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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04833244
Acronym
MAP
Enrollment
198
Registered
2021-04-06
Start date
2017-05-30
Completion date
2020-12-31
Last updated
2024-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rotator Cuff Injuries

Keywords

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

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.

Interventions

BEHAVIORALTriangular 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.

BEHAVIORALPlacebo

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

Sponsors

Carnegie Mellon University
CollaboratorOTHER
Manhattan Physical Medicine and Rehabilitation, LLP
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes 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.

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Rotator cuff syndrome -

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between facial expression parameters and patient pain-scale ratingsOutcome measured within 1 minute of interventionChanges in facial muscular activity with changes in pain status
Reduction of pain in abduction and flexion following the triangular forearm support. maneuver.Outcome measured within 1 minute of interventionChanges in Likert scale pain scores by patient and examinermaneuver abduction and flexion.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026