- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02817269
Referred Pain Patterns Infraspinatus Muscle
October 27, 2016 updated by: Emilio-José Poveda-Pagán, Universidad Miguel Hernandez de Elche
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
96
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Patients with evidence of serious medical illness.
- Cognitive impairment.
- Psychosocial disorders.
- Bilateral affectation of shoulder pain.
- Pregnancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Manual palpation group
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.
|
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.
|
Experimental: Deep dry needling group
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
One month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence active trigger point
Time Frame: One month
|
Active trigger point is considered: Soreness taut band and familiar pain.
|
One month
|
Evocation of Local Twitch Response
Time Frame: One month
|
These were assigned a numerical value of 0 (yes) or 1 (no) for better statistical handling of the data.
|
One month
|
Subjective pain intensity: Visual Analogue Scale (VAS)
Time Frame: One month
|
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.
|
One month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: José V Segura-Heras, PhD in math, UNIVERSIDAD MIGUEL HERNÁNDEZ DE ELCHE (ALICANTE)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2016
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
September 1, 2016
Study Registration Dates
First Submitted
June 21, 2016
First Submitted That Met QC Criteria
June 26, 2016
First Posted (Estimate)
June 29, 2016
Study Record Updates
Last Update Posted (Estimate)
October 28, 2016
Last Update Submitted That Met QC Criteria
October 27, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UniversidadMHE-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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