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Dry Needling for Shoulder Pain in Stroke Patients

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry Needling
Physical Therapy
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • César Fernández-de-las-Peñas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry needling

Physical Therapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Presence of active trigger points in the shoulder musculature
Manual palpation of active trigger points in the shoulder muscles will be conducted

Full Information

First Posted
October 6, 2018
Last Updated
December 27, 2018
Sponsor
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT03703193
Brief Title
Dry Needling for Shoulder Pain in Stroke Patients
Official Title
Dry Needling for Shoulder Pain and Presence of Post-needling Induced-Pain in PAtients Who Had Suffered a Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 19, 2018 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
December 21, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling
Arm Type
Experimental
Arm Description
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.
Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
This group will receive a single session of modulatory interventions targeting modulation of central nervous system.
Intervention Type
Other
Intervention Name(s)
Dry Needling
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physical Therapy
Intervention Description
A single session of modulatory interventions targeting modulation of central nervous system.
Primary Outcome Measure Information:
Title
Changes in post-dry needling pain intensity with a numerical pain rate scale before and after the intervention
Description
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to record post-dry needling soreness in the targeted area
Time Frame
Baseline, 24 hours (1 day) after and 72 hours (3 days) after treatment the intervention
Secondary Outcome Measure Information:
Title
Changes in spontaneous shoulder pain with a numerical pain rate scale before and after the intervention
Description
A Numerical Pain Rate Scale (NPRS, 0-10) will be used to assess spontaneous shoulder pain
Time Frame
Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention
Title
Presence of active trigger points in the shoulder musculature
Description
Manual palpation of active trigger points in the shoulder muscles will be conducted
Time Frame
Baseline, 72 hours (3 days) and 168 hours (7 days) after treatment the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
César Fernández-de-las-Peñas
City
Alcorcon
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

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Dry Needling for Shoulder Pain in Stroke Patients

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