Dry Needling and Bobath Treatment Clinical Effects Focused on Stroke Patients
- Conditions
- Ischemic StrokeSpasticity
- Interventions
- Other: Dry needling in a non myofascial trigger points area plus physical therapy based on Bobath conceptOther: Dry needling in a myofascial trigger points area plus physical therapy based on Bobath concept
- Registration Number
- NCT03906305
- Lead Sponsor
- Universidad Rey Juan Carlos
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dry needling in a non myofascial trigger points area Dry needling in a non myofascial trigger points area plus physical therapy based on Bobath concept The intervention will consist of a sixty minutes physical therapy session based on the modulating Bobath technique focused on the upper limb. Besides, during the intervention patients will receive deep dry needling that will be inserted into a non trigger point spastic muscle of the shoulder. Dry needling in a myofascial trigger points area Dry needling in a myofascial trigger points area plus physical therapy based on Bobath concept The intervention will consist of a sixty minutes physical therapy session based on the modulating Bobath technique focused on the upper limb. Besides, during the intervention patients will receive deep dry needling that will be inserted into trigger point spastic muscle of the shoulder.
- Primary Outcome Measures
Name Time Method Changes in spasticity before and after the intervention Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention It will be measured using the Modified Ashworth Scale. The Modified Ashworth Scale evaluates the muscle tone in patients with central nervous system lesions. It consists of 5 ordinal categories: 0 (no increase in muscle tone), 1 (slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion), 1+ (slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder less than half of the range of motion), 2 (more marked increase in muscle tone through most of the range of motion, but affected parts easily moved), 3 (considerable increase in muscle tone, passive movement difficult) and 4 (the part affects this rigid extension or flexion).
- Secondary Outcome Measures
Name Time Method Changes in shoulder pain before and after the intervention Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention Numerical Pain Rating Scale (NPRS, 0,10) The Numerical Pain Rating Scale evaluates the intensity of pain perceived between 0 (absence of pain) and 10 (maximum intensity of inimaginable pain).
Changes in Function of the Upper Extremity before and after the intervention Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention Upper limb function will be measured using both Motor Evaluation Scale for Upper Extremity in Stroke patients (MESUPES) and the reaching performance scale (RPS).
The MESUPES includes eight items with six response categories (scores 0-5), and nine hand items with three response categories (scores 0-2). The total score of this scale is 58 points.
The RPS evaluates 6 components. Four components are related to reaching close and far targets: trunk displacement, movement smoothness, shoulder movements, and elbow movements. The 2 additional components globally rate the quality of prehension and the accomplishment of the task. The total score of this scale is 18 points.
Trial Locations
- Locations (1)
Polibea Sur neurorehabilitation clinic
🇪🇸Madrid, Alcorcón/Madrid, Spain