Clinical trial NCT01817348: Effect of Combined Intra-articular Injection of Lidocaine Plus Physiotherapy in Treatment of Frozen Shoulder
Official title: Effect of Combined Intra-articular Injection of Lidocaine Plus Physiotherapy in Treatment of Frozen Shoulder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Frozen Shoulder
Adhesive Capsulitis
Keywords: Adhesive capsulitis
Frozen shoulder
Shoulder pain
Intra-articular injection
Lidocaine injection
Physiotherapy
Manipulation
Stretch exercise
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2013-03-25
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in range of motion at 3-months intervention
timeFrame: baseline; 1 month; 2 months; 3 months
measure: Change from Baseline in range of motion at 3 months post-intervention
timeFrame: baseline; 1 and 3 months after completion
Secondary outcomes:
measure: Visual analog scale (VAS)
timeFrame: baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
measure: 36-Item Short-form health survey (SF-36)
timeFrame: baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
measure: Shoulder Rating Questionnaire (SRQ)
timeFrame: baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
measure: Shoulder Disability Questionnaire (SDQ)
timeFrame: baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Lin-Fen Hsieh, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsu WC, Wang TL, Lin YJ, Hsieh LF, Tsai CM, Huang KH. Addition of lidocaine injection immediately before physiotherapy for frozen shoulder: a randomized controlled trial. PLoS One. 2015 Feb 25;10(2):e0118217. doi: 10.1371/journal.pone.0118217. eCollection 2015.