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.
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.
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
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
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
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
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
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.
- First posted20 Jul 2020
- Study start1 Feb 2018
- Primary completion7 Jun 2018
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mélanie Roch, Université de Sherbrooke
- Investigators
- Nathaly Gaudreault, PhD, Study director, Université de Sherbrooke
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effect of Dry Needling on the Viscoelastic Properties of a Trigger Point on the Infraspinatus Muscle Measured With the MyotonPro
- ClinicalTrials.gov ID
- NCT04476381
- Acronym / sponsor ID
- MON07
- Conditions
- Shoulder Pain
- Keywords
- myofascial trigger points,, dry needling,, stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The immediate effects (0-30 minutes) of a dry needling intervention on a trigger point on their viscoelastic properties (tone, elasticity and stiffness)
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| Dry needling of a trigger point in the infraspinatus muscle | Experimental | Procedure: Dry needlingInsertion 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dry needlingInsertion of a Optimed 40mm x 0.30 single use, sterile acupuncture needle into a active trigger point in the infraspinatus muscle | Procedure or surgery | Dry needling of a trigger point in the infraspinatus muscle |
Primary outcome
Tone in Hertz measured with a myotonometer on the trigger point
Time frame: baseline
Measurement of the tone in Hz with the myotonometer MyotonPro on the trigger point
Tone in Hertz measured with a myotonometer on the trigger point
Time frame: immediately after the intervention
Measurement of the tone in Hz with the myotonometer MyotonPro on the trigger point
Tone in Hertz measured with a myotonometer on the trigger point
Time frame: 30 minutes after the intervention
Measurement of the tone in Hz with the myotonometer MyotonPro on the trigger point
Stiffness in N/m with a myotonometer on the trigger point
Time frame: baseline
Measurement of the stiffness in N/m with the myotonometer MyotonPro on the trigger point
Stiffness in N/m with a myotonometer on the trigger point
Time frame: immediately after the intervention
Measurement of the stiffness in N/m with the myotonometer MyotonPro on the trigger point
Stiffness in N/m with a myotonometer on the trigger point
Time frame: 30 minutes after the intervention
Measurement of the stiffness in N/m with the myotonometer MyotonPro on the trigger point
Elasticity (no units: inversely proportional to the decrement of the oscillations) with a myotonometer on the trigger point
Time frame: baseline
Measurement of the elasticity with the MyotonPro
Elasticity (no units: inversely proportional to the decrement of the oscillations) with a myotonometer on the trigger point
Time frame: immediately after the intervention
Measurement of the elasticity with the MyotonPro
Elasticity (no units: inversely proportional to the decrement of the oscillations) with a myotonometer on the trigger point
Time frame: 30 minutes after the intervention
Measurement of the elasticity with the MyotonPro
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
Related trials for Shoulder Pain
RecruitingObservational study
Night Pain Module for Rotator Cuff-Related Shoulder Pain
Shoulder Pain, Rotator Cuff Related Shoulder Pain
Active, not recruiting
Comparative Effects of Cyriax Approach With and Without Mobilization With Movement in Shoulder Restriction With Rotator Cuff Tendinopathy
Rotator Cuff Tendinopathy
Not yet recruiting
Effects of Different Kinesio Taping Methods in Subacromial Impingement Syndrome
Subacromial Impingement Syndrome
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
RecruitingObservational study
Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaly Gaudreault, PhD study director
Université de Sherbrooke
1 site in 1 country: see every site and its status.
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.