Dry Needling in Post-operative Shoulder Pain

Proximal Humeral Fracture Fixated With PHILOS© Plate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122315
• Other study ID #: CP13-060
• Status: Completed
• Phase: N/A
• First received: April 19, 2014
• Last updated: April 22, 2014
• Start date: February 2013
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Humeral Fractures
• Proximal Humeral Fracture Fixated With PHILOS© Plate
• Rotator Cuff Tear Surgical Repair
• Shoulder Fractures
• Shoulder Pain

Intervention

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
• Physical therapy
Best-evidence physical therapy intervention

Locations

Country	Name	City	State
Spain	Jose Luis Arias Buría	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
César Fernández-de-las-Peñas

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and one week after the intervention	Yes