Treatment Study of Frozen Shoulder: Corticosteroid Injection in Joint Versus Wait and See Policy

NCT01570985 | Unknown Phase 3 DMC

• 2 other identifiers: FSS-2010-SKB2008-004385-49
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study on the treatment of frozen shoulder with injection of cortisone into the shoulder joint. The purpose of the study is to evaluate whether injection with stretching of the shoulder capsule or plain injection is more effective than no specific treatment.

Conditions

Shoulder Capsulitis; Shoulder Adhesive Capsulitis; Frozen Shoulder

Keywords

shoulder capsulitis; frozen shoulder; adhesive capsulitis; distension; corticosteroid injection; intraarticular injection

Outcome Measures

Primary Outcomes (1)

• Shoulder pain and disability index (SPADI)

  The primary outcome measure is Shoulder Pain and Disability Index (SPADI). According to a previous study, the SPADI score of ≥10 indicate clinically important improvement (or worsening) of shoulder function (Williams et al. 1995). A total of 3 measurements will be taken for all participants: baseline measurement on day 1, 2nd measurement on the 31st day and last measurement the 61st day. All end point effect measurements (primary, secondary \& tertiary) are targeted at 61 days.In addition pain and function (SPADI) will be evaluated at 6 months and 12 months.

  8 weeks

Secondary Outcomes (1)

• A 10-point Numerical Pain Rating Scale (NPRS)

  8 weeks

Study Arms (3)

Steroid injection Without distension

ACTIVE COMPARATOR

Group 1 consists of patients receiving Triamcinolone acetonide 20 mg intraarticular injection with Lidocaine 10mg/ml 3 ml and a total of 4 ml solution.

Drug: Triamcinolone Acetonide

Steroid with distension

ACTIVE COMPARATOR

Patients in group 2 will receive intraarticular Triamcinolone Acetonide 20 mg, 3 ml Lidocaine and physiological natrium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards up to 20 ml

Drug: Triamcinolone Acetonide

Control

NO INTERVENTION

Group 3 will serve as control group and patients in this group could receive any other treatment other than corticosteroid injections or per oral corticosteroid medication. The control group will remain without treatment with corticosteroids, in injection or tablet form till 61 days, which is also the last day of the outcome measurements.

Interventions

Triamcinolone Acetonide DRUG

Triamcinolone 20 mg intraarticular injection with Lidocaine 10mg/ml 3 ml and variable amount of saline of 4 ml solution on day 1, day 7, day 17 and day 31st.

Also known as: Kenacort-T H02A B08

Steroid injection Without distension

Eligibility Criteria

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

You may qualify if:

• Patients who on clinical examination show reduced shoulder movements with pain where commonly lateral rotation is most restricted, medial rotation least restricted and abduction is somewhat restricted, somewhere in between the two other movements, is called a capsular pattern of movement confirming shoulder capsulitis
• Had had the condition for at least 2 months
• Reduction of movement is at least 30% of normal in two of the three passive movements
• Are ready to undergo treatment as set up before hand (agree to participate in one of the three groups)
• Agree not to undergo other treatment simultaneously directed at the stiff shoulder other than in the control group
• Patient has voluntarily given his/her written consent for participation
• Has not already received intraarticular corticosteroid injection prior to entry in the study less than 4 weeks earlier

You may not qualify if:

• Diabetes, as in some diabetic patients, steroids can disturb the regulation of their blood sugar levels.
• One of the two shoulder movements are normal, either passive abduction or passive lateral rotation
• Have some systemic disease where use of corticosteroids is either contraindicated or affect the coexisting disorder
• Patients with asthma using steroid inhalations or steroids orally
• There are other coexisting disorders in the arm or patient has a painful neck that can disturb pain and functional assessment of the shoulder
• Pregnant and breast feeding mothers
• Patients under 18 years of age
• Patients who do not understand Norwegian
• Patients who have reduced intellectual capacity for consent-giving

Sponsors & Collaborators

• Satya Pal Sharma: lead
• Norwegian Medical Association: collaborator

Study Sites (1)

Rolland legesenter

Ulset, Hordaland, NO-5115, Norway

Location

Related Publications (2)

• Sharma SP, Moe-Nilssen R, Kvale A, Baerheim A. Predicting outcome in frozen shoulder (shoulder capsulitis) in presence of comorbidity as measured with subjective health complaints and neuroticism. BMC Musculoskelet Disord. 2017 Sep 2;18(1):380. doi: 10.1186/s12891-017-1740-9.

  PMID: 28865441 DERIVED

• Sharma SP, Baerheim A, Moe-Nilssen R, Kvale A. Adhesive capsulitis of the shoulder, treatment with corticosteroid, corticosteroid with distension or treatment-as-usual; a randomised controlled trial in primary care. BMC Musculoskelet Disord. 2016 May 26;17:232. doi: 10.1186/s12891-016-1081-0.

  PMID: 27229470 DERIVED

MeSH Terms

Conditions

Bursitis; Dilatation, Pathologic

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Anders Barheim, MD PhD

  University of Bergen

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: March 27, 2012
• First Posted: April 4, 2012
• Study Start: February 1, 2010
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2015
• Last Updated: May 28, 2015

Record last verified: 2015-05

Locations

NO (1)