Clinical trial NCT04747938: Frozen Shoulder Treated by Energy Accumulator
Official title: Treating Frozen Shoulder With Integrative Medicine Approach by the Energy Accumulator - a Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frozen Shoulder
Keywords: Frozen Shoulder
Integrative Medicine
Energy Accumulator
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Frozen shoulder is a painful and disabling disorder of unclear cause, affecting middle-age people after their 5th decades. They suffer from annoying pain and limited shoulder mobility. Energy Accumulator provides a better way of relief through an integrative medicine concept.

Detailed description: Frozen shoulder is common among middle-aged persons in the 5th and 6th decades. The pain can be acute or chronic. Patients feel stiffness over the shoulder, shown by restriction in range of motion. The etiology includes trauma, cervical disc degeneration, physical strain, psychosocial problems and even genetic factors. The predisposing factors include immobilization of the arm for a long time, rotator cuff or biceps tendinitis, tenosynovitis of the long head of the biceps, congenital deformity of the shoulder girdle, scapula-costal cementing, ligamentous injury, osteoarthritis, muscular fibrosis or nutritional deficiencies. The pathology is unclear but it is widely believed that it is related to inflammation in the joint and surrounding soft tissues which lead to fibrosis. Frozen Shoulder can be divided into Primary Frozen Shoulder which occurs spontaneously without other diseases; and Secondary Frozen Shoulder is associated with joint diseases, such as osteoarthritis or fractures.

UKFROST was a multi-centre randomized clinical trial comparing 3 parallel groups (arms) of frozen shoulder patients treated 1) under anaesthesia + steroid injection 2) under anaesthesia + arthoscopy, and 3) physiotherapy + steriod injection..The large-scale study proves physiotherapy program beneficial to frozen shoulder patients, and, the effectiveness might further improve by introducing East-Meets-West component - Chinese Medicine.

Eligibility criteria: Inclusion Criteria:

* male or female gender with age between 40-65
* affect one shoulder only
* onset is more than 3 months at the time of inclusion into the study

Exclusion Criteria:

* unstable medical conditions
* unstable mental state
* have skin lesion over the shoulder
* skin sensitivity to heat
* pregnant or under lactation
* could not comply with heat treatment of the shoulder.

Primary outcomes:
measure: Visual Analogue Scale (10-point Likert scale)
timeFrame: Baseline
measure: Visual Analogue Scale (10-point Likert scale)
timeFrame: 4 weeks
measure: Oxford Shoulder Score (OSS)
timeFrame: Baseline
measure: Oxford Shoulder Score (OSS)
timeFrame: 4 weeks
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: 4 weeks
measure: Short Form-12 (SF-12)
timeFrame: Baseline
measure: Short Form-12 (SF-12)
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
measure: Range of motion
timeFrame: Baseline
measure: Range of motion
timeFrame: 4 weeks
Locations:
Study officials:
affiliation: Chinese Univerisity of Hong Kong
name: Kevin Ki-Wai Ho, Dr.
role: PRINCIPAL_INVESTIGATOR
References: