Clinical trial NCT03462693: Dry Needling in Stroke in Sub-Acute Phase to Improve Upper Limb
Official title: Effectiveness of Dry Needling in Upper Limb Function in Patients With Stroke in Sub-acute Phase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functionality
Spasticity, Muscle
Quality of Life
Lead sponsor: Guadarrama Hospital
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed description: Once each patient has signed the informed consent document and it has been verified that the inclusion criteria are met, it will be assigned the same identification number (ID) that is related to its Clinical History (CH) by simple coding; custody of the file with the relationship of each ID with its CH will be the responsibility of the principal investigator. Patients admitted to the Guadarrama Hospital with the diagnosis of stroke and who meet the eligibility criteria will be treated by their usual physiotherapist, who will administer the standard dry needling intervention plus standard physiotherapy treatment or only standard physiotherapy treatment as a function of being trained and qualified to administer dry needling.

Patients will receive 6 sessions of DNHS® (Dry Needling for Hypertonicity and Spasticity) technique with an interval of 1 week between each session (1st to 4th sessions) and every 15 days (5th and 6th sessions). The procedure will be applied according to the corresponding protocols established in the NWPs (Normalized Work Plans) used in the usual clinical practice in the Guadarrama Hospital. All patients (both groups) will receive standard daily physiotherapy treatment for the affected arm according to the NWPs used in the Guadarrama Hospital.

The DNHS® technique is specifically indicated for the treatment of spasticity. This technique differs from that usually used to relieve pain and deactivate myofascial trigger points (MTPs). The muscles to be treated are placed in a submaximum stretching position; the evaluation criteria when defining the needle insertion zone are based on finding an increase in modularity and muscle activity in the area when the muscle undergoes rapid stretching. Once the area to be treated is located, the needle is inserted and moves between 0.5 and 1 cm in / deep and fan out / surface to cause a local or global spasm reaction. Treatment ceases when the frequency of these responses decreases markedly or disappears. If the patient feels "not tolerable" pain (some discomfort from the dry needling is usual), you can stop the treatment at any time. Before and after each dry needling session or standard physiotherapy treatment patients will be evaluated by an independend assessor blinded to intervention , using the upper limb block of the Fugl-Meyer scale that assesses motor skills and sensitivity of the affected arm, evaluation of pain through NRS10 and assessment of spasticity of muscles to be treated by MMAS. Also, at the beginning, in the 4th session and at the end of the study, the Euro-QoL 5D 5L quality of life survey will be administered, with a license for use. In addition BSS and ULP will be evaluated at the beginning and at the end of the study. In each dry needling session, the caliber of the needle used, the number of fast-in and fast-out of the needle and the number of the spasm reactions caused for the purpose of establishing the dose pattern shall be recorded for each treated muscle.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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...

Primary outcomes:
measure: Fugl-Meyer Upper Limb Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Modification of Modified Ashworth Scale
timeFrame: 8 weeks
measure: Euro QoL 5D quality of life scale
timeFrame: 8 weeks
Other outcomes:
measure: Numerical Rating Scale 10-points scale
timeFrame: 8 weeks
measure: Brunnstrom Recovery Stages
timeFrame: 8 weeks
measure: Upper limb pattern
timeFrame: 8 weeks
Locations:
city: Guadarrama
country: Spain
facility: J.Nicolas Cuenca Zaldivar
state: Madrid
Study officials:
affiliation: Guadarrama Hospital
name: Mr Cuenca Zaldivar
role: PRINCIPAL_INVESTIGATOR
References: