Musculoskeletal ManipulationsNCT02842918
The Effect of Thoracic Spine Manipulation on Peripheral Neurodynamic Mobility
A study testing Spinal Manual Therapy and Spinal Range of Motion in people with Musculoskeletal Manipulations, run by Shenandoah University at 1 site in United States.
Trial summary
No studies have investigated the effects of a supine thoracic spine manipulation (TSM) on neurodynamic mobility, as compared to a sham intervention. This study aims to determine the immediate effects of TSM on the Upper Limb Provocation Test (ULPT) and Seated Slump Test (SST) compared to a sham intervention in… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Manipulations
- What is being tested?
- Spinal Manual Therapy and Spinal Range of Motion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to Feb 2017
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Upper Limb Provocation Test results with limitation of greater than 60 deg of elbow extension at the time of measurement
- Seated Slump Test results with limitation of greater than 22 deg of knee extension at the time of measurement
Who cannot join
- History of cervical or lumbar pain requiring medical intervention within the last two years, history of upper or lower extremity paresthesia/numbness, self reported bone density disorders, previous spinal cord injury, diagnosed intervertebral disc herniation, previous diagnosis of spinal stenosis or disc pathology, current pregnancy, history of circulatory or neurological disorders, history of spine and extremity fractures or dislocations in the last two years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Immediate Effects of Thoracic Spine Manipulation Versus a Sham Comparator on the Upper Limb Provocation Test and Seated Slump Test
No studies have investigated the effects of a supine thoracic spine manipulation (TSM) on neurodynamic mobility, as compared to a sham intervention. This study aims to determine the immediate effects of TSM on the Upper Limb Provocation Test (ULPT) and Seated Slump Test (SST) compared to a sham intervention in asymptomatic subjects with neurodynamic limitations.
Read the detailed description
A convenience sample will be utilized to obtain subjects. Subjects will be given a brief questionnaire to identify possible contraindications for spinal treatment techniques and exclude individuals if necessary. Subjects will be randomized into one of two groups (spinal manual therapy or spinal range of motion which will serve as the name for the placebo group) and participate in neurodynamic testing procedures of the upper extremity (Upper Limb Provocation Testing) as well as lower extremity (Seated Slump Test). Subjects who are determined to be positive for one or more limbs will receive either a thoracic spine manipulation technique (spinal manual therapy) or a thoracic spine sham manipulation technique (spinal range of motion/placebo). After application of the technique, previously positive limbs will be retested. In attempt to determine validity and believability of the sham procedure and perception of its effect, subjects will be asked if they believe their upper/lower quarter mobility will change based on the group name and after the technique is applied. Subjects will also be asked if they believed they were in the treatment or placebo group.
- Conditions
- Musculoskeletal Manipulations
- Being tested
- Spinal Manual Therapy, Spinal Range of Motion
- Keywords
- Thoracic Spine Manipulation, Neurodynamics, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Manual TherapyProcedure or surgery
Also called Active treatment group
Spinal Range of MotionProcedure or surgery
Also called Placebo/Sham group
| Study group | Role | What they receive |
|---|---|---|
| Spinal Manual Therapy | Active comparator | Supine thoracic spine manipulation located between the levels of T4-T7 Receives: Procedure: Spinal Manual Therapy; Procedure: Spinal Range of Motion |
| Spinal Range of Motion | Sham comparator | Supine thoracic spine sham manipulation located between the levels of T4-T7; identical procedure as the active treatment intervention but without the delivery of high velocity low amplitude thrust Receives: Procedure: Spinal Manual Therapy; Procedure: Spinal Range of Motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Limb Provocation Test Range of Motion Change (measured in degrees of elbow extension)
Subjects will lie on their back with their shoulder slightly off the edge of a treatment table. The investigator will then bend the subjects neck away from the shoulder being tested and position the arm into the starting test position. The investigator will then straighten the subjects elbow until it is fully extended, or until the subject reports discomfort or an abnormal feeling in their arm. This procedure will be completed before and immediately after either the treatment intervention (manipulation) or the sham intervention is completed.
Measured: Pre and Immediately Post Intervention
Seated Slump Test Range of Motion Change (measured in degrees of knee extension)
Subjects will sit at the edge of treatment table. Subjects will be asked to flex then neck towards their chest. The investigator will then apply a gentle force to their upper back and will ask the subject to remain in this position. The investigator will move the subjects foot upwards and straighten their leg until it is fully extended or until the subject reports discomfort or an abnormal feeling in their leg.This procedure will be completed before and immediately after either the treatment intervention (manipulation) or the sham intervention is completed.
Measured: Pre and Immediately Post Intervention
Secondary outcomes (2)
Believability of Sham - measured via questionnaire
Subjects will be asked whether they believe they were in the active treatment group or the sham/placebo group after final measurements are taken.
Measured: Immediately Post Intervention (after final measurements are read and recorded)
Perceived effect - measured via questionnaire
Subjects will be asked whether they believe their upper and/or lower quarter mobility will change based on the group name they are assigned.
Measured: Pre Intervention (immediately after initial measurements are recorded and prior to intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal ManipulationsStudies 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
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenandoah University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aaron Hartstein, Shenandoah University
- Investigators
- Sheri A Hale, PhD, PT, ATC, Study director, Shenandoah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842918
- Sponsor's protocol ID
- ShenandoahU
- Status last verified
- Apr 2017
- First submitted
- 19 Jul 2016
- Last updated
- 25 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be available to analyze; Subject grouping will not be available to participants in attempt to control believability of the sham comparator
Publications
Michener LA, Kardouni JR, Sousa CO, Ely JM. Validation of a sham comparator for thoracic spinal manipulation in patients with shoulder pain. Man Ther. 2015 Feb;20(1):171-5. doi: 10.1016/j.math.2014.08.008. Epub 2014 Sep 6.
PubMed 25261090Davis DS, Anderson IB, Carson MG, Elkins CL, Stuckey LB. Upper Limb Neural Tension and Seated Slump Tests: The False Positive Rate among Healthy Young Adults without Cervical or Lumbar Symptoms. J Man Manip Ther. 2008;16(3):136-41. doi: 10.1179/jmt.2008.16.3.136.
PubMed 19119402Szlezak AM, Georgilopoulos P, Bullock-Saxton JE, Steele MC. The immediate effect of unilateral lumbar Z-joint mobilisation on posterior chain neurodynamics: a randomised controlled study. Man Ther. 2011 Dec;16(6):609-13. doi: 10.1016/j.math.2011.06.004. Epub 2011 Jul 13.
PubMed 21742541Chu J, Allen DD, Pawlowsky S, Smoot B. Peripheral response to cervical or thoracic spinal manual therapy: an evidence-based review with meta analysis. J Man Manip Ther. 2014 Nov;22(4):220-9. doi: 10.1179/2042618613Y.0000000062.
PubMed 25395830Schmid A, Brunner F, Wright A, Bachmann LM. Paradigm shift in manual therapy? Evidence for a central nervous system component in the response to passive cervical joint mobilisation. Man Ther. 2008 Oct;13(5):387-96. doi: 10.1016/j.math.2007.12.007. Epub 2008 Mar 3.
PubMed 18316238
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immediate Effects of Thoracic Spine Manipulation Versus a Sham Comparator on the Upper Limb Provocation Test and Seated Slump Test
- ClinicalTrials.gov ID
- NCT02842918
- Acronym / sponsor ID
- ShenandoahU
- Conditions
- Musculoskeletal Manipulations
- Keywords
- Thoracic Spine Manipulation, Neurodynamics, Sham
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Shenandoah UniversityUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 25 Jul 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.
No studies have investigated the effects of a supine thoracic spine manipulation (TSM) on neurodynamic mobility, as compared to a sham intervention. This study aims to determine the immediate effects of TSM on the Upper Limb Provocation Test (ULPT) and Seated Slump Test (SST) compared to a sham intervention in asymptomatic subjects with neurodynamic limitations.
Detailed description
A convenience sample will be utilized to obtain subjects. Subjects will be given a brief questionnaire to identify possible contraindications for spinal treatment techniques and exclude individuals if necessary. Subjects will be randomized into one of two groups (spinal manual therapy or spinal range of motion which will serve as the name for the placebo group) and participate in neurodynamic testing procedures of the upper extremity (Upper Limb Provocation Testing) as well as lower extremity (Seated Slump Test). Subjects who are determined to be positive for one or more limbs will receive either a thoracic spine manipulation technique (spinal manual therapy) or a thoracic spine sham manipulation technique (spinal range of motion/placebo). After application of the technique, previously positive limbs will be retested. In attempt to determine validity and believability of the sham procedure and perception of its effect, subjects will be asked if they believe their upper/lower quarter mobility will change based on the group name and after the technique is applied. Subjects will also be asked if they believed they were in the treatment or placebo group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Manual Therapy | Active comparator | Procedure: Spinal Manual Therapy, Procedure: Spinal Range of MotionSupine thoracic spine manipulation located between the levels of T4-T7 |
| Spinal Range of Motion | Sham comparator | Procedure: Spinal Manual Therapy, Procedure: Spinal Range of MotionSupine thoracic spine sham manipulation located between the levels of T4-T7; identical procedure as the active treatment intervention but without the delivery of high velocity low amplitude thrust |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Upper Limb Provocation Test results with limitation of greater than 60 deg of elbow extension at the time of measurement
- Seated Slump Test results with limitation of greater than 22 deg of knee extension at the time of measurement
Key exclusion criteria (1 listed)
- History of cervical or lumbar pain requiring medical intervention within the last two years, history of upper or lower extremity paresthesia/numbness, self reported bone density disorders, previous spinal cord injury, diagnosed intervertebral disc herniation, previous diagnosis of spinal stenosis or disc pathology, current pregnancy, history of circulatory or neurological disorders, history of spine and extremity fractures or dislocations in the last two years
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 |
|---|---|---|
| Spinal Manual TherapyAlso: Active treatment group | Procedure or surgery | Spinal Manual Therapy, Spinal Range of Motion |
| Spinal Range of MotionAlso: Placebo/Sham group | Procedure or surgery | Spinal Manual Therapy, Spinal Range of Motion |
Primary outcome
Upper Limb Provocation Test Range of Motion Change (measured in degrees of elbow extension)
Time frame: Pre and Immediately Post Intervention
Subjects will lie on their back with their shoulder slightly off the edge of a treatment table. The investigator will then bend the subjects neck away from the shoulder being tested and position the arm into the starting test position. The investigator will then straighten the subjects elbow until it is fully extended, or until the subject reports discomfort or an abnormal feeling in their arm. This procedure will be completed before and immediately after either the treatment intervention (manipulation) or the sham intervention is completed.
Seated Slump Test Range of Motion Change (measured in degrees of knee extension)
Time frame: Pre and Immediately Post Intervention
Subjects will sit at the edge of treatment table. Subjects will be asked to flex then neck towards their chest. The investigator will then apply a gentle force to their upper back and will ask the subject to remain in this position. The investigator will move the subjects foot upwards and straighten their leg until it is fully extended or until the subject reports discomfort or an abnormal feeling in their leg.This procedure will be completed before and immediately after either the treatment intervention (manipulation) or the sham intervention is completed.
2 secondary outcomes
Believability of Sham - measured via questionnaire
Time frame: Immediately Post Intervention (after final measurements are read and recorded)
Perceived effect - measured via questionnaire
Time frame: Pre Intervention (immediately after initial measurements are recorded and prior to intervention)
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 25 Apr 2017.
- Results publication: PubMed 25261090Michener LA, Kardouni JR, Sousa CO, Ely JM. Validation of a sham comparator for thoracic spinal manipulation in patients with shoulder pain. Man Ther. 2015 Feb;20(1):171-5. doi: 10.1016/j.math.2014.08.008. Epub 2014 Sep 6.
- Results publication: PubMed 19119402Davis DS, Anderson IB, Carson MG, Elkins CL, Stuckey LB. Upper Limb Neural Tension and Seated Slump Tests: The False Positive Rate among Healthy Young Adults without Cervical or Lumbar Symptoms. J Man Manip Ther. 2008;16(3):136-41. doi: 10.1179/jmt.2008.16.3.136.
- Results publication: PubMed 21742541Szlezak AM, Georgilopoulos P, Bullock-Saxton JE, Steele MC. The immediate effect of unilateral lumbar Z-joint mobilisation on posterior chain neurodynamics: a randomised controlled study. Man Ther. 2011 Dec;16(6):609-13. doi: 10.1016/j.math.2011.06.004. Epub 2011 Jul 13.
- Results publication: PubMed 25395830Chu J, Allen DD, Pawlowsky S, Smoot B. Peripheral response to cervical or thoracic spinal manual therapy: an evidence-based review with meta analysis. J Man Manip Ther. 2014 Nov;22(4):220-9. doi: 10.1179/2042618613Y.0000000062.
- Results publication: PubMed 18316238Schmid A, Brunner F, Wright A, Bachmann LM. Paradigm shift in manual therapy? Evidence for a central nervous system component in the response to passive cervical joint mobilisation. Man Ther. 2008 Oct;13(5):387-96. doi: 10.1016/j.math.2007.12.007. Epub 2008 Mar 3.
- Individual participant dataSharing planned: Yes. Data will be available to analyze; Subject grouping will not be available to participants in attempt to control believability of the sham comparator
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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.
Sheri A Hale, PhD, PT, ATC study director
Shenandoah University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Manual Therapy and Spinal Range of Motion in people with Musculoskeletal Manipulations, run by Shenandoah University 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 2 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 25 Apr 2017. 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. Some participants in this study may receive a placebo. 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?
Upper Limb Provocation Test Range of Motion Change (measured in degrees of elbow extension) (time frame: Pre and Immediately Post Intervention). The study lists 2 primary outcomes in all. 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 NCT02842918, which also lists 5 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 25 Apr 2017.