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

July 14, 2021 updated by: Beverly Albert, Neuro Performance Integration

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Utah
      • Park City, Utah, United States, 84060
        • Recruiting
        • Neuro Performance Integration
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: Rehabilitation
Participants will engage in 20 minutes of prescribed at-home exercise 5 times per week, for 12 weeks.
Other Names:
  • Injury Prevention Therapy
  • Isometric Exercise
Experimental: Soft Tissue Mobilization
Procedure: 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:
  • Manual Therapy
Experimental: Soft Tissue Mobilization and Rehabiliation
Procedure: 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:
  • Manual Therapy
Other: Rehabilitation
Participants will engage in 20 minutes of prescribed at-home exercise 5 times per week, for 12 weeks.
Other Names:
  • Injury Prevention Therapy
  • Isometric Exercise

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

This is where you will find people and organizations involved with this study.

Sponsor

Neuro Performance Integration

Investigators

  • Principal Investigator: Beverly Albert, MS, Neuro Performance Integration

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2021

Primary Completion (Anticipated)

December 23, 2022

Study Completion (Anticipated)

March 31, 2023

Study Registration Dates

First Submitted

May 3, 2021

First Submitted That Met QC Criteria

May 5, 2021

First Posted (Actual)

May 11, 2021

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 14, 2021

Last Verified

July 1, 2021

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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