Deep Dry Needling for the Management of Post-stroke Spasticity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier:
NCT01950338
First received: September 21, 2013
Last updated: October 28, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Stroke
Other: Dry needling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CHANGES IN SPASTICITY, WIDESPREAD PRESSURE PAIN SENSITIVITY, AND BAROPODOMETRY AFTER DRY NEEDLING IN STROKE PATIENTS

Resource links provided by NLM:


Further study details as provided by Universidad Rey Juan Carlos:

Primary Outcome Measures:
  • Changes in spasticity before and after the intervention [ Time Frame: Baseline and immediate after the inetrvention ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and immediate after the inetrvention ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline and immediate after the inetrvention ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 34
Study Start Date: January 2013
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Other: 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.
No Intervention: Control group
The control group will not receive any intervention.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01950338

Locations
Spain
Universidad Rey Juan Carlos
Alcorcón, Madrid, Spain, 28922
Sponsors and Collaborators
Universidad Rey Juan Carlos
Investigators
Principal Investigator: Jaime Salom, PT, MSc Universidad Rey Juan Carlos
Study Chair: César Fernández-de-las-Peñas, PT, DO, PhD Universidad Rey Juan Carlos
  More Information

No publications provided

Responsible Party: César Fernández-de-las-Peñas, PROFESSOR, Universidad Rey Juan Carlos
ClinicalTrials.gov Identifier: NCT01950338     History of Changes
Other Study ID Numbers: URJC 52/2012
Study First Received: September 21, 2013
Last Updated: October 28, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Muscle Spasticity
Stroke
Cerebral Infarction
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on April 17, 2014