Dry Needling Treatment in Hemiplegic Shoulder Pain

Sponsor
Kars State Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04790071
Collaborator
(none)
46
2
2
6.2
23
3.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Conventional physical therapy
  • Other: Conventional physical therapy plus dry needling
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Prospective randomised controlledProspective randomised controlled
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Does Dry Needling Treatment Make an Extra Contribution to Conventional Treatment in Hemiplegic Shoulder Pain?
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
Apr 9, 2021
Actual Study Completion Date :
Apr 9, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in visual analog scale score [3 months]

    It grades pain of the patients between 0 and 10 points. Higher scores represent a worse outcome

  2. Change in range of motion [3 months]

    Shoulder range of motion of the patients is evaluated in abduction, flexion, and external rotation. Higher measurements represent a better outcome

  3. Change in Quick The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire score [3 months]

    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.

  4. Change in Fugl-Meyer Assessment score [3 months]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kars State Hosital Kars Turkey
2 Kars State Hospital Kars Turkey

Sponsors and Collaborators

  • Kars State Hospital

Investigators

  • Principal Investigator: Fatih Bagcier, Kars State Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatih Bagcier, Study Principal Investigator, Kars State Hospital
ClinicalTrials.gov Identifier:
NCT04790071
Other Study ID Numbers:
  • 2015-KAEK-43-20-12
First Posted:
Mar 10, 2021
Last Update Posted:
Jun 10, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fatih Bagcier, Study Principal Investigator, Kars State Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2021