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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03703193
Other study ID # URJC1512201600817
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2018
Est. completion date December 21, 2018

Study information

Verified date December 2018
Source Universidad Rey Juan Carlos
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date December 21, 2018
Est. primary completion date December 21, 2018
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Spain César Fernández-de-las-Peñas Alcorcon Madrid

Sponsors (1)

Lead Sponsor Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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