NCT04476381

Brief Summary

The immediate effects (0-30 minutes) of a dry needling intervention on a trigger point on their viscoelastic properties (tone, elasticity and stiffness)

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 Feb 2018

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

Study Start

First participant enrolled

February 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
Last Updated

July 20, 2020

Status Verified

July 1, 2020

Enrollment Period

4 months

First QC Date

May 27, 2020

Last Update Submit

July 14, 2020

Conditions

Keywords

myofascial trigger points,dry needling,stiffness

Outcome Measures

Primary Outcomes (9)

  • Tone in Hertz measured with a myotonometer on the trigger point

    Measurement of the tone in Hz with the myotonometer MyotonPro on the trigger point

    baseline

  • Tone in Hertz measured with a myotonometer on the trigger point

    Measurement of the tone in Hz with the myotonometer MyotonPro on the trigger point

    immediately after the intervention

  • Tone in Hertz measured with a myotonometer on the trigger point

    Measurement of the tone in Hz with the myotonometer MyotonPro on the trigger point

    30 minutes after the intervention

  • Stiffness in N/m with a myotonometer on the trigger point

    Measurement of the stiffness in N/m with the myotonometer MyotonPro on the trigger point

    baseline

  • Stiffness in N/m with a myotonometer on the trigger point

    Measurement of the stiffness in N/m with the myotonometer MyotonPro on the trigger point

    immediately after the intervention

  • Stiffness in N/m with a myotonometer on the trigger point

    Measurement of the stiffness in N/m with the myotonometer MyotonPro on the trigger point

    30 minutes after the intervention

  • Elasticity (no units: inversely proportional to the decrement of the oscillations) with a myotonometer on the trigger point

    Measurement of the elasticity with the MyotonPro

    baseline

  • Elasticity (no units: inversely proportional to the decrement of the oscillations) with a myotonometer on the trigger point

    Measurement of the elasticity with the MyotonPro

    immediately after the intervention

  • Elasticity (no units: inversely proportional to the decrement of the oscillations) with a myotonometer on the trigger point

    Measurement of the elasticity with the MyotonPro

    30 minutes after the intervention

Study Arms (1)

Dry needling of a trigger point in the infraspinatus muscle

EXPERIMENTAL

Insertion a a acupuncture type needle into a trigger point in the infraspinatus muscle on the painful side to decrease the stiffness and tone and increase the elasticity

Procedure: Dry needling

Interventions

Dry needlingPROCEDURE

Insertion of a Optimed 40mm x 0.30 single use, sterile acupuncture needle into a active trigger point in the infraspinatus muscle

Dry needling of a trigger point in the infraspinatus muscle

Eligibility Criteria

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

You may qualify if:

  • present with chronic shoulder pain of non-traumatic origin (rated at least 2/10 on a numeric rating scale (NRS) for more than 3 months. The pain had to be located in the shoulder area or referred in the area of the infraspinatus as described by Travell and Simons (1999);
  • have a hyperirritable spot within a palpable tight band that reproduced the participant's pain when compressed by palpation; and
  • have a body mass index (BMI) lower than 28

You may not qualify if:

  • diagnosis of capsulitis, cancer, or metastasis;
  • previous shoulder or thorax surgery or a mastectomy;
  • shoulder girdle bone fracture;
  • C4-C5 or C6 radiculopathy;
  • known osteoporotic profile (positive bone densitometry);
  • apparent atrophy of the infraspinatus fossa (visual interpretation) and
  • contraindications to receive a DN intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRCHUS-Physius Lab

Sherbrooke, Quebec, J1H5N4, Canada

Location

MeSH Terms

Conditions

Shoulder Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Nathaly Gaudreault, PhD

    Université de Sherbrooke

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: One group, one measurement of the viscoelastic properties with the MyotonPro of a single trigger point before the dry needle insertion, one measurement with the MyotonPro right after and 30 minutes later
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 27, 2020

First Posted

July 20, 2020

Study Start

February 1, 2018

Primary Completion

June 7, 2018

Study Completion

September 20, 2019

Last Updated

July 20, 2020

Record last verified: 2020-07

Locations