Clinical trial NCT06653855: The Effect of Cupping on Spasticity and Function of the Lower Extremity During Rehabilitation After Stroke
Official title: The Effect of Cupping on Spasticity and Function of the Lower Extremity During Rehabilitation After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke Gait Rehabilitation
Keywords: Cupping
Spasticity
stroke
rehabilitation
Lead sponsor: Ascension Health
Sponsor class: INDUSTRY
Collaborators: name: Governors State University
First posted: 2024-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: At enrollment and then at 1, 2, and 3 months of treatment.
Secondary outcomes:
measure: Six-Minute Walk Test (6MWT)
timeFrame: At enrollment and then at 1, 2, and 3 months of treatment.
measure: Timed Up and Go (TUG) Test
timeFrame: At enrollment and then at 1, 2, and 3 months of treatment.
measure: Berg Balance Scale (BBS)
timeFrame: At enrollment and then at 1, 2, and 3 months of treatment.
Other outcomes:
Locations:
city: Joliet
country: United States
facility: Ascension Rehabilitation of Joliet
state: Illinois
Study officials:
References:
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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
citation: 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.