Clinical trial NCT03546517: Effectiveness of Dry Needling (DNHS Technique) in Patients With Chronic Stroke
Official title: Effectiveness of Dry Needling (DNHS Technique) in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Spasticity
Keywords: myofascial trigger point
dry needling
spasticity
stroke
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 23
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Fugl-Meyer Scale
timeFrame: 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
Secondary outcomes:
measure: Modified Modified Ashworth Scale
timeFrame: 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
measure: Electromyography (EMG)
timeFrame: 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
measure: Tonometry (measurement of muscle tone with a device)
timeFrame: 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
measure: Quality of Life (Euro QoL5D)
timeFrame: Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Universidad San Jorge
Study officials:
References:
citation: Calvo S, Brandin-de la Cruz N, Jimenez-Sanchez C, Bravo-Esteban E, Herrero P. Effects of dry needling on function, hypertonia and quality of life in chronic stroke: a randomized clinical trial. Acupunct Med. 2022 Aug;40(4):312-321. doi: 10.1177/09645284211056347. Epub 2021 Dec 13.