Dry Needling in Post-operative Shoulder Pain

April 22, 2014 updated by: César Fernández-de-las-Peñas

EFFECTIVENESS OF THE INCLUSION OF TRIGGER POINT DRY NEEDLING INTO A MULTIMODAL PHYSICAL THERAPY PROGRAM FOR POST-OPERATIVE SHOULDER PAIN

Fractures of the proximal humerus account for between 5% and 8% off all reported fractures. Post-operative shoulder pain is highly frequent. Due to either surgical procedure, soft tissues surrounding the shoulder area can be damaged. The purpose of the current clinical trial was to compare the effects of physiotherapy versus physiotherapy plus TrP-DN on pain and function in patients who exhibit post-operative shoulder pain after a PHILOS procedure for proximal humeral fixation or rotator cuff tear repair.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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, Spain
        • Jose Luis Arias Buría

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:

  • proximal humeral fracture
  • rotator cuff tear
  • open reduction and internal fixation with PHILOS© plate (Synthes, Switzerland)
  • rotator cuff tear repair
  • post-operative shoulder pain
  • active TrPs in the neck-shoulder muscles

Exclusion Criteria:

  • no active TrPs
  • multiple fracture
  • previous surgery
  • cervical radiculopathy or myelopathy
  • diagnosis of fibromialgia
  • having undergone any physical therapy intervention in the year before the surgery
  • fear of needles
  • any contraindication for dry needling

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
Intervention / Treatment
Experimental: Physical therapy plus dry needling
Best-evidence physical therapy intervention in addition to a single session of TrP-DN targeted to active TrPs in the neck-shoulder muscles.
Other: Physical therapy plus dry needling
Best-evidence physical therapy intervention in addition to a single session of TrP-DN targeted to active TrPs in the neck-shoulder muscles
Active Comparator: Physical therapy
Best-evidence physical therapy intervention
Other: Physical therapy
Best-evidence physical therapy intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Constant-Murley score before and after the intervention
Time Frame: Baseline and one week after the intervention
The Constant-Murley score is a 100-point scoring system that is divided into 4 main sub-scales: pain (15 points); activities of daily living (20 points); range of motion (40 points); and strength (25 points). Higher score represents better function
Baseline and one week after the intervention

Collaborators and Investigators

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

Sponsor

César Fernández-de-las-Peñas

Investigators

  • Study Chair: Cesar Fernández-de-las-Peñas, 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

February 1, 2013

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

April 19, 2014

First Submitted That Met QC Criteria

April 22, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 22, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP13-060

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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