FasciaNCT02564081
Remote Effects of Lower Limb Stretching
A study testing Static Stretching lower limb and Static stretching Cervical in people with Fascia and Randomized Controlled Trial, run by Goethe University at 1 site in Germany.
Trial summary
Recent research suggests that the skeletal muscles and the fibrous connective tissue form a body-wide network of myofascial chains. A systematic analysis of dissection studies suggests that fascia links at least a variety of muscles to myofascial chains (Wilke et al. 2015). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fascia, Randomized Controlled Trial, Stretching
- What is being tested?
- Static Stretching lower limb and Static stretching Cervical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Dec 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy participants after subscribing informed consent
Who cannot join
- severe orthopedic, cardiovascular, neurological, psychiatric or endocrine diseases, not completely healed traumata, drug intake in the past 48 hours, pregnancy and presence of muscle soreness.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Sports Medicine, Goethe University Frankfurt/Main
Frankfurt am Main, Hesse, 60487
About this study
Recent research suggests that the skeletal muscles and the fibrous connective tissue form a body-wide network of myofascial chains. A systematic analysis of dissection studies suggests that fascia links at least a variety of muscles to myofascial chains (Wilke et al. 2015). As fascia can modify its stiffness, strain transmission along these meridians is supposable (Norton-Old et al. 2013). Tensile transmission along myofascial chains might contribute to the proper functioning of the movement system. However, despite solid evidence from in vitro studies, scarce data is available concerning the in vivo behavior of the meridians. The present study is conducted to resolve this research deficit and to elucidate whether stretching of the lower limb muscles increases neck mobility. Healthy subjects (n = 3 x 20) participate in the randomized controlled trial. One group performs three 30 s bouts of static stretching for the gastrocnemius and the hamstrings respectively. A control group remains inactive for the same time. Participants of the third group perform 6x30 s bouts of static stretching of the cervical spine in zhe sagittal plane (flexion only). Pre and post intervention as well as 5 min after the intervention, maximal cervical range of motion (ROM) in flexion/extension, lateral flexion and rotation was assessed using an ultrasonic movement analysis system.
- Conditions
- Fascia, Randomized Controlled Trial, Stretching, Myofascial
- Being tested
- Static Stretching lower limb, Static stretching Cervical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Static Stretching lower limbOther
Static stretching CervicalOther
| Study group | Role | What they receive |
|---|---|---|
| Static Stretching lower limb | Experimental | Three 30 s bouts of static stretching for the gastrocnemius and the hamstrings respectively Receives: Other: Static Stretching lower limb |
| Static stretching Cervical | Active comparator | Six 30 s bouts of static stretching of the cervical spine in the sagittal plane (flexion only) Receives: Other: Static stretching Cervical |
| Ctrl | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal cervical range of motion in flexion/extension
Measured: 2 min.
Secondary outcomes (2)
Maximal cervical range of motion in lateral flexion
Measured: 2 min.
Maximal cervical range of motion in rotation
Measured: 2 min.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FasciaStudies 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Dr. Winfried Banzer, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564081
- Sponsor's protocol ID
- SpM2015-001
- Status last verified
- Feb 2016
- First submitted
- 29 Sep 2015
- Last updated
- 2 Feb 2016
- Results posted
- No
Publications
Wilke J, Krause F, Vogt L, Banzer W. What Is Evidence-Based About Myofascial Chains: A Systematic Review. Arch Phys Med Rehabil. 2016 Mar;97(3):454-61. doi: 10.1016/j.apmr.2015.07.023. Epub 2015 Aug 14.
PubMed 26281953Norton-Old KJ, Schache AG, Barker PJ, Clark RA, Harrison SM, Briggs CA. Anatomical and mechanical relationship between the proximal attachment of adductor longus and the distal rectus sheath. Clin Anat. 2013 May;26(4):522-30. doi: 10.1002/ca.22116. Epub 2012 Jun 14.
PubMed 23553712
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Effects of Lower Limb Stretching
- ClinicalTrials.gov ID
- NCT02564081
- Acronym / sponsor ID
- SpM2015-001
- Conditions
- Fascia, Randomized Controlled Trial, Stretching, Myofascial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Sep 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.
Recent research suggests that the skeletal muscles and the fibrous connective tissue form a body-wide network of myofascial chains. A systematic analysis of dissection studies suggests that fascia links at least a variety of muscles to myofascial chains (Wilke et al. 2015). As fascia can modify its stiffness, strain transmission along these meridians is supposable (Norton-Old et al. 2013). Tensile transmission along myofascial chains might contribute to the proper functioning of the movement system. However, despite solid evidence from in vitro studies, scarce data is available concerning the in vivo behavior of the meridians. The present study is conducted to resolve this research deficit and to elucidate whether stretching of the lower limb muscles increases neck mobility. Healthy subjects (n = 3 x 20) participate in the randomized controlled trial. One group performs three 30 s bouts of static stretching for the gastrocnemius and the hamstrings respectively. A control group remains inactive for the same time. Participants of the third group perform 6x30 s bouts of static stretching of the cervical spine in zhe sagittal plane (flexion only). Pre and post intervention as well as 5 min after the intervention, maximal cervical range of motion (ROM) in flexion/extension, lateral flexion and rotation was assessed using an ultrasonic movement analysis system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Static Stretching lower limb | Experimental | Other: Static Stretching lower limbThree 30 s bouts of static stretching for the gastrocnemius and the hamstrings respectively |
| Static stretching Cervical | Active comparator | Other: Static stretching CervicalSix 30 s bouts of static stretching of the cervical spine in the sagittal plane (flexion only) |
| Ctrl | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy participants after subscribing informed consent
Key exclusion criteria (1 listed)
- severe orthopedic, cardiovascular, neurological, psychiatric or endocrine diseases, not completely healed traumata, drug intake in the past 48 hours, pregnancy and presence of muscle soreness.
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 |
|---|---|---|
| Static Stretching lower limb | Other | Static Stretching lower limb |
| Static stretching Cervical | Other | Static stretching Cervical |
Primary outcome
Maximal cervical range of motion in flexion/extension
Time frame: 2 min.
2 secondary outcomes
Maximal cervical range of motion in lateral flexion
Time frame: 2 min.
Maximal cervical range of motion in rotation
Time frame: 2 min.
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 2 Feb 2016.
- Background: PubMed 26281953Wilke J, Krause F, Vogt L, Banzer W. What Is Evidence-Based About Myofascial Chains: A Systematic Review. Arch Phys Med Rehabil. 2016 Mar;97(3):454-61. doi: 10.1016/j.apmr.2015.07.023. Epub 2015 Aug 14.
- Background: PubMed 23553712Norton-Old KJ, Schache AG, Barker PJ, Clark RA, Harrison SM, Briggs CA. Anatomical and mechanical relationship between the proximal attachment of adductor longus and the distal rectus sheath. Clin Anat. 2013 May;26(4):522-30. doi: 10.1002/ca.22116. Epub 2012 Jun 14.
Related trials for Fascia
Active, not recruiting
The Role Of Fascia And Breathing Exercises In The Treatment Of Cervicogenic Headache
Cervicogenic Headache
Not yet recruiting
Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
Postoperative Pain, Acute Pain
Not yet recruiting
Erector Spinae Plane Block With or Without Thoracolumbar Fascia Injection for Chronic Low Back Pain
Chronic Low Back Pain
RecruitingPhase 4
Preoperative BOTOX® Injection for Large Ventral Hernia Repair
Hernia Abdominal Wall, Botox Injection
Recruiting
Erector Spinae Plane vs Serratus Anterior Plane Catheter Infusions for Acute Pain Management in Patients With Traumatic Rib Fractures
Traumatic Rib Fracture(s), Traumatic Rib Fracture
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 Static Stretching lower limb and Static stretching Cervical in people with Fascia and Randomized Controlled Trial, run by Goethe University at 1 site in Germany.
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 2 Feb 2016. 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 Germany. 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?
Maximal cervical range of motion in flexion/extension (time frame: 2 min.). 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 NCT02564081, which also lists 2 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 2 Feb 2016.