Effectiveness of Dry Needling (DNHS Technique) in Patients With Chronic Stroke

NCT03546517 | Completed

• 1 other identifier: DNHS_stroke
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Study hypothesis: The DNHS technique, performed via one session of deep dry needling of myofascial trigger points applied to the biceps brachii, brachialis, flexor digitorum superficialis, flexor digitorum profundus, triceps brachii, extensor digitorum and adductor pollicis muscle is effective for decreasing spasticity and muscle stiffness (both of which are components of hypertonia) as well as for improving the upper limb function of the previously described muscles in patients with chronic cerebral vascular accident (CVA), assessed both post-intervention and after 15 days. General aims To analyse the immediate therapeutic effect of the DNHS technique and the effect at 15 days follow-up, for the following variables:

• Spasticity
• Muscle stiffness
• Upper limb function
• Patient perceived quality of life Materials and methods Population: patients from the province of Zaragoza (Spain) diagnosed with a haemorrhagic or ischemic CVA by a neurologist. Recruitment strategy: recruitment will take place via the Stroke Association in Aragon (AIDA) \[Aragon Stroke Association\] in the province of Zaragoza, Spain, seeing as the greater proportion of patients who have suffered a stroke and are in the chronic stage of the illness go to this centre to receive treatment. Thus, this avoids patients having to travel elsewhere for the study. Furthermore, in the case of patients who wish to participate in the study after having received information via third persons or via other means and who are not members of the Association or do not attend the centre on a regular basis, the Association AIDA has offered to allow these people to attend for free, making its facilities available and supporting the development of this study.

Conditions

Stroke; Spasticity

Keywords

myofascial trigger point; dry needling; spasticity; stroke

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Scale

  Scale measuring Upper Limb Function in stroke patients. The motor and sensory assessments are scored on a three-point ordinal scale (0 -2) in which a higher score indicates superior results. The motor assessment measures voluntary limb movement and includes a subscale for the Upper Extremity (33 items; score range, 0-66). The sensory assessment measures limb sensation. Sensation is assessed as absent, impaired, or normal for light touch (two items each for Upper Extremity (UE) and Lower Extremity (LE); score range, 0-8) and proprioception (four items each for UE and LE; score range, 0-16) for a total sensory Fugl-Meyer (FM) score of 24. Fugl-Meyer Assessment (FMA) has shown to have an excellent intra and interrater reliability (0.89-0.99). The estimated minimal clinical important difference (MCID) of the UE-FM scores ranged from 4.25 to 7.25 points .

  Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention

Secondary Outcomes (4)

• Modified Modified Ashworth Scale

  Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention

• Electromyography (EMG)

  Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention

• Tonometry (measurement of muscle tone with a device)

  Change between baseline (immediately before intervention) and post intervention (immediately after intervention). Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention

• Quality of Life (Euro QoL5D)

  Change between baseline (immediately before intervention) and follow-up at 2 weeks after intervention

Study Arms (2)

Intervention with DNHS technique

EXPERIMENTAL

Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis

Other: Dry Needling

Sham Dry Needling

SHAM COMPARATOR

Sham Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis

Other: Sham Dry Needling

Interventions

Dry Needling OTHER

Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis

Also known as: DNHS technique

Intervention with DNHS technique

Sham Dry Needling OTHER

Sham Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis

Sham Dry Needling

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have been diagnosed with a haemorrhagic or ischemic CVA by a neurologist.
• Cognitive level: minimental state examination (MMSE) ≥ 27 points. All patients must have a good cognitive level in order to ensure that they are able to communicate with the professionals involved in the study in order to understand the exercises and thus fulfil the objectives for participation.
• Presence of spasticity ≥1 according to the Modified Modified Ashworth Scale (MMAS) score during the flexion-extension movement of the wrist and elbow in at least one of the muscles of the upper limb evaluated.
• Age: between 30 - 90 years. In this range of age CVA's are more common, according to data from the Spanish Statistical Office.
• Evolution: over 6 months must have passed since the CVA episode. Most of the studies reviewed involve patients who are in the chronic stage of illness. This will ensure that the changes found are due to our intervention and not related to plasticity mechanisms occurring after the injury (this will be considered objectively by performing an assessment at baseline, which will be repeated 1 week later, immediately before and after the dry needling intervention).

You may not qualify if:

• Concomitance of degenerative illnesses which can alter the results.
• Presence of fixed contractures: 4 according to the MMAS score
• Suffering from epileptic fits that are not medically controlled.
• Fear of needles.
• No tolerance to pain caused by needling.
• Those unable to commit to attendance.

Sponsors & Collaborators

• Universidad San Jorge: lead

Study Sites (1)

Universidad San Jorge

Zaragoza, 50830, Spain

Location

Related Publications (1)

• Calvo S, Brandin-de la Cruz N, Jimenez-Sanchez C, Bravo-Esteban E, Herrero P. Effects of dry needling on function, hypertonia and quality of life in chronic stroke: a randomized clinical trial. Acupunct Med. 2022 Aug;40(4):312-321. doi: 10.1177/09645284211056347. Epub 2021 Dec 13.

  PMID: 34894776 DERIVED

MeSH Terms

Conditions

Stroke; Muscle Spasticity

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients and assessor are blinded but the physiotherapist giving the treatment is not blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of iPhysio Research Group, San Jorge University

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: June 6, 2018
• Study Start: June 19, 2018
• Primary Completion: July 30, 2018
• Study Completion: September 4, 2018
• Last Updated: September 20, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)