## Protocol Section
### Identification Module
**NCT ID:** NCT02049879

**Brief Title:** Daily Activity After Corticosteroids Injection Among Knee Osteoarthritis Patients

**Official Title:** Quantification of Daily Physical Activity After an Intra-articular Corticosteroid Injection in Patients With Knee Osteoarthritis

#### Organization Study ID Info
**ID:** INF-2010
#### Organization
**Class:** OTHER
**Full Name:** Laval University
### Status Module
#### Completion Date
**Date:** 2012-08

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-03-03

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-02-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-08

**Type:** ACTUAL

#### Start Date
**Date:** 2008-11

**Status Verified Date:** 2014-02

#### Study First Post Date
**Date:** 2014-01-30
**Type:** ESTIMATED
**Study First Submit Date:** 2014-01-28
**Study First Submit QC Date:** 2014-01-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Laval University

#### Responsible Party

**Investigator Affiliation:** Laval University

**Investigator Full Name:** Philippe Corbeil

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The objective of this study was to objectively measure daily physical activity and spatiotemporal gait pattern, as well as improvements in self reported symptoms and quality of life, before and six weeks after an intra-articular corticosteroids injection in patients suffering from knee osteoarthritis. Fourteen patients with unilateral knee osteoarthritis were recruited. The intra-articular corticosteroid injection was given at the end of the second week. Physical activity was objectively measured by an accelerometer worn by the participants for eight weeks. In addition, the Western Ontario and McMaster Universities Arthritis Index (WOMAC), the Medical Outcome Study Short Form-36 (MOS-SF36) and gait trials were completed every two weeks to assess symptoms, quality of life and spatiotemporal parameters of gait.

### Conditions Module

**Conditions:**

- Knee Osteoarthritis

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 14

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Corticosteroids injection

**Intervention Names:**

- Drug: Corticosteroids injection

**Label:** Injection

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Injection

**Description:** A solution of triamcinolone 40 mg (Kenalog) mixed with 3 cc of 2% xylocaine without epinephrine.

**Name:** Corticosteroids injection

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in Knee pain

**Time Frame:** Change from Baseline at 2, 4 and 6 weeks

**Measure:** Change in physical activity

**Time Frame:** Change from baseline at 2, 4 and 6 weeks

#### Secondary Outcomes

**Description:** Assessment with WOMAC and MOS-SF36 questionnaires

**Measure:** Change in function and quality of life

**Time Frame:** Change from baseline at 2, 4 and 6 weeks

**Description:** Gait symmetry was verified with regards to the swing and stance phase durations and step length

**Measure:** Change in Spatiotemporal gait parameters

**Time Frame:** Change from Baseline at 2, 4 and 6 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 50 years old or more
* Medial knee osteoarthritis (Kellgren \& Lawrence Grade I to III)

Exclusion Criteria:

* Intra-articular injection during the last six months
* Isolated femoro-patellar arthritis
* Rheumatoid arthritis
* Knee instability
* Spinal stenosis
* Lower limb fracture over the last year
* Lower limb surgery in the last three months

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Quebec

**Country:** Canada

**Facility:** Pavillon de l'Éducation Physique et des Sports - Université Laval

**Zip:** G1V 0A6

#### Overall Officials

**Official 1:**

**Affiliation:** Laval University

**Name:** Philippe Corbeil, PhD

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Laval University

**Name:** Yoann Dessery, MSc

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Laval University

**Name:** Étienne Belzile, MD

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Dessery Y, Belzile EL, Turmel S, Dore J, Diallo B, Corbeil P. Modulation of physical activity to optimize pain sensation following an intra-articular corticosteroid injection in patients with knee osteoarthritis. ScientificWorldJournal. 2014;2014:209165. doi: 10.1155/2014/209165. Epub 2014 Nov 16.

**PMID:** 25478585

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001168

- Term: Arthritis

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000012216

- Term: Rheumatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

### Condition Browse Module - Browse Leaves

- ID: M12926

- Name: Osteoarthritis

- Relevance: HIGH

- As Found: Osteoarthritis

- ID: M22168

- Name: Osteoarthritis, Knee

- Relevance: HIGH

- As Found: Knee Osteoarthritis

- ID: M4476

- Name: Arthritis

- Relevance: LOW

- As Found: Unknown

- ID: M10621

- Name: Joint Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15045

- Name: Rheumatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6323

- Name: Collagen Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010003

- Term: Osteoarthritis

- ID: D000020370

- Term: Osteoarthritis, Knee

### Intervention Browse Module - Browse Branches

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: ChanBlk

- Name: Channel Blockers

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: PhSol

- Name: Pharmaceutical Solutions

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: VaCoAg

- Name: Vasoconstrictor Agents

- Abbrev: Resp

- Name: Respiratory System Agents

### Intervention Browse Module - Browse Leaves

- ID: M11014

- Name: Lidocaine

- Relevance: LOW

- As Found: Unknown

- ID: M21860

- Name: Pharmaceutical Solutions

- Relevance: LOW

- As Found: Unknown

- ID: M16975

- Name: Triamcinolone Acetonide

- Relevance: LOW

- As Found: Unknown

- ID: M16974

- Name: Triamcinolone

- Relevance: LOW

- As Found: Unknown

- ID: M237966

- Name: Triamcinolone hexacetonide

- Relevance: LOW

- As Found: Unknown

- ID: M209573

- Name: Triamcinolone diacetate

- Relevance: LOW

- As Found: Unknown

- ID: M7992

- Name: Epinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M30371

- Name: Racepinephrine

- Relevance: LOW

- As Found: Unknown

- ID: M211043

- Name: Epinephryl borate

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
