Effects of Dry Needling When Applied to the Infraspinatus Muscle in People With Chronic Shoulder Pain

March 18, 2020 updated by: Nathaly Gaudreault, Université de Sherbrooke

Neurophysiological, Biomechanical and Clinical Effects of Dry Needling Versus Sham Needling When Applied to the Infraspinatus Muscle in People With Chronic Shoulder Pain: a Randomized Pilot Study

Up to 77% of patients with chronic shoulder pain have a trigger point (TrP) in the infraspinatus muscle. These TrPs can lead to pain, limitation of activities and reduced quality of life. Dry needling (DN) is gaining popularity as a treatment for TrPs in physiotherapy. However, its clinical effects remain poorly understood mechanistically and its neurophysiological effects little studied.

The primary objective of this study is to determine the feasibility of a larger scale study.

The secondary objective of this study is to to explore the immediate neurophysiological, biomechanical and clinical effects of DN and sham needling when applied to TrP of the infraspinatus muscle in people with chronic non-traumatic shoulder pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Methodology

In this randomized, double-blind, parallel-group trial, twenty adults with chronic non-traumatic shoulder pain and with a infraspinatus TrP will be recruited according to established criteria. Participants will be randomized into two groups: one group (n = 10) receiving a DN in the infraspinatus TrP and another group (n = 10) receiving a sham needling.

Recruitment strategies

Recruitment will be done through posters that will be posted on bulletin boards of the Faculty of Medicine and Health Sciences of the University of Sherbrooke and in physiotherapy clinics in the region. The persons interested will be invited to contact the research assistant in charge of the study to verify their eligibility to participate.

Data collection procedure

The experimental procedure will take place in a laboratory located at the Research Center on Aging in Sherbrooke, Quebec, Canada. Upon arrival, individuals will be greeted by a research assistant. Verification of the presence of TrP in the infraspinatus to confirm eligibility to participate will be carried out by a physiotherapist with more than 20 years of experience in the identification of TrPs and with the application of DN, according to the following procedure: Participants will be asked to lie in a decubitus lateral position on a treatment table and on the asymptomatic side. The upper arm will be supported on a box placed in front of them, so that the muscles can be relaxed, but the arm will be positioned in a and have a slight horizontal adduction to slightly stretch the fibers of the infraspinatus muscle. Manual palpation with flat fingers and perpendicular to the fibers will be used to identify the tight muscle band. Once a tight muscle band has been identified, the physiotherapist will search within this band for a contraction node, namely the TrP. Once she had identified this TrP with a non-toxic black Sharpie pencil, she will validate with the patient that the compression of this TrP reproduces local or referred pain. This pain should correspond to the pain patterns known to the infraspinatus according to Simons and Travell, 1999 and reproduce the pain known by the patient. This pain should be at least a 1/10 intensity on the visual analog scale (VAS). Ineligible participants will receive advices from the physiotherapist as well as a prescription for exercises related to their condition and a list of physiotherapists they can consult.

The research assistant will explain the nature of the project to the selected participants, he will make sure that the participants have no contraindications to receive DN and/or for transcranial magnetic stimulation (TMS) examination, and he will obtain written informed consent. Participants will then complete a questionnaire used to collect baseline medical information.

Intervention (DN and Sham)

DN will be performed by a certified clinician, experienced with the technique. She will explain the purpose of the intervention and she will review the contraindications and precautions for DN to ensure that the procedure is safe. The technique used is recommended by l'Ordre professionnel de la physiothérapie du Québec (OPPQ). The clinician will insert a sterile disposable acupuncture needle, OPTIMED (non-silicone), 40 mm x 0.30 caliber. The direction of the needle will be slightly oblique, directly in the TrP and in the direction of the muscle fibers. The production of a twitch is expected, gliding and rotation of the needle may be performed to produce this effect, if necessary. The needle will be removed after the twitch. The same procedure will be used for the sham group, except that the needle will be inserted at the subcutaneous level, at the depth of the superficial adipous tissues

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 4C4
        • Centre de recherche sur le vieillissement

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Unilateral, chronic non-traumatic shoulder pain (VAS ≥ 2/10; >3 months)
  2. Localized pain in the shoulder region or referred according to the territory of the infraspinatus (Travell and Simons, 1999)
  3. Presence of a palpable nodule inside a tight muscle band reproducing the patient's pain

Exclusion Criteria:

  1. Cancer or metastasis in organs or tissues above the pelvis (< 5 years)
  2. Shoulder capsulitis
  3. Shoulder, thorax or mastectomy surgeries
  4. Shoulder bone fracture (< 6 months)
  5. C4-C5 or C6 radiculopathy
  6. Osteoporosis or excessive atrophy of the infraspinous fossa (infraspinatus <10 mm)
  7. Body mass index (BMI) > 28

Exclusion (TMS security):

  1. Pregnant woman
  2. Neurological, psychiatric or epilepsy conditions
  3. Implants (e.g. Neurostimulator, pacemaker, cerebral aneurysm clip, screw or plate), metallic foreign body in the eye
  4. Head trauma with loss of consciousness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dry needling (DN)
Intramuscular insertion
Other: Dry needling
Intramuscular insertion of an OPTIMED 40mm x 0.3mm acupuncture needle in a trigger point of the infraspinatus muscle
Sham Comparator: Sham needling (SN)
Intradermal insertion
Other: Sham needling (SN)
Intradermal insertion of an OPTIMED 40mm x 0.3mm acupuncture needle over the infraspinatus region

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Through study completion, an average of 10 months
Average number of participants recruited per month
Through study completion, an average of 10 months
Exclusion rate
Time Frame: Through study completion, an average of 10 months
Number of participants excluded from the study due to eligibility criteria (e.g. too narrow, are they clear)
Through study completion, an average of 10 months
Refusal rate
Time Frame: Through study completion, an average of 10 months
Number of participants who refused to participate (e.g. fear of needle, fear of transcranial magnetic stimulation)
Through study completion, an average of 10 months
Retention rate
Time Frame: Baseline, immediately after and 24 hours post-treatment evaluation
Number of loss at follow-up
Baseline, immediately after and 24 hours post-treatment evaluation
Length of time of the procedure
Time Frame: Baseline, immediately after and 24 hours post-treatment evaluation
Average time needed per participant (testing and intervention)
Baseline, immediately after and 24 hours post-treatment evaluation
Safety of the procedure: adverse effects
Time Frame: Immediately after intervention to 24 hours post-treatment
Listing of any adverse effects
Immediately after intervention to 24 hours post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Corticospinal excitability of the infraspinatus
Time Frame: At baseline, immediately after intervention, 24 hours after the intervention
Tested with transcranial magnetic stimulation (TMS) connected to a neuronavigation device, characterized by the active motor threshold and expressed in stimulator maximum power percentage
At baseline, immediately after intervention, 24 hours after the intervention
Glenohumeral arthrokinematics
Time Frame: At baseline, immediately after intervention, 24 hours after the intervention
Captured images are taken using ultrasound imaging (GE Logiq-e; linear array 5-12MHz) at 0° and 30° of external rotation. Measurements in cm included: 1) subacromial space (position of the humeral head relative to the acromion); 2) anteroposterior position of the humeral head relative to the glenoid.
At baseline, immediately after intervention, 24 hours after the intervention
Pressure pain perceived
Time Frame: At baseline, immediately after intervention, 24 hours after the intervention
Obtained using an algometer (directly applied on the TrP; average of three measurements taken at 30 sec. interval), characterized by the threshold of discomfort and expressed in kg.
At baseline, immediately after intervention, 24 hours after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Ordre Professionnel de la Physiothérapie du Québec (OPPQ)

Investigators

  • Study Director: Guillaume Léonard, PhD, Université de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2019

Primary Completion (Actual)

December 20, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

March 11, 2020

First Submitted That Met QC Criteria

March 18, 2020

First Posted (Actual)

March 20, 2020

Study Record Updates

Last Update Posted (Actual)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 18, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-3133

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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