Clinical trial NCT04933318: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegic Shoulder Pain
Keywords: Rehabilitation
Exercise
TENS
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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)

Primary outcomes:
measure: Change from baseline VAS (visual analog scale) at 4th and 8th week
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Change from baseline quality of life (short form 36) at 4th and 8th week
timeFrame: up to 8 weeks
measure: Change from baseline shoulder range of motion (ROM) at 4th and 8th week
timeFrame: up to 8 weeks
measure: Change from baseline Beck depression inventory (BDI) at 4th and 8th week
timeFrame: up to 8 weeks
measure: Change from baseline Brunnstrom staging at 4th and 8th week
timeFrame: up to 8 weeks
measure: Change from baseline Functional ambulation score (FAS) at 4th and 8th week
timeFrame: up to 8 weeks
measure: Change from baseline functional independence measure (FIM) at 4th and 8th week
timeFrame: up to 8 weeks
measure: Change from baseline modified ashworth scale (MAS) at 4th and 8th week
timeFrame: up to 8 weeks
measure: Change from baseline fugl meyer assessment at 4th and 8th week
timeFrame: up to 8 weeks
measure: Change from baseline Shoulder Disability Questionnaire (SDQ) at 4th and 8th week
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Hilal Yeşil
state: Afyon
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: Hilal Yesil, MD
role: PRINCIPAL_INVESTIGATOR
References: