Different Types of Cupping Therapy and Ankle Range of Motion

July 23, 2024 updated by: Northern Michigan University

The Effect of Different Types of Cupping Therapy on Acute Changes in Ankle Dorsiflexion

The purpose of this study was to determine the acute effects of different manual cupping therapy protocols on ankle range of motion, compared to sham treatments, in generally healthy adults with limited ankle range of motion (i.e., ankle dorsiflexion less than 40 degrees).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this study was to determine the acute effects of different manual cupping therapy protocols on ankle range of motion, compared to sham treatments, in generally healthy adults with limited ankle range of motion (i.e., ankle dorsiflexion less than 40 degrees). Participants had their baseline ankle dorsiflexion measured with a digital inclinometer in a weight-bearing modified lunge position by a certified athletic trainer. Participants who were eligible for the study were then randomly assigned to one of 4 groups; 2 of which were intervention groups (i.e., dynamic cupping, static cupping) and 2 of which were sham treatments (i.e., static sham cupping, dynamic sham cupping). Each participant was blinded to the therapy they were randomized to and all received a total of 10 minutes of the cupping therapy (either actual or sham). In general, cupping therapy consisted of creating a negative pressure in four 2" diameter plastic cups placed on the gastrocnemius. Sham cups had small holes in them allowing air to leak out. Cups were also attached with adhesive tape to all participants to ensure blinding. Depending on the treatment received, participants either were asked to lie still in the prone position or perform ankle exercises during the 10 minutes while the cups were attached. Immediately after receiving treatment, participants had their ankle dorsiflexion measured again using the same procedure described for baseline measurement.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Michigan
      • Marquette, Michigan, United States, 49855
        • Northern Michigan University

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Limited ankle dorsiflexion (less than 40 degrees of weight bearing ankle dorsiflexion at baselines)
  • Never received cupping therapy prior to the study
  • No lower extremity injuries in the past 6 months
  • No contraindications associated with cupping therapy (e.g., deep vein thrombosis, pregnancy, bone fracture, or sunburn/rash)
  • Generally healthy

Exclusion Criteria:

  • Ankle dorsiflexion greater than or equal to 40 degrees during weight bearing ankle dorsiflexion at baseline
  • Received cupping therapy in the past
  • Has a lower extremity injury or has had a lower extremity injury in the past 6 months
  • Self-reported a contraindication associated with cupping therapy (e.g., deep vein thrombosis, pregnancy, bone fracture, or sunburn/rash).

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Static cupping
Negative pressure was created inside 4 plastic cups (2" diameter) placed on the gastrocnemius by drawing out air with two full pumps via a manual suction tool and participants laid in the prone position for 10 minutes while the cups stayed attached to the skin. Cups were attached to the skin with adhesive tape.
Other: Static cupping
4 cups were placed on the gastrocnemius, negative pressure was applied and participants lay prone on a table for 10 minutes.
Experimental: Dynamic cupping
Negative pressure was created inside 4 plastic cups (2" diameter) placed on the gastrocnemius by drawing out air with two full pumps via a manual suction tool and participants laid in the prone position for 5 minutes while the cups stayed attached to the skin. Participants then completed two sets of 10 full range ankle pumps with a rest period of 30 seconds between sets (approximately 2 minutes). For the remaining 3 minutes, participants remained still in the prone position with the cups remaining attached. Cups were attached to the skin with adhesive tape.
Other: Dynamic cupping
4 cups were placed on the gastrocnemius, negative pressure was applied and participants lay prone on a table for 5 minutes, then did ankle exercises for 3 minutes, and lastly lay prone on the table for the last 3 minutes.
Sham Comparator: Dynamic sham cupping
Negative pressure was created inside 4 plastic cups (2" diameter) placed on the gastrocnemius by drawing out air with two full pumps via a manual suction tool and participants laid in the prone position for 5 minutes while the cups stayed attached to the skin. Participants then completed two sets of 10 full range ankle pumps with a rest period of 30 seconds between sets (approximately 2 minutes). For the remaining 3 minutes, participants remained still in the prone position with the cups remaining attached. Cups were attached to the skin with adhesive tape. However, the sham cups had a small hole in them which allowed pressure to leak out.
Other: Dynamic sham cupping
4 cups were placed on the gastrocnemius, negative pressure was applied and participants lay prone on a table for 5 minutes, then did ankle exercises for 3 minutes, and lastly lay prone on the table for the last 3 minutes. A pin hole in the cup allowed pressure to slowly leak out during the treatment.
Sham Comparator: Static sham cupping
Negative pressure was created inside 4 plastic cups (2" diameter) placed on the gastrocnemius by drawing out air with two full pumps via a manual suction tool and participants laid in the prone position for 10 minutes while the cups stayed attached to the skin. Cups were attached to the skin with adhesive tape. However, the sham cups had a small hole in them which allowed pressure to leak out.
Other: Static sham cupping
4 cups were placed on the gastrocnemius, negative pressure was applied and participants lay prone on a table for 10 minutes. A pin hole in the cup allowed pressure to slowly leak out during the treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in average ankle dorsiflexion (degrees) using a digital inclinometer
Time Frame: Baseline and immediately after receiving treatment.
Weight bearing ankle dorsiflexion measured by performing a modified lunge and bringing the knee forward as far as possible without allowing the heel to come off of the ground. A digital inclinometer was placed vertically over the tibial tuberosity and the measurement was reported as the average of three trials, in degrees.
Baseline and immediately after receiving treatment.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Northern Michigan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Megan C Nelson, PhD, Northern Michigan University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS-22-1287

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual data will be shared, data will only be shared in aggregate form.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings