Manual Therapy and Rehabilitation on Pain and Physical Functioning for Chronic Knee Pain

Study Overview
=================
Brief Summary
-----------------
This is a research study examining if hands-on therapy and prescribed exercise is an effective way to manage and reduce knee pain. It will also look at physical benefits of this treatment including balance, strength, and flexibility. Participation will include 2 assessment days and a 12-week treatment cycle. Assessments will be conducted during week 1 and after treatment. The treatment will vary based on the assigned group. This may include 12 in-person manual therapy sessions occurring once per week and or 12-weeks of at-home therapy occurring 5 times per week. The greatest risk of participation includes possible muscle/joint soreness, injury during at-home exercises, and loss of confidentiality.

Official Title
-----------------
Soft Tissue Mobilization and Rehabilitation on Pain and Physical Functioning for Non-Specific Chronic Knee Pain: A Randomized Clinical Trail

Conditions
-----------------
Non-Specific Chronic Knee Pain

Intervention / Treatment
-----------------
* Procedure: Soft Tissue Mobilization
* Other: Rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults experiencing non-specific knee pain for 3 or more months. Pain must be 3/10 (VAS) or higher. Exclusion Criteria: Pain due to knee surgery, fracture, tumor, trauma, or those on medication for mood disorder (assessed on case by case basis).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomly assigned to one of three groups 1) Manual Therapy, 2) Rehabilitation, or 3) Combination of both
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Soft Tissue Mobilization<br> | Procedure: Soft Tissue Mobilization<br>* Soft Tissue Mobilization will be provided to participants by Licensed Chiropractor focusing on structures of the lower and upper leg. This will be provided for 20 minutes, once per week for 12 weeks.<br>* Other names: Manual Therapy;|
| Experimental: Rehabilitation<br> | Other: Rehabilitation<br>* Participants will engage in 20 minutes of prescribed at-home exercise 5 times per week, for 12 weeks.<br>* Other names: Isometric Exercise;|
| Experimental: Soft Tissue Mobilization and Rehabiliation<br> | Procedure: Soft Tissue Mobilization<br>* Soft Tissue Mobilization will be provided to participants by Licensed Chiropractor focusing on structures of the lower and upper leg. This will be provided for 20 minutes, once per week for 12 weeks.<br>* Other names: Manual Therapy;Other: Rehabilitation<br>* Participants will engage in 20 minutes of prescribed at-home exercise 5 times per week, for 12 weeks.<br>* Other names: Isometric Exercise;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perceived Pain | The Visual Analogue Scale (VAS) will be used to quantify pain. The scale ranges from 1 (no pain) to 10 (worst pain). | This will be measured pre- and post- intervention (week 1 and week 13). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | A goniometer will be used to assess range of motion of the hip and knee. | This will be measured pre- and post- intervention (week 1 and week 13) | 
| Modified Clinical Test of Sensory Integration and Balance | The Balance Tracking System will be used to assess balance. | This will be measured pre- and post- intervention (week 1 and week 13). | 
| Isometric Strength | A crane scale will be used to measure changes in isometric strength (pounds). The hamstring and quadricep will be assessed. | This will be measured pre- and post- intervention (week 1 and week 13). | 
| Limits of Stability | The Balance Tracking System will be used to assess limits of stability. | This will be measured pre- and post- intervention (week 1 and week 13). |