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The Effects of Stretching Versus Static and Dynamic Cupping on Lumbar Range of Motion

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ClinicalTrials.gov Identifier: NCT04230850
Recruitment Status : Completed
First Posted : January 18, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Cathy Arnot, University of South Carolina

Brief 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.

Condition or disease Intervention/treatment Phase
Stiffness; Spine Other: Static Cupping Other: Dynamic Cupping Other: Stretching Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Investigator, Outcomes Assessor)
Masking Description: The people collecting the data will not be aware of which intervention group the subjects were allocated to.
Primary Purpose: Treatment
Official Title: The Effects of Stretching Versus Static and Dynamic Cupping on Lumbar Range of Motion
Actual Study Start Date : January 20, 2020
Actual Primary Completion Date : June 1, 2020
Actual Study Completion Date : September 1, 2020

Arm Intervention/treatment
Active Comparator: Mildly Impaired Group
This group will consist of participants with 35-50 degrees of lumbar flexion.
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).

Other: 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).

Other: 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).

Active Comparator: Moderately Impaired Group
This group will consist of participants with 20-34 degrees of lumbar flexion.
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).

Other: 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).

Other: 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).

Active Comparator: Highly Impaired Group
This group will consist of participants with less than 20 degrees of lumbar flexion.
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).

Other: 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).

Other: 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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230850


Locations
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United States, South Carolina
University of South Carolina
Columbia, South Carolina, United States, 29205
Sponsors and Collaborators
University of South Carolina
Investigators
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Principal Investigator: Cathy Arnot, DPT University of South Carolina
Publications:
Clarkson, H. M. (2013). Musculoskeletal assessment: Joint motion and muscle testing (3rd ed.). Philadelphia: Wolters Kluwer & Lippincot Williams & Wilkins.
Kisner, C., Colby, L. A., & Borstad, J. (2017). Therapeutic exercise: Foundations and techniques. Fa Davis.
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.

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Responsible Party: Cathy Arnot, Clinical Associate Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT04230850    
Other Study ID Numbers: Pro00092733
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data collected will be analyzed and interpreted only by the investigators listed for University of South Carolina.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cathy Arnot, University of South Carolina:
Cupping therapy on lumbar stiffness