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Completed

NCT Number: NCT04833244

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

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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Key information

Conditions

Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cara Cipriano

New York, 10022, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Rotator cuff syndrome -

Exclusion criteria

Psychological or emotional instability

Other orthopedic conditions of the shoulders

Cosmetic facial surgery

-

Treatment and study plan

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.

Other names: Modified Dolphin Pose, Modified Headstand

Placebo

Behavioral

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

Primary outcomes

  1. Correlation between facial expression parameters and patient pain-scale ratings

    Time frame: Outcome measured within 1 minute of intervention

    Changes in facial muscular activity with changes in pain status

  2. Reduction of pain in abduction and flexion following the triangular forearm support. maneuver.

    Time frame: Outcome measured within 1 minute of intervention

    Changes in Likert scale pain scores by patient and examinermaneuver abduction and flexion.

Sponsors and collaborators

Lead sponsor

Manhattan Physical Medicine and Rehabilitation, LLP

Other

Collaborators

  • Carnegie Mellon University

Registry information

Acronym: MAP

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 6, 2021
Registry last updated
May 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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