Hemiplegic Shoulder PainNCT04933318
Effects of TENS and Interference on Pain, Functional Status and Range of Motion in Shoulder Pain in Stroke Patients
A study testing TENS and IFC in people with Hemiplegic Shoulder Pain, run by Hilal Yeşil at 1 site in Turkey (Türkiye).
Trial summary
Effects of TENS and Interference on Pain, Functional Status and Range of Motion in Shoulder Pain in Stroke Patients Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hemiplegic Shoulder Pain
- What is being tested?
- TENS and IFC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Mar 2017to 10 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Effects of TENS and Interference on Pain, Functional Status and Range of Motion in Shoulder Pain in Stroke Patients
Read the 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
- Being tested
- TENS, shamTENS, IFC, shamIFC
- Keywords
- Rehabilitation, Exercise, TENS
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSOther
Transcutaneus electrical nerve stimulation (TENS)- analgesic current therapy
shamTENSOther
shamTranscutaneus electrical nerve stimulation (shamTENS)- analgesic current therapy
IFCOther
Interferential current therapy (IFC)- analgesic current therapy
shamIFCOther
shamInterferential current therapy (shamIFC)- analgesic current therapy
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Active comparator | Transcutaneous electrical nerve stimulation (TENS)- analgesic current therapy Receives: Other: TENS |
| shamTENS | Sham comparator | shamTranscutaneous electrical nerve stimulation (TENS)- analgesic current therapy Receives: Other: shamTENS |
| Interferential current therapy (IFC) | Active comparator | Interferential current therapy (IFC)- analgesic current therapy Receives: Other: IFC |
| shamIFC | Sham comparator | shamInterferential current therapy (IFC)- analgesic current therapy Receives: Other: shamIFC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 8 weeks
Secondary outcomes (9)
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start14 Mar 2017
- Primary completion10 May 2021
- Study completion10 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiplegic Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hilal Yeşil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hilal Yeşil, Afyonkarahisar Health Sciences University
- Investigators
- Hilal Yesil, MD, Principal investigator, Afyonkarahisar Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933318
- Sponsor's protocol ID
- HYSHHO
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of TENS and Interference on Pain, Functional Status and Range of Motion in Shoulder Pain in Stroke Patients
- ClinicalTrials.gov ID
- NCT04933318
- Acronym / sponsor ID
- HYSHHO
- Conditions
- Hemiplegic Shoulder Pain
- Keywords
- Rehabilitation, Exercise, TENS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hilal YeşilUniversity, hospital or other
- Study start
- 14 Mar 2017 (actual)
- Primary completion
- 10 May 2021 (actual)
- Study completion
- 10 May 2021 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous electrical nerve stimulation (TENS) | Active comparator | Other: TENSTranscutaneous electrical nerve stimulation (TENS)- analgesic current therapy |
| shamTENS | Sham comparator | Other: shamTENSshamTranscutaneous electrical nerve stimulation (TENS)- analgesic current therapy |
| Interferential current therapy (IFC) | Active comparator | Other: IFCInterferential current therapy (IFC)- analgesic current therapy |
| shamIFC | Sham comparator | Other: shamIFCshamInterferential current therapy (IFC)- analgesic current therapy |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (8 listed)
- Neoplasia
- uncontrolled hypertension
- Serious arrhythmias
- Having pacemakers
- Epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TENSTranscutaneus electrical nerve stimulation (TENS)- analgesic current therapy | Other | Transcutaneous electrical nerve stimulation (TENS) |
| shamTENSshamTranscutaneus electrical nerve stimulation (shamTENS)- analgesic current therapy | Other | shamTENS |
| IFCInterferential current therapy (IFC)- analgesic current therapy | Other | Interferential current therapy (IFC) |
| shamIFCshamInterferential current therapy (shamIFC)- analgesic current therapy | Other | shamIFC |
Primary outcome
Change from baseline VAS (visual analog scale) at 4th and 8th week
Time frame: up to 8 weeks
The patients were asked to make an assesment of their pain level between 0 and 10 scale
9 secondary outcomes
Change from baseline quality of life (short form 36) at 4th and 8th week
Time frame: up to 8 weeks
Change from baseline shoulder range of motion (ROM) at 4th and 8th week
Time frame: up to 8 weeks
Change from baseline Beck depression inventory (BDI) at 4th and 8th week
Time frame: up to 8 weeks
Change from baseline Brunnstrom staging at 4th and 8th week
Time frame: up to 8 weeks
Change from baseline Functional ambulation score (FAS) at 4th and 8th week
Time frame: up to 8 weeks
Change from baseline functional independence measure (FIM) at 4th and 8th week
Time frame: up to 8 weeks
Change from baseline modified ashworth scale (MAS) at 4th and 8th week
Time frame: up to 8 weeks
Change from baseline fugl meyer assessment at 4th and 8th week
Time frame: up to 8 weeks
Change from baseline Shoulder Disability Questionnaire (SDQ) at 4th and 8th week
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
Related trials for Hemiplegic Shoulder Pain
Not yet recruiting
Laser Therapy Versus Transcutaneous Electical Nerve Stimulation at Hemiplegic Shoulder Pain
Hemiplegic Shoulder Pain
Not yet recruiting
Effectiveness of High-intensity Peripheral Magnetic Stimulation on Hemiplegic Shoulder Pain After Stroke
Hemiplegic Shoulder Pain
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
Recruiting
High-Intensity Laser Therapy in Hemiplegic Shoulder Pain
Hemiplegia and/or Hemiparesis Following Stroke
RecruitingObservational study
Effects of Hemiplegic Shoulder Pain on Upper Extremity Motor Function, Trunk Control, Fear of Falling, Mobility and Indepence in Activities of Daily Living in Patients With Stroke
Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilal Yesil, MD principal investigator
Afyonkarahisar Health Sciences University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS and IFC in people with Hemiplegic Shoulder Pain, run by Hilal Yeşil at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline VAS (visual analog scale) at 4th and 8th week (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.