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

Sponsor

Manhattan Physical Medicine and Rehabilitation, LLP (Other)

Overall Status

Completed

CT.gov ID

NCT04833244

Collaborator

Carnegie Mellon University (Other)

198

Enrollment

Location

Arms

Actual Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Injuries	Behavioral: Triangular Forearm Support Behavioral: Placebo	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

198 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

May 1, 2017

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: 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. Other Names: Modified Dolphin Pose, Modified Headstand
Placebo Comparator: 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.	Behavioral: Placebo Patients will be asked to raise arms overhead for 45 seconds.

Arm

Intervention/Treatment

Active Comparator: 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.

Behavioral: 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.

Other Names:

Modified Dolphin Pose, Modified Headstand

Placebo Comparator: 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.

Behavioral: Placebo

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

Outcome Measures

Primary Outcome Measures

Correlation between facial expression parameters and patient pain-scale ratings [Outcome measured within 1 minute of intervention]
Changes in facial muscular activity with changes in pain status
Reduction of pain in abduction and flexion following the triangular forearm support. maneuver. [Outcome measured within 1 minute of intervention]
Changes in Likert scale pain scores by patient and examinermaneuver abduction and flexion.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Rotator cuff syndrome -

Exclusion Criteria:

Psychological or emotional instability

Other orthopedic conditions of the shoulders

Cosmetic facial surgery

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cara Cipriano	New York	New York	United States	10022

Sponsors and Collaborators

Manhattan Physical Medicine and Rehabilitation, LLP
Carnegie Mellon University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Article describing efficacy of the TFS maneuver

Publications

"Yoga-Based Maneuver Effectively Treats Rotator Cuff Syndrome." Fishman, Loren M.; Wilkins, Allen N.; Ovadia, Tova; Topics in Geriatric Rehabilitation . 27(2):151-161, April/June 2011.

Responsible Party:

Manhattan Physical Medicine and Rehabilitation, LLP

ClinicalTrials.gov Identifier:

NCT04833244

Other Study ID Numbers:

PRO00018713

First Posted:

Apr 6, 2021

Last Update Posted:

Apr 6, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Manhattan Physical Medicine and Rehabilitation, LLP

Tree Number(s) C26.761.340 C26.803.063 C26.874.400

Unique ID D000070636

Additional relevant MeSH terms:

Rotator Cuff Injuries

Study Results

No Results Posted as of Apr 6, 2021