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

NCT04833244 | Completed

• 1 other identifier: PRO00018713
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Injuries

Keywords

Tree Number(s) C26.761.340 C26.803.063 C26.874.400; Unique ID D000070636

Outcome Measures

Primary Outcomes (2)

• Correlation between facial expression parameters and patient pain-scale ratings

  Changes in facial muscular activity with changes in pain status

  Outcome measured within 1 minute of intervention

• 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.

  Outcome measured within 1 minute of intervention

Study Arms (2)

Interventional

ACTIVE COMPARATOR

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

Control

PLACEBO COMPARATOR

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

Interventions

Triangular Forearm Support 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.

Also known as: Modified Dolphin Pose, Modified Headstand

Interventional

Placebo BEHAVIORAL

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

Control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Rotator cuff syndrome -

You may not qualify if:

• Psychological or emotional instability
• Other orthopedic conditions of the shoulders
• Cosmetic facial surgery

Sponsors & Collaborators

• Manhattan Physical Medicine and Rehabilitation, LLP: lead
• Carnegie Mellon University: collaborator

Study Sites (1)

Cara Cipriano

New York, New York, 10022, United States

Location

Related Publications (1)

• "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.

  BACKGROUND

Related Links

• Article describing efficacy of the TFS maneuver

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: April 6, 2021
• Study Start: May 30, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)