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

NCT ID: NCT01817348

Last Updated: 2016-10-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-02-28

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.

Conditions

Frozen Shoulder; Adhesive Capsulitis

Keywords

Adhesive capsulitis; Frozen shoulder; Shoulder pain; Intra-articular injection; Lidocaine injection; Physiotherapy; Manipulation; Stretch exercise

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lidocaine group

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.

Group Type: EXPERIMENTAL

Lidocaine group

Intervention Type: PROCEDURE

• 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.

Physiotherapy (PT)

Intervention Type: OTHER

\- Include electric therapy, hot pack, followed by stretch exercise and joint mobilization

PT group

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

Group Type: PLACEBO_COMPARATOR

Physiotherapy (PT)

Intervention Type: OTHER

\- Include electric therapy, hot pack, followed by stretch exercise and joint mobilization

Interventions

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.

Intervention Type: PROCEDURE

Physiotherapy (PT)

\- Include electric therapy, hot pack, followed by stretch exercise and joint mobilization

Intervention Type: OTHER

Other Intervention Names

Physiotherapy

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shin Kong Wu Ho-Su Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lin-Fen Hsieh, M.D.

Role: PRINCIPAL_INVESTIGATOR

Shin Kong Wu Ho-Su Memorial Hospital

Locations

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 25714415 (View on PubMed)

Other Identifiers

20121001R

Identifier Type: -

Identifier Source: org_study_id