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Myofascial Pain SyndromeNCT02179320

Evaluation of the Efficacy and Neurological Effects of Dry Needling in the Treatment of Myofascial Pain Syndrome

A study testing Dry needling and acupuncture needle 0,25 x 40mm in people with Myofascial Pain Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.

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

AIM OF INVESTIGATION: To evaluate in a prospective, randomized, sham-controlled study the pattern of analgesic efficacy of trigger point dry needling in Myofascial Pain Syndrome (MPS) patients. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Myofascial Pain Syndrome
What is being tested?
Dry needling and acupuncture needle 0,25 x 40mm
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteBrazil
Study dates
Feb 2014to Feb 2015
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Assymetric shoulder pain (VAS on painful side : VAS on non painful side > 2:1)
  • Pain due to unilateral Myofascial Pain Syndrome of the trapezius muscle.
  • Chronic pain, with duration of at least 3 months and VAS > 40/100
  • Patients with pain at least 4 days in a week
  • Patients without neurological pain, as in DN4 score less than 4
  • Age over 18 years
  • Patients with stable drug treatment over at least 15 days, without any acute pharmacological changes during the study
  • Patients who read, understood and signed the Free and Clarified Consent Term

Who cannot join

  • Patients with major depression, according to DSM-IV criteria
  • History of bipolar mood disorder, panic syndrome or psychosis
  • Intermittent pain history
  • Refusal to sing the Consent Term
  • Patients not able to attend all the follow-ups
  • Patients with another pain syndrome in shoulders

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    São Paulo, São Paulo, 05403-010

Other trials in Brazil

About this study

AIM OF INVESTIGATION: To evaluate in a prospective, randomized, sham-controlled study the pattern of analgesic efficacy of trigger point dry needling in Myofascial Pain Syndrome (MPS) patients.

Read the detailed description

This study will be performed in patients with shoulder pain due to excess of nociception associated with chronic Myofascial Pain Syndrome in asymmetrical unilateral trapezius muscle trigger points.

Patients will be randomly assigned to two treatment arms: Active (A) (n=20) and Sham (S) (n=21). Group A will receive actual treatment with trigger point dry needling. Group S will receive a sham treatment, with the needle inserted superficially in the skin, without reaching the muscle underneath it.

The duration and pain elicited during active and sham dry needling will be controlled for. Patients will be evaluated one week before needling (D-7), on the day of dry needling (D0) and seven days after the procedure (D+7).

Patients will fill out the Brazilian version of the Douleur Neuropathique 4, Beck Depression Inventory, Brief Pain Inventory (BPI), McGill Pain Questionnaire-SF (SFMPQ), Hospital Anxiety and Depression Scale and Global Impression of Change, and also a 14-day Carnet to more accurately evaluate their daily pain before and after the treatment.

For the evaluation of neurologic changes, we will evaluate local hyperalgesia, tactile, mechanical, static and thermal sensitivity with thermal quantitative sensorial testing (TQS), and also mapping of the painful area, before and after treatment in both D0 and D+7.

Being tested
Dry needling, acupuncture needle 0,25 x 40mm
Keywords
Myofascial Pain Syndrome, Dry needling, Clinical Trial
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 needlingProcedure or surgery

    Dry needling of the painful muscles, with an acupuncture needle 0,25 x 40mm

  • acupuncture needle 0,25 x 40mmDevice

Study groups in NCT02179320
Study groupRoleWhat they receive
Dry needlingActive comparatorDry needling for myofascial pain syndrome, in the trapezius muscle.
Receives: Procedure: Dry needling; Device: acupuncture needle 0,25 x 40mm
Sham needlingSham comparatorSuperficial dry needling in the trapezius muscle
Receives: Procedure: Dry needling

What is being measured

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

  1. Analgesic effects of dry needling

    Maximum, average and lowest pain will be evaluated daily 7 days before the treatment, on the day of the treatment, and also 7 days after the treatment is done.

    Measured: Within the first 7 days after treatment

Secondary outcomes (1)

  1. Neurologic effects of dry needling

    Tactile, mechanical, static and thermal sensitivity will be evaluated with thermal quantitative sensorial testing, as well as hyperalgesia. The painful area will also be mapped to compara before and after treatment results.

    Measured: Within the first 7 days after treatment

Timeline

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

  1. First posted1 Jul 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionFeb 2015
  4. Study completionFeb 2015

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, Care provider, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02179320
Sponsor's protocol ID
HC-GDOR-MIOFASCIAL
Status last verified
Apr 2015
First submitted
27 Jun 2014
Last updated
3 May 2018
Results posted
No
Data monitoring committee
No

Publications

  • Yap EC. Myofascial pain--an overview. Ann Acad Med Singap. 2007 Jan;36(1):43-8.

    PubMed 17285185

  • Gerwin RD. Classification, epidemiology, and natural history of myofascial pain syndrome. Curr Pain Headache Rep. 2001 Oct;5(5):412-20. doi: 10.1007/s11916-001-0052-8.

    PubMed 11560806

  • Ga H, Choi JH, Park CH, Yoon HJ. Dry needling of trigger points with and without paraspinal needling in myofascial pain syndromes in elderly patients. J Altern Complement Med. 2007 Jul-Aug;13(6):617-24. doi: 10.1089/acm.2006.6371.

    PubMed 17718644

  • Cummings TM, White AR. Needling therapies in the management of myofascial trigger point pain: a systematic review. Arch Phys Med Rehabil. 2001 Jul;82(7):986-92. doi: 10.1053/apmr.2001.24023.

    PubMed 11441390

  • McCain GA, Bell DA, Mai FM, Halliday PD. A controlled study of the effects of a supervised cardiovascular fitness training program on the manifestations of primary fibromyalgia. Arthritis Rheum. 1988 Sep;31(9):1135-41. doi: 10.1002/art.1780310908.

    PubMed 3048273

  • Giamberardino MA. Referred muscle pain/hyperalgesia and central sensitisation. J Rehabil Med. 2003 May;(41 Suppl):85-8. doi: 10.1080/16501960310010205.

    PubMed 12817663

  • Ge HY, Fernandez-de-las-Penas C, Arendt-Nielsen L. Sympathetic facilitation of hyperalgesia evoked from myofascial tender and trigger points in patients with unilateral shoulder pain. Clin Neurophysiol. 2006 Jul;117(7):1545-50. doi: 10.1016/j.clinph.2006.03.026. Epub 2006 Jun 5.

    PubMed 16737848

  • Hong CZ, Simons DG. Pathophysiologic and electrophysiologic mechanisms of myofascial trigger points. Arch Phys Med Rehabil. 1998 Jul;79(7):863-72. doi: 10.1016/s0003-9993(98)90371-9.

    PubMed 9685106

  • Hong CZ. Treatment of myofascial pain syndrome. Curr Pain Headache Rep. 2006 Oct;10(5):345-9. doi: 10.1007/s11916-006-0058-3.

    PubMed 16945250

  • Giamberardino MA, Affaitati G, Fabrizio A, Costantini R. Myofascial pain syndromes and their evaluation. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):185-98. doi: 10.1016/j.berh.2011.01.002.

    PubMed 22094195

  • Skootsky SA, Jaeger B, Oye RK. Prevalence of myofascial pain in general internal medicine practice. West J Med. 1989 Aug;151(2):157-60.

    PubMed 2788962

  • SOLA AE, RODENBERGER ML, GETTYS BB. Incidence of hypersensitive areas in posterior shoulder muscles; a survey of two hundred young adults. Am J Phys Med. 1955 Dec;34(6):585-90. No abstract available.

    PubMed 13268620

  • 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

  • Ge HY, Fernandez-de-Las-Penas C, Madeleine P, Arendt-Nielsen L. Topographical mapping and mechanical pain sensitivity of myofascial trigger points in the infraspinatus muscle. Eur J Pain. 2008 Oct;12(7):859-65. doi: 10.1016/j.ejpain.2007.12.005. Epub 2008 Jan 18.

    PubMed 18203637

Questions about this trial

What is this clinical trial studying?

A study testing Dry needling and acupuncture needle 0,25 x 40mm in people with Myofascial Pain Syndrome, run by University of Sao Paulo General Hospital at 1 site in Brazil.

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 8 inclusion and 6 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 3 May 2018. 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 Brazil. 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?

Analgesic effects of dry needling (time frame: Within the first 7 days after treatment). 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 NCT02179320, which also lists 14 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 3 May 2018.

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