Dry Needling on Myofascial Trigger Points in Older Adults With Nonspecific Shoulder Pain

Shoulder Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032602
• Other study ID #: v5EGIU
• Status: Completed
• Phase: N/A
• First received: January 6, 2014
• Last updated: August 15, 2014
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• Deep Dry Needling

Locations

Country	Name	City	State
Spain	University of Alcala	Alcala de Henares	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
University of Alcala

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, 5 minutes	Yes
Primary	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.	Baseline, 5 minutes	Yes
Primary	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.	Baseline, 5 minutes	Yes
Primary	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.	Baseline, 5 minutes	Yes
Primary	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.	Baseline, 1 week	Yes
Primary	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.	Baseline,1 week	Yes
Primary	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.	Baseline, 1 week	Yes
Primary	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.	Baseline, 1 week	Yes

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