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

Hemiplegic Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04933318
• Other study ID #: HYSHHO
• Status: Completed
• Phase: N/A
• Start date: March 14, 2017
• Est. completion date: May 10, 2021

Study information

• Verified date: June 2021
• Source: Afyonkarahisar Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 10, 2021
• Est. primary completion date: May 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hemiplegic Shoulder Pain
• Shoulder Pain

Intervention

Other:
• TENS
Transcutaneus electrical nerve stimulation (TENS)- analgesic current therapy
• shamTENS
shamTranscutaneus electrical nerve stimulation (shamTENS)- analgesic current therapy
• IFC
Interferential current therapy (IFC)- analgesic current therapy
• shamIFC
shamInterferential current therapy (shamIFC)- analgesic current therapy

Locations

Country	Name	City	State
Turkey	Hilal Yesil	Merkez	Afyon

Sponsors (1)

Lead Sponsor	Collaborator
Hilal Yesil

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	up to 8 weeks
Secondary	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.	up to 8 weeks
Secondary	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.	up to 8 weeks
Secondary	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.	up to 8 weeks
Secondary	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.	up to 8 weeks
Secondary	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.	up to 8 weeks
Secondary	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.	up to 8 weeks
Secondary	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.	up to 8 weeks
Secondary	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.	up to 8 weeks