Dry Needling Treatment in Hemiplegic Shoulder Pain

Does Dry Needling Treatment Make an Extra Contribution to Conventional Treatment in Hemiplegic Shoulder Pain?

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

Study Overview

• Status: Completed
• Conditions: Shoulder Pain; Myofascial Pain; Hemiplegia
• Intervention / Treatment: Other: Conventional physical therapy; Other: Conventional physical therapy plus dry needling

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Kars, Turkey
    • Kars State Hosital
  • Kars, Turkey
    • Kars State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional therapy; It covers the classical physical therapy modalities that patients will take for shoulder pain.	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).
Active Comparator: Conventional therapy plus dry needling; It covers the classical physical therapy modalities that patients will take for shoulder pain. It also refers to the dry needling treatment to be applied.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Kars State Hospital
• Investigators: Principal Investigator: Fatih Bagcier, Kars State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): April 9, 2023
• Study Completion (Actual): April 9, 2023

Study Registration Dates

• First Submitted: February 27, 2021
• First Submitted That Met QC Criteria: March 6, 2021
• First Posted (Actual): March 10, 2021

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Hemiplegic shoulder pain; Conventional treatment; Dry needling
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Paralysis; Shoulder Pain; Hemiplegia
• Other Study ID Numbers: 2015-KAEK-43-20-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will be shared upon reasonable request

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No