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Completed

NCT Number: NCT01817348

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.

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Key information

Conditions

Frozen Shoulder Adhesive Capsulitis Arthralgia Bursitis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine group

Procedure
  • 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
  • Include electric therapy, hot pack, followed by stretch exercise and joint mobilization

Other names: Physiotherapy

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Shin Kong Wu Ho-Su Memorial Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Mar 25, 2013
Registry last updated
Oct 28, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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