NCT06513078

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable healthy

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

Study Start

First participant enrolled

April 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
Last Updated

July 25, 2024

Status Verified

July 1, 2024

Enrollment Period

11 months

First QC Date

July 16, 2024

Last Update Submit

July 23, 2024

Conditions

Keywords

Ankle dorsiflexionDynamic cuppingStatic cupping

Outcome Measures

Primary Outcomes (1)

  • Change in average ankle dorsiflexion (degrees) using a digital inclinometer

    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.

Study Arms (4)

Static cupping

EXPERIMENTAL

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

Static sham cupping

SHAM COMPARATOR

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

Dynamic cupping

EXPERIMENTAL

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

Dynamic sham cupping

SHAM COMPARATOR

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

Interventions

4 cups were placed on the gastrocnemius, negative pressure was applied and participants lay prone on a table for 10 minutes.

Static 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.

Static 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.

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. A pin hole in the cup allowed pressure to slowly leak out during the treatment.

Dynamic sham cupping

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Michigan University

Marquette, Michigan, 49855, United States

Location

Study Officials

  • Megan C Nelson, PhD

    Northern Michigan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants did not know whether they were receiving actual cupping treatment or a sham treatment.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2024

First Posted

July 22, 2024

Study Start

April 1, 2022

Primary Completion

March 1, 2023

Study Completion

March 31, 2023

Last Updated

July 25, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

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

Locations