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Non-Specific Effects of Manual Therapy

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ClinicalTrials.gov Identifier: NCT03017534
Recruitment Status : Completed
First Posted : January 11, 2017
Last Update Posted : October 9, 2017
Sponsor:
Information provided by (Responsible Party):
Aaron Hartstein, Shenandoah University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Musculoskeletal Manipulations Placebo Effect Procedure: Spinal Manual Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Non-Specific Effects of Manual Therapy: A Mixed-Methods Investigation of Contextual and Social Interactions
Actual Study Start Date : January 2017
Actual Primary Completion Date : May 2017
Actual Study Completion Date : October 2017

Arm Intervention/treatment
Experimental: Gender Match, Labcoat, Explanation
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
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

Experimental: Gender Match, Labcoat, No Explanation
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
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

Experimental: Gender Match, No Labcoat, Explanation
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
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

Experimental: Gender Match, No Labcoat, No Explanation
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
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

Experimental: Gender Mis-match, Labcoat, Explanation
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
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

Experimental: Gender Mis-match, Labcoat, No Explan.
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
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

Experimental: Gender Mis-match, No Labcoat, Explan.
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
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

Experimental: Gender Mis-match, No Labcoat, No Explan.
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
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017534


Locations
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United States, Virginia
Shenandoah University
Winchester, Virginia, United States, 22601
Sponsors and Collaborators
Shenandoah University
Investigators
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Study Director: Sheri A Hale, PT, PhD, ATC Shenandoah University

Publications of Results:
Other Publications:
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Responsible Party: Aaron Hartstein, Assistant Professor, Division of Physical Therapy, Shenandoah University
ClinicalTrials.gov Identifier: NCT03017534     History of Changes
Other Study ID Numbers: ShenandoahU (2)
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: October 9, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Aaron Hartstein, Shenandoah University:
Patient-Therapist Interaction
Non-Specific Effects
Manual Therapy
Neurodynamics
Sham