Musculoskeletal PainNCT02530190
Investigation of Popular Recovery Techniques for Ultramarathon Recovery
A study testing intermittent pneumatic compression and massage in people with Musculoskeletal Pain, run by Western States Endurance Run Research Foundation at 1 site in United States.
Trial summary
The study is a randomized clinical trial examining the effectiveness of massage and intermittent pneumatic compression on recovery from a 161-km ultramarathon. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- intermittent pneumatic compression and massage
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jul 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Entry in the Western States Endurance Run
Who cannot join
- Failure to finish race
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Northern California Health Care System
Sacramento, California, 95655
About this study
The study is a randomized clinical trial examining the effectiveness of massage and intermittent pneumatic compression on recovery from a 161-km ultramarathon.
Read the detailed description
The study is a randomized clinical trial examining the effectiveness of massage and intermittent pneumatic compression on recovery from a 161-km ultramarathon. Participants of the 2015 161-km Western States Endurance Run were randomized to a 20-minute post-race intervention of massage, intermittent pneumatic compression or supine rest. Each subject completed two 400 m runs at maximum speed before the race, and on days 3 and 5 after the race, and also provided muscle pain and soreness ratings and overall muscular fatigue scores before and for 7 days after the race.
- Conditions
- Musculoskeletal Pain
- Being tested
- intermittent pneumatic compression, massage
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent pneumatic compressionDevice
20 minutes of intermittent pneumatic compression to lower extremities
massageProcedure or surgery
20 minutes of massage to lower extremities
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | 20 minutes of supine rest |
| Intermittent pneumatic compression | Active comparator | 20 minutes of intermittent pneumatic compression Receives: Device: intermittent pneumatic compression |
| Massage | Active comparator | 20 minutes of massage therapy Receives: Procedure: massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
400 m run time
self-timed 400 m run as fast as possible
Measured: 5 days
Secondary outcomes (2)
Lower body muscle pain and soreness rating
Subjective rating of lower body muscle pain and soreness on 10-point Likert scale
Measured: 5 days
Overall muscular fatigue score
Subjective rating of overall muscular fatigue on a 12-cm visual analog scale
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
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 Musculoskeletal PainStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western States Endurance Run Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin D. Hoffman, MD, Western States Endurance Run Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02530190
- Sponsor's protocol ID
- WSER 2015
- Status last verified
- Aug 2015
- First submitted
- 18 Aug 2015
- Last updated
- 20 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hoffman MD, Badowski N, Chin J, Stuempfle KJ. A Randomized Controlled Trial of Massage and Pneumatic Compression for Ultramarathon Recovery. J Orthop Sports Phys Ther. 2016 May;46(5):320-6. doi: 10.2519/jospt.2016.6455. Epub 2016 Mar 23.
PubMed 27011305
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Popular Recovery Techniques for Ultramarathon Recovery
- ClinicalTrials.gov ID
- NCT02530190
- Acronym / sponsor ID
- WSER 2015
- Conditions
- Musculoskeletal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Western States Endurance Run Research FoundationUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 Aug 2015 (estimated)
- 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.
The study is a randomized clinical trial examining the effectiveness of massage and intermittent pneumatic compression on recovery from a 161-km ultramarathon.
Detailed description
The study is a randomized clinical trial examining the effectiveness of massage and intermittent pneumatic compression on recovery from a 161-km ultramarathon. Participants of the 2015 161-km Western States Endurance Run were randomized to a 20-minute post-race intervention of massage, intermittent pneumatic compression or supine rest. Each subject completed two 400 m runs at maximum speed before the race, and on days 3 and 5 after the race, and also provided muscle pain and soreness ratings and overall muscular fatigue scores before and for 7 days after the race.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –20 minutes of supine rest |
| Intermittent pneumatic compression | Active comparator | Device: intermittent pneumatic compression20 minutes of intermittent pneumatic compression |
| Massage | Active comparator | Procedure: massage20 minutes of massage therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Entry in the Western States Endurance Run
Key exclusion criteria (1 listed)
- Failure to finish race
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 |
|---|---|---|
| intermittent pneumatic compression20 minutes of intermittent pneumatic compression to lower extremities | Device | Intermittent pneumatic compression |
| massage20 minutes of massage to lower extremities | Procedure or surgery | Massage |
Primary outcome
400 m run time
Time frame: 5 days
self-timed 400 m run as fast as possible
2 secondary outcomes
Lower body muscle pain and soreness rating
Time frame: 5 days
Overall muscular fatigue score
Time frame: 5 days
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 20 Aug 2015.
- Derived from this study: PubMed 27011305Hoffman MD, Badowski N, Chin J, Stuempfle KJ. A Randomized Controlled Trial of Massage and Pneumatic Compression for Ultramarathon Recovery. J Orthop Sports Phys Ther. 2016 May;46(5):320-6. doi: 10.2519/jospt.2016.6455. Epub 2016 Mar 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent pneumatic compression and massage in people with Musculoskeletal Pain, run by Western States Endurance Run Research Foundation 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 1 inclusion and 1 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 20 Aug 2015. 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?
400 m run time (time frame: 5 days). 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 NCT02530190, 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 20 Aug 2015.