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Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients

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ClinicalTrials.gov Identifier: NCT03709797
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Sandra Palacios Alfonso, Universidad de León

Brief Summary:

Shoulder pain in people with spinal cord injury is one of the most prevalent in acute and chronic patients because of weakness in shoulder periarticular muscles, and also because of overuse of these part of the body in assistive devices.

This study aims to evidence if dry needling (a physiotherapy technique) is also useful in patients with spinal cord injury, and how long it could hold out without or less pain.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Myofascial Pain Syndrome Shoulder Pain Puncture Procedure: Dry needling in infraspinatus muscle Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients: a Randomized Controlled Clinical Trial
Actual Study Start Date : November 9, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group
Experimental group will receive dry needling treatment.
Procedure: Dry needling in infraspinatus muscle
Dry needling technique with multiple rapid needle insertion.

Sham Comparator: Control group
Control group will receive sham dry needling treatment.
Procedure: Dry needling in infraspinatus muscle
Dry needling technique with multiple rapid needle insertion.




Primary Outcome Measures :
  1. Disabilities of the Arm, Shoulder and Hand Spanish version (DASHe). [ Time Frame: Change from baseline and one week later. ]

    In upper limb pathology this test evaluates functional activities in relation to the difficulty involved in performing them with a score between 1 and 5.

    The DASHe questionnaire consists of a main part of 30 items, and two specific modules for people who work with musical instruments / sports or for the workplace. In this study, only the main part has been used. The 30 items have a score of 1 to 5, with 5 being the maximum of the valued symptom, and at least 27 questions of 3 must be answered.

    The disability / symptom score will therefore be between 0 (best possible score) and 100 (worst possible score).



Secondary Outcome Measures :
  1. Pressure Pain Thershold (algometry). [ Time Frame: Change from baseline, immediately after intervention and one week later. ]
    Baseline®dolorimeter - 22lb / 10kg, STOCK CODE: 12-1442 It will be measured with an algometer that is an instrument that provides quantitative / objective information on pain at a specific point, depending on the pressure on which it is applied. A circle is drawn around the trigger point on which the indelible marker test will be performed to confirm in the last measurement which is the exact point on which it is worked. 3 consecutive measurements are made at the same point, waiting between one and another measurement for a period between 30-60 seconds, and the average of the 3 measurements will be used as a statistical value.

  2. McGill Pain Questionnaire (Spanish version). [ Time Frame: Change from baseline and one week later. ]
    This scale consists of a set of 78 adjectives included in 20 groups (including 2 to 6 in each group) and that express a characteristic of pain. Within these 20 groups we find the Pain Rating Index (PRI) divided into: sensory (groups 1-10), affective (groups 11-15), evaluative (group 16) and miscellaneous (group 17-20) ), of which the patient can only choose one word from each of the 20 groups, choosing only those adjectives that best suit his pain sensation. It also includes a category on the changes that experimental pain, and another with a rate of pain intensity (Present Pain Index = PPI).

  3. Visual Analog Scale (VAS) [ Time Frame: Change from baseline and one week later. ]
    This scale is a line of 10 centimeters without marks between the parameters without pain and unbearable pain, where the patient has to mark between those parameters where his pain is.

  4. Shoulder Pain And Disability Index Spanish version (SPADIe). [ Time Frame: Change from baseline and one week later. ]
    It consists of a 10-item scale that assesses shoulder pain and the difficulties in activities of daily life that it generates, divided into two main sections: the first 4 items refer to the intensity of pain and the last 6 refer to the difficulty of carrying out specific activities. All the items have a minimum score of 0 and a maximum of 10, therefore the total score is between 0 and 100, with 0 being the best possible value in relation to pain and difficulty, and 100 being the highest value and so much more painful and disabling.

  5. Range Of Movement (ROM) [ Time Frame: Change from baseline, immediately after intervention and one week later. ]
    Objective will be to measure different ranges of movement of the affected upper limb (internal rotation and horizontal adduction) in question due to myofascial pain syndrome. In this case the movements that passively will be measured with a bubble inclinometer.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least one year after Spinal Cord Injury (chronic patients).
  • Spinal Cord Injury under C5-C6 spinal level with American Spinal Injury Association (ASIA) classification.
  • Patients with shoulder pain and at least one active trigger point in infraspinatus muscle.

Exclusion Criteria:

  • Be apprehensive to the needles (belonephobia).
  • Immunosuppression.
  • Drug instability.
  • Other medical causes that, under medical prescription, dry needling in the shoulder are discouraged.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709797


Contacts
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Contact: Sandra Ms Palacios Alfonso +34650667306 sandra.palac@gmail.com

Locations
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Spain
Sandra Palacios Alfonso Recruiting
Burgos, Spain, 09007
Contact: Sandra Palacios Alfonso, PhD student    650667306    sandra.palac@gmail.com   
Sponsors and Collaborators
Universidad de León

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Responsible Party: Sandra Palacios Alfonso, PhD Student, Universidad de León
ClinicalTrials.gov Identifier: NCT03709797     History of Changes
Other Study ID Numbers: ULeon-020-2018
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sandra Palacios Alfonso, Universidad de León:
Spinal Cord Injury
Shoulder Pain
Myofascial Pain Syndrome
Dry Needling

Additional relevant MeSH terms:
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Syndrome
Wounds and Injuries
Spinal Cord Injuries
Somatoform Disorders
Shoulder Pain
Myofascial Pain Syndromes
Fibromyalgia
Disease
Pathologic Processes
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Mental Disorders
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Rheumatic Diseases
Neuromuscular Diseases