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Deep Dry Needling for the Management of Post-stroke Spasticity

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ClinicalTrials.gov Identifier: NCT01950338
Recruitment Status : Completed
First Posted : September 25, 2013
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
César Fernández-de-las-Peñas, Universidad Rey Juan Carlos

Tracking Information
First Submitted Date  ICMJE September 21, 2013
First Posted Date  ICMJE September 25, 2013
Last Update Posted Date October 29, 2013
Study Start Date  ICMJE January 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2013)
Changes in spasticity before and after the intervention [ Time Frame: Baseline and immediate after the inetrvention ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 24, 2013)
Changes in spasticity before and after the intervention [ Time Frame: Baseline and immediate after the inetrvention ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2013)
  • Changes in pressure pain sensitivity before and after the intervention [ Time Frame: Baseline and immediate after the inetrvention ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2013)
  • Changes in pressure pain sensitivity before and after the intervention [ Time Frame: Baseline and immediate after the inetrvention ]
    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.
  • Changes in baropodometry outcomes before and after the intervention [ Time Frame: Baseline and immediate after the inetrvention ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Deep Dry Needling for the Management of Post-stroke Spasticity
Official Title  ICMJE CHANGES IN SPASTICITY, WIDESPREAD PRESSURE PAIN SENSITIVITY, AND BAROPODOMETRY AFTER DRY NEEDLING IN STROKE PATIENTS
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Stroke
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Dry needling
  • No Intervention: Control group
    The control group will not receive any intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 28, 2013)
34
Original Estimated Enrollment  ICMJE
 (submitted: September 24, 2013)
40
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01950338
Other Study ID Numbers  ICMJE URJC 52/2012
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
Study Sponsor  ICMJE Universidad Rey Juan Carlos
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jaime Salom, PT, MSc Universidad Rey Juan Carlos
Study Chair: César Fernández-de-las-Peñas, PT, DO, PhD Universidad Rey Juan Carlos
PRS Account Universidad Rey Juan Carlos
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP