Dry Needling in Stroke to Improve the Upper Limb Functionality

NCT03248986 | Completed DMC

• 1 other identifier: 1.0
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, observational, prospective, single dynamic cohort study with before-after design. Treatment with 6 sessions using dry needling with DNHS® (Dry Needling for Hypertonicity and Spasticity) on the spastic muscles of the affected arm in patients with stroke. Spasticity will be assessed by Modifying Modified Ashworth Scale (MMAS), functionality with the Fugl-Meyer scale for the upper limb, motor recovery with Brunnstrom Stages Scale (BSS) and upper limb spasticity pattern (ULP), pain by 10-points Numerical Rating Scale (NRS10) and the quality of life with the Euro QoL 5D survey.

Conditions

Spasticity, Muscle; Functionality; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper Limb Scale.

  Evaluation of the functionality of the affected arm

  8 weeks

Secondary Outcomes (2)

• Modification of Modified Ashworth Scale

  8 weeks

• Euro QoL 5D quality of life scale

  8 weeks

Other Outcomes (3)

• Numerical Rating Scale 10-points scale

  8 weeks

• Brunnstrom Recovery Stages

  8 weeks

• Upper limb pattern

  8 weeks

Interventions

Dry needling OTHER

Dry needling of the spastic muscles of the affected arm through DNHS®.

Eligibility Criteria

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

Study Population

Patients with the diagnosis of stroke entering for the first time at the Hospital Guadarrama

You may qualify if:

• They must voluntarily understand and sign the relevant informed consent documents and information sheet, before any evaluation / procedure related to the study is conducted.
• Male or female, ≥ 18 years old at the time of consent.
• Have the diagnosis of hemispheric ischemic or hemorrhagic stroke without excluding other causes (surgical, traumatic, etc ...).
• Show spasticity in the affected upper limb, with an MMAS score of 1-3 in one of the following muscle groups: finger flexors, wrist flexors, elbow flexors, forearm pronators, adductors, or internal rotators of the shoulder.

You may not qualify if:

• Presence of stiffness (score of 4 in MMAS) or hypotonia (MMAS of 0).
• Severe cognitive impairment, severe language problems, severe vision or hearing impairments that prevent compression and active patient collaboration during evaluation tests.
• Have received treatment by injection of TBA in the 2 months prior to the start of the study.
• Any medical condition that contraindicates dry needling.
• Present some contraindication for the application of dry puncture: Pregnancy, insurmountable fear of needles, allergy to metals (nickel), presence of lesions in the puncture area, scars, tattoos...

Sponsors & Collaborators

• Guadarrama Hospital: lead
• University of San Jorge: collaborator

Study Sites (1)

J.Nicolas Cuenca Zaldivar

Guadarrama, Madrid, 28440, Spain

Location

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• J. Nicolas Cuenca Zaldivar

  Guadarrama Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 8 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Rehabilitation Service Principal Investigator

Study Record Dates

• First Submitted: August 8, 2017
• First Posted: August 15, 2017
• Study Start: February 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: January 1, 2018
• Last Updated: March 7, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)