Non-Specific Effects of Manual Therapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Non-Specific Effects of Manual Therapy: A Mixed-Methods Investigation of Contextual and Social Interactions

Conditions
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Musculoskeletal Manipulations, Placebo Effect

Intervention / Treatment
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* Procedure: Spinal Manual Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Upper Limb Provocation Test results with limitation greater than 60 deg of elbow extension at the time of measurement Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gender Match, Labcoat, Explanation<br>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. | Procedure: Spinal Manual Therapy<br>* 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<br>|
| Experimental: Gender Match, Labcoat, No Explanation<br>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. | Procedure: Spinal Manual Therapy<br>* 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<br>|
| Experimental: Gender Match, No Labcoat, Explanation<br>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. | Procedure: Spinal Manual Therapy<br>* 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<br>|
| Experimental: Gender Match, No Labcoat, No Explanation<br>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. | Procedure: Spinal Manual Therapy<br>* 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<br>|
| Experimental: Gender Mis-match, Labcoat, Explanation<br>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. | Procedure: Spinal Manual Therapy<br>* 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<br>|
| Experimental: Gender Mis-match, Labcoat, No Explan.<br>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. | Procedure: Spinal Manual Therapy<br>* 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<br>|
| Experimental: Gender Mis-match, No Labcoat, Explan.<br>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. | Procedure: Spinal Manual Therapy<br>* 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<br>|
| Experimental: Gender Mis-match, No Labcoat, No Explan.<br>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. | Procedure: Spinal Manual Therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and Immediately Post Intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sham, Patient-Therapist Interaction, Non-Specific Effects, Manual Therapy, Neurodynamics