The Effects of Stretching Versus Static and Dynamic Cupping on Lumbar Range of Motion
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 12, 2019
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
January 20, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedNovember 16, 2020
November 1, 2020
4 months
December 12, 2019
November 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Active Straight Leg Raise
At baseline, immediately following treatment, 24-hour follow up
Pain Pressure Threshold
At baseline, immediately following treatment, 24-hour follow up
Numeric Pain Rating Scale
At baseline, immediately following treatment, 24-hour follow up
Study Arms (3)
Mildly Impaired Group
ACTIVE COMPARATORThis group will consist of participants with 35-50 degrees of lumbar flexion.
Moderately Impaired Group
ACTIVE COMPARATORThis group will consist of participants with 20-34 degrees of lumbar flexion.
Highly Impaired Group
ACTIVE COMPARATORThis group will consist of participants with less than 20 degrees of lumbar flexion.
Interventions
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).
Eligibility Criteria
You may qualify if:
- years or older, 50 degrees or less of lumbar flexion
You may not qualify if:
- Cancer, organ failure, collagen disorders, deep vein thrombosis, pacemakers, bleeding disorders, recent fever
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of South Carolina
Columbia, South Carolina, 29205, United States
Related Publications (26)
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PMID: 23266331BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Cathy Arnot, DPT
University of South Carolina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The people collecting the data will not be aware of which intervention group the subjects were allocated to.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Associate Professor
Study Record Dates
First Submitted
December 12, 2019
First Posted
January 18, 2020
Study Start
January 20, 2020
Primary Completion
June 1, 2020
Study Completion
September 1, 2020
Last Updated
November 16, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share
All data collected will be analyzed and interpreted only by the investigators listed for University of South Carolina.