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

Manhattan Physical Medicine and Rehabilitation, LLP

Status: Completed

Conditions: Rotator Cuff Injuries

Treatments: Behavioral: Placebo; Behavioral: Triangular Forearm Support

Study type: Interventional

Funder types: Other

Identifiers

NCT04833244

PRO00018713

Details and patient eligibility

About

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.

Full 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.

Enrollment: 198 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Rotator cuff syndrome -

Exclusion criteria

Psychological or emotional instability

Other orthopedic conditions of the shoulders

Cosmetic facial surgery

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 2 patient groups, including a placebo group

Interventional

Active Comparator group

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.

Treatment:

Behavioral: Triangular Forearm Support

Control

Placebo Comparator group

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.

Treatment:

Behavioral: Placebo