Muscle TightnessNCT01856972
Does the Addition of Manual Therapy Techniques Increase Gastrocnemius/Soleus Length More Than Stretching Alone?
A study testing Instrument Assisted Soft Tissue Mobilization, Rearfoot joint mobilization and Static stretching/ROM exercises in people with Muscle Tightness, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This study will examine the short term effects of adding manual therapy techniques to static stretching in Dorsiflexion (DF) Range of Motion (ROM). The investigators will be studying 2 forms of manual therapy, a rear-foot thrust joint mobilization (TJM), and Instrument assisted soft tissue mobilization (IASTM). Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Muscle Tightness
- What is being tested?
- Instrument Assisted Soft Tissue Mobilization, Rearfoot joint mobilization and Static stretching/ROM exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Jun 2014
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- healthy feet and ankles must have limited dorsiflexion ROM. Limited dorsiflexion will be judged by patient having <12 degrees of DF PROM with knee extended, or <50 degrees of weight bearing DF ROM with the knee flexed.
Who cannot join
- inability to fully weight bear through their lower extremities
- have <0-90 degrees of ROM in their knees
- inability to follow directions
- presence of a Lower Extremity fracture
- pregnant or nursing
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital Sports and Orthopedic PT East Broad St location
Columbus, Ohio, 43213
About this study
This study will examine the short term effects of adding manual therapy techniques to static stretching in Dorsiflexion (DF) Range of Motion (ROM). The investigators will be studying 2 forms of manual therapy, a rear-foot thrust joint mobilization (TJM), and Instrument assisted soft tissue mobilization (IASTM). By comparing 3 groups: TJM+static stretching versus IASTM + static stretching versus static stretching alone the investigators wish to see if there are any short term benefits in DF ROM by adding either of these interventions to static stretching.
The manual therapy treatment will occur over 2 sessions and DF ROM measurements will be taken 4 times over a 2 week period.
Read more
The population that the investigators wish to examine are subjects with healthy feet and ankles, but with limited DF ROM.
The primary objective of this study is to see if subjects with decreased dorsiflexion motion will experience greater increases in dorsiflexion motion with the addition of manual therapy of static stretching alone.
Our hypothesis is subjects who receive manual therapy therapy and static stretching will experience a significant increase in DF ROM as compared to subjects who receive static stretching alone. More specifically subjects who are treated with the IASTM will experience greater results than subjects who are treated with the rear-foot thrust mobilization.
- Conditions
- Muscle Tightness
- Being tested
- Instrument Assisted Soft Tissue Mobilization, Rearfoot joint mobilization, Static stretching/ROM exercises
- Keywords
- Limited Dorsiflexion Range of Motion, Gastrocnemius tightness, Soleus tightness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft Tissue MobilizationProcedure or surgery
Also called IASTM, SASTM
IASTM treatment: will be performed with the sound assisted soft tissue mobilization tool #5. Patient will be placed in the prone position with the ankle in a relaxed position. The treating therapist will perform 10 scanning strokes in the caudal, cephalic, medial, lateral directions for a total of 40 strokes over the Gastrocnemius/Soleus complex. The therapist can then perform more concentrated strokes in areas noted by the therapist as tight, with a maximum treatment time of 5 minutes.
Rearfoot joint mobilizationProcedure or surgery
Also called Talocrural caudal thrust mobilization, Talocrural manipulation
A high velocity-low amplitude distractive thrust is directed at the talocrural joint. The procedure is performed with the patient in the supine position. The therapist interlaces hands over the dorsum of the foot with 5th digit placed on talus. The therapist slightly pronates and dorsiflexes the foot. Tension is taken up in a caudal direction until the soft tissue barrier is engaged. A distractive thrust is then applied. This is performed up to 2 times. If the therapist notes a cavitation, the patient is progressed to ROM exercises. If there is no cavitation is noted by the therapist the thrust mobilization is reapplied.
Static stretching/ROM exercisesOther
Gastrocnemius stretch at wall 3 sets of 30 second holds. Soleus stretch at wall 3 sets of 30 second holds. Standing bilateral dorsiflexion on step x30 with full ROM. Standing bilateral plantar flexion on step x30 with full ROM.
| Study group | Role | What they receive |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization | Experimental | Subjects randomized into this treatment arm will receive Instrument Assisted Soft Tissue Mobilization to the Gastrocnemius/Soleus complex, as well as a standard stretching/ROM protocol Receives: Procedure: Instrument Assisted Soft Tissue Mobilization; Other: Static stretching/ROM exercises |
| Rearfoot joint mobilization | Experimental | Subjects randomized into this treatment arm will receive a rear-foot joint mobilization as well as a standard stretching/ROM protocol Receives: Procedure: Rearfoot joint mobilization; Other: Static stretching/ROM exercises |
| Static stretching/ROM exercises | Active comparator | This is the control group consisting of Static stretching/ROM exercises. No manual intervention is performed with the group. The subjects will perform the standard stretching and ROM protocol Receives: Other: Static stretching/ROM exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight bearing dorsiflexion Range of Motion
Subjects will perform 3 practice range of motion (ROM) before the first measurement is taken. Subjects will then be measured for Dorsiflexion range of motion with knee in full extension and then with knee flexed 3 times each. With each measurement subjects will be instructed to bend the ankle forward as far as possible without their heel leaving the ground. The average value for these 3 measurements will be calculated and that will be the subjects DF ROM measurement. The change in ROM at each measurement will be the outcome we are measuring
Measured: Immediately prior to treatment, Immediately following treatment (same day), 2 day follow up visit,and at 2 weeks (12-16 days after initial session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Muscle TightnessStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mitchell Selhorst, Nationwide Children's Hospital
- Investigators
- Mitchell C Selhorst, MPT, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856972
- Sponsor's protocol ID
- IRB13-00096
- Status last verified
- Jun 2014
- First submitted
- 14 May 2013
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Konor MM, Morton S, Eckerson JM, Grindstaff TL. Reliability of three measures of ankle dorsiflexion range of motion. Int J Sports Phys Ther. 2012 Jun;7(3):279-87.
PubMed 22666642Fong CM, Blackburn JT, Norcross MF, McGrath M, Padua DA. Ankle-dorsiflexion range of motion and landing biomechanics. J Athl Train. 2011 Jan-Feb;46(1):5-10. doi: 10.4085/1062-6050-46.1.5.
PubMed 21214345Piva SR, Fitzgerald GK, Wisniewski S, Delitto A. Predictors of pain and function outcome after rehabilitation in patients with patellofemoral pain syndrome. J Rehabil Med. 2009 Jul;41(8):604-12. doi: 10.2340/16501977-0372.
PubMed 19565153Radford JA, Burns J, Buchbinder R, Landorf KB, Cook C. Does stretching increase ankle dorsiflexion range of motion? A systematic review. Br J Sports Med. 2006 Oct;40(10):870-5; discussion 875. doi: 10.1136/bjsm.2006.029348. Epub 2006 Aug 22.
PubMed 16926259Hammer WI. The effect of mechanical load on degenerated soft tissue. J Bodyw Mov Ther. 2008 Jul;12(3):246-56. doi: 10.1016/j.jbmt.2008.03.007. Epub 2008 Jun 3.
PubMed 19083680Schaefer JL, Sandrey MA. Effects of a 4-week dynamic-balance-training program supplemented with Graston instrument-assisted soft-tissue mobilization for chronic ankle instability. J Sport Rehabil. 2012 Nov;21(4):313-26. doi: 10.1123/jsr.21.4.313.
PubMed 23118072Fryer GA, Mudge JM, McLaughlin PA. The effect of talocrural joint manipulation on range of motion at the ankle. J Manipulative Physiol Ther. 2002 Jul-Aug;25(6):384-90. doi: 10.1067/mmt.2002.126129.
PubMed 12183696Bozymski EM, Isaacs KL. Special diagnostic and therapeutic considerations in elderly patients with upper gastrointestinal disease. J Clin Gastroenterol. 1991;13 Suppl 2:S65-75. doi: 10.1097/00004836-199112002-00009.
PubMed 1885904
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Addition of Manual Therapy Techniques Increase Gastrocnemius/Soleus Length More Than Stretching Alone?
- ClinicalTrials.gov ID
- NCT01856972
- Acronym / sponsor ID
- IRB13-00096
- Conditions
- Muscle Tightness
- Keywords
- Limited Dorsiflexion Range of Motion, Gastrocnemius tightness, Soleus tightness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 May 2013 (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.
This study will examine the short term effects of adding manual therapy techniques to static stretching in Dorsiflexion (DF) Range of Motion (ROM). The investigators will be studying 2 forms of manual therapy, a rear-foot thrust joint mobilization (TJM), and Instrument assisted soft tissue mobilization (IASTM). By comparing 3 groups: TJM+static stretching versus IASTM + static stretching versus static stretching alone the investigators wish to see if there are any short term benefits in DF ROM by adding either of these interventions to static stretching.
The manual therapy treatment will occur over 2 sessions and DF ROM measurements will be taken 4 times over a 2 week period.
The population that the investigators wish to examine are subjects with healthy feet and ankles, but with limited DF ROM.
The primary objective of this study is to see if subjects with decreased dorsiflexion motion will experience greater increases in dorsiflexion motion with the addition of manual therapy of static stretching alone.
Our hypothesis is subjects who receive manual therapy therapy and static stretching will experience a significant increase in DF ROM as compared to subjects who receive static stretching alone. More specifically subjects who are treated with the IASTM will experience greater results than subjects who are treated with the rear-foot thrust mobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Instrument Assisted Soft Tissue Mobilization | Experimental | Procedure: Instrument Assisted Soft Tissue Mobilization, Other: Static stretching/ROM exercisesSubjects randomized into this treatment arm will receive Instrument Assisted Soft Tissue Mobilization to the Gastrocnemius/Soleus complex, as well as a standard stretching/ROM protocol |
| Rearfoot joint mobilization | Experimental | Procedure: Rearfoot joint mobilization, Other: Static stretching/ROM exercisesSubjects randomized into this treatment arm will receive a rear-foot joint mobilization as well as a standard stretching/ROM protocol |
| Static stretching/ROM exercises | Active comparator | Other: Static stretching/ROM exercisesThis is the control group consisting of Static stretching/ROM exercises. No manual intervention is performed with the group. The subjects will perform the standard stretching and ROM protocol |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- healthy feet and ankles must have limited dorsiflexion ROM. Limited dorsiflexion will be judged by patient having <12 degrees of DF PROM with knee extended, or <50 degrees of weight bearing DF ROM with the knee flexed.
Key exclusion criteria (5 listed)
- inability to fully weight bear through their lower extremities
- have <0-90 degrees of ROM in their knees
- inability to follow directions
- presence of a Lower Extremity fracture
- pregnant or nursing
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 |
|---|---|---|
| Instrument Assisted Soft Tissue MobilizationAlso: IASTM, SASTMIASTM treatment: will be performed with the sound assisted soft tissue mobilization tool #5. Patient will be placed in the prone position with the ankle in a relaxed position. The treating therapist will perform 10 scanning strokes in the caudal, cephalic, medial, lateral directions for a total of 40 strokes over the Gastrocnemius/Soleus complex. The therapist can then perform more concentrated strokes in areas noted by the therapist as tight, with a maximum treatment time of 5 minutes. | Procedure or surgery | Instrument Assisted Soft Tissue Mobilization |
| Rearfoot joint mobilizationAlso: Talocrural caudal thrust mobilization, Talocrural manipulationA high velocity-low amplitude distractive thrust is directed at the talocrural joint. The procedure is performed with the patient in the supine position. The therapist interlaces hands over the dorsum of the foot with 5th digit placed on talus. The therapist slightly pronates and dorsiflexes the foot. Tension is taken up in a caudal direction until the soft tissue barrier is engaged. A distractive thrust is then applied. This is performed up to 2 times. If the therapist notes a cavitation, the patient is progressed to ROM exercises. If there is no cavitation is noted by the therapist the thrust mobilization is reapplied. | Procedure or surgery | Rearfoot joint mobilization |
| Static stretching/ROM exercisesGastrocnemius stretch at wall 3 sets of 30 second holds. Soleus stretch at wall 3 sets of 30 second holds. Standing bilateral dorsiflexion on step x30 with full ROM. Standing bilateral plantar flexion on step x30 with full ROM. | Other | Instrument Assisted Soft Tissue Mobilization, Rearfoot joint mobilization, Static stretching/ROM exercises |
Primary outcome
Change in Weight bearing dorsiflexion Range of Motion
Time frame: Immediately prior to treatment, Immediately following treatment (same day), 2 day follow up visit,and at 2 weeks (12-16 days after initial session)
Subjects will perform 3 practice range of motion (ROM) before the first measurement is taken. Subjects will then be measured for Dorsiflexion range of motion with knee in full extension and then with knee flexed 3 times each. With each measurement subjects will be instructed to bend the ankle forward as far as possible without their heel leaving the ground. The average value for these 3 measurements will be calculated and that will be the subjects DF ROM measurement. The change in ROM at each measurement will be the outcome we are measuring
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 11 Jun 2014.
- Background: PubMed 22666642Konor MM, Morton S, Eckerson JM, Grindstaff TL. Reliability of three measures of ankle dorsiflexion range of motion. Int J Sports Phys Ther. 2012 Jun;7(3):279-87.
- Background: PubMed 21214345Fong CM, Blackburn JT, Norcross MF, McGrath M, Padua DA. Ankle-dorsiflexion range of motion and landing biomechanics. J Athl Train. 2011 Jan-Feb;46(1):5-10. doi: 10.4085/1062-6050-46.1.5.
- Background: PubMed 19565153Piva SR, Fitzgerald GK, Wisniewski S, Delitto A. Predictors of pain and function outcome after rehabilitation in patients with patellofemoral pain syndrome. J Rehabil Med. 2009 Jul;41(8):604-12. doi: 10.2340/16501977-0372.
- Background: PubMed 16926259Radford JA, Burns J, Buchbinder R, Landorf KB, Cook C. Does stretching increase ankle dorsiflexion range of motion? A systematic review. Br J Sports Med. 2006 Oct;40(10):870-5; discussion 875. doi: 10.1136/bjsm.2006.029348. Epub 2006 Aug 22.
- Background: PubMed 19083680Hammer WI. The effect of mechanical load on degenerated soft tissue. J Bodyw Mov Ther. 2008 Jul;12(3):246-56. doi: 10.1016/j.jbmt.2008.03.007. Epub 2008 Jun 3.
- Background: PubMed 23118072Schaefer JL, Sandrey MA. Effects of a 4-week dynamic-balance-training program supplemented with Graston instrument-assisted soft-tissue mobilization for chronic ankle instability. J Sport Rehabil. 2012 Nov;21(4):313-26. doi: 10.1123/jsr.21.4.313.
- Background: PubMed 12183696Fryer GA, Mudge JM, McLaughlin PA. The effect of talocrural joint manipulation on range of motion at the ankle. J Manipulative Physiol Ther. 2002 Jul-Aug;25(6):384-90. doi: 10.1067/mmt.2002.126129.
- Background: PubMed 1885904Bozymski EM, Isaacs KL. Special diagnostic and therapeutic considerations in elderly patients with upper gastrointestinal disease. J Clin Gastroenterol. 1991;13 Suppl 2:S65-75. doi: 10.1097/00004836-199112002-00009.
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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.
Mitchell C Selhorst, MPT principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrument Assisted Soft Tissue Mobilization, Rearfoot joint mobilization and Static stretching/ROM exercises in people with Muscle Tightness, run by Nationwide Children's Hospital 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 5 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 11 Jun 2014. 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 Weight bearing dorsiflexion Range of Motion (time frame: Immediately prior to treatment, Immediately following treatment (same day), 2 day follow up visit,and at 2 weeks (12-16 days after initial session)). 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 NCT01856972, which also lists 8 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 11 Jun 2014.