Clinical trial NCT03906305: Dry Needling and Bobath Treatment Clinical Effects Focused on Stroke Patients
Official title: Changes in Clinical Outcomes After Application of Physical Therapy and Dry Needling Intervention in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Spasticity
Keywords: Muscle Spasticity
Dry Needling
Stroke
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 18
Sex: ALL
Minimum age (years): 35
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: In this study patients will receive dry needling intervention in shoulder muscles. The following muscles will be addressed: upper trapezius, supraspinatus, deltoid anterior fibers and infraspinatus.

They will also receive physical therapy based on Bobath concept. All the subjects belong to Madrid Polibea Sur neurorehabilitation clinic. The sample of the study is estimated to consist of twenty patients, with a washout period of forty five days after the intervention.

The data will be collected by an external physical therapist. All the therapists belong to Polibea Sur neurological clinic and Madrid Rey Juan Carlos University departments of physical therapy, occupational therapy, rehabilitation and physical medicine, experts in neurological treatment and trained in dry needling.
Primary purpose: TREATMENT

Brief summary: The investigators aim to determine if dry needling technique in a non myofascial trigger point area generate the same changes in spasticity, function and pain responses as with dry needling in a myofascial trigger point area.

Detailed description: Spasticity is a consequence of multiple diseases that affect the Central Nervous System, such as stroke and other neurodegenerative diseases. Its pathophysiology is unclear and the variety of clinical symptoms is determined by the injury location. Several studies have suggested the possibility of active pain treatment effectiveness through myofascial trigger points management. One of these interventions is dry needling, which has been used in several scientific studies. However, these investigations have been based on spasm response or deep dry needling mechanisms always over a trigger point, but none of the participants compare the possible mechanical effects of the insertion of a needle into a spastic muscle without targeting specifically a trigger point. Therefore, the aim of this study is to evaluate the effects on spasticity, pain and motor function after a dry needling intervention versus the insertion of a needle into a non trigger point area in patients who had experienced a stroke.

Eligibility criteria: Inclusion Criteria:

* Medical diagnosis of unilateral ischemic Stroke
* Unilateral hemiplegia resulting from Stroke
* Evolution of at least 6 months since the Stroke
* Age between 35 and 81 years of age
* Presence of hypertonia in the upper extremity
* Restricted shoulder range of motion

Exclusion Criteria:

* Recurrent Stroke
* Previous treatment with nerve blocks, motor point injections with neurolytic agents for Spasticity at any time, or with BTX-A in the previous 6 months
* Cognitive deficits
* Progressive or severe neurological diseases, eg, heart conditions, unstable hypertension, fractures or implants in upper extremity
* Belonephobia (fear to needles)
* Have received pharmacological treatment for shoulder pain 3 months before the study
* Existence of peripheral nerve injury
* Previous history of fracture in the gleno-humeral joint
* Episodes of epilepsy in the year prior to participation in the study

Primary outcomes:
measure: Changes in spasticity before and after the intervention
timeFrame: Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention
Secondary outcomes:
measure: Changes in shoulder pain before and after the intervention
timeFrame: Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention
measure: Changes in Function of the Upper Extremity before and after the intervention
timeFrame: Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Polibea Sur neurorehabilitation clinic
state: Alcorcón/Madrid
Study officials:
affiliation: Universidad Rey Juan Carlos
name: Ana I de la Llave Rincon, Doctor
role: STUDY_DIRECTOR
References:
citation: Mendigutia-Gomez A, Martin-Hernandez C, Salom-Moreno J, Fernandez-de-Las-Penas C. Effect of Dry Needling on Spasticity, Shoulder Range of Motion, and Pressure Pain Sensitivity in Patients With Stroke: A Crossover Study. J Manipulative Physiol Ther. 2016 Jun;39(5):348-358. doi: 10.1016/j.jmpt.2016.04.006. Epub 2016 May 7.
citation: Hernandez-Ortiz AR, Ponce-Luceno R, Saez-Sanchez C, Garcia-Sanchez O, Fernandez-de-Las-Penas C, de-la-Llave-Rincon AI. Changes in Muscle Tone, Function, and Pain in the Chronic Hemiparetic Shoulder after Dry Needling Within or Outside Trigger Points in Stroke Patients: A Crossover Randomized Clinical Trial. Pain Med. 2020 Nov 1;21(11):2939-2947. doi: 10.1093/pm/pnaa132.