Non-Specific Effects of Manual Therapy

NCT ID: NCT03017534

Last Updated: 2017-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-10-31

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.

Conditions

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Musculoskeletal Manipulations Placebo Effect

Keywords

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Patient-Therapist Interaction Non-Specific Effects Manual Therapy Neurodynamics Sham

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Spinal Manual Therapy

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Spinal Manual Therapy

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Spinal Manual Therapy

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Spinal Manual Therapy

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Spinal Manual Therapy

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Spinal Manual Therapy

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Spinal Manual Therapy

Intervention Type PROCEDURE

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

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.

Group Type EXPERIMENTAL

Spinal Manual Therapy

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shenandoah University

OTHER

Sponsor Role lead

Responsible Party

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Aaron Hartstein

Assistant Professor, Division of Physical Therapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sheri A Hale, PT, PhD, ATC

Role: STUDY_DIRECTOR

Shenandoah University

Locations

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Shenandoah University

Winchester, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22294849 (View on PubMed)

Bialosky 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.

Reference Type BACKGROUND
PMID: 19027342 (View on PubMed)

O'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.

Reference Type BACKGROUND
PMID: 26427530 (View on PubMed)

Testa 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.

Reference Type BACKGROUND
PMID: 27133031 (View on PubMed)

Davis 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.

Reference Type RESULT
PMID: 19119402 (View on PubMed)

Other Identifiers

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ShenandoahU (2)

Identifier Type: -

Identifier Source: org_study_id