Quantum Spectrum Radiation Emitter for Adhesive Capsulitis

NCT ID: NCT02133833

Last Updated: 2014-07-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2014-12-31

Brief Summary

This is a prospective, self-controlled study to evaluate the efficacy of the Quantum spectrum radiation emitter for adhesive capsulitis.

Detailed Description

Adhesive capsulitis (also termed frozen shoulder, stiff painful shoulder, or periarthritis) is a common cause of shoulder pain estimated to affect 2-5% of the general population.

The disorder is characterized by spontaneous onset of shoulder pain and progressive global stiffness of the glenohumeral joint accompanied by significant disability. Most studies have suggested a self-limiting condition lasting an average of two to three years, although significant numbers of people have residual clinically detectable restriction of movement beyond three years, and smaller numbers have residual disability.

Many interventions have been advocated for the treatment of adhesive capsulitis, although only limited data from randomised controlled trials are available. In addition, there are not enough data to either support or refute the efficacy of any of the commonly used interventions for this condition, including non-steroidal anti-inflammatory drugs, corticosteroid injections, and physiotherapy. Oral steroids were first advocated in the 1950s, with claims that they expedited recovery and reduced the need for manipulation under anaesthesia. However, these medications are associated with many adverse reactions.

The aims of this study are to determine whether three weeks' treatment with quantum spectrum radiation emitter in patients with adhesive capsulitis is effective for improving pain, function, and range of motion.

Conditions

Shoulder Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Quantum Spectrum Radiation Emitter

five pieces of Quantum Spectrum Radiation Emitter will be placed on the affected shoulder daily for three weeks.

Group Type: EXPERIMENTAL

Quantum Spectrum Radiation Emitter

Intervention Type: DEVICE

The patients receive stimulation treatment of Quantum Spectrum Radiation Emitter (5 quantum chips) daily for three weeks. The emitters are placed around the shoulder.

Interventions

Quantum Spectrum Radiation Emitter

The patients receive stimulation treatment of Quantum Spectrum Radiation Emitter (5 quantum chips) daily for three weeks. The emitters are placed around the shoulder.

Intervention Type: DEVICE

Other Intervention Names

Brand names: Bio-Qi

Eligibility Criteria

Inclusion Criteria

• ability to provide written informed consent
• over 18 years old
• with pain and stiffness in one shoulder predominantly for three weeks or more
• restriction of passive motion in at least one shoulder by more than 30˚ in two or more planes of movement, measured at the time of the onset of pain with a gravity inclinometer.

Exclusion Criteria

• hypertensive patients
• patients with cardiac arrhythmias
• patients with epilepsy
• patients with pacemakers, hearing aids or other electronic components
• pregnant patients
• patients with radiological evidence of osteoarthritis of the shoulder or fracture;calcification about the shoulder joint;reason to suspect a complete rotator cuff tear (weakness of arm elevation, a positive"drop arm sign", a high riding humerus visible on X ray of the shoulder or demonstration of a complete rotator cuff tear on ultrasound)
• patients likely not to comply with follow up (for example, living too far away to attend for follow-up assessment, or indicating they would be unable or unwilling to attend for outcome assessment)
• patients without written informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Junxie Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhu Y Yuan

Role: PRINCIPAL_INVESTIGATOR

Nanjing Junxie Hosipital

Locations

Junxie Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Zhu Y yuan

Role: primary

zyy86yy@sina.com

025-80865003

Other Identifiers

11zyy

Identifier Type: -

Identifier Source: org_study_id