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OpenTrials
Completed

NCT Number: NCT03017534

Non-Specific Effects of Manual Therapy

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shenandoah University

Winchester, Virginia, 22601, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Shenandoah University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2017
Registry last updated
Oct 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.