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

November 12, 2020 updated by: Cathy Arnot, University of South Carolina
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.

Study Overview

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

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • South Carolina
      • Columbia, South Carolina, United States, 29205
        • University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
At baseline, immediately following treatment, 24-hour follow up
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 20, 2020

Primary Completion (ACTUAL)

June 1, 2020

Study Completion (ACTUAL)

September 1, 2020

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

January 13, 2020

First Posted (ACTUAL)

January 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00092733

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data collected will be analyzed and interpreted only by the investigators listed for University of South Carolina.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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