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

Not Applicable

Completed

• Conditions: Hemiplegic Shoulder Pain
• Interventions: Other: TENS; Other: shamTENS; Other: shamIFC; Other: IFC

• Registration Number: NCT04933318
• Lead Sponsor: Hilal Yeşil

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.

Study Timeline

• Study Start: 2017-03-14
• Primary Completion: 2021-05-10
• Study Completion: 2021-05-10
• Status Verified: 2021-06
• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-15
• Last Update Submitted: 2021-06-15
• Study First Posted: 2021-06-21
• Last Update Posted: 2021-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

8. 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transcutaneous electrical nerve stimulation (TENS)	TENS	Transcutaneous electrical nerve stimulation (TENS)- analgesic current therapy
shamTENS	shamTENS	shamTranscutaneous electrical nerve stimulation (TENS)- analgesic current therapy
shamIFC	shamIFC	shamInterferential current therapy (IFC)- analgesic current therapy
Interferential current therapy (IFC)	IFC	Interferential current therapy (IFC)- analgesic current therapy

Primary Outcome Measures

Name	Time	Method
Change from baseline VAS (visual analog scale) at 4th and 8th week	up to 8 weeks	The patients were asked to make an assesment of their pain level between 0 and 10 scale

Secondary Outcome Measures

Name	Time	Method
Change from baseline shoulder range of motion (ROM) at 4th and 8th week	up to 8 weeks	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	up to 8 weeks	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 Shoulder Disability Questionnaire (SDQ) at 4th and 8th week	up to 8 weeks	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.
Change from baseline quality of life (short form 36) at 4th and 8th week	up to 8 weeks	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 Brunnstrom staging at 4th and 8th week	up to 8 weeks	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	up to 8 weeks	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	up to 8 weeks	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	up to 8 weeks	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	up to 8 weeks	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.

Trial Locations

Locations (1)

Hilal Yeşil; 🇹🇷 Merkez, Afyon, Turkey