Dry Needling on Myofascial Trigger Points in Older Adults With Nonspecific Shoulder Pain
Primary Purpose
Shoulder Pain
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Deep Dry Needling
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain focused on measuring Myofascial Pain Syndromes, Trigger Point, Shoulder Pain, Aged
Eligibility Criteria
Inclusion Criteria:
- people aged 65 or over with uni or bilateral non-specific shoulder pain and with at least one active and one latent MTrP in the infraspinatus homolateral to the painful shoulder
Exclusion Criteria:
- prior diagnosis of myopathy or neuropathy; cognitive deficit in the medical record; cervical spine, rotator cuff tendons or glenohumeral joint problems in the medical record; corticoid infiltration or local anaesthetic during the previous year or during follow-up; surgical procedure affecting the upper limb or preceding cervical; ingestion of antiaggregant, anti-coagulant, analgesic or anti-inflammatory medication or abusive substances in the week prior to treatment and during follow-up were excluded from the study
Sites / Locations
- University of Alcala
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1, CG: Active MTrP
2, EG: Active+Latent MTrPs
Arm Description
a single session of physical therapy intervention which will be consisted on Deep Dry Needling of the active MTrP most hyperalgesic to palpation of the infraspinatus muscle homolateral to painful shoulder
The same treatment described above for the Control Group, combined with the Deep Dry Needling of the most hyperalgesic latent MTrP, both located in the infraspinatus muscle homolateral to the painful shoulder.
Outcomes
Primary Outcome Measures
Change from baseline in Pain Intensity on the Numerical Rating Scale (NRS) at 5 minutes
Pain Intensity was measured with the Numerical Rating Scale (NRS) of 11 points (interval of 0-10), where 0 corresponds to no pain and 10 corresponds to the worst pain imaginable. In order to show a parametric analysis of the obtained data, a graphical representation of 11 spaces describes levels for the discrimination of the patient. The subjects will be asked to determine the subjective pain intensity of the painful shoulder using a finger.
Change from baseline in Pain Pressure Threshold of anterior deltoid at 5 minutes
Pressure Pain Threshold (PPT) will be measured with a WAGNER FDK/FDN Series Force Dial Fisher type analogue algometer (Wagner Instruments, Greenwich, USA) which varies between 0-10 kg/cm2. After indicating the most hyperalgesic latent Myofascial Trigger Point (MTrP) of anterior deltoid muscle (located in referred pain area and with the same C5-6 segmentary innervation levels), examiner will determine PPT of such point.
Change from baseline in Maximum Grip Strength at 5 minutes
Maximum grip strength, defined as the maximum isometric muscular force in kg used in the manual pressure of a hydraulic dynamometer, will be measured with a JAMAR type hydraulic manual analogical dynamometer with an interval of 0-90kg to objectify the weakness of latent Myofascial Trigger Points (MTrPs) of the forearm. According to the fatigability of older adults, a single measurement will be performed to measure the manual grip strength.
Change from baseline in Pressure Pain Threshold of extensor carpi radialis brevis at 5 minutes
Pressure Pain Threshold (PPT) will be measured with a WAGNER FDK/FDN Series Force Dial Fisher type analogue algometer (Wagner Instruments, Greenwich, USA) which varies between 0-10 kg/cm2. After indicating the most hyperalgesic latent Myofascial Trigger Point (MTrP) of extensor carpi radialis brevis muscle (located in referred pain area and with the same C5-6 segmentary innervation levels), examiner will determine PPT of such point.
Change from baseline in Pain Intensity on the Numerical Rating Scale (NRS) at 1 week
Pain Intensity was measured with the Numerical Rating Scale (NRS) of 11 points (interval of 0-10), where 0 corresponds to no pain and 10 corresponds to the worst pain imaginable. In order to show a parametric analysis of the obtained data, a graphical representation of 11 spaces describes levels for the discrimination of the patient. The subjects will be asked to determine the subjective pain intensity of the painful shoulder using a finger.
Change from baseline in Pressure Pain Threshold of anterior deltoid at 1 week
Pressure Pain Threshold (PPT) will be measured with a WAGNER FDK/FDN Series Force Dial Fisher type analogue algometer (Wagner Instruments, Greenwich, USA) which varies between 0-10 kg/cm2. After indicating the most hyperalgesic latent Myofascial Trigger Point (MTrP) of anterior deltoid muscle (located in referred pain area and with the same C5-6 segmentary innervation levels), examiner will determine PPT of such point.
Change from baseline in Maximum Grip Strength at 1 week
Maximum grip strength, defined as the maximum isometric muscular force in kg used in the manual pressure of a hydraulic dynamometer, will be measured with a JAMAR type hydraulic manual analogical dynamometer with an interval of 0-90kg to objectify the weakness of latent Myofascial Trigger Points (MTrPs) of the forearm. According to the fatigability of older adults, a single measurement will be performed to measure the manual grip strength.
Change from baseline in Pressure Pain Threshold of extensor carpi radialis brevis at 1 week
Pressure Pain Threshold (PPT) will be measured with a WAGNER FDK/FDN Series Force Dial Fisher type analogue algometer (Wagner Instruments, Greenwich, USA) which varies between 0-10 kg/cm2. After indicating the most hyperalgesic latent Myofascial Trigger Point (MTrP) of extensor carpi radialis brevis muscle (located in referred pain area and with the same C5-6 segmentary innervation levels), examiner will determine PPT of such point.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02032602
Brief Title
Dry Needling on Myofascial Trigger Points in Older Adults With Nonspecific Shoulder Pain
Official Title
Efficacy of Dry Needling on Myofascial Trigger Points in Adults Over 65 Years Old With Non-specific Shoulder Pain: Single Blind Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Background: Non-specific shoulder pain has a high prevalence in older adults and provokes functional alterations. Besides, there are difficulties for its clinical diagnosis, lack of effectiveness in the treatment and not much evidence is found regarding invasive physical therapy techniques in this population.
Purpose: To determine the efficacy of a single physical therapy intervention with deep dry needling on latent and active myofascial trigger points in older adults with non-specific shoulder pain.
Methods: Pilot Study, Single Blind Randomized Controlled Clinical Trial on 60 subjects aged 65 and over, will be diagnosed with nonspecific shoulder pain. The study will be approved by the Clinical Research Ethics Committee of the area. Sample will be recruited at their home and at a care center, and randomly will be distributed in Experimental Group (n=30), which will be received a session of Deep Dry Needling on an active and a latent Myofascial Trigger Points of the infraspinatus muscle; and Control Group (n=30), receiving a session of Deep Dry Needling only on an active Myofascial Trigger Point. A blind examiner will be evaluated Pain Intensity, Pain Pressure Threshold (anterior deltoid; extensor carpi radialis brevis) and Grip Strength, before, immediately after intervention and after a week of treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Myofascial Pain Syndromes, Trigger Point, Shoulder Pain, Aged
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1, CG: Active MTrP
Arm Type
Active Comparator
Arm Description
a single session of physical therapy intervention which will be consisted on Deep Dry Needling of the active MTrP most hyperalgesic to palpation of the infraspinatus muscle homolateral to painful shoulder
Arm Title
2, EG: Active+Latent MTrPs
Arm Type
Experimental
Arm Description
The same treatment described above for the Control Group, combined with the Deep Dry Needling of the most hyperalgesic latent MTrP, both located in the infraspinatus muscle homolateral to the painful shoulder.
Intervention Type
Other
Intervention Name(s)
Deep Dry Needling
Primary Outcome Measure Information:
Title
Change from baseline in Pain Intensity on the Numerical Rating Scale (NRS) at 5 minutes
Description
Pain Intensity was measured with the Numerical Rating Scale (NRS) of 11 points (interval of 0-10), where 0 corresponds to no pain and 10 corresponds to the worst pain imaginable. In order to show a parametric analysis of the obtained data, a graphical representation of 11 spaces describes levels for the discrimination of the patient. The subjects will be asked to determine the subjective pain intensity of the painful shoulder using a finger.
Time Frame
Baseline, 5 minutes
Title
Change from baseline in Pain Pressure Threshold of anterior deltoid at 5 minutes
Description
Pressure Pain Threshold (PPT) will be measured with a WAGNER FDK/FDN Series Force Dial Fisher type analogue algometer (Wagner Instruments, Greenwich, USA) which varies between 0-10 kg/cm2. After indicating the most hyperalgesic latent Myofascial Trigger Point (MTrP) of anterior deltoid muscle (located in referred pain area and with the same C5-6 segmentary innervation levels), examiner will determine PPT of such point.
Time Frame
Baseline, 5 minutes
Title
Change from baseline in Maximum Grip Strength at 5 minutes
Description
Maximum grip strength, defined as the maximum isometric muscular force in kg used in the manual pressure of a hydraulic dynamometer, will be measured with a JAMAR type hydraulic manual analogical dynamometer with an interval of 0-90kg to objectify the weakness of latent Myofascial Trigger Points (MTrPs) of the forearm. According to the fatigability of older adults, a single measurement will be performed to measure the manual grip strength.
Time Frame
Baseline, 5 minutes
Title
Change from baseline in Pressure Pain Threshold of extensor carpi radialis brevis at 5 minutes
Description
Pressure Pain Threshold (PPT) will be measured with a WAGNER FDK/FDN Series Force Dial Fisher type analogue algometer (Wagner Instruments, Greenwich, USA) which varies between 0-10 kg/cm2. After indicating the most hyperalgesic latent Myofascial Trigger Point (MTrP) of extensor carpi radialis brevis muscle (located in referred pain area and with the same C5-6 segmentary innervation levels), examiner will determine PPT of such point.
Time Frame
Baseline, 5 minutes
Title
Change from baseline in Pain Intensity on the Numerical Rating Scale (NRS) at 1 week
Description
Pain Intensity was measured with the Numerical Rating Scale (NRS) of 11 points (interval of 0-10), where 0 corresponds to no pain and 10 corresponds to the worst pain imaginable. In order to show a parametric analysis of the obtained data, a graphical representation of 11 spaces describes levels for the discrimination of the patient. The subjects will be asked to determine the subjective pain intensity of the painful shoulder using a finger.
Time Frame
Baseline, 1 week
Title
Change from baseline in Pressure Pain Threshold of anterior deltoid at 1 week
Description
Pressure Pain Threshold (PPT) will be measured with a WAGNER FDK/FDN Series Force Dial Fisher type analogue algometer (Wagner Instruments, Greenwich, USA) which varies between 0-10 kg/cm2. After indicating the most hyperalgesic latent Myofascial Trigger Point (MTrP) of anterior deltoid muscle (located in referred pain area and with the same C5-6 segmentary innervation levels), examiner will determine PPT of such point.
Time Frame
Baseline,1 week
Title
Change from baseline in Maximum Grip Strength at 1 week
Description
Maximum grip strength, defined as the maximum isometric muscular force in kg used in the manual pressure of a hydraulic dynamometer, will be measured with a JAMAR type hydraulic manual analogical dynamometer with an interval of 0-90kg to objectify the weakness of latent Myofascial Trigger Points (MTrPs) of the forearm. According to the fatigability of older adults, a single measurement will be performed to measure the manual grip strength.
Time Frame
Baseline, 1 week
Title
Change from baseline in Pressure Pain Threshold of extensor carpi radialis brevis at 1 week
Description
Pressure Pain Threshold (PPT) will be measured with a WAGNER FDK/FDN Series Force Dial Fisher type analogue algometer (Wagner Instruments, Greenwich, USA) which varies between 0-10 kg/cm2. After indicating the most hyperalgesic latent Myofascial Trigger Point (MTrP) of extensor carpi radialis brevis muscle (located in referred pain area and with the same C5-6 segmentary innervation levels), examiner will determine PPT of such point.
Time Frame
Baseline, 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
people aged 65 or over with uni or bilateral non-specific shoulder pain and with at least one active and one latent MTrP in the infraspinatus homolateral to the painful shoulder
Exclusion Criteria:
prior diagnosis of myopathy or neuropathy; cognitive deficit in the medical record; cervical spine, rotator cuff tendons or glenohumeral joint problems in the medical record; corticoid infiltration or local anaesthetic during the previous year or during follow-up; surgical procedure affecting the upper limb or preceding cervical; ingestion of antiaggregant, anti-coagulant, analgesic or anti-inflammatory medication or abusive substances in the week prior to treatment and during follow-up were excluded from the study
Facility Information:
Facility Name
University of Alcala
City
Alcala de Henares
State/Province
Madrid
ZIP/Postal Code
E-28871
Country
Spain
12. IPD Sharing Statement
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Dry Needling on Myofascial Trigger Points in Older Adults With Nonspecific Shoulder Pain
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