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

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.

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis; Frozen Shoulder
• Intervention / Treatment: Procedure: Lidocaine group; Other: Physiotherapy (PT)

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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; Other Names: Physiotherapy
Placebo Comparator: 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.	Other: Physiotherapy (PT); - Include electric therapy, hot pack, followed by stretch exercise and joint mobilization; Other Names: Physiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital
• Investigators: Principal Investigator: Lin-Fen Hsieh, M.D., Shin Kong Wu Ho-Su Memorial Hospital

Publications and helpful links

General Publications

• 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. Erratum In: PLoS One. 2015;10(4):e0125289.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: January 8, 2013
• First Submitted That Met QC Criteria: March 20, 2013
• First Posted (Estimate): March 25, 2013

Study Record Updates

• Last Update Posted (Estimate): October 28, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Physiotherapy; Adhesive capsulitis; Shoulder pain; Frozen shoulder; Manipulation; Intra-articular injection; Lidocaine injection; Stretch exercise
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 20121001R