NCT04230850

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
2 days until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

December 12, 2019

Last Update Submit

November 12, 2020

Conditions

Keywords

Cupping therapy on lumbar stiffness

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 COMPARATOR

This group will consist of participants with 35-50 degrees of lumbar flexion.

Other: Static CuppingOther: Dynamic CuppingOther: Stretching

Moderately Impaired Group

ACTIVE COMPARATOR

This group will consist of participants with 20-34 degrees of lumbar flexion.

Other: Static CuppingOther: Dynamic CuppingOther: Stretching

Highly Impaired Group

ACTIVE COMPARATOR

This group will consist of participants with less than 20 degrees of lumbar flexion.

Other: Static CuppingOther: Dynamic CuppingOther: Stretching

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).

Highly Impaired GroupMildly Impaired GroupModerately Impaired Group

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).

Highly Impaired GroupMildly Impaired GroupModerately Impaired Group

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).

Highly Impaired GroupMildly Impaired GroupModerately Impaired Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Related Publications (26)

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    PMID: 16319739BACKGROUND
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    PMID: 27346888BACKGROUND
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    BACKGROUND
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    PMID: 27568831BACKGROUND
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    PMID: 24669545BACKGROUND
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    PMID: 31083729BACKGROUND
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    PMID: 29573870BACKGROUND
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    PMID: 22466247BACKGROUND
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    BACKGROUND
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    PMID: 15496995BACKGROUND
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    PMID: 22319684BACKGROUND
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    PMID: 9327823BACKGROUND
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    PMID: 17509436BACKGROUND
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    PMID: 8583171BACKGROUND
  • 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.

    BACKGROUND
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    PMID: 3614975BACKGROUND
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    BACKGROUND
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    PMID: 9474108BACKGROUND
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    PMID: 19627942BACKGROUND
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    PMID: 4048283BACKGROUND
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    PMID: 15928561BACKGROUND
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    PMID: 23266331BACKGROUND

Study Officials

  • Cathy Arnot, DPT

    University of South Carolina

    PRINCIPAL INVESTIGATOR

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
Model Details: 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.
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.

Locations