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Deep Dry Needling for the Management of Post-stroke Spasticity

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Dry needling
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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Universidad Rey Juan Carlos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dry needling group

Control group

Arm Description

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.

The control group will not receive any intervention.

Outcomes

Primary Outcome Measures

Changes in spasticity before and after the intervention
Spasticity in the affected ankle joint will be evaluated with the Modified Modified Ashworth Scale (MMAS). The examiner passively will move the ankle in dorsal-flexion direction, back and forth at least 5 times and will evaluate the degree of resistance to the movement on a scale from 0-4. This outcome will take 1 minute approximately.

Secondary Outcome Measures

Changes in pressure pain sensitivity before and after the intervention
Pressure pain sensitivity will be bilaterally assessed with a mechanical pressure algometer (Pain Diagnosis and Treatment Inc, New York, USA) over the deltoid muscle, the second metacarpal and the tibialis anterior muscle to determine changes in widespread pressure sensitivity. This outcome will take 5 minute approximately.
Changes in baropodometry outcomes before and after the intervention
The following baropodometric data will be bilaterally collected from each patient: support surface (cm2), percentage of load (%) and force distribution (%) of both forefoot and rear foot. Additionally, we will also calculate mean and maximum pressure of each foot, affected and non-affected. This outcome will take 10 minutes approximately.

Full Information

First Posted
September 21, 2013
Last Updated
October 28, 2013
Sponsor
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT01950338
Brief Title
Deep Dry Needling for the Management of Post-stroke Spasticity
Official Title
CHANGES IN SPASTICITY, WIDESPREAD PRESSURE PAIN SENSITIVITY, AND BAROPODOMETRY AFTER DRY NEEDLING IN STROKE PATIENTS
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

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
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dry needling group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will not receive any intervention.
Intervention Type
Other
Intervention Name(s)
Dry needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in spasticity before and after the intervention
Description
Spasticity in the affected ankle joint will be evaluated with the Modified Modified Ashworth Scale (MMAS). The examiner passively will move the ankle in dorsal-flexion direction, back and forth at least 5 times and will evaluate the degree of resistance to the movement on a scale from 0-4. This outcome will take 1 minute approximately.
Time Frame
Baseline and immediate after the inetrvention
Secondary Outcome Measure Information:
Title
Changes in pressure pain sensitivity before and after the intervention
Description
Pressure pain sensitivity will be bilaterally assessed with a mechanical pressure algometer (Pain Diagnosis and Treatment Inc, New York, USA) over the deltoid muscle, the second metacarpal and the tibialis anterior muscle to determine changes in widespread pressure sensitivity. This outcome will take 5 minute approximately.
Time Frame
Baseline and immediate after the inetrvention
Title
Changes in baropodometry outcomes before and after the intervention
Description
The following baropodometric data will be bilaterally collected from each patient: support surface (cm2), percentage of load (%) and force distribution (%) of both forefoot and rear foot. Additionally, we will also calculate mean and maximum pressure of each foot, affected and non-affected. This outcome will take 10 minutes approximately.
Time Frame
Baseline and immediate after the inetrvention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Salom, PT, MSc
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
César Fernández-de-las-Peñas, PT, DO, PhD
Organizational Affiliation
Universidad Rey Juan Carlos
Official's Role
Study Chair
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain

12. IPD Sharing Statement

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Deep Dry Needling for the Management of Post-stroke Spasticity

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