Dry Needling in Patients Who Had Experience Stroke

NCT02579291 | Completed DMC

• 1 other identifier: URJC 07-2015
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals who had experience a stroke usually suffer from spasticity at medium and long-terms. The presence of spasticity in the lower extremity implies several impairments for standing and walking inducing high disability. A recent study has proposed the use of dry needling for improving spasticity in the lower extremity. No study has investigated the effects of deep dry needling inserted into spastic musculature in stabilometry and moto function in patients who had experience a stroke. A randomized controlled trial investigating the effects of the inclusion of deep dry needling into a Bobath interventional program on spasticity, motor function and balance (stabilometry) in individuals who had experience a stroke

Conditions

Stroke

Keywords

Stroke; Dry needling; Spasticity; Motor function; Stabilometry

Outcome Measures

Primary Outcomes (1)

• Changes in spasticity before and 10 minutes 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.

  Baseline and immediate after the intervention

Secondary Outcomes (2)

• Changes in motor function before and 10 minutes after the intervention

  Baseline and immediate after the intervention

• Changes in stabilometry outcomes before and 10 minutes after the intervention

  Baseline and immediate after the intervention

Study Arms (2)

Dry needling

EXPERIMENTAL

The experimental group will receive a single session of Bobath therapy including techniques targeting modulation of central nervous system. In addition, this group will receive a single session of dry needling into the tibialis posterior muscle with a disposable stainless steel needle (0.3mm x 50mm)

Other: Dry needling

Bobath

ACTIVE COMPARATOR

This group will receive a single session of Bobath therapy including techniques targeting modulation of central nervous system.

Other: Bobath

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

Bobath OTHER

Patients will receive different neuromodulatory interventions based on the Bobath concept with the aim to decrease spasticity on the lower extremity

Bobath

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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
• cognitive deficits;
• progressive or severe neurologic diseases;
• fear to needles;
• any contraindication for dry needling

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Cesar Fernandez-de-Las-Peñas

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (1)

• Sanchez-Mila Z, Salom-Moreno J, Fernandez-de-Las-Penas C. Effects of dry needling on post-stroke spasticity, motor function and stability limits: a randomised clinical trial. Acupunct Med. 2018 Dec;36(6):358-366. doi: 10.1136/acupmed-2017-011568. Epub 2018 Jul 9.

  PMID: 29986902 DERIVED

MeSH Terms

Conditions

Stroke; Muscle Spasticity

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• CESAR FERNANDEZ-DE-LAS-PEÑAS

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

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: Head Division

Study Record Dates

• First Submitted: October 12, 2015
• First Posted: October 19, 2015
• Study Start: October 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 12, 2016

Record last verified: 2016-05

Locations

ES (1)