Quantum Spectrum Radiation Emitter for Adhesive Capsulitis

Phase 1

• Conditions: Shoulder Pain

• Registration Number: NCT02133833
• Lead Sponsor: Nanjing Junxie Hospital

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.

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-05-06
• Study First Posted: 2014-05-08
• Status Verified: 2014-07
• Study Start: 2014-07
• Last Update Submitted: 2014-07-03
• Last Update Posted: 2014-07-04
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
self-reported pain and function scores	at first day and 3 weeks	Participants' overall assessment of pain, night pain, and activity related pain are each measured using a vertical Likert scale labelled"no pain"( = 0) at the bottom and"maximum imaginable pain"( = 10) at the top.
Croft score	at first day and 3 weeks	The Croft shoulder disability questionnaire are recorded as a yes or a no, and the number of positive responses is summated to give a score out of 22.
Range of active motion	at first day and 3 weeks	A standardised protocol is used to measure active total shoulder flexion and abduction.
The shoulder pain and disability index	at first day and 3 weeks	The shoulder pain and disability index (SPADI) is calculated by summing and then averaging the items of the two subscales.
DASH score	at first day and 3 weeks	The"disabilities arm shoulder and hand"(DASH) questionnaire has 30 items relating to functional activities and symptoms.
Participant-rated improvement	at first day and 3 weeks	Participant-rated improvement using a five point categorical scale (marked improvement, moderate improvement, the same, moderate worsening, marked worsening).

Secondary Outcome Measures

Name	Time	Method
SF-36	at first day and 3 weeks	The short form 36 item health survey (SF-36) is a self administered, 36 item generic indicator of health status which consists of eight subscales representing eight dimensions of quality of life: physical function, role limitations because of physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations because of emotional problems, and general mental health. Each of the eight subscales is rescaled from 0-100; higher scores represent better health.
The health assessment questionnaire	at baseline and three weeks	The health assessment questionnaire (HAQ) is a well validated, 9-item, arthritis specific functional assessment measure and asks about two or three fixed items in eight areas of daily life. The disability score is between 0 (no disability) and 3 (highest disability).

Trial Locations

Locations (1)

Junxie Hospital; 🇨🇳 Nanjing, Jiangsu, China