HemiplegiaNCT04790071
Dry Needling Treatment in Hemiplegic Shoulder Pain
A study testing Conventional physical therapy and Conventional physical therapy plus dry needling in people with Hemiplegia and Shoulder Pain, run by Kars State Hospital at 2 sites in Turkey (Türkiye).
Trial summary
To evaluate the efficacy of dry needling therapy on shoulder pain and upper extremity functions in hemiplegic patients. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Hemiplegia, Shoulder Pain, Myofascial Pain
- What is being tested?
- Conventional physical therapy and Conventional physical therapy plus dry needling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Oct 2022to 9 Apr 2023
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The patients included in the study were aged between 30-60 years, with at least a 3-month history of hemorrhagic or ischemic stroke.
Who cannot join
- if they had severe difficulty in communication
- had received a corticosteroid injection within 3 months prior to enrollment
- had bleeding diathesis, a history of shoulder surgery
- a preexisting painful shoulder disorder, or had a cardiac pacemaker.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Kars State Hosital
Kars
Kars State Hospital
Kars
About this study
Official title: Does Dry Needling Treatment Make an Extra Contribution to Conventional Treatment in Hemiplegic Shoulder Pain?
To evaluate the efficacy of dry needling therapy on shoulder pain and upper extremity functions in hemiplegic patients.
Read the detailed description
The myofascial trigger point is an overlooked issue in hemiplegic shoulder pain. Our aim in this study is to evaluate whether dry needling treatment contributes to the conventional treatment approach.
- Conditions
- Hemiplegia, Shoulder Pain, Myofascial Pain
- Being tested
- Conventional physical therapy, Conventional physical therapy plus dry needling
- Keywords
- Hemiplegic shoulder pain, Conventional treatment, Dry needling
- Medical subject headings
- Hemiplegia, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional physical therapyOther
Conventional physical therapy: The patients received physical therapy to the shoulder, transcutaneous electrical nerve stimulation, and stretching and strengthening exercises (5 days per week for three weeks in a total of 15 sessions).
Conventional physical therapy plus dry needlingOther
Conventional physical therapy plus dry needling: The patients received physical therapy to the shoulder, including transcutaneous electrical nerve stimulation, stretching, and strengthening exercise (5 days per week for three weeks in a total of 15 sessions). And also, a total of 3 dry needling sessions were applied at 7-day intervals.
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | Active comparator | It covers the classical physical therapy modalities that patients will take for shoulder pain. Receives: Other: Conventional physical therapy |
| Conventional therapy plus dry needling | Active comparator | It covers the classical physical therapy modalities that patients will take for shoulder pain. It also refers to the dry needling treatment to be applied. Receives: Other: Conventional physical therapy plus dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in visual analog scale score
It grades pain of the patients between 0 and 10 points. Higher scores represent a worse outcome
Measured: 3 months
Change in range of motion
Shoulder range of motion of the patients is evaluated in abduction, flexion, and external rotation. Higher measurements represent a better outcome
Measured: 3 months
Change in Quick The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire score
The Quick DASH is an 11-item measure of the magnitude of disability and symptoms specific to the upper extremity. The first 6 items measure the degree of difficulty in performing various physical activities because of a shoulder, arm, and hand problem, and the other 5 items related to quality of sleeping, social activities, and daily activities, and the intensity of pain and numbness.
Measured: 3 months
Change in Fugl-Meyer Assessment score
The FM scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. It is divided into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start1 Oct 2022
- Primary completion9 Apr 2023
- Study completion9 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemiplegiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomised controlled
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kars State Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Bagcier, Kars State Hospital
- Investigators
- Fatih Bagcier, Principal investigator, Kars State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04790071
- Sponsor's protocol ID
- 2015-KAEK-43-20-12
- Status last verified
- Jun 2023
- First submitted
- 27 Feb 2021
- Last updated
- 12 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be shared upon reasonable request
Publications
Bagcier F, Yurdakul OV, Deniz G, Akbulut A, Celik Y, Temel MH. Is Dry Needling Treatment an Extra Contribution to Conventional Treatment for Hemiplegic Shoulder Pain? A Prospective, Randomized Controlled Study. Med Acupunct. 2023 Oct 1;35(5):236-245. doi: 10.1089/acu.2023.0060. Epub 2023 Oct 17.
PubMed 37900876
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Dry Needling Treatment Make an Extra Contribution to Conventional Treatment in Hemiplegic Shoulder Pain?
- ClinicalTrials.gov ID
- NCT04790071
- Acronym / sponsor ID
- 2015-KAEK-43-20-12
- Conditions
- Hemiplegia, Shoulder Pain, Myofascial Pain
- Keywords
- Hemiplegic shoulder pain, Conventional treatment, Dry needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Kars State HospitalUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 9 Apr 2023 (actual)
- Study completion
- 9 Apr 2023 (actual)
- First posted
- 10 Mar 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.
To evaluate the efficacy of dry needling therapy on shoulder pain and upper extremity functions in hemiplegic patients.
Detailed description
The myofascial trigger point is an overlooked issue in hemiplegic shoulder pain. Our aim in this study is to evaluate whether dry needling treatment contributes to the conventional treatment approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomised controlled
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | Active comparator | Other: Conventional physical therapyIt covers the classical physical therapy modalities that patients will take for shoulder pain. |
| Conventional therapy plus dry needling | Active comparator | Other: Conventional physical therapy plus dry needlingIt covers the classical physical therapy modalities that patients will take for shoulder pain. It also refers to the dry needling treatment to be applied. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The patients included in the study were aged between 30-60 years, with at least a 3-month history of hemorrhagic or ischemic stroke.
Key exclusion criteria (4 listed)
- if they had severe difficulty in communication
- had received a corticosteroid injection within 3 months prior to enrollment
- had bleeding diathesis, a history of shoulder surgery
- a preexisting painful shoulder disorder, or had a cardiac pacemaker.
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 |
|---|---|---|
| Conventional physical therapyConventional physical therapy: The patients received physical therapy to the shoulder, transcutaneous electrical nerve stimulation, and stretching and strengthening exercises (5 days per week for three weeks in a total of 15 sessions). | Other | Conventional therapy |
| Conventional physical therapy plus dry needlingConventional physical therapy plus dry needling: The patients received physical therapy to the shoulder, including transcutaneous electrical nerve stimulation, stretching, and strengthening exercise (5 days per week for three weeks in a total of 15 sessions). And also, a total of 3 dry needling sessions were applied at 7-day intervals. | Other | Conventional therapy plus dry needling |
Primary outcome
Change in visual analog scale score
Time frame: 3 months
It grades pain of the patients between 0 and 10 points. Higher scores represent a worse outcome
Change in range of motion
Time frame: 3 months
Shoulder range of motion of the patients is evaluated in abduction, flexion, and external rotation. Higher measurements represent a better outcome
Change in Quick The Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire score
Time frame: 3 months
The Quick DASH is an 11-item measure of the magnitude of disability and symptoms specific to the upper extremity. The first 6 items measure the degree of difficulty in performing various physical activities because of a shoulder, arm, and hand problem, and the other 5 items related to quality of sleeping, social activities, and daily activities, and the intensity of pain and numbness.
Change in Fugl-Meyer Assessment score
Time frame: 3 months
The FM scale is a 226-point multi-item Likert-type scale developed as an evaluative measure of recovery from hemiplegic stroke. It is divided into 5 domains: motor function, sensory function, balance, joint range of motion, and joint pain. Each domain contains multiple items, each scored on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully).
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 12 Jun 2023.
- Derived from this study: PubMed 37900876Bagcier F, Yurdakul OV, Deniz G, Akbulut A, Celik Y, Temel MH. Is Dry Needling Treatment an Extra Contribution to Conventional Treatment for Hemiplegic Shoulder Pain? A Prospective, Randomized Controlled Study. Med Acupunct. 2023 Oct 1;35(5):236-245. doi: 10.1089/acu.2023.0060. Epub 2023 Oct 17.
- Individual participant dataSharing planned: No. Individual participant data will be shared upon reasonable request
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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.
Fatih Bagcier principal investigator
Kars State Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional physical therapy and Conventional physical therapy plus dry needling in people with Hemiplegia and Shoulder Pain, run by Kars State Hospital at 2 sites 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 4 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 12 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 in visual analog scale score (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04790071, which also lists 1 linked publication.
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 12 Jun 2023.