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

NCT ID: NCT04933318

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-14
• Study Completion Date: 2021-05-10

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.

Conditions

Hemiplegic Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Transcutaneous electrical nerve stimulation (TENS)

Transcutaneous electrical nerve stimulation (TENS)- analgesic current therapy

Group Type: ACTIVE_COMPARATOR

TENS

Intervention Type: OTHER

Transcutaneus electrical nerve stimulation (TENS)- analgesic current therapy

shamTENS

shamTranscutaneous electrical nerve stimulation (TENS)- analgesic current therapy

Group Type: SHAM_COMPARATOR

shamTENS

Intervention Type: OTHER

shamTranscutaneus electrical nerve stimulation (shamTENS)- analgesic current therapy

Interferential current therapy (IFC)

Interferential current therapy (IFC)- analgesic current therapy

Group Type: ACTIVE_COMPARATOR

IFC

Intervention Type: OTHER

Interferential current therapy (IFC)- analgesic current therapy

shamIFC

shamInterferential current therapy (IFC)- analgesic current therapy

Group Type: SHAM_COMPARATOR

shamIFC

Intervention Type: OTHER

shamInterferential current therapy (shamIFC)- analgesic current therapy

Interventions

TENS

Transcutaneus electrical nerve stimulation (TENS)- analgesic current therapy

Intervention Type: OTHER

shamTENS

shamTranscutaneus electrical nerve stimulation (shamTENS)- analgesic current therapy

Intervention Type: OTHER

IFC

Interferential current therapy (IFC)- analgesic current therapy

Intervention Type: OTHER

shamIFC

shamInterferential current therapy (shamIFC)- analgesic current therapy

Intervention Type: OTHER

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

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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hilal Yeşil

OTHER

Sponsor Role: lead

Responsible Party

Hilal Yeşil

Assoc.Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Hilal Yesil, MD

Role: PRINCIPAL_INVESTIGATOR

Afyonkarahisar Health Sciences University

Locations

Hilal Yeşil

Merkez, Afyonkarahisar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HYSHHO

Identifier Type: -

Identifier Source: org_study_id