Acupuncture TherapyNCT03478800
Acupuncture in Adolescent Football Players
A study testing Acupuncture in people with Acupuncture Therapy and Sports Medicine, run by Mayo Clinic at 1 site in United States.
Trial 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? Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Acupuncture Therapy, Sports Medicine
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2018to 29 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Acupuncture treatment within the past year
- Known active musculoskeletal injury or condition, immunocompromised state, prosthetic heart valve, pregnancy or known history of bleeding disorder.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: 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?
Read the 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.
- Conditions
- Acupuncture Therapy, Sports Medicine
- Being tested
- Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| High school football players and acupuncture | Experimental | 50 healthy high school football players without active musculoskeletal injury Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately before and after acupuncture during the study period (2.5 weeks)
Secondary outcomes (1)
Sense of well-being
'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.
Measured: immediately before and after acupuncture, during the study period (2.5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2018
- Study start13 Aug 2018
- Primary completion29 Aug 2018
- Study completion29 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acupuncture TherapyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward R. Laskowski, Mayo Clinic
- Investigators
- Edward R Laskowski, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03478800
- Sponsor's protocol ID
- 17-003475
- Status last verified
- Nov 2018
- First submitted
- 15 Jun 2017
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31135462
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Effects of Acupuncture on Muscle Soreness and Sense of Well-being in an Adolescent Football Population.
- ClinicalTrials.gov ID
- NCT03478800
- Acronym / sponsor ID
- 17-003475
- Conditions
- Acupuncture Therapy, Sports Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 29 Aug 2018 (actual)
- Study completion
- 29 Aug 2018 (actual)
- First posted
- 27 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High school football players and acupuncture | Experimental | Procedure: Acupuncture50 healthy high school football players without active musculoskeletal injury |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Acupuncture treatment within the past year
- Known active musculoskeletal injury or condition, immunocompromised state, prosthetic heart valve, pregnancy or known history of bleeding disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureEach 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. | Procedure or surgery | High school football players and acupuncture |
Primary outcome
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.
1 secondary outcome
Sense of well-being
Time frame: immediately before and after acupuncture, during the study period (2.5 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
- Derived from this study: PubMed 31135462Luetmer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward R Laskowski principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Acupuncture Therapy and Sports Medicine, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle soreness after post-exercise acupuncture therapy (time frame: immediately before and after acupuncture during the study period (2.5 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03478800, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.