Musculoskeletal ManipulationsNCT03017534
Non-Specific Effects of Manual Therapy
A study testing Spinal Manual Therapy in people with Musculoskeletal Manipulations and Placebo Effect, run by Shenandoah University at 1 site in United States.
Trial summary
The mechanism responsible for improvement following manual physical therapy techniques is unknown. Previous studies have indicated both biomechanical and neurophysiologic effects which may be responsible for clinical changes observed. Yet, other studies report clinical changes following sham interventions. 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, Placebo Effect
- What is being tested?
- Spinal Manual Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Oct 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 greater than 60 deg of elbow 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: Non-Specific Effects of Manual Therapy: A Mixed-Methods Investigation of Contextual and Social Interactions
The mechanism responsible for improvement following manual physical therapy techniques is unknown. Previous studies have indicated both biomechanical and neurophysiologic effects which may be responsible for clinical changes observed. Yet, other studies report clinical changes following sham interventions. Through a mixed-methods design, this study aims to gain more understanding of the social and contextual factors that may be related to the improvement often observed following manual therapy techniques.
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 manual therapy treatment techniques and exclude individuals if necessary. Subjects will be randomized into one of eight groups (three variables, each with two conditions including: therapist gender match/mismatch, lab coat worn/not worn, detailed explanation/colloquial conversation about the technique) and participate in neurodynamic testing for the upper quarter via the Upper Limb Provocation Test. Subjects who are determined to be positive for one or more extremities will receive a sham thoracic spine manipulation technique. After application of the technique, previously positive limbs will be retested. Individuals who respond favorably to the sham technique upon reassessment will participate in an exit interview with open-ended questions in attempt to gain more insight into the factors which may have influenced their neurodynamic mobility improvement.
- Conditions
- Musculoskeletal Manipulations, Placebo Effect
- Being tested
- Spinal Manual Therapy
- Keywords
- Patient-Therapist Interaction, Non-Specific Effects, Manual Therapy, 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
Supine thoracic spine sham manipulation located between the levels of T4-7; identical procedure as an active treatment intervention but without the delivery of a high velocity low amplitude thrust
| Study group | Role | What they receive |
|---|---|---|
| Gender Match, Labcoat, Explanation | Experimental | Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, wearing a labcoat and receive a detailed anatomic explanation of the technique. Receives: Procedure: Spinal Manual Therapy |
| Gender Match, Labcoat, No Explanation | Experimental | Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, wearing a labcoat, and receive a colloquial discussion of the technique. Receives: Procedure: Spinal Manual Therapy |
| Gender Match, No Labcoat, Explanation | Experimental | Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, not wearing a labcoat, and receive a detailed anatomic explanation of the technique. Receives: Procedure: Spinal Manual Therapy |
| Gender Match, No Labcoat, No Explanation | Experimental | Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, not wearing a labcoat, and receive a colloquial discussion of the technique. Receives: Procedure: Spinal Manual Therapy |
| Gender Mis-match, Labcoat, Explanation | Experimental | Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender mis-matched therapist, wearing a labcoat and receive a detailed anatomic explanation of the technique. Receives: Procedure: Spinal Manual Therapy |
| Gender Mis-match, Labcoat, No Explan. | Experimental | Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender mis-matched therapist, wearing a labcoat, and receive a colloquial discussion of the technique. Receives: Procedure: Spinal Manual Therapy |
| Gender Mis-match, No Labcoat, Explan. | Experimental | Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender mis-matched therapist, not wearing a labcoat, and receive a detailed anatomic explanation of the technique. Receives: Procedure: Spinal Manual Therapy |
| Gender Mis-match, No Labcoat, No Explan. | Experimental | Subjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, not wearing a labcoat, and receive a colloquial discussion of the technique. Receives: Procedure: Spinal Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Upper Limb Provocation Test (ULPT)
Subjects will lie on their back with their shoulder slightly off the edge of a treatment table. The investigator will sidebend the subjects neck away from the extremity being tested and gradually move the extremity into the following positions: scapular depression, shoulder 90 deg abduction, shoulder 90 deg external rotation, forearm supination, wrist/finger extension, and elbow extension. The investigator will assess for symptoms at each phase throughout the test. At the onset of symptoms, sensitization maneuvers will be completed to determine if the origin of the symptoms is neurodynamic in nature and not myofascial.
Measured: Baseline and Immediately Post Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMay 2017
- Study completionOct 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
- 24 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, PT, PhD, ATC, Study director, Shenandoah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017534
- Sponsor's protocol ID
- ShenandoahU (2)
- Status last verified
- Oct 2017
- First submitted
- 9 Jan 2017
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bialosky JE, Bishop MD, George SZ, Robinson ME. Placebo response to manual therapy: something out of nothing? J Man Manip Ther. 2011 Feb;19(1):11-9. doi: 10.1179/2042618610Y.0000000001.
PubMed 22294849Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
PubMed 19027342O'Keeffe M, Cullinane P, Hurley J, Leahy I, Bunzli S, O'Sullivan PB, O'Sullivan K. What Influences Patient-Therapist Interactions in Musculoskeletal Physical Therapy? Qualitative Systematic Review and Meta-Synthesis. Phys Ther. 2016 May;96(5):609-22. doi: 10.2522/ptj.20150240. Epub 2015 Oct 1.
PubMed 26427530Testa M, Rossettini G. Enhance placebo, avoid nocebo: How contextual factors affect physiotherapy outcomes. Man Ther. 2016 Aug;24:65-74. doi: 10.1016/j.math.2016.04.006. Epub 2016 Apr 20.
PubMed 27133031Davis 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 19119402
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Specific Effects of Manual Therapy: A Mixed-Methods Investigation of Contextual and Social Interactions
- ClinicalTrials.gov ID
- NCT03017534
- Acronym / sponsor ID
- ShenandoahU (2)
- Conditions
- Musculoskeletal Manipulations, Placebo Effect
- Keywords
- Patient-Therapist Interaction, Non-Specific Effects, Manual Therapy, Neurodynamics, Sham
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Shenandoah UniversityUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 11 Jan 2017 (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 mechanism responsible for improvement following manual physical therapy techniques is unknown. Previous studies have indicated both biomechanical and neurophysiologic effects which may be responsible for clinical changes observed. Yet, other studies report clinical changes following sham interventions. Through a mixed-methods design, this study aims to gain more understanding of the social and contextual factors that may be related to the improvement often observed following manual therapy techniques.
Detailed description
A convenience sample will be utilized to obtain subjects. Subjects will be given a brief questionnaire to identify possible contraindications for manual therapy treatment techniques and exclude individuals if necessary. Subjects will be randomized into one of eight groups (three variables, each with two conditions including: therapist gender match/mismatch, lab coat worn/not worn, detailed explanation/colloquial conversation about the technique) and participate in neurodynamic testing for the upper quarter via the Upper Limb Provocation Test. Subjects who are determined to be positive for one or more extremities will receive a sham thoracic spine manipulation technique. After application of the technique, previously positive limbs will be retested. Individuals who respond favorably to the sham technique upon reassessment will participate in an exit interview with open-ended questions in attempt to gain more insight into the factors which may have influenced their neurodynamic mobility improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Gender Match, Labcoat, Explanation | Experimental | Procedure: Spinal Manual TherapySubjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, wearing a labcoat and receive a detailed anatomic explanation of the technique. |
| Gender Match, Labcoat, No Explanation | Experimental | Procedure: Spinal Manual TherapySubjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, wearing a labcoat, and receive a colloquial discussion of the technique. |
| Gender Match, No Labcoat, Explanation | Experimental | Procedure: Spinal Manual TherapySubjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, not wearing a labcoat, and receive a detailed anatomic explanation of the technique. |
| Gender Match, No Labcoat, No Explanation | Experimental | Procedure: Spinal Manual TherapySubjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, not wearing a labcoat, and receive a colloquial discussion of the technique. |
| Gender Mis-match, Labcoat, Explanation | Experimental | Procedure: Spinal Manual TherapySubjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender mis-matched therapist, wearing a labcoat and receive a detailed anatomic explanation of the technique. |
| Gender Mis-match, Labcoat, No Explan. | Experimental | Procedure: Spinal Manual TherapySubjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender mis-matched therapist, wearing a labcoat, and receive a colloquial discussion of the technique. |
| Gender Mis-match, No Labcoat, Explan. | Experimental | Procedure: Spinal Manual TherapySubjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender mis-matched therapist, not wearing a labcoat, and receive a detailed anatomic explanation of the technique. |
| Gender Mis-match, No Labcoat, No Explan. | Experimental | Procedure: Spinal Manual TherapySubjects will receive Spinal Manual Therapy (sham thoracic spine manipulation) by a gender matched therapist, not wearing a labcoat, and receive a colloquial discussion of the technique. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Upper Limb Provocation Test results with limitation greater than 60 deg of elbow 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 TherapySupine thoracic spine sham manipulation located between the levels of T4-7; identical procedure as an active treatment intervention but without the delivery of a high velocity low amplitude thrust | Procedure or surgery | Gender Match, Labcoat, Explanation, Gender Match, Labcoat, No Explanation, Gender Match, No Labcoat, Explanation, Gender Match, No Labcoat, No Explanation, Gender Mis-match, Labcoat, Explanation, Gender Mis-match, Labcoat, No Explan., Gender Mis-match, No Labcoat, Explan., Gender Mis-match, No Labcoat, No Explan. |
Primary outcome
Change in Upper Limb Provocation Test (ULPT)
Time frame: Baseline and Immediately Post Intervention
Subjects will lie on their back with their shoulder slightly off the edge of a treatment table. The investigator will sidebend the subjects neck away from the extremity being tested and gradually move the extremity into the following positions: scapular depression, shoulder 90 deg abduction, shoulder 90 deg external rotation, forearm supination, wrist/finger extension, and elbow extension. The investigator will assess for symptoms at each phase throughout the test. At the onset of symptoms, sensitization maneuvers will be completed to determine if the origin of the symptoms is neurodynamic in nature and not myofascial.
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 9 Oct 2017.
- Background: PubMed 22294849Bialosky JE, Bishop MD, George SZ, Robinson ME. Placebo response to manual therapy: something out of nothing? J Man Manip Ther. 2011 Feb;19(1):11-9. doi: 10.1179/2042618610Y.0000000001.
- Background: PubMed 19027342Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.
- Background: PubMed 26427530O'Keeffe M, Cullinane P, Hurley J, Leahy I, Bunzli S, O'Sullivan PB, O'Sullivan K. What Influences Patient-Therapist Interactions in Musculoskeletal Physical Therapy? Qualitative Systematic Review and Meta-Synthesis. Phys Ther. 2016 May;96(5):609-22. doi: 10.2522/ptj.20150240. Epub 2015 Oct 1.
- Background: PubMed 27133031Testa M, Rossettini G. Enhance placebo, avoid nocebo: How contextual factors affect physiotherapy outcomes. Man Ther. 2016 Aug;24:65-74. doi: 10.1016/j.math.2016.04.006. Epub 2016 Apr 20.
- 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.
- Individual participant dataSharing planned: No
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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, PT, PhD, 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 in people with Musculoskeletal Manipulations and Placebo Effect, 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 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 9 Oct 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. 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 Upper Limb Provocation Test (ULPT) (time frame: Baseline and Immediately Post Intervention). 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 NCT03017534, 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 9 Oct 2017.