NCT06160011

Brief Summary

Epicondylitis is one of the most common pathologies in tennis players. The search for an effective treatment is necessary for the relief of symptoms and the return to sports practice. Therefore, a ddry needling treatment in combination with electricity is postulated as an alternative to isolated dry needling treatment or conventional physiotherapy treatment. Data will be collected in relation to pain and muscle activation by EMG in order to check the effectiveness of these techniques as well as the muscle activation that is generated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

December 9, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

November 20, 2023

Last Update Submit

December 4, 2024

Conditions

Keywords

Electrical dry needlingEMGTennisPhysiotherapy

Outcome Measures

Primary Outcomes (3)

  • Muscular activation

    Electromyography: the adequate electrical activity of the muscles will be observed and the nerves will show adequate conduction of electrical impulses. This indicates normal and healthy functioning of the neuromuscular system

    30 minutes

  • Subjective Pain

    Numeric Pain Rating Scale: Single 11-point numerical scale where scores correspond to Pain scores are interpreted as: 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain and 7-10 = severe pain. 7-10 = severe pain

    Initial, up to 2 weeks, and up to 6 weeks

  • Algometry

    Pressure algometer is an instrument with a circular disk on which the pressure measurements are displayed (with a range of 5 kg, divided into 10 parts of half a kilogram), and a rubber tip with a circular surface of 1 cm2, which allows transferring the pressure force to deep tissues.

    Initial, up to 2 weeks, and up to 6 weeks

Study Arms (3)

Intervention Group Electrical Dry Needling amd Physiotherapy

EXPERIMENTAL

The intervention group will receive a treatment composed by electrical dry needling and conventional physiotherapy treatment

Other: Electrical dry needling + Conventional physiotherapy

Intervention Group Dry Needling amd Physiotherapy

ACTIVE COMPARATOR

This group will receive a treatment composed by dry needling and conventional physiotherapy treatment

Other: Dry needling + Conventional physiotherapy

Control Group

PLACEBO COMPARATOR

Control group will receive conventional physiotherapy treatment

Other: Conventional physiotherapy

Interventions

Electrical dry needling and conventional physiotherapy treatment (massage, pressure release): 2 sessions

Intervention Group Electrical Dry Needling amd Physiotherapy

Dry needling and conventional physiotherapy treatment (massage, pressure release): 2 sessions

Intervention Group Dry Needling amd Physiotherapy

Conventional physiotherapy treatment (massage, pressure release): 2 sessions

Control Group

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • tennis players of both sexes
  • federated and non-federated of Castilla y León
  • playing tennis for at least 2 years
  • presence if one trigger point in epicondilar musculature

You may not qualify if:

  • not informed consent signature
  • nervous, vascular, articular or musculoskeletal system alterations
  • tests or techniques performed fear (belonephobia)
  • pregnancy
  • allergic to any type of metal or body oil
  • active febrile proces
  • current pain treatments in the area involved
  • surgery in the last year for upper limb pathologies
  • cognitive alterations
  • taking painkillers or anti-inflammatory drugs 24 hours before the start of the study or taking them during the duration of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Salamanca

Salamanca, Salamanca, 37007, Spain

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Elbow TendinopathyTendinopathyMuscular DiseasesMusculoskeletal DiseasesElbow InjuriesArm InjuriesWounds and InjuriesTendon Injuries

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 20, 2023

First Posted

December 7, 2023

Study Start

December 1, 2023

Primary Completion

April 30, 2024

Study Completion

August 31, 2024

Last Updated

December 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations