Muscle HypertoniaNCT02808923
Effects of Long-term Foam Rolling Compared to Static Stretching on Hamstring Muscle Flexibility
A study testing Foam Rolling and Static Stretching in people with Muscle Hypertonia, run by Creighton University.
Trial summary
The purpose of this study to to compare the long-term effects of foam rolling in comparison to static stretching and a control group on hamstring flexibility. The investigators hypothesize that participants in the foam rolling and static stretching group will demonstrate increased flexibility to the control group, but… Read more about this study
- Who is it for?
- Ages 19 to 40 years
- Conditions the study is for
- Muscle Hypertonia
- What is being tested?
- Foam Rolling and Static Stretching
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to Aug 2016
- 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 19 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Active 90/90 hamstring length goniometric measurement of greater than 10 degrees at baseline
- Active straight leg raise of less than 90 degrees
Who cannot join
- History of lower extremity injury including but not limited to sprain, strain, fracture, or any surgical intervention that lead to a decrease in activity greater than two weeks within the last six months
- Current involvement in a lower extremity flexibility program outside of their regular activity
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this study to to compare the long-term effects of foam rolling in comparison to static stretching and a control group on hamstring flexibility. The investigators hypothesize that participants in the foam rolling and static stretching group will demonstrate increased flexibility to the control group, but will a difference will not be observed between the foam rolling and static stretching groups.
- Conditions
- Muscle Hypertonia
- Being tested
- Foam Rolling, Static Stretching
- Medical subject headings
- Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foam RollingOther
Participants will perform unilateral hamstring rolling for 2 repetitions of 1 minute with 15 second rest breaks on each leg with a 6"x 36" foam roller.
Static StretchingOther
Participants will perform supine static hamstring stretch on a wall for 2 repetitions of 1 minute with 15 second rest breaks on each leg. When the position no longer causes a moderate stretching sensation to the hamstring, subjects will move their bodies closer to the wall to intensify the stretch.
| Study group | Role | What they receive |
|---|---|---|
| Foam rolling | Experimental | Participants in the foam rolling group will perform unilateral rolling of the hamstring musculature from ischial tuberosity to posterior knee in supine for 2 repetitions of 1 minute with 15 second rest between repetitions at a consistent cadence of 1 second superiorly and 1 second inferiorly. Subjects will be asked to adjust pressure as needed to maintain a consistent moderate pressure on the treatment area. Participants will use new and individually issued high density foam rollers that are 6" diameter x 36" length. Receives: Other: Foam Rolling |
| Static stretching | Experimental | Participants in the static stretching group will perform sustained static hamstring stretching for 2 repetitions of 1 minute bouts for the same leg before switching sides using moderate pressure in supine against the wall. Subjects will rest for 15 seconds between repetitions and adjust distance from the wall to perceive moderate intensity. Receives: Other: Static Stretching |
| Control | No intervention | The control group will perform their regular baseline activities without the addition of a specific lower extremity flexibility program. If the subjects are currently performing stretching of any mode at baseline, they will be allowed to continue with that activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 90/90 hamstring length
Participant is supine, hip flexed to 90 degrees, knee extension range of motion measured actively from 90 degree starting position with a standard goniometer
Measured: Baseline, 3 weeks, 6 weeks
Secondary outcomes (3)
Change in Active straight leg raise - Range of motion
Participant is supine, with contralateral leg straight the participant will actively raise the leg until end of range with hip flexion being measured by goniometer
Measured: Baseline, 3 weeks, 6 weeks
Change in Active straight leg raise - Functional Movement Screen
Participant is supine, with contralateral leg straight the participant will actively raise the leg until end of range. This end range will be compared to a standardized position using a dowel and will be scored according to the functional movement screen.
Measured: Baseline, 3 weeks, 6 weeks
Change in Sit-and-reach
Using a standardized sit-and-reach box, participants will sit with legs together, knees extended, and hands overlapped and extended in front of the body. The subject will forward flex until end range of motion measured in centimeters.
Measured: Baseline, 3 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Muscle HypertoniaStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Trevor Schongalla, DPT, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808923
- Sponsor's protocol ID
- 908292-1
- Status last verified
- Jun 2016
- First submitted
- 15 Jun 2016
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Non-identifying participant demographics and data on outcome measures (range of motion) for the study may be made available through publication or presentation on the study.
Publications
Mistry GS, Vyas NJ, Sheth, MS. Comparison of hamstrings flexibility in subjects with chronic low back pain versus normal individuals. J Clin Exp Res. 2014; 2(1): 85-88.
Barnes. The Basic Science Myofascial Release: Morphologic Change in Connective Tissue. Journal of Bodywork and Movement Therapies. 1997;1(4):231-238.
Cunha AC, Burke TN, Franca FJ, Marques AP. Effect of global posture reeducation and of static stretching on pain, range of motion, and quality of life in women with chronic neck pain: a randomized clinical trial. Clinics (Sao Paulo). 2008 Dec;63(6):763-70. doi: 10.1590/s1807-59322008000600010.
PubMed 19060998Cheatham SW, Kolber MJ, Cain M, Lee M. THE EFFECTS OF SELF-MYOFASCIAL RELEASE USING A FOAM ROLL OR ROLLER MASSAGER ON JOINT RANGE OF MOTION, MUSCLE RECOVERY, AND PERFORMANCE: A SYSTEMATIC REVIEW. Int J Sports Phys Ther. 2015 Nov;10(6):827-38.
PubMed 26618062Page P. Current concepts in muscle stretching for exercise and rehabilitation. Int J Sports Phys Ther. 2012 Feb;7(1):109-19.
PubMed 22319684Chan SP, Hong Y, Robinson PD. Flexibility and passive resistance of the hamstrings of young adults using two different static stretching protocols. Scand J Med Sci Sports. 2001 Apr;11(2):81-6. doi: 10.1034/j.1600-0838.2001.011002081.x.
PubMed 11252465Schleip R. Fascial plasticity - a new neurobiological explanation: Part 1. Jounral of Bodywork and Movement Therapies. 2003;7(1): 11-19.
MacDonald GZ, Penney MD, Mullaley ME, Cuconato AL, Drake CD, Behm DG, Button DC. An acute bout of self-myofascial release increases range of motion without a subsequent decrease in muscle activation or force. J Strength Cond Res. 2013 Mar;27(3):812-21. doi: 10.1519/JSC.0b013e31825c2bc1.
PubMed 22580977Sullivan KM, Silvey DB, Button DC, Behm DG. Roller-massager application to the hamstrings increases sit-and-reach range of motion within five to ten seconds without performance impairments. Int J Sports Phys Ther. 2013 Jun;8(3):228-36.
PubMed 23772339Pearcey GE, Bradbury-Squires DJ, Kawamoto JE, Drinkwater EJ, Behm DG, Button DC. Foam rolling for delayed-onset muscle soreness and recovery of dynamic performance measures. J Athl Train. 2015 Jan;50(1):5-13. doi: 10.4085/1062-6050-50.1.01. Epub 2014 Nov 21.
PubMed 25415413Skarabot J, Beardsley C, Stirn I. Comparing the effects of self-myofascial release with static stretching on ankle range-of-motion in adolescent athletes. Int J Sports Phys Ther. 2015 Apr;10(2):203-12.
PubMed 25883869Peacock CA, Krein DD, Antonio J, Sanders GJ, Silver TA, Colas M. Comparing Acute Bouts of Sagittal Plane Progression Foam Rolling vs. Frontal Plane Progression Foam Rolling. J Strength Cond Res. 2015 Aug;29(8):2310-5. doi: 10.1519/JSC.0000000000000867.
PubMed 25647651Healey KC, Hatfield DL, Blanpied P, Dorfman LR, Riebe D. The effects of myofascial release with foam rolling on performance. J Strength Cond Res. 2014 Jan;28(1):61-8. doi: 10.1519/JSC.0b013e3182956569.
PubMed 23588488Halperin I, Aboodarda SJ, Button DC, Andersen LL, Behm DG. Roller massager improves range of motion of plantar flexor muscles without subsequent decreases in force parameters. Int J Sports Phys Ther. 2014 Feb;9(1):92-102.
PubMed 24567860Junker DH, Stoggl TL. The Foam Roll as a Tool to Improve Hamstring Flexibility. J Strength Cond Res. 2015 Dec;29(12):3480-5. doi: 10.1519/JSC.0000000000001007.
PubMed 25992660
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Long-term Foam Rolling Compared to Static Stretching on Hamstring Muscle Flexibility
- ClinicalTrials.gov ID
- NCT02808923
- Acronym / sponsor ID
- 908292-1
- Conditions
- Muscle Hypertonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (estimated)
- First posted
- 22 Jun 2016 (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 purpose of this study to to compare the long-term effects of foam rolling in comparison to static stretching and a control group on hamstring flexibility. The investigators hypothesize that participants in the foam rolling and static stretching group will demonstrate increased flexibility to the control group, but will a difference will not be observed between the foam rolling and static stretching groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Foam rolling | Experimental | Other: Foam RollingParticipants in the foam rolling group will perform unilateral rolling of the hamstring musculature from ischial tuberosity to posterior knee in supine for 2 repetitions of 1 minute with 15 second rest between repetitions at a consistent cadence of 1 second superiorly and 1 second inferiorly. Subjects will be asked to adjust pressure as needed to maintain a consistent moderate pressure on the treatment area. Participants will use new and individually issued high density foam rollers that are 6" diameter x 36" length. |
| Static stretching | Experimental | Other: Static StretchingParticipants in the static stretching group will perform sustained static hamstring stretching for 2 repetitions of 1 minute bouts for the same leg before switching sides using moderate pressure in supine against the wall. Subjects will rest for 15 seconds between repetitions and adjust distance from the wall to perceive moderate intensity. |
| Control | No intervention | –The control group will perform their regular baseline activities without the addition of a specific lower extremity flexibility program. If the subjects are currently performing stretching of any mode at baseline, they will be allowed to continue with that activity. |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Active 90/90 hamstring length goniometric measurement of greater than 10 degrees at baseline
- Active straight leg raise of less than 90 degrees
Key exclusion criteria (2 listed)
- History of lower extremity injury including but not limited to sprain, strain, fracture, or any surgical intervention that lead to a decrease in activity greater than two weeks within the last six months
- Current involvement in a lower extremity flexibility program outside of their regular activity
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 |
|---|---|---|
| Foam RollingParticipants will perform unilateral hamstring rolling for 2 repetitions of 1 minute with 15 second rest breaks on each leg with a 6"x 36" foam roller. | Other | Foam rolling |
| Static StretchingParticipants will perform supine static hamstring stretch on a wall for 2 repetitions of 1 minute with 15 second rest breaks on each leg. When the position no longer causes a moderate stretching sensation to the hamstring, subjects will move their bodies closer to the wall to intensify the stretch. | Other | Static stretching |
Primary outcome
Change in 90/90 hamstring length
Time frame: Baseline, 3 weeks, 6 weeks
Participant is supine, hip flexed to 90 degrees, knee extension range of motion measured actively from 90 degree starting position with a standard goniometer
3 secondary outcomes
Change in Active straight leg raise - Range of motion
Time frame: Baseline, 3 weeks, 6 weeks
Change in Active straight leg raise - Functional Movement Screen
Time frame: Baseline, 3 weeks, 6 weeks
Change in Sit-and-reach
Time frame: Baseline, 3 weeks, 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2016.
- BackgroundMistry GS, Vyas NJ, Sheth, MS. Comparison of hamstrings flexibility in subjects with chronic low back pain versus normal individuals. J Clin Exp Res. 2014; 2(1): 85-88.
- BackgroundBarnes. The Basic Science Myofascial Release: Morphologic Change in Connective Tissue. Journal of Bodywork and Movement Therapies. 1997;1(4):231-238.
- Background: PubMed 19060998Cunha AC, Burke TN, Franca FJ, Marques AP. Effect of global posture reeducation and of static stretching on pain, range of motion, and quality of life in women with chronic neck pain: a randomized clinical trial. Clinics (Sao Paulo). 2008 Dec;63(6):763-70. doi: 10.1590/s1807-59322008000600010.
- Background: PubMed 26618062Cheatham SW, Kolber MJ, Cain M, Lee M. THE EFFECTS OF SELF-MYOFASCIAL RELEASE USING A FOAM ROLL OR ROLLER MASSAGER ON JOINT RANGE OF MOTION, MUSCLE RECOVERY, AND PERFORMANCE: A SYSTEMATIC REVIEW. Int J Sports Phys Ther. 2015 Nov;10(6):827-38.
- Background: PubMed 22319684Page P. Current concepts in muscle stretching for exercise and rehabilitation. Int J Sports Phys Ther. 2012 Feb;7(1):109-19.
- Background: PubMed 11252465Chan SP, Hong Y, Robinson PD. Flexibility and passive resistance of the hamstrings of young adults using two different static stretching protocols. Scand J Med Sci Sports. 2001 Apr;11(2):81-6. doi: 10.1034/j.1600-0838.2001.011002081.x.
- BackgroundSchleip R. Fascial plasticity - a new neurobiological explanation: Part 1. Jounral of Bodywork and Movement Therapies. 2003;7(1): 11-19.
- Background: PubMed 22580977MacDonald GZ, Penney MD, Mullaley ME, Cuconato AL, Drake CD, Behm DG, Button DC. An acute bout of self-myofascial release increases range of motion without a subsequent decrease in muscle activation or force. J Strength Cond Res. 2013 Mar;27(3):812-21. doi: 10.1519/JSC.0b013e31825c2bc1.
- Background: PubMed 23772339Sullivan KM, Silvey DB, Button DC, Behm DG. Roller-massager application to the hamstrings increases sit-and-reach range of motion within five to ten seconds without performance impairments. Int J Sports Phys Ther. 2013 Jun;8(3):228-36.
- Background: PubMed 25415413Pearcey GE, Bradbury-Squires DJ, Kawamoto JE, Drinkwater EJ, Behm DG, Button DC. Foam rolling for delayed-onset muscle soreness and recovery of dynamic performance measures. J Athl Train. 2015 Jan;50(1):5-13. doi: 10.4085/1062-6050-50.1.01. Epub 2014 Nov 21.
- Background: PubMed 25883869Skarabot J, Beardsley C, Stirn I. Comparing the effects of self-myofascial release with static stretching on ankle range-of-motion in adolescent athletes. Int J Sports Phys Ther. 2015 Apr;10(2):203-12.
- Background: PubMed 25647651Peacock CA, Krein DD, Antonio J, Sanders GJ, Silver TA, Colas M. Comparing Acute Bouts of Sagittal Plane Progression Foam Rolling vs. Frontal Plane Progression Foam Rolling. J Strength Cond Res. 2015 Aug;29(8):2310-5. doi: 10.1519/JSC.0000000000000867.
- Individual participant dataSharing planned: Yes. Non-identifying participant demographics and data on outcome measures (range of motion) for the study may be made available through publication or presentation on the study.
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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.
Trevor Schongalla, DPT principal investigator
Creighton University
Questions about this trial
What is this clinical trial studying?
A study testing Foam Rolling and Static Stretching in people with Muscle Hypertonia, run by Creighton University.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Trevor Schongalla, DPT (541-777-0686, trevorschongalla@creighton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 90/90 hamstring length (time frame: Baseline, 3 weeks, 6 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 NCT02808923, which also lists 21 linked publications.
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 22 Jun 2016; AzTrials last refreshed its copy on 1 Nov 2026.