Frozen ShoulderNCT01817348
Effect of Combined Intra-articular Injection of Lidocaine Plus Physiotherapy in Treatment of Frozen Shoulder
A study testing Lidocaine group and Physiotherapy (PT) in people with Frozen Shoulder and Adhesive Capsulitis, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Frozen Shoulder, Adhesive Capsulitis
- What is being tested?
- Lidocaine group and Physiotherapy (PT)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2013to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
Read the 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
- Being tested
- Lidocaine group, Physiotherapy (PT)
- Keywords
- Adhesive capsulitis, Frozen shoulder, Shoulder pain, Intra-articular injection, Lidocaine injection, Physiotherapy, Manipulation, Stretch exercise
- Medical subject headings
- Bursitis, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine groupProcedure or surgery
- 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)Other
Also called Physiotherapy
- Include electric therapy, hot pack, followed by stretch exercise and joint mobilization
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine group | Experimental | 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. Receives: Procedure: Lidocaine group; Other: Physiotherapy (PT) |
| PT group | Placebo comparator | - Apply to every patient, each by the same physical therapist, 3 times weekly for 3 months or till the patients gain satisfactory results. Receives: Other: Physiotherapy (PT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: baseline; 1 and 3 months after completion
Secondary outcomes (4)
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
Measured: 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
Measured: 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)
Measured: 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.
Measured: baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lin-Fen Hsieh, M.D., Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817348
- Sponsor's protocol ID
- 20121001R
- Status last verified
- Oct 2016
- First submitted
- 8 Jan 2013
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 25714415
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Combined Intra-articular Injection of Lidocaine Plus Physiotherapy in Treatment of Frozen Shoulder
- ClinicalTrials.gov ID
- NCT01817348
- Acronym / sponsor ID
- 20121001R
- Conditions
- Frozen Shoulder, Adhesive Capsulitis
- Keywords
- Adhesive capsulitis, Frozen shoulder, Shoulder pain, Intra-articular injection, Lidocaine injection, Physiotherapy, Manipulation, Stretch exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shin Kong Wu Ho-Su Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 25 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine group | Experimental | Procedure: Lidocaine group, Other: Physiotherapy (PT)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. |
| PT group | Placebo comparator | Other: Physiotherapy (PT)- Apply to every patient, each by the same physical therapist, 3 times weekly for 3 months or till the patients gain satisfactory results. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Lidocaine group |
| Physiotherapy (PT)Also: Physiotherapy- Include electric therapy, hot pack, followed by stretch exercise and joint mobilization | Other | Lidocaine group, PT group |
Primary outcome
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
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
4 secondary outcomes
Visual analog scale (VAS)
Time frame: 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
Shoulder Rating Questionnaire (SRQ)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Derived from this study: PubMed 25714415Hsu 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.
Related trials for Frozen Shoulder
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Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin-Fen Hsieh, M.D. principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine group and Physiotherapy (PT) in people with Frozen Shoulder and Adhesive Capsulitis, run by Shin Kong Wu Ho-Su Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in range of motion at 3-months intervention (time frame: baseline; 1 month; 2 months; 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01817348, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.