Deep Dry Needling for the Management of Post-stroke Spasticity

NCT01950338 | Completed DMC

• 1 other identifier: URJC 52/2012
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Changes in pressure pain sensitivity before and after the intervention

  Baseline and immediate after the inetrvention

• Changes in baropodometry outcomes before and after the intervention

  Baseline and immediate after the inetrvention

Study Arms (2)

Dry needling group

EXPERIMENTAL

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

Control group

NO INTERVENTION

The control group will not receive any intervention.

Interventions

Dry needling OTHER

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.

Dry needling group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First-ever unilateral stroke;
• hemiplegia resulting from stroke;
• unilateral equinovarus gait with independent walk;
• able to ambulate without supporting devices.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Stroke

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Jaime Salom, PT, MSc

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

• César Fernández-de-las-Peñas, PT, DO, PhD

  Universidad Rey Juan Carlos

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: September 21, 2013
• First Posted: September 25, 2013
• Study Start: January 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

ES (1)