Back to resultsDry Needling Treatment in Hemiplegic Shoulder Pain
Primary Purpose
Hemiplegia, Shoulder Pain, Myofascial Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional physical therapy
Conventional physical therapy plus dry needling
Sponsored by
About this trial
This is an interventional treatment trial for Hemiplegia focused on measuring Hemiplegic shoulder pain, Conventional treatment, Dry needling
Eligibility Criteria
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.
Sites / Locations
- Kars State Hosital
- Kars State Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional therapy
Conventional therapy plus dry needling
Arm Description
It covers the classical physical therapy modalities that patients will take for shoulder pain.
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.
Outcomes
Primary Outcome Measures
Change in visual analog scale score
It grades pain of the patients between 0 and 10 points. Higher scores represent a worse outcome
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
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.
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04790071
Brief Title
Dry Needling Treatment in Hemiplegic Shoulder Pain
Official Title
Does Dry Needling Treatment Make an Extra Contribution to Conventional Treatment in Hemiplegic Shoulder Pain?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
April 9, 2023 (Actual)
Study Completion Date
April 9, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kars State Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy of dry needling therapy on shoulder pain and upper extremity functions in hemiplegic patients.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Shoulder Pain, Myofascial Pain
Keywords
Hemiplegic shoulder pain, Conventional treatment, Dry needling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomised controlled
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional therapy
Arm Type
Active Comparator
Arm Description
It covers the classical physical therapy modalities that patients will take for shoulder pain.
Arm Title
Conventional therapy plus dry needling
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Conventional physical therapy plus dry needling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in visual analog scale score
Description
It grades pain of the patients between 0 and 10 points. Higher scores represent a worse outcome
Time Frame
3 months
Title
Change in range of motion
Description
Shoulder range of motion of the patients is evaluated in abduction, flexion, and external rotation. Higher measurements represent a better outcome
Time Frame
3 months
Title
Change in Quick The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire score
Description
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.
Time Frame
3 months
Title
Change in Fugl-Meyer Assessment score
Description
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).
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fatih Bagcier
Organizational Affiliation
Kars State Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kars State Hosital
City
Kars
Country
Turkey
Facility Name
Kars State Hospital
City
Kars
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will be shared upon reasonable request
Learn more about this trial
Dry Needling Treatment in Hemiplegic Shoulder Pain
We'll reach out to this number within 24 hrs