ClinicalTrials.gov
ClinicalTrials.gov Menu

Acupuncture in Adolescent Football Players

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03478800
Recruitment Status : Not yet recruiting
First Posted : March 27, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Edward R. Laskowski, Mayo Clinic

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?


Condition or disease Intervention/treatment Phase
Acupuncture Therapy Sports Medicine Procedure: Acupuncture Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Feasibility and Effects of Acupuncture on Muscle Soreness and Sense of Well-being in an Adolescent Football Population.
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: High school football players and acupuncture
50 healthy high school football players without active musculoskeletal injury
Procedure: Acupuncture
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03478800


Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Edward R Laskowski Mayo Clinic

Responsible Party: Edward R. Laskowski, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03478800     History of Changes
Other Study ID Numbers: 17-003475
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No