Dry Needling for Shoulder Pain in Stroke Patients

NCT03703193 | Completed DMC

• 1 other identifier: URJC1512201600817
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in spontaneous shoulder pain with a numerical pain rate scale before and after the intervention

  Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention

• Presence of active trigger points in the shoulder musculature

  Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention

Study Arms (2)

Dry needling

EXPERIMENTAL

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

Physical Therapy

ACTIVE COMPARATOR

This group will receive a single session of modulatory interventions targeting modulation of central nervous system.

Other: Physical Therapy

Interventions

Dry Needling OTHER

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.

Dry needling

Physical Therapy OTHER

A single session of modulatory interventions targeting modulation of central nervous system.

Physical Therapy

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

César Fernández-de-las-Peñas

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Stroke

Interventions

Dry Needling; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department

Study Record Dates

• First Submitted: October 6, 2018
• First Posted: October 11, 2018
• Study Start: October 19, 2018
• Primary Completion: December 21, 2018
• Study Completion: December 21, 2018
• Last Updated: December 28, 2018

Record last verified: 2018-12

Locations

ES (1)