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

Primary Purpose

Shoulder Capsulitis, Shoulder Adhesive Capsulitis, Frozen Shoulder

Status
Unknown status
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Triamcinolone Acetonide
Triamcinolone Acetonide
Sponsored by
Satya Pal Sharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Capsulitis focused on measuring shoulder capsulitis, frozen shoulder, adhesive capsulitis, distension, corticosteroid injection, intraarticular injection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rolland legesenter

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

No Intervention

Arm Label

Steroid injection Without distension

Steroid with distension

Control

Arm Description

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.

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 27, 2012
Last Updated
May 26, 2015
Sponsor
Satya Pal Sharma
Collaborators
Norwegian Medical Association
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1. Study Identification

Unique Protocol Identification Number
NCT01570985
Brief Title
Treatment Study of Frozen Shoulder: Corticosteroid Injection in Joint Versus Wait and See Policy
Acronym
FSS
Official Title
Outcome in Shoulder Capsulitis (Frozen Shoulder) Between Corticosteroid and Corticosteroid With Distension Compared to Wait and See Policy, a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2010 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Satya Pal Sharma
Collaborators
Norwegian Medical Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Capsulitis, Shoulder Adhesive Capsulitis, Frozen Shoulder
Keywords
shoulder capsulitis, frozen shoulder, adhesive capsulitis, distension, corticosteroid injection, intraarticular injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Steroid injection Without distension
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Steroid with distension
Arm Type
Active Comparator
Arm Description
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
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Kenacort-T H02A B08
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Kenacort-T H02A B08
Intervention Description
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
Primary Outcome Measure Information:
Title
Shoulder pain and disability index (SPADI)
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
A 10-point Numerical Pain Rating Scale (NPRS)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Barheim, MD PhD
Organizational Affiliation
University of Bergen
Official's Role
Study Chair
Facility Information:
Facility Name
Rolland legesenter
City
Ulset
State/Province
Hordaland
ZIP/Postal Code
NO-5115
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
28865441
Citation
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.
Results Reference
derived
PubMed Identifier
27229470
Citation
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.
Results Reference
derived

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

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