Shoulder PainNCT02032602
Dry Needling on Myofascial Trigger Points in Older Adults With Nonspecific Shoulder Pain
A study testing Deep Dry Needling in people with Shoulder Pain, run by University of Alcala at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Deep Dry Needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Shoulder Pain
- Being tested
- Deep Dry Needling
- Keywords
- Myofascial Pain Syndromes, Trigger Point, Shoulder Pain, Aged
- Medical subject headings
- Shoulder Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Dry NeedlingOther
| Study group | Role | What they receive |
|---|---|---|
| 1, CG: Active MTrP | Active comparator | 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 Receives: Other: Deep Dry Needling |
| 2, EG: Active+Latent MTrPs | Experimental | 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. Receives: Other: Deep Dry Needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 5 minutes
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.
Measured: Baseline, 5 minutes
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.
Measured: Baseline, 5 minutes
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.
Measured: Baseline, 5 minutes
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.
Measured: Baseline, 1 week
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.
Measured: Baseline,1 week
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.
Measured: Baseline, 1 week
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.
Measured: Baseline, 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cesar Calvo Lobo, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032602
- Sponsor's protocol ID
- v5EGIU
- Status last verified
- Aug 2014
- First submitted
- 6 Jan 2014
- Last updated
- 18 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02032602
- Acronym / sponsor ID
- v5EGIU
- Conditions
- Shoulder Pain
- Keywords
- Myofascial Pain Syndromes, Trigger Point, Shoulder Pain, Aged
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 10 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1, CG: Active MTrP | Active comparator | Other: Deep Dry Needlinga 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 |
| 2, EG: Active+Latent MTrPs | Experimental | Other: Deep Dry NeedlingThe 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Dry Needling | Other | 1, CG: Active MTrP, 2, EG: Active+Latent MTrPs |
Primary outcome
Change from baseline in Pain Intensity on the Numerical Rating Scale (NRS) at 5 minutes
Time frame: Baseline, 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
Time frame: Baseline, 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
Time frame: Baseline, 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
Time frame: Baseline, 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
Time frame: Baseline, 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
Time frame: Baseline,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
Time frame: Baseline, 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
Time frame: Baseline, 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep Dry Needling in people with Shoulder Pain, run by University of Alcala at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Pain Intensity on the Numerical Rating Scale (NRS) at 5 minutes (time frame: Baseline, 5 minutes). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2014; AzTrials last refreshed its copy on 6 Nov 2026.