Quantum Spectrum Radiation Emitter for Adhesive Capsulitis

Shoulder Pain Clinical Trial

Official title:

Quantum Spectrum Radiation Emitter for Adhesive Capsulitis (Frozen Shoulder or Stiff Painful Shoulder): a Prospective, Self-controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02133833
• Other study ID #: 11zyy
• Status: Recruiting
• Phase: Phase 1
• First received: March 27, 2014
• Last updated: July 3, 2014
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: July 2014
• Source: Nanjing Junxie Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Junxie Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Junxie Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	self-reported pain and function scores	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.	at first day and 3 weeks	No
Primary	The shoulder pain and disability index	The shoulder pain and disability index (SPADI) is calculated by summing and then averaging the items of the two subscales.	at first day and 3 weeks	No
Primary	Croft score	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.	at first day and 3 weeks	No
Primary	DASH score	The"disabilities arm shoulder and hand"(DASH) questionnaire has 30 items relating to functional activities and symptoms.	at first day and 3 weeks	No
Primary	Participant-rated improvement	Participant-rated improvement using a five point categorical scale (marked improvement, moderate improvement, the same, moderate worsening, marked worsening).	at first day and 3 weeks	No
Primary	Range of active motion	A standardised protocol is used to measure active total shoulder flexion and abduction.	at first day and 3 weeks	No
Secondary	The health assessment questionnaire	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).	at baseline and three weeks	No
Secondary	SF-36	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.	at first day and 3 weeks	No