The Effect of Cupping on Spasticity and Function of the Lower Extremity During Rehabilitation After Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke Gait Rehabilitation
• Intervention / Treatment: Other: Dry Static Cupping; Other: Placebo cupping; Other: Standard physical therapy treatment

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Scott Getsoian; Phone Number: 815-735-9261; Email: sgetsoian@govst.edu
• Study Contact Backup: Name: Laura Nurczyk; Phone Number: 815-741-7114; Email: laura.nurczyk@ascension-external.org

Study Locations

• United States
  • Illinois
    • Joliet, Illinois, United States, 60435
      • Recruiting
      • Ascension Rehabilitation of Joliet
      • Contact: Laura Nurczyk; Phone Number: 815-741-7114; Email: laura.nurczyk@ascension-external.org
      • Contact: Kathlene Getsoian; Phone Number: 815-735-9261; Email: klf74@comcast.net
      • Contact: Scott Getsoian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Absent sensation of the areas to be cupped
• Significant cognitive impairment
• Pregnancy
• Prescription anticoagulant medications
• Blood clotting disorder
• Uncontrolled hypertension
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cupping group; This group (arm) will receive the dry static cupping intervention, along with the standard physical therapy treatment.	Other: Dry Static Cupping; 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.; Other: Standard physical therapy treatment; 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.
Sham Comparator: Placebo cupping group; 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.	Other: Placebo cupping; 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.; Other: Standard physical therapy treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At enrollment and then at 1, 2, and 3 months of treatment.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	At enrollment and then at 1, 2, and 3 months of treatment.

Collaborators and Investigators

• Sponsor: Scott Getsoian
• Collaborators: Governors State University

Publications and helpful links

General Publications

• Kim 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.
• 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.
• 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
• Pontes 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.
• Shen 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.
• Michalsen 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.
• Al-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.

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: stroke; rehabilitation; Spasticity; Cupping
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Muscle Spasticity; Stroke
• Other Study ID Numbers: RIL20240041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No