Automatic Multimodal Assessment of Occurrence and Intensity of Pain for Research and Clinical Use

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

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-30

Study Completion Date

2020-12-31

Brief Summary

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170 patients with rotator cuff syndrome will be filmed abducting and flexing their arms before learning a simple maneuver that alleviates most of the pain 90% of the time. They will then be filmed performing the same abduction and flexion of their arms. The patients will rate their pain on the common 10-point pain scale after abducting and flexing their arms before and after the maneuver.

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Detailed Description

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Facial expression and truncal metrics correlate strongly with occurrence and intensity of pain. Rotator cuff syndrome almost invariably gives significant pain, especially with abduction and flexion of the arms. A simple maneuver that alleviates that pain 90% of the time, by activating the subscapularis to perform the function of the damaged supraspinatus muscle. This study strives to correlate facial and truncal characteristics with the ten-point pain scale by correlating the filmed changes in facial and truncal characteristics with the variations in patient-rated pain before and after the pain-controlling maneuver.

Once effective, the maneuver may be repeated for a number of days, after which time patients generally remain pain-free permanently.

Conditions

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Rotator Cuff Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomized, controlled study in which the patient and investigator are blinded.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

After qualifying, patients are randomized into intervention or control groups. The investigator and care provider then film the patient, teach the interventional or sham maneuver, and film the patient again. The outcomes assessor then evaluates the patient responses and filmed behaviors, but is not informed about whether the patient received the interventional maneuver or the sham maneuver.

Study Groups

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Interventional

Patients are taught to draw their shoulders away from their heads and necks, activating the subscapularis and pectoralis muscles. When asked immediately afterwards to abduct and flex their shoulders, these muscles perform the action that generally engages the injured supraspinatus muscle, causing significant pain. However, when these muscles are substituted for the injured supraspinatus, abduction and flexion subsequently occur painlessly.

Group Type ACTIVE_COMPARATOR

Triangular Forearm Support

Intervention Type BEHAVIORAL

The intervention, the Triangular Forearm Support requires drawing the shoulders away from the subject's head and neck. This requires at least a mild force that this action can oppose. The most-favored maneuver is to have patients stand 2 feet away from a wall, interlock their fingers, and place their forearms to form two sides of an equilateral triangle against the wall. They then place their heads within the triangle, the backs of their heads close to or in on contact with the heels of their hands. Then, pressing against the wall with their elbows and forearms, they draw their shoulders as far away from the wall as possible, retaining contact between the wall and the tops of their heads. Subjects remain in this position for 45 seconds, at which time they stand erect and repeat the abduction and flexion maneuver.

Control

Patients are taught a sham maneuver that does little or nothing to alleviate the pain of abduction and flexion of the shoulders. Therefore their pain levels before and after learning the maneuver are likely to be similar.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BEHAVIORAL

Patients will be asked to raise arms overhead for 45 seconds.

Interventions

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Triangular Forearm Support

The intervention, the Triangular Forearm Support requires drawing the shoulders away from the subject's head and neck. This requires at least a mild force that this action can oppose. The most-favored maneuver is to have patients stand 2 feet away from a wall, interlock their fingers, and place their forearms to form two sides of an equilateral triangle against the wall. They then place their heads within the triangle, the backs of their heads close to or in on contact with the heels of their hands. Then, pressing against the wall with their elbows and forearms, they draw their shoulders as far away from the wall as possible, retaining contact between the wall and the tops of their heads. Subjects remain in this position for 45 seconds, at which time they stand erect and repeat the abduction and flexion maneuver.

Intervention Type BEHAVIORAL