NCT04790071

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 10, 2021

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2023

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

February 27, 2021

Last Update Submit

June 9, 2023

Conditions

Keywords

Hemiplegic shoulder painConventional treatmentDry needling

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 COMPARATOR

It covers the classical physical therapy modalities that patients will take for shoulder pain.

Other: Conventional physical therapy

Conventional therapy plus dry needling

ACTIVE COMPARATOR

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

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 therapy

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.

Conventional therapy plus dry needling

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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)

Location

Kars State Hospital

Kars, Turkey (Türkiye)

Location

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.

MeSH Terms

Conditions

HemiplegiaShoulder Pain

Interventions

Dry Needling

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsArthralgiaJoint DiseasesMusculoskeletal DiseasesPain

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy Modalities

Study Officials

  • Fatih Bagcier

    Kars State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective randomised controlled
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

Locations