- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04880954
Manual Therapy and Rehabilitation on Pain and Physical Functioning for Chronic Knee Pain
Soft Tissue Mobilization and Rehabilitation on Pain and Physical Functioning for Non-Specific Chronic Knee Pain: A Randomized Clinical Trail
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Beverly Albert, MS
- Phone Number: 435-640-0429
- Email: beverlyalbert@npipc.com
Study Locations
-
-
Utah
-
Park City, Utah, United States, 84060
- Recruiting
- Neuro Performance Integration
-
Contact:
- Jake Shores, DC
- Phone Number: 435-640-0429
- Email: drshores@npipc.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rehabilitation
|
Participants will engage in 20 minutes of prescribed at-home exercise 5 times per week, for 12 weeks.
Other Names:
|
Experimental: Soft Tissue Mobilization
|
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.
Other Names:
|
Experimental: Soft Tissue Mobilization and Rehabiliation
|
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.
Other Names:
Participants will engage in 20 minutes of prescribed at-home exercise 5 times per week, for 12 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Perceived Pain
Time Frame: This will be measured pre- and post- intervention (week 1 and week 13).
|
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
Time Frame: This will be measured pre- and post- intervention (week 1 and week 13)
|
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
Time Frame: This will be measured pre- and post- intervention (week 1 and week 13).
|
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
Time Frame: This will be measured pre- and post- intervention (week 1 and week 13).
|
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
Time Frame: This will be measured pre- and post- intervention (week 1 and week 13).
|
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).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Beverly Albert, MS, Neuro Performance Integration
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- #21-NPI-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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