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

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ClinicalTrials.gov Identifier: NCT01817348
Recruitment Status : Completed
First Posted : March 25, 2013
Last Update Posted : October 28, 2016
Sponsor:
Information provided by (Responsible Party):
Shin Kong Wu Ho-Su Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Frozen Shoulder Adhesive Capsulitis Procedure: Lidocaine group Other: Physiotherapy (PT) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Combined Intra-articular Injection of Lidocaine Plus Physiotherapy in Treatment of Frozen Shoulder
Study Start Date : January 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Physiotherapy




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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)

  4. 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.



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01817348


Locations
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Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Sponsors and Collaborators
Shin Kong Wu Ho-Su Memorial Hospital
Investigators
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Principal Investigator: Lin-Fen Hsieh, M.D. Shin Kong Wu Ho-Su Memorial Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shin Kong Wu Ho-Su Memorial Hospital
ClinicalTrials.gov Identifier: NCT01817348     History of Changes
Other Study ID Numbers: 20121001R
First Posted: March 25, 2013    Key Record Dates
Last Update Posted: October 28, 2016
Last Verified: October 2016
Keywords provided by Shin Kong Wu Ho-Su Memorial Hospital:
Adhesive capsulitis
Frozen shoulder
Shoulder pain
Intra-articular injection
Lidocaine injection
Physiotherapy
Manipulation
Stretch exercise
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action