Quantum Spectrum Radiation Emitter for Adhesive Capsulitis
Primary Purpose
Shoulder Pain
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Quantum Spectrum Radiation Emitter
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Pain
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.
Sites / Locations
- Junxie HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Quantum Spectrum Radiation Emitter
Arm Description
five pieces of Quantum Spectrum Radiation Emitter will be placed on the affected shoulder daily for three weeks.
Outcomes
Primary Outcome Measures
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.
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.
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.
DASH score
The"disabilities arm shoulder and hand"(DASH) questionnaire has 30 items relating to functional activities and symptoms.
Participant-rated improvement
Participant-rated improvement using a five point categorical scale (marked improvement, moderate improvement, the same, moderate worsening, marked worsening).
Range of active motion
A standardised protocol is used to measure active total shoulder flexion and abduction.
Secondary Outcome Measures
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02133833
Brief Title
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
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing Junxie Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
N/A
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quantum Spectrum Radiation Emitter
Arm Type
Experimental
Arm Description
five pieces of Quantum Spectrum Radiation Emitter will be placed on the affected shoulder daily for three weeks.
Intervention Type
Device
Intervention Name(s)
Quantum Spectrum Radiation Emitter
Other Intervention Name(s)
Brand names: Bio-Qi
Intervention Description
The patients receive stimulation treatment of Quantum Spectrum Radiation Emitter (5 quantum chips) daily for three weeks. The emitters are placed around the shoulder.
Primary Outcome Measure Information:
Title
self-reported pain and function scores
Description
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.
Time Frame
at first day and 3 weeks
Title
The shoulder pain and disability index
Description
The shoulder pain and disability index (SPADI) is calculated by summing and then averaging the items of the two subscales.
Time Frame
at first day and 3 weeks
Title
Croft score
Description
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.
Time Frame
at first day and 3 weeks
Title
DASH score
Description
The"disabilities arm shoulder and hand"(DASH) questionnaire has 30 items relating to functional activities and symptoms.
Time Frame
at first day and 3 weeks
Title
Participant-rated improvement
Description
Participant-rated improvement using a five point categorical scale (marked improvement, moderate improvement, the same, moderate worsening, marked worsening).
Time Frame
at first day and 3 weeks
Title
Range of active motion
Description
A standardised protocol is used to measure active total shoulder flexion and abduction.
Time Frame
at first day and 3 weeks
Secondary Outcome Measure Information:
Title
The health assessment questionnaire
Description
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).
Time Frame
at baseline and three weeks
Title
SF-36
Description
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.
Time Frame
at first day and 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhu Y Yuan
Organizational Affiliation
Nanjing Junxie Hosipital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Junxie Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhu Y yuan
Phone
025-80865003
Email
zyy86yy@sina.com
First Name & Middle Initial & Last Name & Degree
Zhu Y Yuan
12. IPD Sharing Statement
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Quantum Spectrum Radiation Emitter for Adhesive Capsulitis
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