Comparison of the Effects of Extracorporeal Shock Wave Therapy and Dry Needing

NCT05952830 | Completed

• 1 other identifier: 560
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

Effective treatment of spasticity after stroke is a very important and serious problem. Some of the therapeutic approach include physiotherapy and medication. In the recent years external corporeal shockwave therapy and dry needling are commonly used for management of spasticity and pain after stroke. the purpose of this study is the comparative study between effectiveness of external corporeal shockwave therapy (ESWT) and dry needling (DN) on spasticity, pain, and upper limb function and sensation in individuals with hemiplegia. Methods: In this study, individuals with hemiplegia were randomized 1:1 to parallel ESWT-Group (n = 10) or DN group (CG) (n = 10). Upper Extremity Functions, Sensation, Spasticity and Pain were evaluated. All measurement indicators were be evaluate before treatment and immediately after one session treatment. Mixedmodel repeated measured ANOVAs were then employed to determine if a group\*time interaction existed on the effects of the treatment on each outcome variable for each group as the between-subjects variable and time as the within-subjects variables.

Conditions

Hemiplegia

Keywords

Hemiplegia; external corporeal shockwave therapy; dry needling; spasticity

Outcome Measures

Primary Outcomes (4)

• Jebsen Taylor Test of Hand Function (JTHF)

  To do JTHF the participant seat on a chair in front of a table. The test consist of 7 parts. For the first part (writing) individuals will be given a blank A4 paper and a pen and asked to write a sentence shown to them. For the second part (page turning task), a booklet with A4 paper size pages will be given to the individual and asked to turn 5 pages as fast as possible. For the third part (collecting and dropping small objects), 2 covers, 2 book clips and 2 coins will be used. These materials will be placed on a plate, spaced apart, on the table, right in front of the individual's hand to administer the test.

  1 month

• Purdue Pegboard Test (PPT)

  : To do PPT, the participant seat on a chair in front of a table while the board is on the table. Nails a washers placed in the holes above the board. After the explanation of the test and letting the participant to practice; the test starts. The patient must put the nails in 30 second in the first 3 test; the maximum number that he or she can is the test result. first with the non affected hand, then with the other hand, and finally with both hands simultaneously from top to bottom. In the final subtest, individuals will use both hands to construct sets of nails and washers in a 60-second period. Finally, the combining score consists of the number of sets of nails and stamps collected (22,23).

  1 month

• 9 Hole Peg Test

  To do 9 hole peg test (9-HPT), the participant seat on a chair in front of a table while the board is on the table. the sticks are on the affected hand side of the individuals and the holes are on the non-affected hand side. The participants must place the sticks in holes and then remove them from the holes as quickly as possible After the explanation of the test and letting the participant to practice; the test starts. Test results will be recorded by measuring the time with a stopwatch from the moment individuals touch the first stick until the last stick is inserted into the board (21).

  1 month

• Spasticity

  We used modified ashworth scale to test spasticity in elbow flexors while the participants lying supine.

  10 minutes

Secondary Outcomes (5)

• Light Touch

  1 month

• Tactile Sense

  1 month

• Pain Sensation

  1 month

• 2 Point Discrimination

  1 month

• Visual Anolog Scale

  1 month

Study Arms (2)

ESWT Group

ACTIVE COMPARATOR

ESWT Group: external corporeal shockwave therapy subjects in ESWT-group receiving one session shock wave therapy given 6,000 impulses at 0.06-0.07 mJ/mm2 (1.2-1.4 bar) at 18 Hz on biceps brachii

Other: ESWT group

DN Group

EXPERIMENTAL

DN Group: dry needling Subjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute

Other: ESWT group; Other: DN group

Interventions

ESWT group OTHER

subjects in ESWT-group receiving one session shock wave therapy given 6,000 impulses at 0.06-0.07 mJ/mm2 (1.2-1.4 bar) at 18 Hz on biceps brachii (17). Subjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute

DN Group; ESWT Group

DN group OTHER

Subjects in DN-group receiving dry needling using disposable stain less steel sterilized needles, 0.25×0.30. DN perform with patients in supine position, arm away from the trunk, and forearm in supination. The fast-in and fast-out cone shape technique adopt and each muscle needled for one minute

DN Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• being between the age of 25-65
• having been diagnosed with a stroke by a specialist, first time stroke
• BBM spasticity, ability to understand command actions
• stable vital signs, unchanged drug doses that might affect muscle spasticity
• taking no antispastic medication
• with Modified Ashworth Scale (MAS) score more than 1 and less than 4 for the upper limb flexor tension

You may not qualify if:

• received Botox, alcohol or phenol block treatments
• received elbow joint surgical orthopedic surgery
• history of epilepsy
• severe mental disorders
• malignant tumors; and limb venous thrombosis
• sensory disturbances
• the presence of any other neurological disorders
• currently receiving other treatments
• ESWT contraindications
• exhibit fear of needles; or have any contraindication to DN

Sponsors & Collaborators

• Kirsehir Ahi Evran Universitesi: lead

Study Sites (2)

Ahi Evran University

Kırşehir, Merkez, 0040, Turkey (Türkiye)

Location

Kırşehir Ahi Evran University

Kırşehir, Merkez, 0040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia; Muscle Spasticity

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Hüseyin Abdul Razzaq Cabbar Sarefi, PT

  Karbala Health Department.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 19, 2023
• Study Start: August 21, 2021
• Primary Completion: August 21, 2021
• Study Completion: October 26, 2021
• Last Updated: July 19, 2023

Record last verified: 2023-07

Locations

TU (2)