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Completed

NCT Number: NCT03546517

Effectiveness of Dry Needling (DNHS Technique) in Patients With Chronic Stroke

Study hypothesis:

The DNHS technique, performed via one session of deep dry needling of myofascial trigger points applied to the biceps brachii, brachialis, flexor digitorum superficialis, flexor digitorum profundus, triceps brachii, extensor digitorum and adductor pollicis muscle is effective for decreasing spasticity and muscle stiffness (both of which are components of hypertonia) as well as for improving the upper limb function of the previously described muscles in patients with chronic cerebral vascular accident (CVA), assessed both post-intervention and after 15 days.

General aims

To analyse the immediate therapeutic effect of the DNHS technique and the effect at 15 days follow-up, for the following variables:

* Spasticity * Muscle stiffness * Upper limb function * Patient perceived quality of life

Materials and methods Population: patients from the province of Zaragoza (Spain) diagnosed with a haemorrhagic or ischemic CVA by a neurologist.

Recruitment strategy: recruitment will take place via the Stroke Association in Aragon (AIDA) [Aragon Stroke Association] in the province of Zaragoza, Spain, seeing as the greater proportion of patients who have suffered a stroke and are in the chronic stage of the illness go to this centre to receive treatment. Thus, this avoids patients having to travel elsewhere for the study. Furthermore, in the case of patients who wish to participate in the study after having received information via third persons or via other means and who are not members of the Association or do not attend the centre on a regular basis, the Association AIDA has offered to allow these people to attend for free, making its facilities available and supporting the development of this study.

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Key information

Conditions

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

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad San Jorge

Zaragoza, 50830, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have been diagnosed with a haemorrhagic or ischemic CVA by a neurologist.
  • Cognitive level: minimental state examination (MMSE) ≥ 27 points. All patients must have a good cognitive level in order to ensure that they are able to communicate with the professionals involved in the study in order to understand the exercises and thus fulfil the objectives for participation.
  • Presence of spasticity ≥1 according to the Modified Modified Ashworth Scale (MMAS) score during the flexion-extension movement of the wrist and elbow in at least one of the muscles of the upper limb evaluated.
  • Age: between 30 - 90 years. In this range of age CVA's are more common, according to data from the Spanish Statistical Office.
  • Evolution: over 6 months must have passed since the CVA episode. Most of the studies reviewed involve patients who are in the chronic stage of illness. This will ensure that the changes found are due to our intervention and not related to plasticity mechanisms occurring after the injury (this will be considered objectively by performing an assessment at baseline, which will be repeated 1 week later, immediately before and after the dry needling intervention).

Exclusion criteria

  • Concomitance of degenerative illnesses which can alter the results.
  • Presence of fixed contractures: 4 according to the MMAS score
  • Suffering from epileptic fits that are not medically controlled.
  • Fear of needles.
  • No tolerance to pain caused by needling.
  • Those unable to commit to attendance.
  • Patients who have received treatment with Botulinum Toxin (BTX A) in the 6 months prior to their inclusion in this study, or those who received said medication or another during the study with the aim of decreasing spasticity.

Treatment and study plan

dry needling

Other

Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis

Other names: DNHS technique

Sham dry needling

Other

Sham Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis

Primary outcomes

  1. Fugl-Meyer Scale

    Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention

    Scale measuring Upper Limb Function in stroke patients. The motor and sensory assessments are scored on a three-point ordinal scale (0 -2) in which a higher score indicates superior results. The motor assessment measures voluntary limb movement and includes a subscale for the Upper Extremity (33 items; score range, 0-66). The sensory assessment measures limb sensation. Sensation is assessed as absent, impaired, or normal for light touch (two items each for Upper Extremity (UE) and Lower Extremity (LE); score range, 0-8) and proprioception (four items each for UE and LE; score range, 0-16) for a total sensory Fugl-Meyer (FM) score of 24. Fugl-Meyer Assessment (FMA) has shown to have an excellent intra and interrater reliability (0.89-0.99). The estimated minimal clinical important difference (MCID) of the UE-FM scores ranged from 4.25 to 7.25 points .

Secondary outcomes

  1. Modified Modified Ashworth Scale

    Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention

    Scale measuring Spasticity/Hypertonia. This scale ranges from 0 to 4 points for each muscle assessed, where 0 is no hypertonia/spasticity and 4 is the highest hypertonia/spasticity.

  2. Electromyography (EMG)

    Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention

    Neurophysiological measurements (electromyographic measurements). The amount of electrical activity will be measured quantitatively, from 0 to an undefined value (depending on every muscle´s activity)

  3. Tonometry (measurement of muscle tone with a device)

    Time frame: Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention

    Muscle stiffness or muscle tone. This device register different parameters like frequency, oscillation, etc that are related to tone, and start from 0 to an undefined number (depending on every muscle). It is a quantitative measurement.

  4. Quality of Life (Euro QoL5D)

    Time frame: Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention

    Quality of Life. This scale measures quality of life. Description: This is a measure of self-reported health outcomes. It consists of two parts: a descriptive system (Part I) and a visual analogue scale (VAS) (Part II). Part I of the scale consists of 5 single-item dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has a 3 point response scale, ranging from worst imaginable health state to best imaginable health state. Scoring/Interpretation: Descriptive data from the 5 dimensions of Part I can be used to generate a health-related quality of life profile for the subject. Part II is scored from 0 (worst health state imaginable) to 100 (best health state imaginable).

Sponsors and collaborators

Lead sponsor

Universidad San Jorge

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2018
Registry last updated
Sep 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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