Dry Needling Treatment in Hemiplegic Shoulder Pain
Does Dry Needling Treatment Make an Extra Contribution to Conventional Treatment in Hemiplegic Shoulder Pain?
1 other identifier
interventional
46
1 country
2
Brief Summary
To evaluate the efficacy of dry needling therapy on shoulder pain and upper extremity functions in hemiplegic patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2022
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2021
CompletedFirst Posted
Study publicly available on registry
March 10, 2021
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 9, 2023
CompletedJune 12, 2023
June 1, 2023
6 months
February 27, 2021
June 9, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Study Arms (2)
Conventional therapy
ACTIVE COMPARATORIt covers the classical physical therapy modalities that patients will take for shoulder pain.
Conventional therapy plus dry needling
ACTIVE COMPARATORIt covers the classical physical therapy modalities that patients will take for shoulder pain. It also refers to the dry needling treatment to be applied.
Interventions
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: 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.
Eligibility Criteria
You may qualify if:
- The patients included in the study were aged between 30-60 years, with at least a 3-month history of hemorrhagic or ischemic stroke.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kars State Hosital
Kars, Turkey (Türkiye)
Kars State Hospital
Kars, Turkey (Türkiye)
Related Publications (1)
Bagcier F, Yurdakul OV, Deniz G, Akbulut A, Celik Y, Temel MH. Is Dry Needling Treatment an Extra Contribution to Conventional Treatment for Hemiplegic Shoulder Pain? A Prospective, Randomized Controlled Study. Med Acupunct. 2023 Oct 1;35(5):236-245. doi: 10.1089/acu.2023.0060. Epub 2023 Oct 17.
PMID: 37900876DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fatih Bagcier
Kars State Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
February 27, 2021
First Posted
March 10, 2021
Study Start
October 1, 2022
Primary Completion
April 9, 2023
Study Completion
April 9, 2023
Last Updated
June 12, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share
Individual participant data will be shared upon reasonable request