NCT03478800

Brief Summary

Is it feasible to perform acupuncture in the training field after sport performance in adolescent football players? Does acupuncture provide a decrease in muscle soreness and improvement in overall sense of well-being in the adolescent football population?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

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

June 15, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

August 13, 2018

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2018

Completed
Last Updated

November 9, 2018

Status Verified

November 1, 2018

Enrollment Period

16 days

First QC Date

June 15, 2017

Last Update Submit

November 7, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in muscle soreness after post-exercise acupuncture therapy

    Musculoskeletal pain or soreness will be measured by a Football Acupuncture Survey designed by the investigators. Participants will first be asked if they had muscle soreness or pain in the last 24-48 hours and if so, if they used any modalities to alleviate it (ice, heat, massage etc) or medications (and if so, which ones). Participants will then be asked about the presence and location of current muscle soreness and to rate the soreness on a 10 point scale with 0 being 'no muscle soreness' and 10 being 'muscle soreness as bad as can be. After acupuncture treatment, they will be the same question. The investigators will evaluate the difference between pre- and post-treatment muscle soreness.

    immediately before and after acupuncture during the study period (2.5 weeks)

Secondary Outcomes (1)

  • Sense of well-being

    immediately before and after acupuncture, during the study period (2.5 weeks)

Other Outcomes (2)

  • Presence or absence of side effects from acupuncture treatment

    immediately before and after acupuncture, during the study period (2.5 weeks)

  • Overall experience and willingness to recommend or consider acupuncture in the future.

    immediately before and after acupuncture, during the study period (2.5 weeks)

Study Arms (1)

High school football players and acupuncture

EXPERIMENTAL

50 healthy high school football players without active musculoskeletal injury

Procedure: Acupuncture

Interventions

AcupuncturePROCEDURE

Each treatment would take approximately 15-20 minutes and would take place immediately after practice for a total of five treatments. The needles are standard (0.2mm diameter #36 gauge 1 inch stainless steel) and during each treatment, 3-6 needles would be placed in the lower extremity in any of the following muscle groups: quadriceps, hamstrings, anterior tibialis, gastrocnemius-soleus complex, medial head of the gastrocnemius, peroneal muscles, or iliotibial band. The athletes would complete brief pre- and post-treatment surveys.

High school football players and acupuncture

Eligibility Criteria

Age13 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Male or female members of the two local high school football teams
  • Age 13-18 years
  • No current musculoskeletal injuries
  • Generally healthy individuals who plan to complete the season barring injury or other unexpected events.

You may not qualify if:

  • Acupuncture treatment within the past year
  • Known active musculoskeletal injury or condition, immunocompromised state, prosthetic heart valve, pregnancy or known history of bleeding disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Luetmer MT, Do A, Canzanello NC, Bauer BA, Laskowski ER. The Feasibility and Effects of Acupuncture on Muscle Soreness and Sense of Well-being in an Adolescent Football Population. Am J Phys Med Rehabil. 2019 Nov;98(11):964-970. doi: 10.1097/PHM.0000000000001226.

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Officials

  • Edward R Laskowski

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 15, 2017

First Posted

March 27, 2018

Study Start

August 13, 2018

Primary Completion

August 29, 2018

Study Completion

August 29, 2018

Last Updated

November 9, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations