Stroke Gait RehabilitationNCT06653855
The Effect of Cupping on Spasticity and Function of the Lower Extremity During Rehabilitation After Stroke
A study testing Dry Static Cupping and Standard physical therapy treatment in people with Stroke Gait Rehabilitation, run by Scott Getsoian at 1 site in United States.
Trial summary
Physical therapists use dry static cupping for the treatment of many conditions, including spasticity for patients post-stroke. While research better describes the effects of dry static cupping for patients with orthopedic conditions, information is lacking on central conditions, such as stroke and resulting… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Stroke Gait Rehabilitation
- What is being tested?
- Dry Static Cupping and Standard physical therapy treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2024to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-80
- Acute stroke (within 6 months of stroke), with spasticity \& hemiparesis of LE
- Referred by doctor for rehabilitation for a stroke-related condition
- Attending Ascension Rehabilitation of Joliet for rehabilitation
- Able to read or verbally understand English or Spanish
Who cannot join
- Absent sensation of the areas to be cupped
- Significant cognitive impairment
- Pregnancy
- Prescription anticoagulant medications
- Blood clotting disorder
- Uncontrolled hypertension
Show all 15Show fewer
- Uncontrolled diabetes
- Open wounds within the cupping area
- Current DVT
- Hematoma over the cupping area
- Fracture over the cupping area
- Active cancer within the cupping area
- Current use of Baclofen
- Current use of Botox
- Current use of an anti-spasticity medication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Ascension Rehabilitation of Joliet
Joliet, Illinois, 60435
Laura Nurczyk, 815-741-7114, laura.nurczyk@ascension-external.org
Kathlene Getsoian, 815-735-9261, klf74@comcast.net
About this study
Physical therapists use dry static cupping for the treatment of many conditions, including spasticity for patients post-stroke. While research better describes the effects of dry static cupping for patients with orthopedic conditions, information is lacking on central conditions, such as stroke and resulting spasticity.
Read the detailed description
Cupping is an ancient alternative medicine. A common form of cupping, called dry static cupping, involves creating negative pressure inside a therapeutic cup. The cup is then placed on the skin, creating a light suction effect. In Eastern Medicine, cupping has been used to treat a variety of diseases. More recently, in Western society, cupping has been used after injury, and among other effects, has been found to improve blood volume and tissue oxygenation to an area. These effects have originally been thought to be peripheral in nature, occurring at the cupping site, hence, why cupping has been used for treatment for conditions like carpal tunnel syndrome, spinal pain, knee osteoarthritis, and other musculoskeletal conditions.
However, a recent systematic review found cupping to be beneficial for rehabilitation after stroke. These conclusions raise the question of a possible mechanism for cupping to improve impairments related to the central nervous system, such as spasticity after stroke. However, many of the studies to date have serious methodological flaws that limit the direct causation of cupping to the reduction of spasticity. As well, the majority of studies only involve the upper extremity. No study has yet looked at the therapeutic effects of dry static cupping on lower extremity spasticity reduction after stroke.
- Conditions
- Stroke Gait Rehabilitation
- Being tested
- Dry Static Cupping, Placebo cupping, Standard physical therapy treatment
- Keywords
- Cupping, Spasticity, stroke, rehabilitation
- Medical subject headings
- Muscle Spasticity, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry Static CuppingOther
A myofascial decompression cupping set with a precision pressure pump will be used to perform dry static cupping to the adductor and hamstring muscle groups of the affected limb, using a negative pressure of 300mmHg for eight minutes each.
Placebo cuppingOther
The same protocol will be used as stated for the Dry static cupping intervention, with the only difference being that the cup will be pumped to 50mmHg instead of 300mmHg.
Standard physical therapy treatmentOther
Treatment will consist of typical physical therapy interventions performed for patients with spasticity of the lower extremity after stroke. These may include, but not be limited to:
- Balance exercise
- Therapeutic exercise
- Neuromuscular/muscular coordination exercise
- Manual (hands on) therapy
- Gait training
The treating physical therapist is left with the autonomy of the standard physical therapy treatment (within the above stated groups of interventions) because patients with the diagnosis of stroke do not all present with the same type or level of impairment. Furthermore co-morbidities (e.g., hypertension) and/or functional level (wheelchair bound vs. independent ambulator) may necessitate different treatment strategies. Therefore, while the general categories of treatment will remain the same across all study patients, it is expected that the treating physical therapist provides patient-specific interventions.
| Study group | Role | What they receive |
|---|---|---|
| Cupping group | Active comparator | This group (arm) will receive the dry static cupping intervention, along with the standard physical therapy treatment. Receives: Other: Dry Static Cupping; Other: Standard physical therapy treatment |
| Placebo cupping group | Sham comparator | This group (arm) will receive a placebo-form of cupping (low, and non-therapeutic pressure amount in the cups), along with the standard physical therapy treatment. Receives: Other: Placebo cupping; Other: Standard physical therapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Ashworth Scale
The Modified Ashworth Scale measures spasticity on a 0-4 ordinal scale, with higher scores indicating greater spasticity. The grade is determined by passively moving a joint/muscle through a high velocity unidirectional quick stretch. For this study, spasticity will be assessed for the hip adductors and hamstrings of the affected side.
Equipment:
Mat Table
Administration:
Patient is positioned in supine on a mat table.
For Hip Adduction: Physical therapist passively moves the affected lower extremity into hip abduction quickly keeping the knee in extension.
For Hamstrings: Physical therapist passively moves the hip to 90 degrees of flexion and allows the knee to bend into knee flexion. Then, the therapist passively moves the affected knee into extension quickly.
Measured: At enrollment and then at 1, 2, and 3 months of treatment.
Secondary outcomes (3)
Six-Minute Walk Test (6MWT)
The Six-minute Walk Test is a measure of aerobic capacity and gait. It is measured in feet on a ratio scale.
Administration:
The patient is instructed to walk down an unobstructed path for six minutes, while the physical therapist walks behind them with a stopwatch and rolling tape measure to monitor the time and steps of the patient during the test. The distance (in feet) that the patient walked, after six minutes, is used as the score for the test.
To note: blood pressure will be taken before and after the test.
Measured: At enrollment and then at 1, 2, and 3 months of treatment.
Timed Up and Go (TUG) Test
The TUG assesses mobility, ability, and fall risk in older adults. It is measured in seconds, on a ratio scale.
Equipment:
- Chair with armrests
- Stopwatch
- Marker to designate 10' turn around point
Administration:
- The patient sits in the chair
- On the command "ready and go" the patient gets up from the chair, walks 10 feet at a comfortable and safe pace, turns, walks back to the chair and sits down.
- Timing begins at the instruction "go" and stops when the patient is seated
- The patient must use the same assistive device for each assessment time, but is able to complete the test with multiple devices or no device.
- The physical therapist will demonstrate the activity to the patient.
Measured: At enrollment and then at 1, 2, and 3 months of treatment.
Berg Balance Scale (BBS)
The Berg Balance Scale is a 14-item test that measures static balance and fall risk in adults. Each item is scored on a 0-4 ordinal scale. At conclusion of the 14 items, the score is tallied.
Equipment: Chair with arms, Chair without arms, Mat, Stopwatch, Yardstick, Slipper/sandal, 7 ¾" step, Blind fold, Tape.
Items (14):
- sitting to standing
- standing unsupported
- sitting unsupported with feet on floor
- standing to sitting
- transfers
- standing unsupported with eyes closed
- standing unsupported with feet together
- reaching forward with outstretched arm
- pick up object from floor
- turn to look behind over each shoulder
- turning 360 degrees
- dynamic weight shifting while standing unsupported
- standing unsupported one foot in front
- standing on one leg
Measured: At enrollment and then at 1, 2, and 3 months of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study startDec 2024 (estimated)
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Stroke Gait RehabilitationStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scott Getsoian
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Governors State University
- Responsible party
- Sponsor-investigator, Scott Getsoian, Ascension Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653855
- Sponsor's protocol ID
- RIL20240041
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim M, Han C ho. The effectiveness and safety of cupping therapy for stroke survivors: A systematic review and meta-analysis of randomized controlled trials. J Korean Med. 2021;42(4):75-101. doi:10.13048/jkm.21039
Choi TY, Ang L, Ku B, Jun JH, Lee MS. Evidence Map of Cupping Therapy. J Clin Med. 2021 Apr 17;10(8):1750. doi: 10.3390/jcm10081750.
PubMed 33920643Pontes NS, Barbosa GM, Almeida Silva HJ, Scattone Silva R, Souza CG, Lins CAA, de Souza MC. Effects of dry cupping on pain, function and quality of life in women with knee osteoarthritis: a protocol for a sham-controlled randomised trial. BMJ Open. 2020 Dec 24;10(12):e039857. doi: 10.1136/bmjopen-2020-039857.
PubMed 33361075Shen WC, Jan YK, Liau BY, Lin Q, Wang S, Tai CC, Lung CW. Effectiveness of self-management of dry and wet cupping therapy for low back pain: A systematic review and meta-analysis. Medicine (Baltimore). 2022 Dec 23;101(51):e32325. doi: 10.1097/MD.0000000000032325.
PubMed 36595746Michalsen A, Bock S, Ludtke R, Rampp T, Baecker M, Bachmann J, Langhorst J, Musial F, Dobos GJ. Effects of traditional cupping therapy in patients with carpal tunnel syndrome: a randomized controlled trial. J Pain. 2009 Jun;10(6):601-8. doi: 10.1016/j.jpain.2008.12.013. Epub 2009 Apr 19.
PubMed 19380259Kim JI, Lee MS, Lee DH, Boddy K, Ernst E. Cupping for treating pain: a systematic review. Evid Based Complement Alternat Med. 2011;2011:467014. doi: 10.1093/ecam/nep035. Epub 2011 Jun 23.
PubMed 19423657Al-Bedah A, Aboushanab TS, Alqaed M, et al. Classification of Cupping Therapy: A Tool for Modernization and Standardization. J Complement Altern Med Res. 2016;1(1):1-10. doi:10.9734/JOCAMR/2016/27222
Qureshi NA, Ali GI, Abushanab TS, El-Olemy AT, Alqaed MS, El-Subai IS, Al-Bedah AMN. History of cupping (Hijama): a narrative review of literature. J Integr Med. 2017 May;15(3):172-181. doi: 10.1016/S2095-4964(17)60339-X.
PubMed 28494847
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Cupping on Spasticity and Function of the Lower Extremity During Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT06653855
- Acronym / sponsor ID
- RIL20240041
- Conditions
- Stroke Gait Rehabilitation
- Keywords
- Cupping, Spasticity, stroke, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Scott GetsoianIndustry (pharma, biotech, devices)
- Collaborators
- Governors State University
- Study start
- Dec 2024 (estimated)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 22 Oct 2024 (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.
Physical therapists use dry static cupping for the treatment of many conditions, including spasticity for patients post-stroke. While research better describes the effects of dry static cupping for patients with orthopedic conditions, information is lacking on central conditions, such as stroke and resulting spasticity.
Detailed description
Cupping is an ancient alternative medicine. A common form of cupping, called dry static cupping, involves creating negative pressure inside a therapeutic cup. The cup is then placed on the skin, creating a light suction effect. In Eastern Medicine, cupping has been used to treat a variety of diseases. More recently, in Western society, cupping has been used after injury, and among other effects, has been found to improve blood volume and tissue oxygenation to an area. These effects have originally been thought to be peripheral in nature, occurring at the cupping site, hence, why cupping has been used for treatment for conditions like carpal tunnel syndrome, spinal pain, knee osteoarthritis, and other musculoskeletal conditions.
However, a recent systematic review found cupping to be beneficial for rehabilitation after stroke. These conclusions raise the question of a possible mechanism for cupping to improve impairments related to the central nervous system, such as spasticity after stroke. However, many of the studies to date have serious methodological flaws that limit the direct causation of cupping to the reduction of spasticity. As well, the majority of studies only involve the upper extremity. No study has yet looked at the therapeutic effects of dry static cupping on lower extremity spasticity reduction after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cupping group | Active comparator | Other: Dry Static Cupping, Other: Standard physical therapy treatmentThis group (arm) will receive the dry static cupping intervention, along with the standard physical therapy treatment. |
| Placebo cupping group | Sham comparator | Other: Placebo cupping, Other: Standard physical therapy treatmentThis group (arm) will receive a placebo-form of cupping (low, and non-therapeutic pressure amount in the cups), along with the standard physical therapy treatment. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30-80
- Acute stroke (within 6 months of stroke), with spasticity \& hemiparesis of LE
- Referred by doctor for rehabilitation for a stroke-related condition
- Attending Ascension Rehabilitation of Joliet for rehabilitation
- Able to read or verbally understand English or Spanish
Key exclusion criteria (15 listed)
- Absent sensation of the areas to be cupped
- Significant cognitive impairment
- Pregnancy
- Prescription anticoagulant medications
- Blood clotting disorder
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 |
|---|---|---|
| Dry Static CuppingA myofascial decompression cupping set with a precision pressure pump will be used to perform dry static cupping to the adductor and hamstring muscle groups of the affected limb, using a negative pressure of 300mmHg for eight minutes each. | Other | Cupping group |
| Placebo cuppingThe same protocol will be used as stated for the Dry static cupping intervention, with the only difference being that the cup will be pumped to 50mmHg instead of 300mmHg. | Other | Placebo cupping group |
| Standard physical therapy treatmentTreatment will consist of typical physical therapy interventions performed for patients with spasticity of the lower extremity after stroke. These may include, but not be limited to: * Balance exercise * Therapeutic exercise * Neuromuscular/muscular coordination exercise * Manual (hands on) therapy * Gait training The treating physical therapist is left with the autonomy of the standard physical therapy treatment (within the above stated groups of interventions) because patients with the diagnosis of stroke do not all present with the same type or level of impairment. Furthermore co-morbidities (e.g., hypertension) and/or functional level (wheelchair bound vs. independent ambulator) may necessitate different treatment strategies. Therefore, while the general categories of treatment will remain the same across all study patients, it is expected that the treating physical therapist provides patient-specific interventions. | Other | Cupping group, Placebo cupping group |
Primary outcome
Modified Ashworth Scale
Time frame: At enrollment and then at 1, 2, and 3 months of treatment.
The Modified Ashworth Scale measures spasticity on a 0-4 ordinal scale, with higher scores indicating greater spasticity. The grade is determined by passively moving a joint/muscle through a high velocity unidirectional quick stretch. For this study, spasticity will be assessed for the hip adductors and hamstrings of the affected side. Equipment: Mat Table Administration: Patient is positioned in supine on a mat table. For Hip Adduction: Physical therapist passively moves the affected lower extremity into hip abduction quickly keeping the knee in extension. For Hamstrings: Physical therapist passively moves the hip to 90 degrees of flexion and allows the knee to bend into knee flexion. Then, the therapist passively moves the affected knee into extension quickly.
3 secondary outcomes
Six-Minute Walk Test (6MWT)
Time frame: At enrollment and then at 1, 2, and 3 months of treatment.
Timed Up and Go (TUG) Test
Time frame: At enrollment and then at 1, 2, and 3 months of treatment.
Berg Balance Scale (BBS)
Time frame: At enrollment and then at 1, 2, and 3 months of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- BackgroundKim M, Han C ho. The effectiveness and safety of cupping therapy for stroke survivors: A systematic review and meta-analysis of randomized controlled trials. J Korean Med. 2021;42(4):75-101. doi:10.13048/jkm.21039
- Background: PubMed 33920643Choi TY, Ang L, Ku B, Jun JH, Lee MS. Evidence Map of Cupping Therapy. J Clin Med. 2021 Apr 17;10(8):1750. doi: 10.3390/jcm10081750.
- Background: PubMed 33361075Pontes NS, Barbosa GM, Almeida Silva HJ, Scattone Silva R, Souza CG, Lins CAA, de Souza MC. Effects of dry cupping on pain, function and quality of life in women with knee osteoarthritis: a protocol for a sham-controlled randomised trial. BMJ Open. 2020 Dec 24;10(12):e039857. doi: 10.1136/bmjopen-2020-039857.
- Background: PubMed 36595746Shen WC, Jan YK, Liau BY, Lin Q, Wang S, Tai CC, Lung CW. Effectiveness of self-management of dry and wet cupping therapy for low back pain: A systematic review and meta-analysis. Medicine (Baltimore). 2022 Dec 23;101(51):e32325. doi: 10.1097/MD.0000000000032325.
- Background: PubMed 19380259Michalsen A, Bock S, Ludtke R, Rampp T, Baecker M, Bachmann J, Langhorst J, Musial F, Dobos GJ. Effects of traditional cupping therapy in patients with carpal tunnel syndrome: a randomized controlled trial. J Pain. 2009 Jun;10(6):601-8. doi: 10.1016/j.jpain.2008.12.013. Epub 2009 Apr 19.
- Background: PubMed 19423657Kim JI, Lee MS, Lee DH, Boddy K, Ernst E. Cupping for treating pain: a systematic review. Evid Based Complement Alternat Med. 2011;2011:467014. doi: 10.1093/ecam/nep035. Epub 2011 Jun 23.
- BackgroundAl-Bedah A, Aboushanab TS, Alqaed M, et al. Classification of Cupping Therapy: A Tool for Modernization and Standardization. J Complement Altern Med Res. 2016;1(1):1-10. doi:10.9734/JOCAMR/2016/27222
- Background: PubMed 28494847Qureshi NA, Ali GI, Abushanab TS, El-Olemy AT, Alqaed MS, El-Subai IS, Al-Bedah AMN. History of cupping (Hijama): a narrative review of literature. J Integr Med. 2017 May;15(3):172-181. doi: 10.1016/S2095-4964(17)60339-X.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dry Static Cupping and Standard physical therapy treatment in people with Stroke Gait Rehabilitation, run by Scott Getsoian at 1 site in United States.
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 5 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 13 Dec 2024. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Scott Getsoian (815-735-9261, sgetsoian@govst.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Ashworth Scale (time frame: At enrollment and then at 1, 2, and 3 months of treatment.). 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 NCT06653855, which also lists 8 linked publications.
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 13 Dec 2024; AzTrials last refreshed its copy on 6 Nov 2026.