Effect of Combined Intra-articular Injection of Lidocaine Plus Physiotherapy in Treatment of Frozen Shoulder

Shin Kong Wu Ho-Su Memorial Hospital

Status: Completed

Conditions: Frozen Shoulder; Adhesive Capsulitis

Treatments: Other: Physiotherapy (PT); Procedure: Lidocaine group

Study type: Interventional

Funder types: Other

Identifiers

NCT01817348

20121001R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Lidocaine group

Experimental group

Description:

1% lidocaine 5ml intra-articular injection to shoulder joint + physiotherapy three times weekly * Injection is performed if pain during intervention equals to or greater than 7cm in a 10-cm VAS scale. * Injection frequency is not greater than twice per week and total injection time is limited to 10 times in the whole course * In each week, patient will receive 3 times of PT with or without intra-articular lidocaine injection.

Treatment:

Procedure: Lidocaine group

Other: Physiotherapy (PT)

PT group

Placebo Comparator group

Description:

- Apply to every patient, each by the same physical therapist, 3 times weekly for 3 months or till the patients gain satisfactory results.

Treatment:

Other: Physiotherapy (PT)