- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04230850
The Effects of Stretching Versus Static and Dynamic Cupping on Lumbar Range of Motion
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29205
- University of South Carolina
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Mildly Impaired Group
This group will consist of participants with 35-50 degrees of lumbar flexion.
|
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).
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).
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).
|
ACTIVE_COMPARATOR: Moderately Impaired Group
This group will consist of participants with 20-34 degrees of lumbar flexion.
|
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).
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).
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).
|
ACTIVE_COMPARATOR: Highly Impaired Group
This group will consist of participants with less than 20 degrees of lumbar flexion.
|
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).
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).
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Back Range of Motion
Time Frame: At baseline, immediately following treatment, 24-hour follow up
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Active Straight Leg Raise
Time Frame: At baseline, immediately following treatment, 24-hour follow up
|
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
|
Pain Pressure Threshold
Time Frame: At baseline, immediately following treatment, 24-hour follow up
|
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.
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At baseline, immediately following treatment, 24-hour follow up
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Numeric Pain Rating Scale
Time Frame: At baseline, immediately following treatment, 24-hour follow up
|
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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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Meucci RD, Fassa AG, Faria NM. Prevalence of chronic low back pain: systematic review. Rev Saude Publica. 2015;49:1. doi: 10.1590/S0034-8910.2015049005874. Epub 2015 Oct 20.
- 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.
- 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.
- 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.
- 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. doi: 10.1097/01.brs.0000188255.10759.7a.
- 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.
- Clarkson, H. M. (2013). Musculoskeletal assessment: Joint motion and muscle testing (3rd ed.). Philadelphia: Wolters Kluwer & Lippincot Williams & Wilkins.
- 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.
- 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.
- Thiese MS, Hegmann KT, Wood EM, Garg A, Moore JS, Kapellusch JM, Foster J, Greene T, Stoddard G, Biggs J; BackWords Study Team. Low-back pain ratings for lifetime, 1-month period, and point prevalences in a large occupational population. Hum Factors. 2014 Feb;56(1):86-97. doi: 10.1177/0018720813493641.
- 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.
- 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.
- Kisner, C., Colby, L. A., & Borstad, J. (2017). Therapeutic exercise: Foundations and techniques. Fa Davis.
- 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.
- Page P. Current concepts in muscle stretching for exercise and rehabilitation. Int J Sports Phys Ther. 2012 Feb;7(1):109-19.
- Bandy WD, Irion JM, Briggler M. The effect of time and frequency of static stretching on flexibility of the hamstring muscles. Phys Ther. 1997 Oct;77(10):1090-6. doi: 10.1093/ptj/77.10.1090.
- 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. doi: 10.1016/j.jmpt.2007.03.001.
- 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.
- 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.
- Fischer AA. Pressure algometry over normal muscles. Standard values, validity and reproducibility of pressure threshold. Pain. 1987 Jul;30(1):115-126. doi: 10.1016/0304-3959(87)90089-3.
- 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.
- Nussbaum EL, Downes L. Reliability of clinical pressure-pain algometric measurements obtained on consecutive days. Phys Ther. 1998 Feb;78(2):160-9. doi: 10.1093/ptj/78.2.160.
- 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.
- 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. doi: 10.1093/ptj/65.10.1478.
- Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Pro00092733
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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