Automated Connective Tissue Torque Sensor (StromaTorque)

Stromatec

Status: Completed

Conditions: Musculoskeletal Pain; Connective Tissue

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT01570647

R44AT004379

Details and patient eligibility

About

The purpose of this study is to develop a measure - the needle torque test - capable of detecting connective tissue abnormalities associated with musculoskeletal disorders.

Full description

Chronic musculoskeletal pain is a source of considerable disability, work absenteeism and health care costs. A major obstacle to the treatment of these conditions is the lack of methods to objectively assess connective tissues and measure the effect of treatments. Needle torque test technology under development in this project will potentially enable objective measurement of connective tissue abnormalities associated with musculoskeletal pain and dysfunction. This could help evaluate the efficacy of various treatments and enhance the objective monitoring of patient progress in clinical practice.

Enrollment: 165 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for chronic low back pain subjects:

• back pain that has disrupted activity for more than half the days in the past 12 months.

Inclusion Criteria for restricted hamstring subjects:

• 90/90 test of more than 20 degrees

Inclusion Criteria for systemic scleroderma subjects:

• physician diagnosis

Inclusion criteria for joint hyperlaxity subjects:

• Beighton test score of 7 or higher

Exclusion Criteria for all subjects:

• surgery or scars in thighs or low back
• neurological or major psychiatric disorder
• bleeding disorders
• acute systemic infection
• pregnancy

Trial design

165 participants in 5 patient groups

Healthy controls

Chronic low back pain

restricted hamstrings

systemic scleroderma

joint hyperlaxity