion of eccentric exercises.

Application of electrolysis to the Achilles tendon and subsequent inclusion of eccentric exercises.

Outcomes

Primary Outcome Measures

Pain intensity.
Measurement of pain intensity using the VAS scale (0 minimum pain, 10 maximum bearable pain).

Secondary Outcome Measures

Pressure pain threshold
Pressure pain threshold measured by algometer over the most hyperalgesic point on the Achilles tendon measured in Newtons.
Range of movement
Measurement of ankle dorsiflexion range of motion measured by digital goniometer.

Full Information

First Posted
October 6, 2023
Last Updated
October 11, 2023
Sponsor
Universidad Católica de Ávila
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1. Study Identification

Unique Protocol Identification Number
NCT06080334
Brief Title
Effectiveness of Dry Needling of the Gastrocnemius Muscle VS Electrolysis in Subjects With Achilles Tendinopathy
Official Title
Effectiveness of Dry Needling of the Gastrocnemius Muscle vs. Electrolysis in Subjects With Achilles Tendinopathy: a Randomised Single-blind Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica de Ávila

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
Achilles tendinopathy is the injury that primarily occurs in athletes and people who engage in repetitive activities that involve the calf muscles, such as running, jumping, and sudden acceleration and deceleration movements. To observe the effectiveness of dry needling in the PGM of the gastrocnemius muscle, in the short and medium term, on the intensity of pain in gastrocnemius muscle, in the short and medium term, on pain intensity in patients with patients with Achilles tendinopathy, compared to the application of ultrasound-guided percutaneous electrolysis on the tendon.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Achilles Tendinopathy, Pain
Keywords
achilles tendon, electrolysis, tendinopathy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dry needling+eccentric exercises
Arm Type
Experimental
Arm Description
Application of dry needling on the hyperalgesic trigger points of the gastrocnemius muscle and subsequent inclusion of eccentric exercises.
Arm Title
Electrolysis+eccentric exercises
Arm Type
Experimental
Arm Description
Application of electrolysis to the Achilles tendon and subsequent inclusion of eccentric exercises.
Intervention Type
Device
Intervention Name(s)
Dry needling
Intervention Description
Dry needling using the Hong technique on the most hyperalgesic trigger point in the gastrocnemius muscle.
Intervention Type
Device
Intervention Name(s)
Electrolysis
Intervention Description
Electrolysis on the Achilles tendon using ultrasound-guided technique.
Primary Outcome Measure Information:
Title
Pain intensity.
Description
Measurement of pain intensity using the VAS scale (0 minimum pain, 10 maximum bearable pain).
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Pressure pain threshold
Description
Pressure pain threshold measured by algometer over the most hyperalgesic point on the Achilles tendon measured in Newtons.
Time Frame
5 weeks
Title
Range of movement
Description
Measurement of ankle dorsiflexion range of motion measured by digital goniometer.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signing of informed consent both to participate in the study and to undergo invasive in the study, as well as to undergo invasive physiotherapy techniques. physiotherapy techniques. Presence of symptoms (swelling or pain) for at least 3 months. Positive Achilles tendon palpation test. Males and females over 18 years of age. Presence of MMP in the gastrocnemius muscle, meeting at least three of the following criteria diagnostic criteria described by Travell and Simons: Presence of palpable tight band. Local pain on pressure at the nodule of the tense band. Recognition by the patient as his usual pain after mechanical after mechanical stimulation of the sensitive nodule. Limitation of range of motion. Exclusion Criteria: Any related acute or chronic musculoskeletal disease that may related chronic musculoskeletal disease, which may affect the results of the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Velázquez Saornil, PhD.
Phone
+34920251020
Email
jorge.velazquezsaornil@ucavila.es
Facility Information:
Facility Name
Jorge Velázquez Saornil
City
Ávila
ZIP/Postal Code
05005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Velázquez Saornil, PhD.
Phone
+34920251020
Email
jorge.velazquezsaornil@ucavila.es

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34616594
Citation
Zunko H, Vauhnik R. Reliability of the weight-bearing ankle dorsiflexion range of motion measurement using a smartphone goniometer application. PeerJ. 2021 Sep 22;9:e11977. doi: 10.7717/peerj.11977. eCollection 2021.
Results Reference
background
PubMed Identifier
25133077
Citation
Kedia M, Williams M, Jain L, Barron M, Bird N, Blackwell B, Richardson DR, Ishikawa S, Murphy GA. The effects of conventional physical therapy and eccentric strengthening for insertional achilles tendinopathy. Int J Sports Phys Ther. 2014 Aug;9(4):488-97.
Results Reference
result
PubMed Identifier
36292308
Citation
Lucena-Anton D, Luque-Moreno C, Valencia-Medero J, Garcia-Munoz C, Moral-Munoz JA. Effectiveness of Dry Needling of Myofascial Trigger Points in the Triceps Surae Muscles: Systematic Review. Healthcare (Basel). 2022 Sep 24;10(10):1862. doi: 10.3390/healthcare10101862.
Results Reference
result
PubMed Identifier
35210467
Citation
Martin-Sacristan L, Calvo-Lobo C, Pecos-Martin D, Fernandez-Carnero J, Alonso-Perez JL. Dry needling in active or latent trigger point in patients with neck pain: a randomized clinical trial. Sci Rep. 2022 Feb 24;12(1):3188. doi: 10.1038/s41598-022-07063-0.
Results Reference
result
PubMed Identifier
29932797
Citation
McDevitt AW, Snodgrass SJ, Cleland JA, Leibold MBR, Krause LA, Mintken PE. Treatment of individuals with chronic bicipital tendinopathy using dry needling, eccentric-concentric exercise and stretching; a case series. Physiother Theory Pract. 2020 Mar;36(3):397-407. doi: 10.1080/09593985.2018.1488023. Epub 2018 Jun 22.
Results Reference
result
PubMed Identifier
36583575
Citation
Asensio-Olea L, Leiros-Rodriguez R, Marques-Sanchez MP, de Carvalho FO, Maciel LYS. Efficacy of percutaneous electrolysis for the treatment of tendinopathies: A systematic review and meta-analysis. Clin Rehabil. 2023 Jun;37(6):747-759. doi: 10.1177/02692155221144272. Epub 2022 Dec 30.
Results Reference
result

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Effectiveness of Dry Needling of the Gastrocnemius Muscle VS Electrolysis in Subjects With Achilles Tendinopathy

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