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

Adhesive Capsulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817348
• Other study ID #: 20121001R
• Status: Completed
• Phase: N/A
• First received: January 8, 2013
• Last updated: October 27, 2016
• Start date: January 2013
• Est. completion date: February 2014

Study information

• Verified date: October 2016
• Source: Shin Kong Wu Ho-Su Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis
• Frozen Shoulder

Intervention

Procedure:
• Lidocaine 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.

Other:
• Physiotherapy (PT)
- Include electric therapy, hot pack, followed by stretch exercise and joint mobilization

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Shin Kong Wu Ho-Su Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline; 1 month; 2 months; 3 months	No
Primary	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	baseline; 1 and 3 months after completion	No
Secondary	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	baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion	No
Secondary	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	baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion	No
Secondary	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)	baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion	No
Secondary	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.	baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion	No