Frozen Shoulder, Adhesive Capsulitis
Conditions
Keywords
Adhesive capsulitis, Frozen shoulder, Shoulder pain, Intra-articular injection, Lidocaine injection, Physiotherapy, Manipulation, Stretch exercise
Brief summary
1. Therapeutic exercise, especially stretch exercise and joint mobilization, remain the mainstay of conservative treatment of frozen shoulder. 1. Nevertheless, shoulder pain during the physiotherapy reduces the treatment effect. 2. Manipulation or arthroscopic release under general anesthesia may avoid pain during the intervention; however, increased risk of humeral shaft fracture and failure of release of pathological tissue were reported. 2. We consider intra-articular injection is a compromized way, from a practical point of veiw, to reduce the pain during physiotherapy. 3. We hypothesize that, intra-articular injection with lidocaine before joint mobilization and stretch exercise, can make the patient pain-free during physiotherapy, and the effect of combined therapy is superior to physiotherapy alone in the treatment of frozen shoulder.
Detailed description
A randomized controlled trial to compare the effect in treatment of frozen shoulder between combined intra-articular injection with lidocaine plus physiotherapy and physiotherapy alone.
Interventions
PROCEDURELidocaine group
* Patient position: prone position with arm under the abdomen and the elbow flexed to a right angle * Injection with a 25-gauge, 1.5-inch long needle fitted with 3ml syringe filled with 3ml 1% lidocaine.
OTHERPhysiotherapy (PT)
\- Include electric therapy, hot pack, followed by stretch exercise and joint mobilization
Sponsors
Shin Kong Wu Ho-Su Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Clinically diagnosed as unilateral frozen shoulder, with the definition as more than 50% loss of passive movement of the shoulder joint relative to the non-affected side, in one or more of the three movement direction (ie. abduction in the frontal plane, forward flexion in sagittal plane, or external rotation in 0 degree of abduction) * Duration of complaints of more than three months * Ability to complete questionnaires in Chinese
Exclusion criteria
* History of shoulder fracture, dislocation, or trauma * History of Rheumatic arthritis, tumor, or other diseases in the shoulder joints * Receive intra-articular corticosteroid injection or manipulation therapy in shoulder joint in recent four weeks * Pregnancy or breast feeding * Allergic to lidocaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in range of motion at 3-months intervention | baseline; 1 month; 2 months; 3 months | * Measured with a conventional goniometer by a physiotherapist, both active and passive range of motion * Including shoulder flexion, abduction, internal rotation, and external rotation * All measurements will be rounded off to the nearest five degrees |
| Change from Baseline in range of motion at 3 months post-intervention | baseline; 1 and 3 months after completion | * Measured with a conventional goniometer by a physiotherapist, both active and passive range of motion * Including shoulder flexion, abduction, internal rotation, and external rotation * All measurements will be rounded off to the nearest five degrees |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale (VAS) | baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion | * Horizontal lines of 100mm, with 0 indicating no pain on the left and 100 indicating very severe pain on the right * Three separate visual analog scales: shoulder pain at rest, during movement, and during the night |
| 36-Item Short-form health survey (SF-36) | baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion | * General health status measurement * 8 subscales for physical functioning, social functioning, role limitations (physical problems, emotional problems), mental health, vitality, pain, and general health perception * Each subscale generates a score from 0 to 100, with higher score indicating better health |
| Shoulder Rating Questionnaire (SRQ) | baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion | * Self-administered questionnaire * Include global assessment, pain, daily activities, recreational and athletic activities, work, satisfaction, and areas for improvement. * Total score ranges from a minimum of 17 points (worst) to a maximum of 100 points (best functional status) |
| Shoulder Disability Questionnaire (SDQ) | baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion | * For shoulder disability measurement * Consists of 23 symptoms that participants respond to with either yes or no or not applicable * Score ranges from 0 to 100, is the number of positive response divided by the number of answered questions multiplied by 100. |
Countries
Taiwan
Outcome results
None listed