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

September 21, 2013
October 28, 2013
January 2013
October 2013   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01950338 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
  • 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.
Not Provided
Not Provided
 
Deep Dry Needling for the Management of Post-stroke Spasticity
CHANGES IN SPASTICITY, WIDESPREAD PRESSURE PAIN SENSITIVITY, AND BAROPODOMETRY AFTER DRY NEEDLING IN STROKE PATIENTS

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Stroke
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.
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
October 2013
October 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01950338
URJC 52/2012
Yes
César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
Universidad Rey Juan Carlos
Not Provided
Principal Investigator: Jaime Salom, PT, MSc Universidad Rey Juan Carlos
Study Chair: César Fernández-de-las-Peñas, PT, DO, PhD Universidad Rey Juan Carlos
Universidad Rey Juan Carlos
October 2013

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