Quantum Spectrum Radiation Emitter for Adhesive Capsulitis

NCT02133833 | Unknown Phase 1

• 1 other identifier: 11zyy
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• Range of active motion

  A standardised protocol is used to measure active total shoulder flexion and abduction.

  at first day and 3 weeks

Secondary Outcomes (2)

• The health assessment questionnaire

  at baseline and three weeks

• SF-36

  at first day and 3 weeks

Study Arms (1)

Quantum Spectrum Radiation Emitter

EXPERIMENTAL

five pieces of Quantum Spectrum Radiation Emitter will be placed on the affected shoulder daily for three weeks.

Device: Quantum Spectrum Radiation Emitter

Interventions

Quantum Spectrum Radiation Emitter DEVICE

The patients receive stimulation treatment of Quantum Spectrum Radiation Emitter (5 quantum chips) daily for three weeks. The emitters are placed around the shoulder.

Also known as: Brand names: Bio-Qi

Quantum Spectrum Radiation Emitter

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing Junxie Hospital: lead

Study Sites (1)

Junxie Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhu Y Yuan

  Nanjing Junxie Hosipital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: May 8, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 4, 2014

Record last verified: 2014-07

Locations

CN (1)