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Completed

NCT Number: NCT03906305

Dry Needling and Bobath Treatment Clinical Effects Focused on Stroke Patients

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.

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Key information

Conditions

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

Age range

35 year–81 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Polibea Sur neurorehabilitation clinic

Madrid, Alcorcón/Madrid, 288922, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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)

Primary outcomes

  1. Changes in spasticity before and after the intervention

    Time frame: 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 outcomes

  1. Changes in shoulder pain before and after the intervention

    Time frame: 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).

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidad Rey Juan Carlos

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 8, 2019
Registry last updated
Nov 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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