## Protocol Section
### Identification Module
**NCT ID:** NCT00211679

**Brief Title:** Intra-articularInjection of Botulinum Toxin Type

**Official Title:** Intra-articularInjection of Botulinum Toxin Type a for the Treatment of Chronic Knee Pain: A Randomized, Placebo Controlled, Double Blind Study

#### Organization Study ID Info
**ID:** Protocol Number 03393B
#### Organization
**Class:** FED
**Full Name:** Minneapolis Veterans Affairs Medical Center
### Status Module
#### Completion Date
**Date:** 2007-06

**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2005-09-21

**Type:** ESTIMATED

**Last Update Submit Date:** 2005-09-13

**Overall Status:** UNKNOWN

#### Start Date
**Date:** 2004-06

**Status Verified Date:** 2005-07

#### Study First Post Date
**Date:** 2005-09-21
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-13
**Study First Submit QC Date:** 2005-09-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Allergan

**Class:** OTHER

**Name:** Center for Veterans Research and Education

#### Lead Sponsor

**Class:** FED

**Name:** Minneapolis Veterans Affairs Medical Center

### Description Module

**Brief Summary:** The purpose of this study is to determine whether intra-articular injection of botulinum toxin is effective in the treatment of chronic knee paindue to arthritis.

**Detailed Description:** Chronic knee pain unresponsive to oral medications and intra-articular corticosteroids and viscosupplements is an important treatment problem, especially for the young, very old and those with complex medical problems that preclude joint reconstructive surgery. We hypothesized that intra-articular botulinum toxin could provide important joint pain relief in these patients. This is a prospective, double blined, placebo controlled 6month trial with an open label extension phase when pain returns to baseline levels (re-injection with 100units of botulinum toxin and 6 months followup thereafter.

Comparisons: Intra-articular injection of bootulinum toxin type a will be compared to intra-articular injection of lidocaine the saline.

### Conditions Module

**Conditions:**

- Arthritis

- Pain

**Keywords:**

- Joint pain

- Knee Pain

- Arthritis

- Intra-articular Botulinum Toxin Type A

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Name:** Botulinum Toxin Type A

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Change in Pain Score

**Measure:** Change in Joint Function

**Measure:** Patient Global Assessment

#### Secondary Outcomes

**Measure:** Pain Relief

**Measure:** Change in Health Status Quality of Life-SF36

**Measure:** Change in Disease specific Health Related QOL-WOMAC

**Measure:** Function improvement by Timed Stands Test and Range of Motion

**Measure:** Physican Assessment of Pain and Global Assessment of Improvement

**Measure:** Safety Measure,

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male or female subjects, 18 years of age or older.

  * Written informed consent and written authorization for use or release of health and research study information have been obtained.
  * Subject has chronic Knee pain for more than 1 year.
  * Subject has pain \>4.5 on numerical rating scale of 0 to 10.
  * Ability to follow study instructions and likely to complete all required visits.
  * Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential if applicable)
  * Patients previously treated with intra-articular corticosteroid or viscosupplementation injections.
  * Patients with rheumatoid arthritis must have failed therapy with standard DMARDs (disease modifying anti-rheumatic drugs) and anti-TNF agents unless they have a contraindication to TNF blockers.
  * Patients who were considered not to be candidates for Knee joint replacement because of young age, abnormalities in periarticular tissues or because of co-morbid conditions.
  * Must be ambulatory and able to perform sit to stand.

Exclusion Criteria:

* Use of aminoglycoside antibiotics, curare-like agents, or other agents that might interfere with neuromuscular function.
* Any medical condition that may put the subject at increased risk with exposure to botulinum neurotoxin including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amytrophic lateral sclerosis, any other disorder that might interfere with neuromuscular function or the presence of severe peripheral neuropathy.
* Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study.
* Known allergy or sensitivity to any of the components in the study medication.
* Evidence of recent alcohol or drug abuse.
* Infection at injection site or systemic infection (postpone study entry until one week following recovery.
* Known, uncontrolled serious systemic disease and/or life expectancy less than 12 months.
* Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment.
* Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
* Patients whose pain is rated as less than 4.5 on a 10 point Numerical Pain Rating scale at the screening visit
* Patients on coumadin or heparin because of increased risk of bleeding in the joint
* Serious or unstable psychiatric disease or cognitive impairment that would limit evaluation of response to treatment.

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mahow001@umn.edu

**Name:** Maren L Mahowald, MD

**Phone:** 6124674190

**Role:** CONTACT

**Contact 2:**

**Email:** Jasvinder.Singh@va.gov

**Name:** Jasvinder A Singh, MD, MPH

**Phone:** 6124674190

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Minneapolis

**Contacts:**

***Contact 1:***

- **Name:** Maren L Mahowald, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 2:***

- **Name:** Jasvinder A Singh, MD MPPH

- **Role:** SUB_INVESTIGATOR

***Contact 3:***

- **Name:** Hollis E Krug, MD

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Minneapolis VAMC

**State:** Minnesota

**Status:** RECRUITING

**Zip:** 55417

#### Overall Officials

**Official 1:**

**Affiliation:** Minneapolis VAMC

**Name:** Maren L Mahowad, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007592

- Term: Joint Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M4476

- Name: Arthritis

- Relevance: HIGH

- As Found: Arthritis

- ID: M20833

- Name: Arthralgia

- 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: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001168

- Term: Arthritis

### Intervention Browse Module - Ancestors

- ID: D000065087

- Term: Acetylcholine Release Inhibitors

- ID: D000049990

- Term: Membrane Transport Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000018678

- Term: Cholinergic Agents

- ID: D000018377

- Term: Neurotransmitter Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000009465

- Term: Neuromuscular Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: VaDiAg

- Name: Vasodilator Agents

### Intervention Browse Module - Browse Leaves

- ID: M5183

- Name: Botulinum Toxins

- Relevance: HIGH

- As Found: Face

- ID: M21257

- Name: Botulinum Toxins, Type A

- Relevance: HIGH

- As Found: Weight loss

- ID: M250193

- Name: abobotulinumtoxinA

- Relevance: HIGH

- As Found: Weight loss

- ID: M3473

- Name: Acetylcholine

- Relevance: LOW

- As Found: Unknown

- ID: M20758

- Name: Cholinergic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M20504

- Name: Neurotransmitter Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000001905

- Term: Botulinum Toxins

- ID: D000019274

- Term: Botulinum Toxins, Type A

- ID: C000542869

- Term: abobotulinumtoxinA

### Misc Info Module

- Version Holder: 2024-05-24
