NCT04968236

Brief Summary

In recent years, dry needling techniques have become widespread in the field of musculoskeletal pain treatment. Specifically, the management of myofascial trigger points has been the focus of these techniques. One of the objectives has been to improve the flexibility of those muscles that, due to the presence of myofascial trigger points, had a decrease in this parameter. This study aims to determine whether the application of a dry needling technique is more effective than analytical stretching of the muscle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

July 9, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

August 30, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

2.3 years

First QC Date

July 9, 2021

Last Update Submit

February 4, 2024

Conditions

Keywords

Deep Dry needlingSuperficial dry needlingmuscle stretchingrectus femoris

Outcome Measures

Primary Outcomes (2)

  • Knee joint range

    Knee flexion motion assessment by using the Goniometer APP, which is a digital goniometer that has proven its reliability and validity.The overall concordance coefficient has shown very good to excellent with active measurements (range, 0.60-0.97).

    Change from baseline at 7 days

  • Muscle strength

    Force will be measured by a manual dynamometer (microFET®2, Hoggan Scientific LLC). Measurements will be taken in Newtons (N). It will be evaluated in the movements of flexion of knee. Manual dynamometry has proven to be a tool with excellent intra-examiner reliability to assess isometric force in flexion of the knee, with an intraclass correlation coefficient (ICC) of 0.96 (0.93-0.98).

    Change from baseline at 7 days

Secondary Outcomes (1)

  • Pressure Pain Threshold (PPT)

    Change from baseline at 7 days

Study Arms (3)

Deep dry needling

EXPERIMENTAL

With the subject lying supine, we will first locate a latent myofascial trigger point in the rectus femoris muscle.Subsequently, we will apply a deep dry needling technique to the latent trigger point and make 10-12 incisions.

Other: Deep Dry Needling

Superficial dry needling

EXPERIMENTAL

With the subject lying supine, we will first locate a latent myofascial trigger point in the rectus femoris muscle.Subsequently, we will apply a superficial dry needling technique to the latent trigger point. Once the needle is placed in the subcutaneous cellular tissue, we manipulate the needle by twisting it until an unpleasant response is provoked. We keep the needle for 5 minutes

Other: Superficial Dry Needling

Passive muscle stretching

EXPERIMENTAL

With the patient positioned in the supine position, the pelvis stabilized with a strap and the lower extremity where we are going to apply the rectus femoris muscle stretch placed outside the table, we perform a passive stretching technique, increasing hip extension and knee flexion until the patient feels the tension. The position is held for 60 seconds.

Other: passive stretching

Interventions

In-and-out into different directions technique to encounter sensitive spots in an MTrP region.

Deep dry needling

This technique involves inserting a needle at a depth that is into the subcutaneous tissue and may be combined with manipulation of the needle while in situ.

Superficial dry needling

Type of stretching in which you stay in one position for a set time. In this case, hip extension and knee flexion.

Passive muscle stretching

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women between 18 and 65 years old.
  • To have at least 70º of knee flexion.
  • Be aware of and accept the study criteria (informed consent).
  • Healthy subjects, without previous hip or knee pathology or involved musculature.

You may not qualify if:

  • To have pain.
  • Having pain in the quadriceps or hip at the time of the study.
  • Currently following physiotherapy or analgesic treatment.
  • Belenophobia (fear of needles).
  • Recent surgery or trauma in the area.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28805, Spain

Location

Physiotherapy and Pain Institute

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 20, 2021

Study Start

August 30, 2021

Primary Completion

December 15, 2023

Study Completion

February 5, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations