Dry Needling for Shoulder Pain in Stroke Patients

Dry Needling for Shoulder Pain and Presence of Post-needling Induced-Pain in PAtients Who Had Suffered a Stroke

Spasticity and pain, particularly int he shoulder region, are the most common impairments experienced by subjects who had experienced a stroke. There is preliminary evidence supporting the role of dry needling for spasticity in patients who had suffered from a stroke. Few data exists on the effects on shoulder pain. In addition, it has been shown that application of dry needling induces post-needling soreness in individuals with musculoskeletal pain. No previous study has investigated the presence and the duration of post-needling soreness in individuals who had experienced a stroke.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Dry Needling; Other: Physical Therapy

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• first-ever unilateral stroke;
• hemiplegia resulting from stroke;
• age between 30 and 60 years old;
• presence of hypertonicity in the upper extremity;
• pain symptoms in the shoulder
• active trigger points in the shoulder muscles reproducing the shoulder pain symptoms

Exclusion Criteria:

• recurrent stroke;
• absence of active trigger points in the shoulder muscles reproducing shoulder symptoms
• previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time;
• previous treatment with botulinum toxin-A in the 6 months prior the study;
• severe cognitive deficits;
• other neurologic diseases,
• underlying complex medical conditions, e.g., heart conditions, unstable hypertension, fracture
• fear to needles;
• any contraindication for deep dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dry needling; The experimental group will receive a single session of modulatory interventions combined with a single session of dry needling into the shoulder muscles which active trigger points will reproduce the shoulder pain symptoms.	Other: Dry Needling; A single session of modulatory interventions combined with a single session of dry needling into the shoulder muscles which active trigger points will reproduce the shoulder pain symptoms.
Active Comparator: Physical Therapy; This group will receive a single session of modulatory interventions targeting modulation of central nervous system.	Other: Physical Therapy; A single session of modulatory interventions targeting modulation of central nervous system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in post-dry needling pain intensity with a numerical pain rate scale before and after the intervention	A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness in the targeted area	Baseline, 24 hours (1 day) after and 72 hours (3 days) after treatment the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in spontaneous shoulder pain with a numerical pain rate scale before and after the intervention	A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous shoulder pain	Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention
Presence of active trigger points in the shoulder musculature	Manual palpation of active trigger points in the shoulder muscles will be conducted	Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention

Collaborators and Investigators

• Sponsor: Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2018
• Primary Completion (Actual): December 21, 2018
• Study Completion (Actual): December 21, 2018

Study Registration Dates

• First Submitted: October 6, 2018
• First Submitted That Met QC Criteria: October 9, 2018
• First Posted (Actual): October 11, 2018

Study Record Updates

• Last Update Posted (Actual): December 28, 2018
• Last Update Submitted That Met QC Criteria: December 27, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Stroke; Shoulder Pain
• Other Study ID Numbers: URJC1512201600817

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No