Clinical trial NCT02133833: Quantum Spectrum Radiation Emitter for Adhesive Capsulitis
Official title: Quantum Spectrum Radiation Emitter for Adhesive Capsulitis (Frozen Shoulder or Stiff Painful Shoulder): a Prospective, Self-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Shoulder Pain
Lead sponsor: Nanjing Junxie Hospital
Sponsor class: OTHER
First posted: 2014-05-08
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: self-reported pain and function scores
timeFrame: at first day and 3 weeks
measure: The shoulder pain and disability index
timeFrame: at first day and 3 weeks
measure: Croft score
timeFrame: at first day and 3 weeks
measure: DASH score
timeFrame: at first day and 3 weeks
measure: Participant-rated improvement
timeFrame: at first day and 3 weeks
measure: Range of active motion
timeFrame: at first day and 3 weeks
Secondary outcomes:
measure: The health assessment questionnaire
timeFrame: at baseline and three weeks
measure: SF-36
timeFrame: at first day and 3 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Junxie Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Junxie Hosipital
name: Zhu Y Yuan
role: PRINCIPAL_INVESTIGATOR
References: