Deep Dry Needling for the Management of Post-stroke Spasticity

Stroke Clinical Trial

Official title:

CHANGES IN SPASTICITY, WIDESPREAD PRESSURE PAIN SENSITIVITY, AND BAROPODOMETRY AFTER DRY NEEDLING IN STROKE PATIENTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01950338
• Other study ID #: URJC 52/2012
• Status: Completed
• Phase: N/A
• First received: September 21, 2013
• Last updated: October 28, 2013
• Start date: January 2013
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad Rey Juan Carlos	Alcorcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Rey Juan Carlos

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and immediate after the inetrvention	Yes
Secondary	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.	Baseline and immediate after the inetrvention	Yes
Secondary	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.	Baseline and immediate after the inetrvention	Yes