Dry Needling and Bobath Treatment Clinical Effects Focused on Stroke Patients

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional treatment trial for Ischemic Stroke focused on measuring Muscle Spasticity, Dry Needling, Stroke

Eligibility Criteria

35 Years - 81 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Polibea Sur neurorehabilitation clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dry needling in a myofascial trigger points area

Dry needling in a non myofascial trigger points area

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Changes in spasticity before and after the 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

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

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.

Full Information

NCT ID

NCT03906305

First Posted

March 13, 2019

Last Updated

November 6, 2019

Sponsor

Universidad Rey Juan Carlos

1. Study Identification

Unique Protocol Identification Number

NCT03906305

Brief Title

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

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

November 26, 2018 (Actual)

Primary Completion Date

October 15, 2019 (Actual)

Study Completion Date

November 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke, Spasticity

Keywords

Muscle Spasticity, Dry Needling, Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

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.

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dry needling in a myofascial trigger points area

Arm Type

Experimental

Arm Description

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.

Arm Title

Dry needling in a non myofascial trigger points area

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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)

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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)

Primary Outcome Measure Information:

Title

Changes in spasticity before and after the intervention

Description

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).

Time Frame

Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention

Secondary Outcome Measure Information:

Title

Changes in shoulder pain before and after the intervention

Description

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).

Time Frame

Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention

Title

Changes in Function of the Upper Extremity before and after the intervention

Description

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.

Time Frame

Baseline, 1, 2, 3, 4, 5, and 6 weeks after each intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

81 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ana I de la Llave Rincon, Doctor

Organizational Affiliation

Universidad Rey Juan Carlos

Official's Role

Study Director

Facility Information:

Facility Name

Polibea Sur neurorehabilitation clinic

City

Madrid

State/Province

Alcorcón/Madrid

ZIP/Postal Code

288922

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

No

Citations:

PubMed Identifier

27167369

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.

Results Reference

background

PubMed Identifier

32488238

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.

Results Reference

derived

Ischemic Stroke, Spasticity

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial