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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Norwegian Medical Association
Information provided by (Responsible Party):
Satya Pal Sharma, University of Bergen
ClinicalTrials.gov Identifier:
NCT01570985
First received: March 27, 2012
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Shoulder Capsulitis
Shoulder Adhesive Capsulitis
Frozen Shoulder
Drug: Triamcinolone Acetonide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Outcome in Shoulder Capsulitis (Frozen Shoulder) Between Corticosteroid and Corticosteroid With Distension Compared to Wait and See Policy, a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Bergen:

Primary Outcome Measures:
  • Shoulder pain and disability index (SPADI) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • A 10-point Numerical Pain Rating Scale (NPRS) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 120
Study Start Date: February 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Steroid injection Without distension
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
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.
Other Name: Kenacort-T H02A B08
Active Comparator: Steroid with distension
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
Patients in group 2 will receive intraarticular Triamcinolone 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
Other Name: Kenacort-T H02A B08
No Intervention: Control
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.

Detailed Description:

Shoulder capsulitis or frozen shoulder is a painful condition causing limitations of shoulder movements. Its incidence is about 2%, comprising mostly women. There is a need for more controlled trials on frozen shoulder preferably in general practice, without using technical guiding instruments for injections as MRI or computer tomography, because the condition is routinely treated in general practice. It was therefore important to conduct this study as similar as possible to current practice. The procedure should be simple, safe and less time consuming.

Patients will be allocated to the study groups by computerized block-randomization with three permutations per block. Group 1 consists of patients receiving Triamcinolone 20 mg intraarticular injection with Lidocaine 10mg/ml 3 ml and a total of 4 ml solution. Group 2 patients will receive intraarticular Triamcinolone 20 mg, 3 ml Lidocaine and the rest with physiological natrium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards up to 20 ml. Group 3 will serve as a 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. The time interval between the 1st and 2nd treatment will be 7 days, between the 2nd and 3rd treatment 10 days, and between the 3rd and 4th treatment 14 days. Patients will also receive a follow-up by mail 6 and 12 months after the inclusion, where pain and function (SPADI) is investigated.

The patients will be explained and instructed in filling out schema for SPADI, NPRS, pain figure, for sleep Bergen Insomnia Scale (BIS), EPQ-N to measure neuroticism, and Subjective Health Complaints (SHC).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01570985

Locations
Norway
Rolland legesenter
Ulset, Hordaland, Norway, NO-5115
Sponsors and Collaborators
Satya Pal Sharma
Norwegian Medical Association
Investigators
Study Chair: Anders Barheim, MD PhD University of Bergen
  More Information

No publications provided

Responsible Party: Satya Pal Sharma, Investigator, University of Bergen
ClinicalTrials.gov Identifier: NCT01570985     History of Changes
Other Study ID Numbers: FSS-2010-SKB, 2008-004385-49
Study First Received: March 27, 2012
Last Updated: December 10, 2013
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by University of Bergen:
shoulder capsulitis
frozen shoulder
adhesive capsulitis
distension
corticosteroid injection
intraarticular injection

Additional relevant MeSH terms:
Periarthritis
Bursitis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014