Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients

February 2, 2019 updated by: Sandra Palacios Alfonso, Universidad de León

Effectiveness of Dry Needling as a Treatment of Shoulder Myofascial Pain Syndrome in Spinal Cord Injury Patients: a Randomized Controlled Clinical Trial

Shoulder pain in people with spinal cord injury is one of the most prevalent in acute and chronic patients because of weakness in shoulder periarticular muscles, and also because of overuse of these part of the body in assistive devices.

This study aims to evidence if dry needling (a physiotherapy technique) is also useful in patients with spinal cord injury, and how long it could hold out without or less pain.

Study Overview

Status

Status

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

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.

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 (Anticipated)

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.
60

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Burgos, Spain, 09007
        • Recruiting
        • Sandra Palacios Alfonso
        • Contact:

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least one year after Spinal Cord Injury (chronic patients).
  • Spinal Cord Injury under C5-C6 spinal level with American Spinal Injury Association (ASIA) classification.
  • Patients with shoulder pain and at least one active trigger point in infraspinatus muscle.

Exclusion Criteria:

  • Be apprehensive to the needles (belonephobia).
  • Immunosuppression.
  • Drug instability.
  • Other medical causes that, under medical prescription, dry needling in the shoulder are discouraged.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Experimental group
Experimental group will receive dry needling treatment.
Procedure: Dry needling in infraspinatus muscle
Dry needling technique with multiple rapid needle insertion.
Sham Comparator: Control group
Control group will receive sham dry needling treatment.
Procedure: Dry needling in infraspinatus muscle
Dry needling technique with multiple rapid needle insertion.

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
Disabilities of the Arm, Shoulder and Hand Spanish version (DASHe).
Time Frame: Change from baseline and one week later.

In upper limb pathology this test evaluates functional activities in relation to the difficulty involved in performing them with a score between 1 and 5.

The DASHe questionnaire consists of a main part of 30 items, and two specific modules for people who work with musical instruments / sports or for the workplace. In this study, only the main part has been used. The 30 items have a score of 1 to 5, with 5 being the maximum of the valued symptom, and at least 27 questions of 3 must be answered.

The disability / symptom score will therefore be between 0 (best possible score) and 100 (worst possible score).
Change from baseline and one week later.

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
Pressure Pain Thershold (algometry).
Time Frame: Change from baseline, immediately after intervention and one week later.
Baseline®dolorimeter - 22lb / 10kg, STOCK CODE: 12-1442 It will be measured with an algometer that is an instrument that provides quantitative / objective information on pain at a specific point, depending on the pressure on which it is applied. A circle is drawn around the trigger point on which the indelible marker test will be performed to confirm in the last measurement which is the exact point on which it is worked. 3 consecutive measurements are made at the same point, waiting between one and another measurement for a period between 30-60 seconds, and the average of the 3 measurements will be used as a statistical value.
Change from baseline, immediately after intervention and one week later.
McGill Pain Questionnaire (Spanish version).
Time Frame: Change from baseline and one week later.
This scale consists of a set of 78 adjectives included in 20 groups (including 2 to 6 in each group) and that express a characteristic of pain. Within these 20 groups we find the Pain Rating Index (PRI) divided into: sensory (groups 1-10), affective (groups 11-15), evaluative (group 16) and miscellaneous (group 17-20) ), of which the patient can only choose one word from each of the 20 groups, choosing only those adjectives that best suit his pain sensation. It also includes a category on the changes that experimental pain, and another with a rate of pain intensity (Present Pain Index = PPI).
Change from baseline and one week later.
Visual Analog Scale (VAS)
Time Frame: Change from baseline and one week later.
This scale is a line of 10 centimeters without marks between the parameters without pain and unbearable pain, where the patient has to mark between those parameters where his pain is.
Change from baseline and one week later.
Shoulder Pain And Disability Index Spanish version (SPADIe).
Time Frame: Change from baseline and one week later.
It consists of a 10-item scale that assesses shoulder pain and the difficulties in activities of daily life that it generates, divided into two main sections: the first 4 items refer to the intensity of pain and the last 6 refer to the difficulty of carrying out specific activities. All the items have a minimum score of 0 and a maximum of 10, therefore the total score is between 0 and 100, with 0 being the best possible value in relation to pain and difficulty, and 100 being the highest value and so much more painful and disabling.
Change from baseline and one week later.
Range Of Movement (ROM)
Time Frame: Change from baseline, immediately after intervention and one week later.
Objective will be to measure different ranges of movement of the affected upper limb (internal rotation and horizontal adduction) in question due to myofascial pain syndrome. In this case the movements that passively will be measured with a bubble inclinometer.
Change from baseline, immediately after intervention and one week later.

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 de León

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 (Actual)

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.
November 9, 2018

Primary Completion (Anticipated)

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.
January 1, 2020

Study Completion (Anticipated)

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.
October 1, 2020

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).
October 8, 2018

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.
October 14, 2018

First Posted (Actual)

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.
October 17, 2018

Study Record Updates

Last Update Posted (Actual)

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.
February 5, 2019

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.
February 2, 2019

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.
February 1, 2019

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.
  • ULeon-020-2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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