AzTrials
AzTrials

Trigger Point Pain, MyofascialNCT04316793

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

A study testing Dry needling in people with Trigger Point Pain, Myofascial and Chronic 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
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Dry needling
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
21 participants
Where
1 siteCanada
Study dates
3 Mar 2019to 20 Dec 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

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

Who cannot join

  • Cancer or metastasis in organs or tissues above the pelvis (< 5 years)
  • Shoulder capsulitis
  • Shoulder, thorax or mastectomy surgeries
  • Shoulder bone fracture (< 6 months)
  • C4-C5 or C6 radiculopathy
  • Osteoporosis or excessive atrophy of the infraspinous fossa (infraspinatus <10 mm)
Show all 11Show fewer
  • Body mass index (BMI) > 28
  • Pregnant woman
  • Neurological, psychiatric or epilepsy conditions
  • Implants (e.g. Neurostimulator, pacemaker, cerebral aneurysm clip, screw or plate), metallic foreign body in the eye
  • Head trauma with loss of consciousness

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Centre de Recherche sur le Vieillissement

    Sherbrooke, Quebec, J1H 4C4

Other trials in Canada

About this study

Official title: 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.

Read the 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

Being tested
Dry needling, Sham needling (SN)
Keywords
Dry needling, Infraspinatus, Neurophysiological effects
Medical subject headings
Myofascial Pain Syndromes

What participants receive

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

  • Dry needlingOther

    Intramuscular insertion of an OPTIMED 40mm x 0.3mm acupuncture needle in a trigger point of the infraspinatus muscle

  • Sham needling (SN)Other

    Intradermal insertion of an OPTIMED 40mm x 0.3mm acupuncture needle over the infraspinatus region

Study groups in NCT04316793
Study groupRoleWhat they receive
Dry needling (DN)ExperimentalIntramuscular insertion
Receives: Other: Dry needling
Sham needling (SN)Sham comparatorIntradermal insertion
Receives: Other: Sham needling (SN)

What is being measured

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

  1. Recruitment rate

    Average number of participants recruited per month

    Measured: Through study completion, an average of 10 months

  2. Exclusion rate

    Number of participants excluded from the study due to eligibility criteria (e.g. too narrow, are they clear)

    Measured: Through study completion, an average of 10 months

  3. Refusal rate

    Number of participants who refused to participate (e.g. fear of needle, fear of transcranial magnetic stimulation)

    Measured: Through study completion, an average of 10 months

  4. Retention rate

    Number of loss at follow-up

    Measured: Baseline, immediately after and 24 hours post-treatment evaluation

  5. Length of time of the procedure

    Average time needed per participant (testing and intervention)

    Measured: Baseline, immediately after and 24 hours post-treatment evaluation

  6. Safety of the procedure: adverse effects

    Listing of any adverse effects

    Measured: Immediately after intervention to 24 hours post-treatment

Secondary outcomes (3)
  1. Corticospinal excitability of the infraspinatus

    Tested with transcranial magnetic stimulation (TMS) connected to a neuronavigation device, characterized by the active motor threshold and expressed in stimulator maximum power percentage

    Measured: At baseline, immediately after intervention, 24 hours after the intervention

  2. Glenohumeral arthrokinematics

    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.

    Measured: At baseline, immediately after intervention, 24 hours after the intervention

  3. Pressure pain perceived

    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.

    Measured: At baseline, immediately after intervention, 24 hours 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 Mar 2020
  2. Study start3 Mar 2019
  3. Primary completion20 Dec 2019
  4. Study completion20 Dec 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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04316793
Sponsor's protocol ID
2019-3133
Status last verified
Mar 2020
First submitted
11 Mar 2020
Last updated
20 Mar 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bron C, Franssen J, Wensing M, Oostendorp RA. Interrater reliability of palpation of myofascial trigger points in three shoulder muscles. J Man Manip Ther. 2007;15(4):203-15. doi: 10.1179/106698107790819477.

    PubMed 19066669
  • Tough EA, White AR, Richards S, Campbell J. Variability of criteria used to diagnose myofascial trigger point pain syndrome--evidence from a review of the literature. Clin J Pain. 2007 Mar-Apr;23(3):278-86. doi: 10.1097/AJP.0b013e31802fda7c.

    PubMed 17314589
  • Cagnie B, Barbe T, De Ridder E, Van Oosterwijck J, Cools A, Danneels L. The influence of dry needling of the trapezius muscle on muscle blood flow and oxygenation. J Manipulative Physiol Ther. 2012 Nov-Dec;35(9):685-91. doi: 10.1016/j.jmpt.2012.10.005.

    PubMed 23206963
  • Dunning J, Butts R, Mourad F, Young I, Flannagan S, Perreault T. Dry needling: a literature review with implications for clinical practice guidelines. Phys Ther Rev. 2014 Aug;19(4):252-265. doi: 10.1179/108331913X13844245102034.

    PubMed 25143704
  • Hidalgo-Lozano A, Fernandez-de-las-Penas C, Alonso-Blanco C, Ge HY, Arendt-Nielsen L, Arroyo-Morales M. Muscle trigger points and pressure pain hyperalgesia in the shoulder muscles in patients with unilateral shoulder impingement: a blinded, controlled study. Exp Brain Res. 2010 May;202(4):915-25. doi: 10.1007/s00221-010-2196-4. Epub 2010 Feb 26.

    PubMed 20186400
  • Rathbone ATL, Grosman-Rimon L, Kumbhare DA. Interrater Agreement of Manual Palpation for Identification of Myofascial Trigger Points: A Systematic Review and Meta-Analysis. Clin J Pain. 2017 Aug;33(8):715-729. doi: 10.1097/AJP.0000000000000459.

    PubMed 28098584
  • Tekin L, Akarsu S, Durmus O, Cakar E, Dincer U, Kiralp MZ. The effect of dry needling in the treatment of myofascial pain syndrome: a randomized double-blinded placebo-controlled trial. Clin Rheumatol. 2013 Mar;32(3):309-15. doi: 10.1007/s10067-012-2112-3. Epub 2012 Nov 9.

    PubMed 23138883
  • Arias-Buria JL, Fernandez-de-Las-Penas C, Palacios-Cena M, Koppenhaver SL, Salom-Moreno J. Exercises and Dry Needling for Subacromial Pain Syndrome: A Randomized Parallel-Group Trial. J Pain. 2017 Jan;18(1):11-18. doi: 10.1016/j.jpain.2016.08.013. Epub 2016 Oct 5.

    PubMed 27720812
  • Baldry P. The integration of acupuncture within medicine in the UK--the British Medical Acupuncture Society's 25th anniversary. Acupunct Med. 2005 Mar;23(1):2-12. doi: 10.1136/aim.23.1.2.

    PubMed 15844434
  • Cagnie B, Dewitte V, Coppieters I, Van Oosterwijck J, Cools A, Danneels L. Effect of ischemic compression on trigger points in the neck and shoulder muscles in office workers: a cohort study. J Manipulative Physiol Ther. 2013 Oct;36(8):482-9. doi: 10.1016/j.jmpt.2013.07.001. Epub 2013 Aug 28.

    PubMed 23993756
  • Chen JT, Chung KC, Hou CR, Kuan TS, Chen SM, Hong CZ. Inhibitory effect of dry needling on the spontaneous electrical activity recorded from myofascial trigger spots of rabbit skeletal muscle. Am J Phys Med Rehabil. 2001 Oct;80(10):729-35. doi: 10.1097/00002060-200110000-00004.

    PubMed 11562554
  • Dorsher PT. Can classical acupuncture points and trigger points be compared in the treatment of pain disorders? Birch's analysis revisited. J Altern Complement Med. 2008 May;14(4):353-9. doi: 10.1089/acm.2007.0810.

    PubMed 18576919
  • Fricton JR, Kroening R, Haley D, Siegert R. Myofascial pain syndrome of the head and neck: a review of clinical characteristics of 164 patients. Oral Surg Oral Med Oral Pathol. 1985 Dec;60(6):615-23. doi: 10.1016/0030-4220(85)90364-0.

    PubMed 3865133
  • Hong CZ. Lidocaine injection versus dry needling to myofascial trigger point. The importance of the local twitch response. Am J Phys Med Rehabil. 1994 Jul-Aug;73(4):256-63. doi: 10.1097/00002060-199407000-00006.

    PubMed 8043247
  • Langevin HM, Churchill DL, Cipolla MJ. Mechanical signaling through connective tissue: a mechanism for the therapeutic effect of acupuncture. FASEB J. 2001 Oct;15(12):2275-82. doi: 10.1096/fj.01-0015hyp.

    PubMed 11641255

Questions about this trial

What is this clinical trial studying?

A study testing Dry needling in people with Trigger Point Pain, Myofascial and Chronic 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 11 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 Mar 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. Some participants in this study may receive a placebo. 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?

Recruitment rate (time frame: Through study completion, an average of 10 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04316793, which also lists 36 linked publications.

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 Mar 2020.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in