Stiffness; SpineNCT04230850
The Effects of Stretching Versus Static and Dynamic Cupping on Lumbar Range of Motion
A study testing Static Cupping, Dynamic Cupping and Stretching in people with Stiffness; Spine, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stiffness; Spine
- What is being tested?
- Static Cupping, Dynamic Cupping and Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2020to 1 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older, 50 degrees or less of lumbar flexion
Who cannot join
- Cancer, organ failure, collagen disorders, deep vein thrombosis, pacemakers, bleeding disorders, recent fever
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29205
About this study
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.
Read the 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.
- Conditions
- Stiffness; Spine
- Being tested
- Static Cupping, Dynamic Cupping, Stretching
- Keywords
- Cupping therapy on lumbar stiffness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static CuppingOther
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 CuppingOther
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).
StretchingOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Mildly Impaired Group | Active comparator | This group will consist of participants with 35-50 degrees of lumbar flexion. Receives: Other: Static Cupping; Other: Dynamic Cupping; Other: Stretching |
| Moderately Impaired Group | Active comparator | This group will consist of participants with 20-34 degrees of lumbar flexion. Receives: Other: Static Cupping; Other: Dynamic Cupping; Other: Stretching |
| Highly Impaired Group | Active comparator | This group will consist of participants with less than 20 degrees of lumbar flexion. Receives: Other: Static Cupping; Other: Dynamic Cupping; Other: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, immediately following treatment, 24-hour follow up
Secondary outcomes (3)
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.
Measured: At baseline, immediately following treatment, 24-hour follow up
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.
Measured: At baseline, immediately following treatment, 24-hour follow up
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.
Measured: At baseline, immediately following treatment, 24-hour follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start20 Jan 2020
- Primary completion1 Jun 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Stiffness; SpineStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel design typically compares two or more treatments. Participants are randomly assigned to one of the groups, treatments are administered, and then the results are compared. In this study, individuals will be placed in one of three groups: static stretching group, dynamic cupping group, or stretching group.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathy Arnot, University of South Carolina
- Investigators
- Cathy Arnot, DPT, Principal investigator, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04230850
- Sponsor's protocol ID
- Pro00092733
- Status last verified
- Nov 2020
- First submitted
- 12 Dec 2019
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data collected will be analyzed and interpreted only by the investigators listed for University of South Carolina.
Publications
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.
PubMed 26891653Markowski 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.
PubMed 24299469Shum 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.
PubMed 16319739Coyle 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.
PubMed 27346888Clarkson, 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.
PubMed 20042941Meucci 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.
PubMed 26487293Yang 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.
PubMed 27568831Thiese 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.
PubMed 24669545Luckhaupt 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.
PubMed 31083729Hartvigsen 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.
PubMed 29573870Delitto 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.
PubMed 22466247Kisner, 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.
PubMed 15496995Page P. Current concepts in muscle stretching for exercise and rehabilitation. Int J Sports Phys Ther. 2012 Feb;7(1):109-19.
PubMed 22319684
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Stretching Versus Static and Dynamic Cupping on Lumbar Range of Motion
- ClinicalTrials.gov ID
- NCT04230850
- Acronym / sponsor ID
- Pro00092733
- Conditions
- Stiffness; Spine
- Keywords
- Cupping therapy on lumbar stiffness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A parallel design typically compares two or more treatments. Participants are randomly assigned to one of the groups, treatments are administered, and then the results are compared. In this study, individuals will be placed in one of three groups: static stretching group, dynamic cupping group, or stretching group.
| Arm | Type | Receives |
|---|---|---|
| Mildly Impaired Group | Active comparator | Other: Static Cupping, Other: Dynamic Cupping, Other: StretchingThis group will consist of participants with 35-50 degrees of lumbar flexion. |
| Moderately Impaired Group | Active comparator | Other: Static Cupping, Other: Dynamic Cupping, Other: StretchingThis group will consist of participants with 20-34 degrees of lumbar flexion. |
| Highly Impaired Group | Active comparator | Other: Static Cupping, Other: Dynamic Cupping, Other: StretchingThis group will consist of participants with less than 20 degrees of lumbar flexion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 18 years or older, 50 degrees or less of lumbar flexion
Key exclusion criteria (1 listed)
- Cancer, organ failure, collagen disorders, deep vein thrombosis, pacemakers, bleeding disorders, recent fever
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Static CuppingTwo 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). | Other | Highly Impaired Group, Mildly Impaired Group, Moderately Impaired Group |
| Dynamic CuppingOne 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). | Other | Highly Impaired Group, Mildly Impaired Group, Moderately Impaired Group |
| StretchingThe 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). | Other | Highly Impaired Group, Mildly Impaired Group, Moderately Impaired Group |
Primary outcome
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.
3 secondary outcomes
Active Straight Leg Raise
Time frame: At baseline, immediately following treatment, 24-hour follow up
Pain Pressure Threshold
Time frame: At baseline, immediately following treatment, 24-hour follow up
Numeric Pain Rating Scale
Time frame: At baseline, immediately following treatment, 24-hour follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Background: PubMed 26891653Rozenfeld 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.
- Background: PubMed 24299469Markowski 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.
- Background: PubMed 16319739Shum 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.
- Background: PubMed 27346888Coyle 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.
- BackgroundClarkson, H. M. (2013). Musculoskeletal assessment: Joint motion and muscle testing (3rd ed.). Philadelphia: Wolters Kluwer & Lippincot Williams & Wilkins.
- Background: PubMed 20042941Kuo 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.
- Background: PubMed 26487293Meucci 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.
- Background: PubMed 27568831Yang 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.
- Background: PubMed 24669545Thiese 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.
- Background: PubMed 31083729Luckhaupt 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.
- Background: PubMed 29573870Hartvigsen 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.
- Background: PubMed 22466247Delitto 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.
- Individual participant dataSharing planned: No. All data collected will be analyzed and interpreted only by the investigators listed for University of South Carolina.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cathy Arnot, DPT principal investigator
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Static Cupping, Dynamic Cupping and Stretching in people with Stiffness; Spine, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Back Range of Motion (time frame: At baseline, immediately following treatment, 24-hour follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04230850, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.