Back to resultsDry Needling in Post-operative Shoulder Pain
Primary Purpose
Proximal Humeral Fracture Fixated With PHILOS© Plate, Rotator Cuff Tear Surgical Repair
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical therapy plus dry needling
Physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Proximal Humeral Fracture Fixated With PHILOS© Plate
Eligibility Criteria
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
Sites / Locations
- Jose Luis Arias Buría
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Physical therapy plus dry needling
Physical therapy
Arm Description
Best-evidence physical therapy intervention in addition to a single session of TrP-DN targeted to active TrPs in the neck-shoulder muscles.
Best-evidence physical therapy intervention
Outcomes
Primary Outcome Measures
Changes in Constant-Murley score before and 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
Secondary Outcome Measures
Full Information
NCT ID
NCT02122315
First Posted
April 19, 2014
Last Updated
April 22, 2014
Sponsor
César Fernández-de-las-Peñas
1. Study Identification
Unique Protocol Identification Number
NCT02122315
Brief Title
Dry Needling in Post-operative Shoulder Pain
Official Title
EFFECTIVENESS OF THE INCLUSION OF TRIGGER POINT DRY NEEDLING INTO A MULTIMODAL PHYSICAL THERAPY PROGRAM FOR POST-OPERATIVE SHOULDER PAIN
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
César Fernández-de-las-Peñas
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Humeral Fracture Fixated With PHILOS© Plate, Rotator Cuff Tear Surgical Repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Physical therapy plus dry needling
Arm Type
Experimental
Arm Description
Best-evidence physical therapy intervention in addition to a single session of TrP-DN targeted to active TrPs in the neck-shoulder muscles.
Arm Title
Physical therapy
Arm Type
Active Comparator
Arm Description
Best-evidence physical therapy intervention
Intervention Type
Other
Intervention Name(s)
Physical therapy plus dry needling
Intervention Description
Best-evidence physical therapy intervention in addition to a single session of TrP-DN targeted to active TrPs in the neck-shoulder muscles
Intervention Type
Other
Intervention Name(s)
Physical therapy
Intervention Description
Best-evidence physical therapy intervention
Primary Outcome Measure Information:
Title
Changes in Constant-Murley score before and after the intervention
Description
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
Time Frame
Baseline and one week after the intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesar Fernández-de-las-Peñas, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Study Chair
Facility Information:
Facility Name
Jose Luis Arias Buría
City
Madrid
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
35727196
Citation
Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Results Reference
derived
Learn more about this trial
Dry Needling in Post-operative Shoulder Pain
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