Dry Needling in Post-operative Shoulder Pain

NCT02122315 | Completed DMC

• 1 other identifier: CP13-060
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Proximal Humeral Fracture Fixated With PHILOS© Plate; Rotator Cuff Tear Surgical Repair

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Physical therapy plus dry needling

EXPERIMENTAL

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

Physical therapy

ACTIVE COMPARATOR

Best-evidence physical therapy intervention

Other: Physical therapy

Interventions

Physical therapy plus dry needling OTHER

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 plus dry needling

Physical therapy OTHER

Best-evidence physical therapy intervention

Physical therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• César Fernández-de-las-Peñas: lead

Study Sites (1)

Jose Luis Arias Buría

Madrid, Madrid, Spain

Location

Related Publications (1)

• 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.

  PMID: 35727196 DERIVED

MeSH Terms

Interventions

Physical Therapy Modalities; Dry Needling

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Complementary Therapies

Study Officials

• Cesar Fernández-de-las-Peñas, PhD

  Universidad Rey Juan Carlos

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head Division

Study Record Dates

• First Submitted: April 19, 2014
• First Posted: April 24, 2014
• Study Start: February 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: April 24, 2014

Record last verified: 2014-04

Locations

ES (1)