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

Rotator Cuff Injuries Clinical Trial

— MAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04833244
• Other study ID #: PRO00018713
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2021
• Source: Manhattan Physical Medicine and Rehabilitation, LLP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

Rotator cuff syndrome - Exclusion Criteria: Psychological or emotional instability Other orthopedic conditions of the shoulders Cosmetic facial surgery -

Related Conditions & MeSH terms

• Rotator Cuff Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Cara Cipriano	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Manhattan Physical Medicine and Rehabilitation, LLP	Carnegie Mellon University

Country where clinical trial is conducted

United States, 

References & 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   Article describing efficacy of the TFS maneuver