Acupuncture for Treatment of Frozen Shoulder Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-12-31

Brief Summary

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Disability of upper limbs due to neurologic and orthopedic disorder or injuries is commonly seen clinically. For example paralysis or paresis of upper limb due to stroke is relatively prevalent, and it may result in severe muscle weakness, pain, contracture, spasticity and disability. These patients need early and regular rehabilitation to regain their function and prevent unnecessary complications such as contracture and disuse atrophy. Proper rehabilitation is important but the challenge is also great. However, rehabilitation training is a very labor-intensive task in which one to one treatment is essential and that will restrict the number of patients served. Moreover, patients receiving home programs are difficult to supervise, resulting in reduced training effect and delayed functional recovery. In order to reduce related cost (including time, personnel, facilities, and expense, etc.) of rehabilitation in hospitals or clinics, this Robot research team had developed a prototype of upper-limb exoskeleton rehabilitation robot and its related technology and human-robot interaction. This robot is used to serve the rehabilitation need of those patients suffering from upper extremities dysfunctions and also can provide careful designed therapeutic program of upper limbs including shoulder and elbow joint exercises. Its control software also provides a therapeutic management system with intelligence and ergonomic consideration. This work was funded by National Taiwan University Hospital (NTUH) since 2008 and has applied for both the U.S. and Taiwan (ROC) patents, where the latter has been approved in Nov. 2011. The clinical trial was firstly approved by Research Ethics Committee B of NTUH in 2009 and finally approved by Department of Health (DOH) in April 2011. This team had completed the clinical trial for healthy subjects and pre-clinical trial for stroke patients. Based upon this experience an innovative and intelligent SMART Robot Rehabilitation System for Frozen Shoulder Syndrome is proposed to prove its safety, efficacy, and cost-effectiveness.

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Detailed Description

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In the first year, the robot was under construction and was not involved in the clinical trial.

Conditions

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Adhesive Capsulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Electroacupuncture

Electroacupuncture and physical therapy

Group Type EXPERIMENTAL

Electroacupuncture and physical therapy

Intervention Type OTHER

real electroacupuncture

Sham-electroacupuncture

Sham-electroacupuncture and physical therapy

Group Type SHAM_COMPARATOR

Sham-electroacupuncture and physical therapy

Intervention Type OTHER

Sham electroacupuncture

Interventions

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Electroacupuncture and physical therapy

real electroacupuncture

Intervention Type OTHER

Sham-electroacupuncture and physical therapy

Sham electroacupuncture

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age from 20 to 65 years old
2. Diagnosis as adhesive capsulitis

Exclusion Criteria

1. History of humeral fracture or trauma event around shoulder girdle
2. Central nervous system disease
3. Shockwave or injection therapy at shoulder joint in past 6 months
4. History or planning for operation at shoulder girdle

Subject within our criteria will receive both examination with ultrasound and treatment, however, there is some limitations for subjects who will be approved examination at shoulder girdle with magnetic resonance imaging:

1. Claustrophobia
2. Metal implant (Pacemaker, artificial valve prosthesis, implantable cardioverter defibrillator, nerve stimulator, in vivo drugs delivery system, intraocular implant, cochlear implants, Swan-Ganz catheter, arterial clips, bullets or metal fragments)
3. Renal insufficiency (Estimated creatinine clearance \< 90 mL/min)
4. Pregnancy and breast milk feeding

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No