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Referred Pain Patterns Infraspinatus Muscle

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manual palpation
Deep dry needling
Sponsored by
Universidad Miguel Hernandez de Elche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Shoulder Pain focused on measuring Shoulder pain, Trigger points, Referred pain, Visual analogue scale

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Manual palpation group

    Deep dry needling group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Prevalence active trigger point
    Active trigger point is considered: Soreness taut band and familiar pain.
    Evocation of Local Twitch Response
    These were assigned a numerical value of 0 (yes) or 1 (no) for better statistical handling of the data.
    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.

    Full Information

    First Posted
    June 21, 2016
    Last Updated
    October 27, 2016
    Sponsor
    Universidad Miguel Hernandez de Elche
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02817269
    Brief Title
    Referred Pain Patterns Infraspinatus Muscle
    Official Title
    Referred Pain Patterns in Trigger Point 2 of the Infraspinatus Muscle in Patients With Shoulder Pain
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    September 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Miguel Hernandez de Elche

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Pain
    Keywords
    Shoulder pain, Trigger points, Referred pain, Visual analogue scale

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    96 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Manual palpation group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Deep dry needling group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Manual palpation
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Deep dry needling
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Mapping of Referred Pain Pattern
    Description
    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.
    Time Frame
    One month
    Secondary Outcome Measure Information:
    Title
    Prevalence active trigger point
    Description
    Active trigger point is considered: Soreness taut band and familiar pain.
    Time Frame
    One month
    Title
    Evocation of Local Twitch Response
    Description
    These were assigned a numerical value of 0 (yes) or 1 (no) for better statistical handling of the data.
    Time Frame
    One month
    Title
    Subjective pain intensity: Visual Analogue Scale (VAS)
    Description
    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.
    Time Frame
    One month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    José V Segura-Heras, PhD in math
    Organizational Affiliation
    UNIVERSIDAD MIGUEL HERNÁNDEZ DE ELCHE (ALICANTE)
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    15100626
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    12122919
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    21711512
    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.
    Results Reference
    result
    PubMed Identifier
    17983467
    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. doi: 10.1186/1471-2474-8-107.
    Results Reference
    result
    PubMed Identifier
    25520926
    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(2):13. doi: 10.7603/s40681-014-0013-2. Epub 2014 Aug 2.
    Results Reference
    result
    PubMed Identifier
    18203637
    Citation
    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.
    Results Reference
    result

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