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Deep Dry Needling for the Management of Post-stroke Spasticity

NCT ID: NCT01950338

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-10-31

Brief Summary

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Stroke is the leading cause of physical disability, particularly due to the presence of spasticity. Different needling techniques, including the use of Botulinum Toxin A are proposed for the management of spasticity. The presence of spasticity in the lower extremity implies several impairments for standing and walking inducing high disability. No study has investigated the effects of deep dry needling inserted into the targeted spastic musculature in patients with stroke. The investigators will conduct a randomized controlled trial investigating the effects of a single session of deep dry needling over the musculature of the leg on spasticity, widespread pressure pain sensitivity and plantar pressures (baropodometry) in individuals with chronic stroke. The investigators hypothesize that patients receiving a single session of dry needling would exhibit a greater reduction in spasticity and pressure sensitivity than those who will not receive the intervention.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Dry needling group

The experimental group will receive a single session of DDN with disposable stainless steel needles (0.3mm x 50mm) that will be inserted into the skin over taut bands of the gastrocnemius and tibialis anterior muscles.

Group Type EXPERIMENTAL

Dry needling

Intervention Type OTHER

Once the most painful spot is located within a palpable spastic taut band, the overlying skin is cleaned with alcohol. The needle will be inserted, penetrating the skin about 15-20mm, until the first local twitch response is obtained. Once the first local twitch response is obtained, the needle will be moved up and down (4 to 5 mm. vertical motions with no rotation) in the muscle at approximately 1Hz for 25-30 seconds.

Control group

The control group will not receive any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dry needling

Once the most painful spot is located within a palpable spastic taut band, the overlying skin is cleaned with alcohol. The needle will be inserted, penetrating the skin about 15-20mm, until the first local twitch response is obtained. Once the first local twitch response is obtained, the needle will be moved up and down (4 to 5 mm. vertical motions with no rotation) in the muscle at approximately 1Hz for 25-30 seconds.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* First-ever unilateral stroke;
* hemiplegia resulting from stroke;
* unilateral equinovarus gait with independent walk;
* able to ambulate without supporting devices.

Exclusion Criteria

* recurrent stroke;
* previous treatment with nerve blocks, motor point injections with neurolytic agents for spasticity at any time, or with BTX-A in the previous 6 months
* not independent in the basic activities of daily living
* severe cognitive deficits;
* progressive or severe neurologic diseases;
* fear to needles;
* any contraindication for dry needling, e.g., anticoagulants, infections, bleeding, or psychotic.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Rey Juan Carlos

OTHER

Sponsor Role lead

Responsible Party

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César Fernández-de-las-Peñas

PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime Salom, PT, MSc

Role: PRINCIPAL_INVESTIGATOR

Universidad Rey Juan Carlos

César Fernández-de-las-Peñas, PT, DO, PhD

Role: STUDY_CHAIR

Universidad Rey Juan Carlos

Locations

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Universidad Rey Juan Carlos

Alcorcón, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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URJC 52/2012

Identifier Type: -

Identifier Source: org_study_id