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Shoulder PainNCT04476381

Immediate Effect of Dry Needling on Trigger Points

A study testing Dry needling in people with Shoulder Pain, run by Université de Sherbrooke at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Shoulder Pain
What is being tested?
Dry needling
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteCanada
Study dates
1 Feb 2018to 20 Sep 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • CRCHUS-Physius Lab

    Sherbrooke, Quebec, J1H5N4

Other trials in Canada

About this study

Official title: Immediate Effect of Dry Needling on the Viscoelastic Properties of a Trigger Point on the Infraspinatus Muscle Measured With the MyotonPro

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

Read the detailed description

Objectives: To investigate the immediate effects of a dry needling puncture on the viscoelastic properties (tone, stiffness and elasticity) of a trigger point (TP) located in the infraspinatus muscle in participants with non-traumatic chronic shoulder pain.

Methods: Forty-eight individuals who presented non-traumatic chronic shoulder pain were recruited. The presence of a TP in the infraspinatus muscle of the painful side was confirmed by an experienced physiotherapist with a palpatory exam according to Travell and Simons criteria. The TP was marked and the viscoelastic properties including tone, stiffness and elasticity were measured with the MyotonPro device by an evaluator. After the first set of measurements (T1), an experienced physiotherapist applied a dry needling puncture to the TP with a pistoning technique to obtain a local twitch response (LTR) with an Optimed 40 x 0.30 mm single use acupuncture needle. The same set of measurements was repeated immediately after the dry needling (T2) and 30 minutes later (T3). Repeated measures ANOVA and post-hoc tests were used to assess changes in viscoelastic properties over time with a significant level set at 0.05.

Conditions
Shoulder Pain
Being tested
Dry needling
Keywords
myofascial trigger points,, dry needling,, stiffness
Medical subject headings
Shoulder Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dry needlingProcedure or surgery

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

Study groups in NCT04476381
Study groupRoleWhat they receive
Dry needling of a trigger point in the infraspinatus muscleExperimentalInsertion 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
Receives: Procedure: Dry needling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: baseline

  2. 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

    Measured: immediately after the intervention

  3. 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

    Measured: 30 minutes after the intervention

  4. 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

    Measured: baseline

  5. 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

    Measured: immediately after the intervention

  6. 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

    Measured: 30 minutes after the intervention

  7. 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

    Measured: baseline

  8. 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

    Measured: immediately after the intervention

  9. 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

    Measured: 30 minutes after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2020
  2. Study start1 Feb 2018
  3. Primary completion7 Jun 2018
  4. Study completion20 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04476381
Sponsor's protocol ID
MON07
Status last verified
Jul 2020
First submitted
27 May 2020
Last updated
20 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Dry needling in people with Shoulder Pain, run by Université de Sherbrooke at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tone in Hertz measured with a myotonometer on the trigger point (time frame: baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.

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Immediate Effect of Dry Needling on Trigger Points | AzTrials