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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04230850
Other study ID # Pro00092733
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 20, 2020
Est. completion date September 1, 2020

Study information

Verified date November 2020
Source University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to fill gaps in the literature regarding the effectiveness of cupping therapy on lumbar stiffness. Participants will be recruited from the University of South Carolina and from local clinics in Columbia, South Carolina. Individuals will be classified based on lumbar range of motion limitations, and then they will be equally dispersed into three treatment groups via stratified randomization. These groups include dynamic cupping, static cupping, or stretching. All participants will be assessed prior to selected treatment to obtain baseline values for four measures: back range of motion (BROM), pain pressure threshold (PPT), active straight leg raise (ASLR), and numeric pain rating scale (NPRS). Participants will be given each measure directly after treatment, followed by a follow-up measurement 24 hours after treatment.


Description:

Cupping therapy has become recently popular in Western culture due to affordability, lack of invasiveness, and low risk of adverse effects. However, there is insufficient evidence of the effectiveness on this treatment technique on decreasing pain and increasing range of motion. This project aims to help fill the gaps by using a larger sample size and clear methodology. The aims of the study include to determine if both static and dynamic cupping therapy have a greater effect on BROM, PPT, ASLR, and NRPS as compared to stretching, and if any changes made are maintained to a different degree over a 24 hour period based on treatment. Additional aims of the study include to determine if there is a difference between type of cupping (static vs dynamic) on these four measures. By performing this study, scientific knowledge of cupping therapy will be improved and expanded, thus impacting how it is used in clinical practice.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date September 1, 2020
Est. primary completion date June 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years or older, 50 degrees or less of lumbar flexion Exclusion Criteria: - Cancer, organ failure, collagen disorders, deep vein thrombosis, pacemakers, bleeding disorders, recent fever

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Static Cupping
Two cups will be applied unilaterally to the lumbar paraspinals. The skin will be elevated to 1.5 cm ensuring standardized pressure. Cups will remain on the treatment area statically for 4 minutes prior to removal. Another 4 minute bout of identical treatment to the contralateral side will follow. (Participants will be equally dispersed into three treatment groups via stratified randomization).
Dynamic Cupping
One cup will be applied ipsilaterally, raising skin to 1.2 cm of standard pressure. The cup will be continuously moved in a sweeping motion between L1 and L5 within a defined width. This process will be repeated on the other side. Each side will be treated for 4 minutes dynamically for a total treatment duration of 8 minutes. (Participants will be equally dispersed into three treatment groups via stratified randomization).
Stretching
The stretching program performed will involve a double knee to chest stretch, cat stretch, camel stretch, and pelvic tilts. Participants will receive a 30 second rest break between each of the four stretches. (Participants will be equally dispersed into three treatment groups via stratified randomization).

Locations

Country Name City State
United States University of South Carolina Columbia South Carolina

Sponsors (1)

Lead Sponsor Collaborator
University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (26)

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Breum J, Wiberg J, Bolton JE. Reliability and concurrent validity of the BROM II for measuring lumbar mobility. J Manipulative Physiol Ther. 1995 Oct;18(8):497-502. — View Citation

Chen HM, Wang HH, Chen CH, Hu HM. Effectiveness of a stretching exercise program on low back pain and exercise self-efficacy among nurses in Taiwan: a randomized clinical trial. Pain Manag Nurs. 2014 Mar;15(1):283-91. doi: 10.1016/j.pmn.2012.10.003. Epub 2012 Dec 23. — View Citation

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Clarkson, H. M. (2013). Musculoskeletal assessment: Joint motion and muscle testing (3rd ed.). Philadelphia: Wolters Kluwer & Lippincot Williams & Wilkins.

Coyle PC, Velasco T, Sions JM, Hicks GE. Lumbar Mobility and Performance-Based Function: An Investigation in Older Adults with and without Chronic Low Back Pain. Pain Med. 2017 Jan 1;18(1):161-168. doi: 10.1093/pm/pnw136. — View Citation

Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30. — View Citation

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Gajdosik RL, LeVeau BF, Bohannon RW. Effects of ankle dorsiflexion on active and passive unilateral straight leg raising. Phys Ther. 1985 Oct;65(10):1478-82. — View Citation

Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, Smeets RJ, Underwood M; Lancet Low Back Pain Series Working Group. What low back pain is and why we need to pay attention. Lancet. 2018 Jun 9;391(10137):2356-2367. doi: 10.1016/S0140-6736(18)30480-X. Epub 2018 Mar 21. Review. — View Citation

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Kuo YL, Tully EA, Galea MP. Kinematics of sagittal spine and lower limb movement in healthy older adults during sit-to-stand from two seat heights. Spine (Phila Pa 1976). 2010 Jan 1;35(1):E1-7. doi: 10.1097/BRS.0b013e3181c47a0e. — View Citation

Liebenson C, Karpowicz AM, Brown SH, Howarth SJ, McGill SM. The active straight leg raise test and lumbar spine stability. PM R. 2009 Jun;1(6):530-5. doi: 10.1016/j.pmrj.2009.03.007. — View Citation

Luckhaupt SE, Dahlhamer JM, Gonzales GT, Lu ML, Groenewold M, Sweeney MH, Ward BW. Prevalence, Recognition of Work-Relatedness, and Effect on Work of Low Back Pain Among U.S. Workers. Ann Intern Med. 2019 Aug 20;171(4):301-304. doi: 10.7326/M18-3602. Epub 2019 May 14. — View Citation

Markowski A, Sanford S, Pikowski J, Fauvell D, Cimino D, Caplan S. A pilot study analyzing the effects of Chinese cupping as an adjunct treatment for patients with subacute low back pain on relieving pain, improving range of motion, and improving function. J Altern Complement Med. 2014 Feb;20(2):113-7. doi: 10.1089/acm.2012.0769. Epub 2013 Dec 3. — View Citation

Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49. pii: S0034-89102015000100408. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20. Review. — View Citation

Nelson RT, Bandy WD. Eccentric Training and Static Stretching Improve Hamstring Flexibility of High School Males. J Athl Train. 2004 Sep;39(3):254-258. — View Citation

Nussbaum EL, Downes L. Reliability of clinical pressure-pain algometric measurements obtained on consecutive days. Phys Ther. 1998 Feb;78(2):160-9. — View Citation

Page P. Current concepts in muscle stretching for exercise and rehabilitation. Int J Sports Phys Ther. 2012 Feb;7(1):109-19. — View Citation

Phattharasupharerk, S., Purepong, N., & Siriphorn, A. Inter-and Intra-Rater Reliability of the Back Range of Motion Instrument (BROM II) for Measuring Lumbar Mobility in Persons with Sedentary Lifestyle.

Potter, L., McCarthy. C., Oldham, J. Algometer reliability in measuring pain thresholds over normal spinal muscles to allow quantification of anti-nociceptive treatment effects. International Journal of Osteopathic Medicine, 9 (2006), pp. 113-119.

Roussel NA, Nijs J, Truijen S, Smeuninx L, Stassijns G. Low back pain: clinimetric properties of the Trendelenburg test, active straight leg raise test, and breathing pattern during active straight leg raising. J Manipulative Physiol Ther. 2007 May;30(4):270-8. — View Citation

Rozenfeld E, Kalichman L. New is the well-forgotten old: The use of dry cupping in musculoskeletal medicine. J Bodyw Mov Ther. 2016 Jan;20(1):173-178. doi: 10.1016/j.jbmt.2015.11.009. Epub 2015 Dec 1. Review. — View Citation

Shum GL, Crosbie J, Lee RY. Symptomatic and asymptomatic movement coordination of the lumbar spine and hip during an everyday activity. Spine (Phila Pa 1976). 2005 Dec 1;30(23):E697-702. — View Citation

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Yang H, Haldeman S, Lu ML, Baker D. Low Back Pain Prevalence and Related Workplace Psychosocial Risk Factors: A Study Using Data From the 2010 National Health Interview Survey. J Manipulative Physiol Ther. 2016 Sep;39(7):459-472. doi: 10.1016/j.jmpt.2016.07.004. Epub 2016 Aug 25. — View Citation

* Note: There are 26 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Back Range of Motion The BROM instrument will be used to measure lumbar range of motion in individuals with lumbar stiffness at initial baseline, the change in range of motion immediately following treatment, and any maintained change at 24 hour follow up. At baseline, immediately following treatment, 24-hour follow up
Secondary Active Straight Leg Raise The ASLR will be used to assess hamstring flexibility in individuals with lumbar stiffness at initial baseline, the change in hamstring flexibility immediately following treatment, and any maintained change at 24 hour follow up. At baseline, immediately following treatment, 24-hour follow up
Secondary Pain Pressure Threshold The Wagner Force Ten FDX Compact Digital Force Gauge hand-held digital algometer will be used to measure pain pressure threshold at initial baseline, the change in pain pressure threshold immediately following treatment, and any maintained change at 24 hour follow up. At baseline, immediately following treatment, 24-hour follow up
Secondary Numeric Pain Rating Scale The Numeric Pain Rating Scale will be used to assess pain in individuals with lumbar stiffness at initial baseline, the change in pain immediately following treatment, and any maintained change in 24 hour follow up. Individuals will be asked to rate their current pain level on a scale of 0-10, with "0" representing no pain and "10" representing the worst pain imaginable. At baseline, immediately following treatment, 24-hour follow up
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