Dry Needling and Bobath Treatment Clinical Effects Focused on Stroke Patients

Sponsor

Universidad Rey Juan Carlos (Other)

Overall Status

Completed

CT.gov ID

NCT03906305

Collaborator

(none)

Enrollment

Location

Arms

11.3

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke Spasticity	Other: Dry needling in a myofascial trigger points area plus physical therapy based on Bobath concept Other: Dry needling in a non myofascial trigger points area plus physical therapy based on Bobath concept	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

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.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.

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Changes in Clinical Outcomes After Application of Physical Therapy and Dry Needling Intervention in Stroke Patients

Actual Study Start Date :

Nov 26, 2018

Actual Primary Completion Date :

Oct 15, 2019

Actual Study Completion Date :

Nov 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dry needling in a myofascial trigger points area 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.	Other: Dry needling in a myofascial trigger points area plus physical therapy based on Bobath concept Other: Dry Needling Participants will receive dry needling application over a myofascial trigger point by an experienced physical therapist with clinical experience in neurological patients, that will be inserted into taut bands of the following shoulder spastic muscles (when a trigger point was present): upper trapezius, supraspinatus, infraspinatus and deltoid anterior. Other: Physical Therapy Participants will receive physical therapy treatment based on the modulating Bobath technique. This technique will be applied using the general parameters, carrying out similar action protocols with every patient, based on the aim of normalizing upper limb muscle tone. Device: stainless steel needles (0.3mm x 50mm)
Active Comparator: Dry needling in a non myofascial trigger points area 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.	Other: Dry needling in a non myofascial trigger points area plus physical therapy based on Bobath concept Other: Dry Needling Participants will receive dry needling application carried out over a non trigger point area by an experienced physical therapist with clinical experience in neurological patients, that will be inserted into a non trigger point spastic muscle of the shoulder area: upper trapezius, supraspinatus, infraspinatus and deltoid anterior. Other: Physical Therapy Participants will receive physical therapy treatment based on the modulating Bobath technique. This technique will be applied using the general parameters, carrying out similar action protocols with every patient, based on the aim of normalizing upper limb muscle tone. Device: stainless steel needles (0.3mm x 50mm)

Arm

Intervention/Treatment

Experimental: Dry needling in a myofascial trigger points area

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.

Other: Dry needling in a myofascial trigger points area plus physical therapy based on Bobath concept

Other: Dry Needling Participants will receive dry needling application over a myofascial trigger point by an experienced physical therapist with clinical experience in neurological patients, that will be inserted into taut bands of the following shoulder spastic muscles (when a trigger point was present): upper trapezius, supraspinatus, infraspinatus and deltoid anterior. Other: Physical Therapy Participants will receive physical therapy treatment based on the modulating Bobath technique. This technique will be applied using the general parameters, carrying out similar action protocols with every patient, based on the aim of normalizing upper limb muscle tone. Device: stainless steel needles (0.3mm x 50mm)

Active Comparator: Dry needling in a non myofascial trigger points area

Other: Dry needling in a non myofascial trigger points area plus physical therapy based on Bobath concept

Other: Dry Needling Participants will receive dry needling application carried out over a non trigger point area by an experienced physical therapist with clinical experience in neurological patients, that will be inserted into a non trigger point spastic muscle of the shoulder area: upper trapezius, supraspinatus, infraspinatus and deltoid anterior. Other: Physical Therapy Participants will receive physical therapy treatment based on the modulating Bobath technique. This technique will be applied using the general parameters, carrying out similar action protocols with every patient, based on the aim of normalizing upper limb muscle tone. Device: stainless steel needles (0.3mm x 50mm)

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 81 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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