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

Primary Purpose

Hemiplegic Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TENS
shamTENS
IFC
shamIFC
Sponsored by
Hilal Yeşil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemiplegic Shoulder Pain focused on measuring Rehabilitation, Exercise, TENS

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1.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

Exclusion Criteria:

  1. Neoplasia
  2. uncontrolled hypertension
  3. Serious arrhythmias
  4. Having pacemakers
  5. Epilepsy
  6. Severe sensory impairment, wound, infection in the application area
  7. bleeding disorders

9. 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)

Sites / Locations

  • Hilal Yeşil

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Sham Comparator

Arm Label

Transcutaneous electrical nerve stimulation (TENS)

shamTENS

Interferential current therapy (IFC)

shamIFC

Arm Description

Transcutaneous electrical nerve stimulation (TENS)- analgesic current therapy

shamTranscutaneous electrical nerve stimulation (TENS)- analgesic current therapy

Interferential current therapy (IFC)- analgesic current therapy

shamInterferential current therapy (IFC)- analgesic current therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from baseline quality of life (short form 36) at 4th and 8th week
The physical and mental health summary scores were the primary components used. Scoring is on a scale of 0 to 100 and a higher score reflects better health-related quality of life.
Change from baseline shoulder range of motion (ROM) at 4th and 8th week
The patients' shoulder joint range of motion will be measured with a goniometer.
Change from baseline Beck depression inventory (BDI) at 4th and 8th week
A total Beck score (0-63) is obtained by giving each question a score of 0-3 in the survey. 17 is considered the threshold value for the degree of depression.
Change from baseline Brunnstrom staging at 4th and 8th week
According to Brunnstrom, the motor recovery of the hemiplegic patient is divided into six stages. These stages are defined according to muscle tone and extremity synergies. Stage 1: The involved side is flaccid, there is no active movement. Stage 6: Isolated joint movement is freely available.
Change from baseline Functional ambulation score (FAS) at 4th and 8th week
It is used to evaluate the support patients need during walking. It has 5 phases. STAGE 0: Non-functional ambulation: The patient does not walk, he can only walk on the parallel bar. STAGE 5: There is independent ambulation.
Change from baseline functional independence measure (FIM) at 4th and 8th week
FIM consists of 2 parts: motor and cognitive skills. Each of the sections contains 18 sub-items under 6 main items (self-care, sphincter control, mobility and transfer, mobility and walking, communication and social perception). The lowest score that can be obtained from the scale is 18, and the highest score is 126.
Change from baseline modified ashworth scale (MAS) at 4th and 8th week
It is used when evaluating the upper extremity muscle tone of patients. Stages on this scale: 0: Muscle tone is normal. 4: The affected parts are rigid in flexion and extension, there is a severe increase in tone.
Change from baseline fugl meyer assessment at 4th and 8th week
It is a stroke-specific, performance-based scale, with each parameter being 0; fail, 1; partially successful and 2; is scored as a completely successful performance. It is based on the motor recovery stages of Twitchell and Brunnstrom.
Change from baseline Shoulder Disability Questionnaire (SDQ) at 4th and 8th week
It is a 16-item pain-related disability questionnaire describing common conditions that exacerbate symptoms in patients with shoulder disease. A score of zero indicates maximum well-being, and a score of 100 indicates maximum ill health.

Full Information

First Posted
June 15, 2021
Last Updated
June 15, 2021
Sponsor
Hilal Yeşil
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1. Study Identification

Unique Protocol Identification Number
NCT04933318
Brief Title
Effects of TENS and Interference on Pain, Functional Status and Range of Motion in Shoulder Pain in Stroke Patients
Official Title
Effects of TENS and Interference on Pain, Functional Status and Range of Motion in Shoulder Pain in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 14, 2017 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
May 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hilal Yeşil

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
Effects of TENS and Interference on Pain, Functional Status and Range of Motion in Shoulder Pain in Stroke Patients
Detailed Description
Hemiplegic shoulder pain treatment methods are, analgesics, local steroid injection, physical therapy modalities and exercise. There are publications about the use of TENS and interferential currents (IFC) in the treatment of hemiplegia related shoulder pain and their effectiveness. However when we look at the literature, we did not find a study that evaluated the efficacy of TENS and IFC in hemiplegic shoulder pain. For this reason, in this study, we aimed to determine the effects of these analgesic treatment modalities on the patient's pain, functional status and shoulder range of motion (ROM) in these patients. 60 stroke patients with shoulder pain randomized to four treatment groups. 15 patients in Group 1 were given TENS treatment to the shoulder area for 25 minutes by conventional method ( 20 sessions, 5 times a week), then, a classical stroke rehabilitation program was applied under the guidance of a physiotherapist.. 15 patients in Group 2 were given shamTENS treatment to the shoulder area for 25 minutes ( 20 sessions, 5 times a week), then, a classical stroke rehabilitation program was applied under the guidance of a physiotherapist.15 patients in Group 3 were given 100 Hz IFC treatment to the shoulder area for 25 minutes ( 20 sessions, 5 times a week), then, a classical stroke rehabilitation program was applied under the guidance of a physiotherapist. 15 patients in Group 4 were given shamIFC treatment to the shoulder area for 25 minutes ( 20 sessions, 5 times a week), then, a classical stroke rehabilitation program was applied under the guidance of a physiotherapist.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Shoulder Pain
Keywords
Rehabilitation, Exercise, TENS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcutaneous electrical nerve stimulation (TENS)
Arm Type
Active Comparator
Arm Description
Transcutaneous electrical nerve stimulation (TENS)- analgesic current therapy
Arm Title
shamTENS
Arm Type
Sham Comparator
Arm Description
shamTranscutaneous electrical nerve stimulation (TENS)- analgesic current therapy
Arm Title
Interferential current therapy (IFC)
Arm Type
Active Comparator
Arm Description
Interferential current therapy (IFC)- analgesic current therapy
Arm Title
shamIFC
Arm Type
Sham Comparator
Arm Description
shamInterferential current therapy (IFC)- analgesic current therapy
Intervention Type
Other
Intervention Name(s)
TENS
Intervention Description
Transcutaneus electrical nerve stimulation (TENS)- analgesic current therapy
Intervention Type
Other
Intervention Name(s)
shamTENS
Intervention Description
shamTranscutaneus electrical nerve stimulation (shamTENS)- analgesic current therapy
Intervention Type
Other
Intervention Name(s)
IFC
Intervention Description
Interferential current therapy (IFC)- analgesic current therapy
Intervention Type
Other
Intervention Name(s)
shamIFC
Intervention Description
shamInterferential current therapy (shamIFC)- analgesic current therapy
Primary Outcome Measure Information:
Title
Change from baseline VAS (visual analog scale) at 4th and 8th week
Description
The patients were asked to make an assesment of their pain level between 0 and 10 scale
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Change from baseline quality of life (short form 36) at 4th and 8th week
Description
The physical and mental health summary scores were the primary components used. Scoring is on a scale of 0 to 100 and a higher score reflects better health-related quality of life.
Time Frame
up to 8 weeks
Title
Change from baseline shoulder range of motion (ROM) at 4th and 8th week
Description
The patients' shoulder joint range of motion will be measured with a goniometer.
Time Frame
up to 8 weeks
Title
Change from baseline Beck depression inventory (BDI) at 4th and 8th week
Description
A total Beck score (0-63) is obtained by giving each question a score of 0-3 in the survey. 17 is considered the threshold value for the degree of depression.
Time Frame
up to 8 weeks
Title
Change from baseline Brunnstrom staging at 4th and 8th week
Description
According to Brunnstrom, the motor recovery of the hemiplegic patient is divided into six stages. These stages are defined according to muscle tone and extremity synergies. Stage 1: The involved side is flaccid, there is no active movement. Stage 6: Isolated joint movement is freely available.
Time Frame
up to 8 weeks
Title
Change from baseline Functional ambulation score (FAS) at 4th and 8th week
Description
It is used to evaluate the support patients need during walking. It has 5 phases. STAGE 0: Non-functional ambulation: The patient does not walk, he can only walk on the parallel bar. STAGE 5: There is independent ambulation.
Time Frame
up to 8 weeks
Title
Change from baseline functional independence measure (FIM) at 4th and 8th week
Description
FIM consists of 2 parts: motor and cognitive skills. Each of the sections contains 18 sub-items under 6 main items (self-care, sphincter control, mobility and transfer, mobility and walking, communication and social perception). The lowest score that can be obtained from the scale is 18, and the highest score is 126.
Time Frame
up to 8 weeks
Title
Change from baseline modified ashworth scale (MAS) at 4th and 8th week
Description
It is used when evaluating the upper extremity muscle tone of patients. Stages on this scale: 0: Muscle tone is normal. 4: The affected parts are rigid in flexion and extension, there is a severe increase in tone.
Time Frame
up to 8 weeks
Title
Change from baseline fugl meyer assessment at 4th and 8th week
Description
It is a stroke-specific, performance-based scale, with each parameter being 0; fail, 1; partially successful and 2; is scored as a completely successful performance. It is based on the motor recovery stages of Twitchell and Brunnstrom.
Time Frame
up to 8 weeks
Title
Change from baseline Shoulder Disability Questionnaire (SDQ) at 4th and 8th week
Description
It is a 16-item pain-related disability questionnaire describing common conditions that exacerbate symptoms in patients with shoulder disease. A score of zero indicates maximum well-being, and a score of 100 indicates maximum ill health.
Time Frame
up to 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1.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 Exclusion Criteria: Neoplasia uncontrolled hypertension Serious arrhythmias Having pacemakers Epilepsy Severe sensory impairment, wound, infection in the application area bleeding disorders 9. 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hilal Yesil, MD
Organizational Affiliation
Afyonkarahisar Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hilal Yeşil
City
Merkez
State/Province
Afyon
ZIP/Postal Code
0300
Country
Turkey

12. IPD Sharing Statement

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

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