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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
* 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.
\- Include electric therapy, hot pack, followed by stretch exercise and joint mobilization
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Change from Baseline in range of motion at 3-months intervention
* 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
Time frame: baseline; 1 month; 2 months; 3 months
Change from Baseline in range of motion at 3 months post-intervention
* 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
Time frame: baseline; 1 and 3 months after completion
Visual analog scale (VAS)
* 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
Time frame: baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
36-Item Short-form health survey (SF-36)
* 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
Time frame: baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
Shoulder Rating Questionnaire (SRQ)
* 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)
Time frame: baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
Shoulder Disability Questionnaire (SDQ)
* 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.
Time frame: baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
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