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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
96

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Manual 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.
Other: Deep dry needling
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Miguel Hernandez de Elche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UniversidadMHE-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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