NCT05793242

Brief Summary

The purpose of this study is to compare the effects of the HyperVolt percussive massage device, body tempering, and dry cupping to static stretching of the hamstrings of healthy adults aged 18-39 years on the active knee extension and back saver sit-and-reach test.While these modalities are frequently used in healthcare settings there is a paucity of research regarding effectiveness. If the effects on flexibility are comparable, patients could save time and money by performing static stretching.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

March 15, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

April 3, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

March 15, 2023

Last Update Submit

April 24, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Active Knee Extension Test (AKE)

    The Active Knee Extension (AKE) Test measures will be conducted by a pair of graders that will be blinded to the intervention applied to the study participants. Participants will have an axis of rotation labeled at the lateral aspect of the knee joint midline. The participant will be instructed to lie down on the table in the supine position. One of the test graders will assist the participant in performing and maintaining 90-degrees of hip flexion throughout this test. The participant will be instructed to extend at the knee as much as possible and told to hold the position for the second grader to measure the knee extension ROM using a goniometer. A total of 3 measurements will be conducted, with the last 2 recorded for data analysis.

    Immediately after intervention

  • Active Knee Extension Test (AKE)

    The Active Knee Extension (AKE) Test measures will be conducted by a pair of graders that will be blinded to the intervention applied to the study participants. Participants will have an axis of rotation labeled at the lateral aspect of the knee joint midline. The participant will be instructed to lie down on the table in the supine position. One of the test graders will assist the participant in performing and maintaining 90-degrees of hip flexion throughout this test. The participant will be instructed to extend at the knee as much as possible and told to hold the position for the second grader to measure the knee extension ROM using a goniometer. A total of 3 measurements will be conducted, with the last 2 recorded for data analysis.

    24 hours after the intervention

  • Back-Saver Sit-and-Reach Test

    The Back-Saver Sit-and-ReachTest will be conducted by a pair of graders that will be blinded to the intervention group of the study participants. A box will be utilized with a ruler placed on top of the box with 9 inches protruding out towards the participant. The ruler will run parallel to the direction of forward movement by the participant. When instructed, the tested lower extremity will remain fully extended at the knee with the plantar side of the foot flat up against the wall of the box. The contralateral non-tested leg will be flexed at the knee, resulting in the plantar side of the foot flat down against the floor. The foot of the non-tested leg will be placed within 2 to 3 inches away from the fully extended tested leg and remain planted at all times during testing procedures. Participants will be instructed to reach forward as far as possible with arms fully extended, back straight, and head up.

    Immediately after intervention

  • Back-Saver Sit-and-Reach Test

    The Back-Saver Sit-and-ReachTest will be conducted by a pair of graders that will be blinded to the intervention group of the study participants. A box will be utilized with a ruler placed on top of the box with 9 inches protruding out towards the participant. The ruler will run parallel to the direction of forward movement by the participant. When instructed, the tested lower extremity will remain fully extended at the knee with the plantar side of the foot flat up against the wall of the box. The contralateral non-tested leg will be flexed at the knee, resulting in the plantar side of the foot flat down against the floor. The foot of the non-tested leg will be placed within 2 to 3 inches away from the fully extended tested leg and remain planted at all times during testing procedures. Participants will be instructed to reach forward as far as possible with arms fully extended, back straight, and head up.

    24 hours after the intervention

Study Arms (4)

Static stretching

ACTIVE COMPARATOR

The static stretch group participants will perform a self-facilitated stretch by looping a strap around the heel of their foot and grasping it with both hands followed by pulling the strap to raise the fully extended leg into hip flexion. The participant will then lift the leg until they reach their maximal tolerable point and then alternate between periods of resting and stretching for a total of 5 minutes.

Other: Static stretching

Hypervolt

EXPERIMENTAL

The HyperVolt percussive massage group participants will receive a therapist-performed HyperVolt technique to the hamstrings for a period of 5 minutes.

Device: Hypervolt

Body tempering

EXPERIMENTAL

The body tempering group participants will receive a therapist-performed body tempering technique to the hamstrings for a period of 5 minutes.

Device: Body Tempering

Dry cupping

EXPERIMENTAL

The dry cupping group participants will receive a therapist-performed dry cupping technique to the hamstrings for a period of 5 minutes.

Device: Dry cupping

Interventions

HypervoltDEVICE

HyperVolt Percussive Massage Device: this will be performed by a physical therapist while the participant is prone. The physical therapist will apply a vibrating device to the back of the thigh with moderate pressure while continuously moving the device for 5 minutes.

Hypervolt

Body Tempering:this will be performed by a physical therapist while the participant is prone. The physical therapist will apply a moderately heavy metal device to the back of the thigh while continuously moving the device for 5 minutes.

Body tempering

Dry Cupping: This will be performed by a physical therapist while the participant is prone. The physical therapist will apply several negative pressure devices to the back of your thigh for 5 minutes.

Dry cupping

Participants will perform a static stretch on their lower extremity. This stretch will be performed by having the participant loop a strap around their heel and grasping it with both hands followed by pulling the strap to raise the fully extended leg into hip flexion. The participant will be instructed to lift the leg until they reach their maximal tolerable point and then to hold the position for 30 seconds. They will then lower the extremity to the table and rest for 15 seconds This self-stretch sequence will be performed for 7 cycles so that the total intervention was equal to the intervention time of the other group (5 minutes).7

Static stretching

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Shortened hamstring length
  • Male participants will display ≤141 degrees of knee extension
  • Female participants will display ≤152 degrees of knee extension

You may not qualify if:

  • history of knee injury
  • hypertension
  • thrombophlebitis
  • inflammation
  • myositis ossificans
  • osteomyelitis
  • open wounds
  • unhealed fractures
  • hematoma or hemophilia
  • pregnancy
  • cancer
  • burns or skin grafts
  • varicose veins
  • synovitis
  • currently taking any anticoagulation medications
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

RECRUITING

Related Publications (6)

  • Blazevich AJ, Gill ND, Kvorning T, Kay AD, Goh AG, Hilton B, Drinkwater EJ, Behm DG. No Effect of Muscle Stretching within a Full, Dynamic Warm-up on Athletic Performance. Med Sci Sports Exerc. 2018 Jun;50(6):1258-1266. doi: 10.1249/MSS.0000000000001539.

  • Aguilar AJ, DiStefano LJ, Brown CN, Herman DC, Guskiewicz KM, Padua DA. A dynamic warm-up model increases quadriceps strength and hamstring flexibility. J Strength Cond Res. 2012 Apr;26(4):1130-41. doi: 10.1519/JSC.0b013e31822e58b6.

  • Konrad A, Glashuttner C, Reiner MM, Bernsteiner D, Tilp M. The Acute Effects of a Percussive Massage Treatment with a Hypervolt Device on Plantar Flexor Muscles' Range of Motion and Performance. J Sports Sci Med. 2020 Nov 19;19(4):690-694. eCollection 2020 Dec.

  • Taber CB, Colter RJ, Davis JJ, Seweje PA, Wilson DP, Foster JZ, Merrigan JJ. The Effects of Body Tempering on Force Production, Flexibility and Muscle Soreness in Collegiate Football Athletes. J Funct Morphol Kinesiol. 2022 Jan 11;7(1):9. doi: 10.3390/jfmk7010009.

  • Williams JG, Gard HI, Gregory JM, Gibson A, Austin J. The Effects of Cupping on Hamstring Flexibility in College Soccer Players. J Sport Rehabil. 2019 May 1;28(4):350-353. doi: 10.1123/jsr.2017-0199. Epub 2018 Dec 4.

  • Gunn LJ, Stewart JC, Morgan B, Metts ST, Magnuson JM, Iglowski NJ, Fritz SL, Arnot C. Instrument-assisted soft tissue mobilization and proprioceptive neuromuscular facilitation techniques improve hamstring flexibility better than static stretching alone: a randomized clinical trial. J Man Manip Ther. 2019 Feb;27(1):15-23. doi: 10.1080/10669817.2018.1475693. Epub 2018 Aug 1.

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Cathy F Arnot, DPT

    University of South Carolina

    STUDY DIRECTOR

Central Study Contacts

Cathy F Arnot, DPT

CONTACT

Matthew Geary, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Director

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 31, 2023

Study Start

April 3, 2023

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

April 26, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations