NCT04933318

Brief Summary

Effects of TENS and Interference on Pain, Functional Status and Range of Motion in Shoulder Pain in Stroke Patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 15, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 21, 2021

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

4.2 years

First QC Date

June 15, 2021

Last Update Submit

June 15, 2021

Conditions

Hemiplegic Shoulder Pain

Keywords

RehabilitationExerciseTENS

Outcome Measures

Primary Outcomes (1)

  • Change from baseline VAS (visual analog scale) at 4th and 8th week

    The patients were asked to make an assesment of their pain level between 0 and 10 scale

    up to 8 weeks

Secondary Outcomes (9)

  • Change from baseline quality of life (short form 36) at 4th and 8th week

    up to 8 weeks

  • Change from baseline shoulder range of motion (ROM) at 4th and 8th week

    up to 8 weeks

  • Change from baseline Beck depression inventory (BDI) at 4th and 8th week

    up to 8 weeks

  • Change from baseline Brunnstrom staging at 4th and 8th week

    up to 8 weeks

  • Change from baseline Functional ambulation score (FAS) at 4th and 8th week

    up to 8 weeks

  • +4 more secondary outcomes

Study Arms (4)

Transcutaneous electrical nerve stimulation (TENS)

ACTIVE COMPARATOR

Transcutaneous electrical nerve stimulation (TENS)- analgesic current therapy

Other: TENS

shamTENS

SHAM COMPARATOR

shamTranscutaneous electrical nerve stimulation (TENS)- analgesic current therapy

Other: shamTENS

Interferential current therapy (IFC)

ACTIVE COMPARATOR

Interferential current therapy (IFC)- analgesic current therapy

Other: IFC

shamIFC

SHAM COMPARATOR

shamInterferential current therapy (IFC)- analgesic current therapy

Other: shamIFC

Interventions

TENSOTHER

Transcutaneus electrical nerve stimulation (TENS)- analgesic current therapy

Transcutaneous electrical nerve stimulation (TENS)
shamTENSOTHER

shamTranscutaneus electrical nerve stimulation (shamTENS)- analgesic current therapy

shamTENS
IFCOTHER

Interferential current therapy (IFC)- analgesic current therapy

Interferential current therapy (IFC)
shamIFCOTHER

shamInterferential current therapy (shamIFC)- analgesic current therapy

shamIFC

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Having shoulder pain due to hemiplegia 2- Having had hemiplegia in the last 8 months 3- Having hemiplegia for the first time 4- Not having a problem in the painful shoulder before hemiplegia 5- normal light touch and pinprick tests of the affected shoulder 6- pain level in the affected extremity as measured by VAS is at least 4 7- Brunnstrom upper extremity stage with 1-2-3

You may not qualify if:

  • Neoplasia
  • uncontrolled hypertension
  • Serious arrhythmias
  • Having pacemakers
  • Epilepsy
  • Severe sensory impairment, wound, infection in the application area
  • bleeding disorders
  • \. Uncooperative patients 10- Patients with acute infection 11- Patients with a history of trauma to the painful shoulder 12- Treatment for pain in the affected shoulder (blockage, intra-articular injection, and physical therapy agent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hilal Yeşil

Merkez, Afyonkarahisar, 0300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Hilal Yesil, MD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assoc.Prof.

Study Record Dates

First Submitted

June 15, 2021

First Posted

June 21, 2021

Study Start

March 14, 2017

Primary Completion

May 10, 2021

Study Completion

May 10, 2021

Last Updated

June 21, 2021

Record last verified: 2021-06

Locations

TU(1)