Dry Needling in Stroke in Sub-Acute Phase to Improve Upper Limb

NCT03462693 | Completed DMC

• 1 other identifier: 2.0
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, observational, prospective, two dynamic cohorts study with before-after design. Group 1: 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 plus standard physiotherapy treatment. Group 2: Standard physiotherapy treatment. 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 5L survey. In both groups the valuations will be made following the same schedule.

Conditions

Functionality; Spasticity, Muscle; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Upper Limb Scale

  The Fugl-Meyer Upper Limb Assessment of Motor Recovery after Stroke evaluates and measures recovery in post-stroke hemiplegic patients. It consists of 4 domains formed by ordinal items of 3 points: 1 (not performed), 2 (partial execution) and 3 (complete execution). The maximum total sum score of the scale is 226. The domains are: Motor block consisting of 33 items with a maximum total sum score of 66 and consisting of the following sections: A: Upper Extremity, B: Wrist, C: Hand and D: Coordination and speed; an increase of 10 points in this block is described as a clinically important change. Three other domains are added to the motor block: H: Sensation, with 6 items with a maximum total sum score of 12, J: Passive joint movement, with 12 items with a maximum total sum score of 24 and J: Joint pain with 12 items with a total maximum sum score of 24.

  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

Study Arms (2)

Group 1

Dry needling plus standard physiotherapy treatment

Other: Dry needling

Group 2

Standard physiotherapy treatment

Interventions

Dry needling OTHER

The DNHS® dry-puncture technology is specifically marked for stroke patients. the muscle to be treated is placed in a submaximal position; the needle is inserted into the present tense bandage and mobilized in the inside and outside for about 1 minute or until the reaction of global spasm ceases

Group 1

Eligibility Criteria

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

Study Population

Patients with the diagnosis of stroke inacute subacute phase 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 Botulinum Toxin A 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

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

• Mr Cuenca Zaldivar

  Guadarrama Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 12, 2018
• Study Start: March 15, 2018
• Primary Completion: October 25, 2018
• Study Completion: October 25, 2018
• Last Updated: May 14, 2019

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)