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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02817269
Other study ID # UniversidadMHE-1
Secondary ID
Status Completed
Phase N/A
First received June 21, 2016
Last updated October 27, 2016
Start date July 2016
Est. completion date September 2016

Study information

Verified date October 2016
Source Universidad Miguel Hernandez de Elche
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial Summary

The first aim of the study will be to identify the most common ReP pattern and compare its coincidence with that described by Travell and Simons. Second, the study aim will be to verify whether there are any significant differences by sex and types of technique used in regard to the ReP pattern of TrP 2 of the infraspinatus muscle, an area described as more sensitive.Finally, the third aim of the study will be to determine whether deep dry needling will evoke the LTR and ReP more easily than manual palpation.


Description:

Patients will be recruited from a university's employee and student population by advertising at the university. Patients with shoulder complaints (described as pain felt in the shoulder or upper arm) will be randomly assigned to either an manual palpation or deep dry needling group. Participants will be randomly divided into 2 groups, a deep dry needling group and manual palpation group. Visual analogue scale (VAS), referred pain (ReP) pattern and features of referred pain of the infraspinatus muscle will be all assessed post-technique.


Recruitment information / eligibility

Status Completed
Enrollment 96
Est. completion date September 2016
Est. primary completion date August 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Aged between 18 and 65 years.

- To remain seated or in front of data visualization screens (tablets, computers or smartphones) for at least 4 hours a day.

- Shoulder complaints in the last six weeks.

Exclusion Criteria:

- Patients with evidence of serious medical illness.

- Cognitive impairment.

- Psychosocial disorders.

- Bilateral affectation of shoulder pain.

- Pregnancy.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Other:
Manual palpation
The manual palpation level will kept constant by applying enough digital pressure to cause the finger nail bed to blanch. When the nail will be turn pale, the amount of pressure will be measured at approximately 3 4kg/cm2 and will be maintained for 5-10 seconds to evoke referred pain. A manual palpation referred pain will be present if the pain radiated far enough for the patient to feel more than just a local pain.
Deep dry needling
Intramuscular needling will be carried out via deep dry needling into myofascial trigger point (MTrP) area without the introduction any substances. The aim is to elicit a local twitch response upon inserting the needle into the MTrP area and perform a neurological stimulation (by rotating the needle 360 degrees) to more easily evoke referred pain, holding for 10 seconds and then extracting the needle gently. The procedure will be followed by one minute of haemostatic compression.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad Miguel Hernandez de Elche

References & Publications (6)

Audette JF, Wang F, Smith H. Bilateral activation of motor unit potentials with unilateral needle stimulation of active myofascial trigger points. Am J Phys Med Rehabil. 2004 May;83(5):368-74, quiz 375-7, 389. — View Citation

Borg-Stein J. Management of peripheral pain generators in fibromyalgia. Rheum Dis Clin North Am. 2002 May;28(2):305-17. Review. — View Citation

Bron C, Dommerholt J, Stegenga B, Wensing M, Oostendorp RA. High prevalence of shoulder girdle muscles with myofascial trigger points in patients with shoulder pain. BMC Musculoskelet Disord. 2011 Jun 28;12:139. doi: 10.1186/1471-2474-12-139. — View Citation

Bron C, Wensing M, Franssen JL, Oostendorp RA. Treatment of myofascial trigger points in common shoulder disorders by physical therapy: a randomized controlled trial [ISRCTN75722066]. BMC Musculoskelet Disord. 2007 Nov 5;8:107. — View Citation

Chou LW, Hsieh YL, Kuan TS, Hong CZ. Needling therapy for myofascial pain: recommended technique with multiple rapid needle insertion. Biomedicine (Taipei). 2014;4:13. Epub 2014 Aug 2. — View Citation

Ge HY, Fernández-de-Las-Peñas 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mapping of Referred Pain Pattern The participants from both groups will ask to report whether ReP is evoked and to describe the ReP pattern using an anatomical map of the upper half of the human body divided into eighteen areas. Nine areas corresponded to the anterior part of the body and the other nine to the posterior part of the body. One month No
Secondary Prevalence active trigger point Active trigger point is considered: Soreness taut band and familiar pain. One month No
Secondary Evocation of Local Twitch Response These were assigned a numerical value of 0 (yes) or 1 (no) for better statistical handling of the data. One month No
Secondary Subjective pain intensity: Visual Analogue Scale (VAS) The VAS for pain measures the amount of pain experienced by a subject on a continuum from 0 to 10, with 0 being no pain and 10 maximum pain. One month No
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