Shoulder PainNCT02817269

Referred Pain Patterns Infraspinatus Muscle

A study testing Manual palpation and Deep dry needling in people with Shoulder Pain, run by Universidad Miguel Hernandez de Elche.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Shoulder Pain
What is being tested?: Manual palpation and Deep dry needling
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: No sites listed yet
Study dates: Jul 2016to Sep 2016
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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged between 18 and 65 years.
To remain seated or in front of data visualization screens (tablets, computers or smartphones) for at least 4 hours a day.
Shoulder complaints in the last six weeks.

Who cannot join

Patients with evidence of serious medical illness.
Cognitive impairment.
Psychosocial disorders.
Bilateral affectation of shoulder pain.
Pregnancy.

About this study

Official title: Referred Pain Patterns in Trigger Point 2 of the Infraspinatus Muscle in Patients With Shoulder Pain

The first aim of the study will be to identify the most common ReP pattern and compare its coincidence with that described by Travell and Simons. Second, the study aim will be to verify whether there are any significant differences by sex and types of technique used in regard to the ReP pattern of TrP 2 of the infraspinatus muscle, an area described as more sensitive.Finally, the third aim of the study will be to determine whether deep dry needling will evoke the LTR and ReP more easily than manual palpation.

Read the detailed description

Patients will be recruited from a university's employee and student population by advertising at the university. Patients with shoulder complaints (described as pain felt in the shoulder or upper arm) will be randomly assigned to either an manual palpation or deep dry needling group. Participants will be randomly divided into 2 groups, a deep dry needling group and manual palpation group. Visual analogue scale (VAS), referred pain (ReP) pattern and features of referred pain of the infraspinatus muscle will be all assessed post-technique.

Conditions: Shoulder Pain
Being tested: Manual palpation, Deep dry needling
Keywords: Shoulder pain, Trigger points, Referred pain, Visual analogue scale
Medical subject headings: Shoulder Pain, Pain, Referred

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Manual palpationOther
The manual palpation level will kept constant by applying enough digital pressure to cause the finger nail bed to blanch. When the nail will be turn pale, the amount of pressure will be measured at approximately 3 4kg/cm2 and will be maintained for 5-10 seconds to evoke referred pain. A manual palpation referred pain will be present if the pain radiated far enough for the patient to feel more than just a local pain.
Deep dry needlingOther
Intramuscular needling will be carried out via deep dry needling into myofascial trigger point (MTrP) area without the introduction any substances. The aim is to elicit a local twitch response upon inserting the needle into the MTrP area and perform a neurological stimulation (by rotating the needle 360 degrees) to more easily evoke referred pain, holding for 10 seconds and then extracting the needle gently. The procedure will be followed by one minute of haemostatic compression.

Study groups in NCT02817269
Study group	Role	What they receive
Manual palpation group	Experimental	For the manual palpation group, the reference position will be a lateral position, lying on the non affected shoulder while the affected side will be explored. The arm and elbow are flexed 90° resting on a pillow and legs placed with 90° hip and knee flexion to stabilize the body, with the head resting on a pillow to maintain body alignment. The physiotherapist will be in front of the participant and carried out the examination with flat palpation using the thumb to identify soreness taut band tried to elicit local twitch response and referred pain in the infraspinatus area. First, three attempts will be made to elicit an local twitch response (LTR) using snapping palpation if a response will be obtained. After LRT, referred pain could also be evoked by palpation. Receives: Other: Manual palpation
Deep dry needling group	Experimental	For the deep dry needling group, the reference position will be a lateral position, lying on the non affected shoulder while the affected side will be explored. The arm and elbow are flexed 90° resting on a pillow and legs placed with 90° hip and knee flexion to stabilize the body, with the head resting on a pillow to maintain body alignment. The physiotherapist will be in front of the participant and carried out the examination with flat palpation using the thumb to identify soreness taut before making the needle insertion. Sterile stainless steel needles (length 40mm/caliber 0.32 with a cylindrical plastic guide) will be used. Receives: Other: Deep dry needling

What is being measured

The primary outcome is the main question the study is designed to answer.

Mapping of Referred Pain Pattern
The participants from both groups will ask to report whether ReP is evoked and to describe the ReP pattern using an anatomical map of the upper half of the human body divided into eighteen areas. Nine areas corresponded to the anterior part of the body and the other nine to the posterior part of the body.
Measured: One month

Secondary outcomes (3)

Prevalence active trigger point
Active trigger point is considered: Soreness taut band and familiar pain.
Measured: One month
Evocation of Local Twitch Response
These were assigned a numerical value of 0 (yes) or 1 (no) for better statistical handling of the data.
Measured: One month
Subjective pain intensity: Visual Analogue Scale (VAS)
The VAS for pain measures the amount of pain experienced by a subject on a continuum from 0 to 10, with 0 being no pain and 10 maximum pain.
Measured: One month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2016Sep 2016

First posted29 Jun 2016 (estimated)
Study startJul 2016
Primary completionAug 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
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: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02817269
Sponsor's protocol ID: UniversidadMHE-1
Status last verified: Oct 2016
First submitted: 21 Jun 2016
Last updated: 28 Oct 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Audette JF, Wang F, Smith H. Bilateral activation of motor unit potentials with unilateral needle stimulation of active myofascial trigger points. Am J Phys Med Rehabil. 2004 May;83(5):368-74, quiz 375-7, 389. doi: 10.1097/01.phm.0000118037.61143.7c.
PubMed 15100626
Borg-Stein J. Management of peripheral pain generators in fibromyalgia. Rheum Dis Clin North Am. 2002 May;28(2):305-17. doi: 10.1016/s0889-857x(02)00004-2.
PubMed 12122919
Bron C, Dommerholt J, Stegenga B, Wensing M, Oostendorp RA. High prevalence of shoulder girdle muscles with myofascial trigger points in patients with shoulder pain. BMC Musculoskelet Disord. 2011 Jun 28;12:139. doi: 10.1186/1471-2474-12-139.
PubMed 21711512
Bron C, Wensing M, Franssen JL, Oostendorp RA. Treatment of myofascial trigger points in common shoulder disorders by physical therapy: a randomized controlled trial [ISRCTN75722066]. BMC Musculoskelet Disord. 2007 Nov 5;8:107. doi: 10.1186/1471-2474-8-107.
PubMed 17983467
Chou LW, Hsieh YL, Kuan TS, Hong CZ. Needling therapy for myofascial pain: recommended technique with multiple rapid needle insertion. Biomedicine (Taipei). 2014;4(2):13. doi: 10.7603/s40681-014-0013-2. Epub 2014 Aug 2.
PubMed 25520926
Ge HY, Fernandez-de-Las-Penas C, Madeleine P, Arendt-Nielsen L. Topographical mapping and mechanical pain sensitivity of myofascial trigger points in the infraspinatus muscle. Eur J Pain. 2008 Oct;12(7):859-65. doi: 10.1016/j.ejpain.2007.12.005. Epub 2008 Jan 18.
PubMed 18203637

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
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All Shoulder Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Referred Pain Patterns in Trigger Point 2 of the Infraspinatus Muscle in Patients With Shoulder Pain
ClinicalTrials.gov ID: NCT02817269
Acronym / sponsor ID: UniversidadMHE-1
Conditions: Shoulder Pain
Keywords: Shoulder pain, Trigger points, Referred pain, Visual analogue scale
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Universidad Miguel Hernandez de ElcheUniversity, hospital or other
Study start: Jul 2016
Primary completion: Aug 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 29 Jun 2016 (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.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Manual palpation group	Experimental	Other: Manual palpationFor the manual palpation group, the reference position will be a lateral position, lying on the non affected shoulder while the affected side will be explored. The arm and elbow are flexed 90° resting on a pillow and legs placed with 90° hip and knee flexion to stabilize the body, with the head resting on a pillow to maintain body alignment. The physiotherapist will be in front of the participant and carried out the examination with flat palpation using the thumb to identify soreness taut band tried to elicit local twitch response and referred pain in the infraspinatus area. First, three attempts will be made to elicit an local twitch response (LTR) using snapping palpation if a response will be obtained. After LRT, referred pain could also be evoked by palpation.
Deep dry needling group	Experimental	Other: Deep dry needlingFor the deep dry needling group, the reference position will be a lateral position, lying on the non affected shoulder while the affected side will be explored. The arm and elbow are flexed 90° resting on a pillow and legs placed with 90° hip and knee flexion to stabilize the body, with the head resting on a pillow to maintain body alignment. The physiotherapist will be in front of the participant and carried out the examination with flat palpation using the thumb to identify soreness taut before making the needle insertion. Sterile stainless steel needles (length 40mm/caliber 0.32 with a cylindrical plastic guide) will be used.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Aged between 18 and 65 years.
To remain seated or in front of data visualization screens (tablets, computers or smartphones) for at least 4 hours a day.
Shoulder complaints in the last six weeks.

Key exclusion criteria (5 listed)

Patients with evidence of serious medical illness.
Cognitive impairment.
Psychosocial disorders.
Bilateral affectation of shoulder pain.
Pregnancy.

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
Manual palpationThe manual palpation level will kept constant by applying enough digital pressure to cause the finger nail bed to blanch. When the nail will be turn pale, the amount of pressure will be measured at approximately 3 4kg/cm2 and will be maintained for 5-10 seconds to evoke referred pain. A manual palpation referred pain will be present if the pain radiated far enough for the patient to feel more than just a local pain.	Other	Manual palpation group
Deep dry needlingIntramuscular needling will be carried out via deep dry needling into myofascial trigger point (MTrP) area without the introduction any substances. The aim is to elicit a local twitch response upon inserting the needle into the MTrP area and perform a neurological stimulation (by rotating the needle 360 degrees) to more easily evoke referred pain, holding for 10 seconds and then extracting the needle gently. The procedure will be followed by one minute of haemostatic compression.	Other	Deep dry needling group

Primary outcome

Mapping of Referred Pain Pattern
Time frame: One month
The participants from both groups will ask to report whether ReP is evoked and to describe the ReP pattern using an anatomical map of the upper half of the human body divided into eighteen areas. Nine areas corresponded to the anterior part of the body and the other nine to the posterior part of the body.

3 secondary outcomes

Prevalence active trigger point
Time frame: One month
Evocation of Local Twitch Response
Time frame: One month
Subjective pain intensity: Visual Analogue Scale (VAS)
Time frame: One month

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 28 Oct 2016.
Results publication: PubMed 15100626Audette JF, Wang F, Smith H. Bilateral activation of motor unit potentials with unilateral needle stimulation of active myofascial trigger points. Am J Phys Med Rehabil. 2004 May;83(5):368-74, quiz 375-7, 389. doi: 10.1097/01.phm.0000118037.61143.7c.
Results publication: PubMed 12122919Borg-Stein J. Management of peripheral pain generators in fibromyalgia. Rheum Dis Clin North Am. 2002 May;28(2):305-17. doi: 10.1016/s0889-857x(02)00004-2.
Results publication: PubMed 21711512Bron C, Dommerholt J, Stegenga B, Wensing M, Oostendorp RA. High prevalence of shoulder girdle muscles with myofascial trigger points in patients with shoulder pain. BMC Musculoskelet Disord. 2011 Jun 28;12:139. doi: 10.1186/1471-2474-12-139.
Results publication: PubMed 17983467Bron C, Wensing M, Franssen JL, Oostendorp RA. Treatment of myofascial trigger points in common shoulder disorders by physical therapy: a randomized controlled trial [ISRCTN75722066]. BMC Musculoskelet Disord. 2007 Nov 5;8:107. doi: 10.1186/1471-2474-8-107.
Results publication: PubMed 25520926Chou LW, Hsieh YL, Kuan TS, Hong CZ. Needling therapy for myofascial pain: recommended technique with multiple rapid needle insertion. Biomedicine (Taipei). 2014;4(2):13. doi: 10.7603/s40681-014-0013-2. Epub 2014 Aug 2.
Results publication: PubMed 18203637Ge HY, Fernandez-de-Las-Penas C, Madeleine P, Arendt-Nielsen L. Topographical mapping and mechanical pain sensitivity of myofascial trigger points in the infraspinatus muscle. Eur J Pain. 2008 Oct;12(7):859-65. doi: 10.1016/j.ejpain.2007.12.005. Epub 2008 Jan 18.
Individual participant dataSharing planned: Undecided

Related trials for Shoulder Pain

Recruiting
Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
Recruiting
Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain

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.

José V Segura-Heras, PhD in math study chair

UNIVERSIDAD MIGUEL HERNÁNDEZ DE ELCHE (ALICANTE)

Questions about this trial

What is this clinical trial studying?

A study testing Manual palpation and Deep dry needling in people with Shoulder Pain, run by Universidad Miguel Hernandez de Elche.

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 3 inclusion and 5 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 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

Mapping of Referred Pain Pattern (time frame: One month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02817269, which also lists 6 linked publications.

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 28 Oct 2016.