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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04790071
Other study ID # 2015-KAEK-43-20-12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date April 9, 2023

Study information

Verified date June 2023
Source Kars State Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To evaluate the efficacy of dry needling therapy on shoulder pain and upper extremity functions in hemiplegic patients.


Description:

The myofascial trigger point is an overlooked issue in hemiplegic shoulder pain. Our aim in this study is to evaluate whether dry needling treatment contributes to the conventional treatment approach.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date April 9, 2023
Est. primary completion date April 9, 2023
Accepts healthy volunteers No
Gender All
Age group 30 Years to 60 Years
Eligibility Inclusion Criteria: - The patients included in the study were aged between 30-60 years, with at least a 3-month history of hemorrhagic or ischemic stroke. Exclusion Criteria: - if they had severe difficulty in communication - had received a corticosteroid injection within 3 months prior to enrollment - had bleeding diathesis, a history of shoulder surgery - a preexisting painful shoulder disorder, or had a cardiac pacemaker.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Conventional physical therapy
Conventional physical therapy: The patients received physical therapy to the shoulder, transcutaneous electrical nerve stimulation, and stretching and strengthening exercises (5 days per week for three weeks in a total of 15 sessions).
Conventional physical therapy plus dry needling
Conventional physical therapy plus dry needling: The patients received physical therapy to the shoulder, including transcutaneous electrical nerve stimulation, stretching, and strengthening exercise (5 days per week for three weeks in a total of 15 sessions). And also, a total of 3 dry needling sessions were applied at 7-day intervals.

Locations

Country Name City State
Turkey Kars State Hosital Kars
Turkey Kars State Hospital Kars

Sponsors (1)

Lead Sponsor Collaborator
Kars State Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in visual analog scale score It grades pain of the patients between 0 and 10 points. Higher scores represent a worse outcome 3 months
Primary Change in range of motion Shoulder range of motion of the patients is evaluated in abduction, flexion, and external rotation. Higher measurements represent a better outcome 3 months
Primary Change in Quick The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire score The Quick DASH is an 11-item measure of the magnitude of disability and symptoms specific to the upper extremity. The first 6 items measure the degree of difficulty in performing various physical activities because of a shoulder, arm, and hand problem, and the other 5 items related to quality of sleeping, social activities, and daily activities, and the intensity of pain and numbness. 3 months
Primary Change in Fugl-Meyer Assessment score The FM scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. It is divided into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). 3 months
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