Non-Specific Effects of Manual Therapy

Not Applicable

Completed

• Conditions: Musculoskeletal Manipulations; Placebo Effect
• Interventions: Procedure: Spinal Manual Therapy

• Registration Number: NCT03017534
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-09
• Study First Submitted QC: 2017-01-10
• Study First Posted: 2017-01-11
• Primary Completion: 2017-05
• Status Verified: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-06
• Last Update Posted: 2017-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gender Match, Labcoat, No Explanation	Spinal Manual Therapy	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.
Gender Mis-match, No Labcoat, No Explan.	Spinal Manual Therapy	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.
Gender Match, Labcoat, Explanation	Spinal Manual Therapy	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.
Gender Mis-match, Labcoat, Explanation	Spinal Manual Therapy	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.
Gender Mis-match, Labcoat, No Explan.	Spinal Manual Therapy	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.
Gender Match, No Labcoat, No Explanation	Spinal Manual Therapy	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.
Gender Mis-match, No Labcoat, Explan.	Spinal Manual Therapy	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.
Gender Match, No Labcoat, Explanation	Spinal Manual Therapy	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.

Primary Outcome Measures

Name	Time	Method
Change in Upper Limb Provocation Test (ULPT)	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.

Trial Locations

Locations (1)

Shenandoah University; 🇺🇸 Winchester, Virginia, United States