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

NCT01817348 | Completed DMC

• 1 other identifier: 20121001R
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Therapeutic exercise, especially stretch exercise and joint mobilization, remain the mainstay of conservative treatment of frozen shoulder.
2. 2.Nevertheless, shoulder pain during the physiotherapy reduces the treatment effect.
3. 3.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.
4. 4.We consider intra-articular injection is a compromized way, from a practical point of veiw, to reduce the pain during physiotherapy.
5. 5.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.

Conditions

Frozen Shoulder; Adhesive Capsulitis

Keywords

Adhesive capsulitis; Frozen shoulder; Shoulder pain; Intra-articular injection; Lidocaine injection; Physiotherapy; Manipulation; Stretch exercise

Outcome Measures

Primary Outcomes (2)

• 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

  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

  baseline; 1 and 3 months after completion

Secondary Outcomes (4)

• Visual analog scale (VAS)

  baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion

• 36-Item Short-form health survey (SF-36)

  baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion

• Shoulder Rating Questionnaire (SRQ)

  baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion

• Shoulder Disability Questionnaire (SDQ)

  baseline; 1 month; 2 months; 3 months; 1 and 3 months after completion

Study Arms (2)

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.

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.

Other: Physiotherapy (PT)

Interventions

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.

Lidocaine group

Physiotherapy (PT) OTHER

\- Include electric therapy, hot pack, followed by stretch exercise and joint mobilization

Also known as: Physiotherapy

Lidocaine group; PT group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shin Kong Wu Ho-Su Memorial Hospital: lead

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 25714415 DERIVED

MeSH Terms

Conditions

Bursitis; Shoulder Pain

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• Lin-Fen Hsieh, M.D.

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2013
• First Posted: March 25, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

TW (1)