Non-Specific Effects of Manual Therapy

NCT03017534 | Completed

• 1 other identifier: ShenandoahU (2)
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Musculoskeletal Manipulations; Placebo Effect

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (8)

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.

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.

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.

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.

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.

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.

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.

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.

Procedure: Spinal Manual Therapy

Interventions

Spinal Manual Therapy 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, 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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Upper Limb Provocation Test results with limitation greater than 60 deg of elbow extension at the time of measurement

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenandoah University: lead

Study Sites (1)

Shenandoah University

Winchester, Virginia, 22601, United States

Location

Related Publications (5)

• 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.

  PMID: 22294849 BACKGROUND

• 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.

  PMID: 19027342 BACKGROUND

• 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.

  PMID: 26427530 BACKGROUND

• 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.

  PMID: 27133031 BACKGROUND

• 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.

  PMID: 19119402 RESULT

Study Officials

• Sheri A Hale, PT, PhD, ATC

  Shenandoah University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Division of Physical Therapy

Study Record Dates

• First Submitted: January 9, 2017
• First Posted: January 11, 2017
• Study Start: January 1, 2017
• Primary Completion: May 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 9, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)