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

October 27, 2016 updated by: Shin Kong Wu Ho-Su Memorial Hospital

  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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 71 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in range of motion at 3-months intervention
Time Frame: baseline; 1 month; 2 months; 3 months
  • 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
Time Frame: baseline; 1 and 3 months after completion
  • 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Visual analog scale (VAS)
Time Frame: baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
  • 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)
Time Frame: baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
  • 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)
Time Frame: baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
  • 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)
Time Frame: baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
  • 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shin Kong Wu Ho-Su Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lin-Fen Hsieh, M.D., Shin Kong Wu Ho-Su Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20121001R

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