Dry Needling and Exercises in Shoulder Pain

March 14, 2016 updated by: César Fernández-de-las-Peñas, Universidad Rey Juan Carlos

Effectiveness of Dry Needling and Eccentric Exercises in Unspecific Shoulder Pain

Shoulder pain is highly prevalent in the society. The role of muscle tissues in this pathology has received increasing interest. Some studies have proposed the role of myofascial trigger points in this population. The purpose of the current clinical trial is to compare the effects of physiotherapy treatment consisting of an eccentric exercise protocol versus the same physical therapy program plus the addition of trigger point dry needling (TrP-DN) on pain and function in patients suffering from unspecific shoulder pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • 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 Locations

  • Spain
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
        • César Fernández-de-las-Peñas

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:

  • Unilateral non-traumatic shoulder pain
  • Shoulder pain from at least 3 months
  • Shoulder pain of more than 4 points on a NPRS

Exclusion Criteria:

  • bilateral shoulder symptoms
  • younger than 18 or older than 65 years
  • history of shoulder fractures or dislocation
  • cervical radiculopathy
  • previous interventions with steroid injections
  • fibromyalgia syndrome
  • previous history of shoulder or neck surgery
  • any type of intervention for the neck-shoulder area during the previous year

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks. In addition, within the second and fourth sessions, they will receive TrP-DN over active TrPs in the shoulder muscles
Other: exercise program
Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks.
Other: TrP-DN
In addition, within the second and fourth sessions, they will receive TrP-DN over active TrPs in the shoulder muscles
Active Comparator: Control group
Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks.
Other: exercise program
Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in disability between baseline and follow-up periods
Time Frame: Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention
The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain
Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in shoulder pain between baseline and follow-up periods
Time Frame: Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' current level of shoulder pain and the worst level of pain experienced in the preceding week in the shoulder area.
Baseline, one week after the last intervention and 3, 6 and 12 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Rey Juan Carlos

Collaborators

Hospital General Universitario Gregorio Marañon

Investigators

  • Principal Investigator: CESAR FERNANDEZ-DE-LAS-PEÑAS, PT, PhD, Universidad Rey Juan Carlos

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

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

January 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 11, 2015

First Submitted That Met QC Criteria

January 13, 2015

First Posted (Estimate)

January 14, 2015

Study Record Updates

Last Update Posted (Estimate)

March 15, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URJC 31/2140

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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