Dry Needling and Bobath Treatment Clinical Effects Focused on Stroke Patients

NCT03906305 | Completed

• 1 other identifier: Pending
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke; Spasticity

Keywords

Muscle Spasticity; Dry Needling; Stroke

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (2)

• Changes in shoulder pain before and after the intervention

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

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

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

Study Arms (2)

Dry needling in a myofascial trigger points area

EXPERIMENTAL

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

Dry needling in a non myofascial trigger points area

ACTIVE COMPARATOR

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

Interventions

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

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)

Dry needling in a myofascial trigger points area

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

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)

Dry needling in a non myofascial trigger points area

Eligibility Criteria

• Age: 35 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Polibea Sur neurorehabilitation clinic

Madrid, Alcorcón/Madrid, 288922, Spain

Location

Related Publications (2)

• 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.

  PMID: 27167369 BACKGROUND

• 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.

  PMID: 32488238 DERIVED

MeSH Terms

Conditions

Ischemic Stroke; Muscle Spasticity; Stroke

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities

Study Officials

• Ana I de la Llave Rincon, Doctor

  Universidad Rey Juan Carlos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: April 8, 2019
• Study Start: November 26, 2018
• Primary Completion: October 15, 2019
• Study Completion: November 6, 2019
• Last Updated: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)