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

NCT04880954 | Unknown

• 1 other identifier: #21-NPI-101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Specific Chronic Knee Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Range of Motion

  This will be measured pre- and post- intervention (week 1 and week 13)

• Modified Clinical Test of Sensory Integration and Balance

  This will be measured pre- and post- intervention (week 1 and week 13).

• Isometric Strength

  This will be measured pre- and post- intervention (week 1 and week 13).

• Limits of Stability

  This will be measured pre- and post- intervention (week 1 and week 13).

Study Arms (3)

Soft Tissue Mobilization

EXPERIMENTAL

Procedure: Soft Tissue Mobilization

Rehabilitation

EXPERIMENTAL

Other: Rehabilitation

Soft Tissue Mobilization and Rehabiliation

EXPERIMENTAL

Procedure: Soft Tissue Mobilization; Other: Rehabilitation

Interventions

Soft Tissue Mobilization PROCEDURE

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.

Also known as: Manual Therapy

Soft Tissue Mobilization; Soft Tissue Mobilization and Rehabiliation

Rehabilitation OTHER

Participants will engage in 20 minutes of prescribed at-home exercise 5 times per week, for 12 weeks.

Also known as: Injury Prevention Therapy, Isometric Exercise

Rehabilitation; Soft Tissue Mobilization and Rehabiliation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults experiencing non-specific knee pain for 3 or more months. Pain must be 3/10 (VAS) or higher.

You may not qualify if:

• Pain due to knee surgery, fracture, tumor, trauma, or those on medication for mood disorder (assessed on case by case basis).

Sponsors & Collaborators

• Neuro Performance Integration: lead

Study Sites (1)

Neuro Performance Integration

Park City, Utah, 84060, United States

RECRUITING

MeSH Terms

Interventions

Musculoskeletal Manipulations; Rehabilitation; Exercise

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Beverly Albert, MS

  Neuro Performance Integration

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beverly Albert, MS

CONTACT

435-640-0429; beverlyalbert@npipc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants will know the group they are randomly assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Director

Model Details: Participants will be randomly assigned to one of three groups 1) Manual Therapy, 2) Rehabilitation, or 3) Combination of both

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 11, 2021
• Study Start: March 31, 2021
• Primary Completion: December 23, 2022
• Study Completion: March 31, 2023
• Last Updated: July 15, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)