Back to resultsEffectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients
Primary Purpose
Spinal Cord Injuries, Myofascial Pain Syndrome, Shoulder Pain
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling in infraspinatus muscle
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Spinal Cord Injury, Shoulder Pain, Myofascial Pain Syndrome, Dry Needling
Eligibility 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.
Sites / Locations
- Sandra Palacios AlfonsoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental group
Control group
Arm Description
Experimental group will receive dry needling treatment.
Control group will receive sham dry needling treatment.
Outcomes
Primary Outcome Measures
Disabilities of the Arm, Shoulder and Hand Spanish version (DASHe).
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
Pressure Pain Thershold (algometry).
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.
McGill Pain Questionnaire (Spanish version).
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).
Visual Analog Scale (VAS)
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.
Shoulder Pain And Disability Index Spanish version (SPADIe).
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.
Range Of Movement (ROM)
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03709797
Brief Title
Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients
Official Title
Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 9, 2018 (Actual)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de León
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Myofascial Pain Syndrome, Shoulder Pain, Puncture
Keywords
Spinal Cord Injury, Shoulder Pain, Myofascial Pain Syndrome, Dry Needling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental group will receive dry needling treatment.
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Control group will receive sham dry needling treatment.
Intervention Type
Procedure
Intervention Name(s)
Dry needling in infraspinatus muscle
Intervention Description
Dry needling technique with multiple rapid needle insertion.
Primary Outcome Measure Information:
Title
Disabilities of the Arm, Shoulder and Hand Spanish version (DASHe).
Description
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).
Time Frame
Change from baseline and one week later.
Secondary Outcome Measure Information:
Title
Pressure Pain Thershold (algometry).
Description
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.
Time Frame
Change from baseline, immediately after intervention and one week later.
Title
McGill Pain Questionnaire (Spanish version).
Description
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).
Time Frame
Change from baseline and one week later.
Title
Visual Analog Scale (VAS)
Description
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.
Time Frame
Change from baseline and one week later.
Title
Shoulder Pain And Disability Index Spanish version (SPADIe).
Description
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.
Time Frame
Change from baseline and one week later.
Title
Range Of Movement (ROM)
Description
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.
Time Frame
Change from baseline, immediately after intervention and one week later.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Ms Palacios Alfonso
Phone
+34650667306
Email
sandra.palac@gmail.com
Facility Information:
Facility Name
Sandra Palacios Alfonso
City
Burgos
ZIP/Postal Code
09007
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Palacios Alfonso, PhD student
Phone
650667306
Email
sandra.palac@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients
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