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

Primary Purpose

Frozen Shoulder, Adhesive Capsulitis

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Lidocaine group
Physiotherapy (PT)
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Frozen Shoulder focused on measuring Adhesive capsulitis, Frozen shoulder, Shoulder pain, Intra-articular injection, Lidocaine injection, Physiotherapy, Manipulation, Stretch exercise

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shin Kong Wu Ho-Su Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lidocaine group

PT group

Arm 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.

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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)
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.

Full Information

First Posted
January 8, 2013
Last Updated
October 27, 2016
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01817348
Brief Title
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

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Therapeutic exercise, especially stretch exercise and joint mobilization, remain the mainstay of conservative treatment of frozen shoulder. Nevertheless, shoulder pain during the physiotherapy reduces the treatment effect. 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. We consider intra-articular injection is a compromized way, from a practical point of veiw, to reduce the pain during physiotherapy. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Frozen Shoulder, Adhesive Capsulitis
Keywords
Adhesive capsulitis, Frozen shoulder, Shoulder pain, Intra-articular injection, Lidocaine injection, Physiotherapy, Manipulation, Stretch exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine group
Arm Type
Experimental
Arm 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.
Arm Title
PT group
Arm Type
Placebo Comparator
Arm Description
- Apply to every patient, each by the same physical therapist, 3 times weekly for 3 months or till the patients gain satisfactory results.
Intervention Type
Procedure
Intervention Name(s)
Lidocaine group
Intervention Description
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
Other
Intervention Name(s)
Physiotherapy (PT)
Other Intervention Name(s)
Physiotherapy
Intervention Description
- Include electric therapy, hot pack, followed by stretch exercise and joint mobilization
Primary Outcome Measure Information:
Title
Change from Baseline in range of motion at 3-months intervention
Description
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
Time Frame
baseline; 1 month; 2 months; 3 months
Title
Change from Baseline in range of motion at 3 months post-intervention
Description
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
Time Frame
baseline; 1 and 3 months after completion
Secondary Outcome Measure Information:
Title
Visual analog scale (VAS)
Description
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
Time Frame
baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
Title
36-Item Short-form health survey (SF-36)
Description
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
Time Frame
baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
Title
Shoulder Rating Questionnaire (SRQ)
Description
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)
Time Frame
baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
Title
Shoulder Disability Questionnaire (SDQ)
Description
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.
Time Frame
baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin-Fen Hsieh, M.D.
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25714415
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. Erratum In: PLoS One. 2015;10(4):e0125289.
Results Reference
derived

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

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