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
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Pain||Device: Quantum Spectrum Radiation Emitter||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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).
- 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.
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
|Nanjing, Jiangsu, China|
|Contact: Zhu Y yuan 025-80865003 firstname.lastname@example.org|
|Principal Investigator: Zhu Y Yuan|
|Principal Investigator:||Zhu Y Yuan||Nanjing Junxie Hosipital|