NCT02817269

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 28, 2016

Status Verified

October 1, 2016

Enrollment Period

1 month

First QC Date

June 21, 2016

Last Update Submit

October 27, 2016

Conditions

Keywords

Shoulder painTrigger pointsReferred painVisual analogue scale

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Prevalence active trigger point

    One month

  • Evocation of Local Twitch Response

    One month

  • Subjective pain intensity: Visual Analogue Scale (VAS)

    One month

Study Arms (2)

Manual palpation group

EXPERIMENTAL

For the manual palpation group, the reference position will be a lateral position, lying on the non affected shoulder while the affected side will be explored. The arm and elbow are flexed 90° resting on a pillow and legs placed with 90° hip and knee flexion to stabilize the body, with the head resting on a pillow to maintain body alignment. The physiotherapist will be in front of the participant and carried out the examination with flat palpation using the thumb to identify soreness taut band tried to elicit local twitch response and referred pain in the infraspinatus area. First, three attempts will be made to elicit an local twitch response (LTR) using snapping palpation if a response will be obtained. After LRT, referred pain could also be evoked by palpation.

Other: Manual palpation

Deep dry needling group

EXPERIMENTAL

For the deep dry needling group, the reference position will be a lateral position, lying on the non affected shoulder while the affected side will be explored. The arm and elbow are flexed 90° resting on a pillow and legs placed with 90° hip and knee flexion to stabilize the body, with the head resting on a pillow to maintain body alignment. The physiotherapist will be in front of the participant and carried out the examination with flat palpation using the thumb to identify soreness taut before making the needle insertion. Sterile stainless steel needles (length 40mm/caliber 0.32 with a cylindrical plastic guide) will be used.

Other: Deep dry needling

Interventions

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.

Manual palpation group

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.

Deep dry needling group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with evidence of serious medical illness.
  • Cognitive impairment.
  • Psychosocial disorders.
  • Bilateral affectation of shoulder pain.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. doi: 10.1097/01.phm.0000118037.61143.7c.

  • Borg-Stein J. Management of peripheral pain generators in fibromyalgia. Rheum Dis Clin North Am. 2002 May;28(2):305-17. doi: 10.1016/s0889-857x(02)00004-2.

  • 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.

  • 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. doi: 10.1186/1471-2474-8-107.

  • Chou LW, Hsieh YL, Kuan TS, Hong CZ. Needling therapy for myofascial pain: recommended technique with multiple rapid needle insertion. Biomedicine (Taipei). 2014;4(2):13. doi: 10.7603/s40681-014-0013-2. Epub 2014 Aug 2.

  • 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.

MeSH Terms

Conditions

Shoulder PainPain, Referred

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • José V Segura-Heras, PhD in math

    UNIVERSIDAD MIGUEL HERNÁNDEZ DE ELCHE (ALICANTE)

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

June 21, 2016

First Posted

June 29, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

October 28, 2016

Record last verified: 2016-10