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Quantum Spectrum Radiation Emitter for Adhesive Capsulitis

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ClinicalTrials.gov Identifier: NCT02133833
Recruitment Status : Unknown
Verified July 2014 by Nanjing Junxie Hospital.
Recruitment status was:  Recruiting
First Posted : May 8, 2014
Last Update Posted : July 4, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Device: Quantum Spectrum Radiation Emitter Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quantum Spectrum Radiation Emitter for Adhesive Capsulitis (Frozen Shoulder or Stiff Painful Shoulder): a Prospective, Self-controlled Trial
Study Start Date : July 2014
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: Quantum Spectrum Radiation Emitter
five pieces of Quantum Spectrum Radiation Emitter will be placed on the affected shoulder daily for three weeks.
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.
Other Name: Brand names: Bio-Qi




Primary Outcome Measures :
  1. self-reported pain and function scores [ Time Frame: 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.

  2. The shoulder pain and disability index [ Time Frame: 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.

  3. Croft score [ Time Frame: 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.

  4. DASH score [ Time Frame: at first day and 3 weeks ]
    The"disabilities arm shoulder and hand"(DASH) questionnaire has 30 items relating to functional activities and symptoms.

  5. Participant-rated improvement [ Time Frame: 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).

  6. Range of active motion [ Time Frame: at first day and 3 weeks ]
    A standardised protocol is used to measure active total shoulder flexion and abduction.


Secondary Outcome Measures :
  1. The health assessment questionnaire [ Time Frame: 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).

  2. SF-36 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02133833


Locations
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China, Jiangsu
Junxie Hospital Recruiting
Nanjing, Jiangsu, China
Contact: Zhu Y yuan    025-80865003    zyy86yy@sina.com   
Principal Investigator: Zhu Y Yuan         
Sponsors and Collaborators
Nanjing Junxie Hospital
Investigators
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Principal Investigator: Zhu Y Yuan Nanjing Junxie Hosipital

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Responsible Party: Nanjing Junxie Hospital
ClinicalTrials.gov Identifier: NCT02133833     History of Changes
Other Study ID Numbers: 11zyy
First Posted: May 8, 2014    Key Record Dates
Last Update Posted: July 4, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
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Shoulder Pain
Bursitis
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms