Dry Needling and Bobath Treatment Clinical Effects Focused on Stroke Patients

NCT ID: NCT03906305

Last Updated: 2019-11-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-26
• Study Completion Date: 2019-11-06

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.

Conditions

Ischemic Stroke; Spasticity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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)

Interventions

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)

Intervention Type: 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)

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: lead

Responsible Party

Alma Rocío Hernández Ortíz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ana I de la Llave Rincon, Doctor

Role: STUDY_DIRECTOR

Universidad Rey Juan Carlos

Locations

Polibea Sur neurorehabilitation clinic

Madrid, Alcorcón/Madrid, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 27167369 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32488238 (View on PubMed)

Other Identifiers

Pending

Identifier Type: -

Identifier Source: org_study_id