search
Back to results

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

Primary Purpose

Rotator Cuff Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Triangular Forearm Support
Placebo
Sponsored by
Manhattan Physical Medicine and Rehabilitation, LLP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rotator Cuff Injuries focused on measuring Tree Number(s) C26.761.340 C26.803.063 C26.874.400, Unique ID D000070636

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Rotator cuff syndrome -

Exclusion Criteria:

Psychological or emotional instability

Other orthopedic conditions of the shoulders

Cosmetic facial surgery

-

Sites / Locations

  • Cara Cipriano

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Interventional

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 7, 2017
Last Updated
April 3, 2021
Sponsor
Manhattan Physical Medicine and Rehabilitation, LLP
Collaborators
Carnegie Mellon University
search

1. Study Identification

Unique Protocol Identification Number
NCT04833244
Brief Title
Automatic Multimodal Assessment of Occurrence and Intensity of Pain for Research and Clinical Use
Acronym
MAP
Official Title
Automatic Multimodal Assessment of Occurrence and Intensity of Pain for Research and Clinical Use
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Manhattan Physical Medicine and Rehabilitation, LLP
Collaborators
Carnegie Mellon University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Injuries
Keywords
Tree Number(s) C26.761.340 C26.803.063 C26.874.400, Unique ID D000070636

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized, controlled study in which the patient and investigator are blinded.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interventional
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Triangular Forearm Support
Other Intervention Name(s)
Modified Dolphin Pose, Modified Headstand
Intervention Description
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
Intervention Name(s)
Placebo
Intervention Description
Patients will be asked to raise arms overhead for 45 seconds.
Primary Outcome Measure Information:
Title
Correlation between facial expression parameters and patient pain-scale ratings
Description
Changes in facial muscular activity with changes in pain status
Time Frame
Outcome measured within 1 minute of intervention
Title
Reduction of pain in abduction and flexion following the triangular forearm support. maneuver.
Description
Changes in Likert scale pain scores by patient and examinermaneuver abduction and flexion.
Time Frame
Outcome measured within 1 minute of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Rotator cuff syndrome - Exclusion Criteria: Psychological or emotional instability Other orthopedic conditions of the shoulders Cosmetic facial surgery -
Facility Information:
Facility Name
Cara Cipriano
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
"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.
Results Reference
background
Links:
URL
http://journals.lww.com/topicsingeriatricrehabilitation/pages/results.aspx?txtkeywords=a+simple+maneuver
Description
Article describing efficacy of the TFS maneuver

Learn more about this trial

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

We'll reach out to this number within 24 hrs