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

NCT06653855 | Recruiting

• 1 other identifier: RIL20240041
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 spasticity.

Conditions

Stroke Gait Rehabilitation

Keywords

Cupping; Spasticity; stroke; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Six-Minute Walk Test (6MWT)

  At enrollment and then at 1, 2, and 3 months of treatment.

• Timed Up and Go (TUG) Test

  At enrollment and then at 1, 2, and 3 months of treatment.

• Berg Balance Scale (BBS)

  At enrollment and then at 1, 2, and 3 months of treatment.

Study Arms (2)

Cupping group

ACTIVE COMPARATOR

This group (arm) will receive the dry static cupping intervention, along with the standard physical therapy treatment.

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.

Other: Placebo cupping; Other: Standard physical therapy treatment

Interventions

Dry Static Cupping OTHER

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.

Cupping group

Placebo cupping OTHER

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.

Placebo cupping group

Standard physical therapy treatment OTHER

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.

Cupping group; Placebo cupping group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Scott Getsoian: lead
• Governors State University: collaborator

Study Sites (1)

Ascension Rehabilitation of Joliet

Joliet, Illinois, 60435, United States

RECRUITING

Related Publications (8)

• 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

  BACKGROUND

• 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.

  PMID: 33920643 BACKGROUND

• 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.

  PMID: 33361075 BACKGROUND

• 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.

  PMID: 36595746 BACKGROUND

• 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.

  PMID: 19380259 BACKGROUND

• 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.

  PMID: 19423657 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 28494847 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity; Stroke

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Scott Getsoian

CONTACT

815-735-9261; sgetsoian@govst.edu

Laura Nurczyk

CONTACT

815-741-7114; laura.nurczyk@ascension-external.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The physical therapist providing the standard physical therapy treatment and the outcomes assessment will be masked to group allocation. However, the therapist administering the cupping and placebo cupping treatments will not be masked to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physical Therapist

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 22, 2024
• Study Start: December 1, 2024
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 13, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)