Acupuncture in Adolescent Football Players

November 7, 2018 updated by: Edward R. Laskowski, Mayo Clinic

The Feasibility and Effects of Acupuncture on Muscle Soreness and Sense of Well-being in an Adolescent Football Population.

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?

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Previous studies on the effects of acupuncture on performance and post-exercise recovery have shown that it reduces perceived pain arising from exercise induced muscle soreness and reduces muscle spasm. Acupuncture has also been shown to serve as an adjunct to improve muscle strength training and to accelerate recovery from workouts and injury.

The investigators' goal is to study approximately 50 high school football players in their true pre-season warm weather training environment. The investigators will measure the effects of acupuncture treatment on muscle soreness and overall sense of well-being by administering pre- and post-treatment surveys. Athletes will undergo five treatment sessions over the course of 2.5 weeks. The treatments will be performed by licensed acupuncturists employed at Mayo Clinic. The study has been approved by the Institutional Review Board at the Mayo Clinic.

Study Type

Interventional

Enrollment (Actual)

42

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

    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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

13 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

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

Exclusion Criteria:

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

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: High school football players and acupuncture
50 healthy high school football players without active musculoskeletal injury
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in muscle soreness after post-exercise acupuncture therapy
Time Frame: immediately before and after acupuncture during the study period (2.5 weeks)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sense of well-being
Time Frame: immediately before and after acupuncture, during the study period (2.5 weeks)
'Sense of well-being' will be measured by a Football Acupuncture Survey designed by the investigators. Sense of well-being is defined on the survey as 'feeling content, happy, healthy, full of energy or relaxed while not feeling upset, anxious or fatigued.' Participants will be asked to rate their overall sense of well-being on a 10 point scale with 0 being 'as bad as it can be' and 10 being 'as good as it can be.' After acupuncture treatment, they will be the same question. The investigators will evaluate the difference between pre- and post-treatment sense of well-being.
immediately before and after acupuncture, during the study period (2.5 weeks)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence or absence of side effects from acupuncture treatment
Time Frame: immediately before and after acupuncture, during the study period (2.5 weeks)
As part of the Survey, after each treatment, participants will also be asked if they experienced side effects from the treatment that day, including but not limited to acupuncture site pain, numbness, tingling, sensations of cold or heat, and dizziness.
immediately before and after acupuncture, during the study period (2.5 weeks)
Overall experience and willingness to recommend or consider acupuncture in the future.
Time Frame: immediately before and after acupuncture, during the study period (2.5 weeks)
As part of the Survey, participants will be asked to rate their overall experience after acupuncture after the treatment that day (poor, fair, good, very good, and excellent); whether or not they would recommend acupuncture to other teammates or athletes (yes/no); and whether or not they would consider acupuncture in the future (yes/no).
immediately before and after acupuncture, during the study period (2.5 weeks)

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Edward R Laskowski, Mayo Clinic

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.

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)

August 13, 2018

Primary Completion (ACTUAL)

August 29, 2018

Study Completion (ACTUAL)

August 29, 2018

Study Registration Dates

First Submitted

June 15, 2017

First Submitted That Met QC Criteria

March 23, 2018

First Posted (ACTUAL)

March 27, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2018

Last Update Submitted That Met QC Criteria

November 7, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 17-003475

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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