Enhancing the Effectiveness of Physical Therapy for People With Knee Osteoarthritis

NCT01314183 | Completed Phase 2

• 1 other identifier: 1R01HS019624-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

The overall aim of the project is to examine the clinical and cost-effectiveness of utilizing booster sessions(periodic face-to-face follow-up appointments that take place several weeks or months following discharge from the supervised therapy program designed to review the patient's current rehabilitation program, troubleshoot any problems with the program, and make recommendations for program progression or modification) in the delivery of exercise therapy, and supplementing exercise therapy with manual therapy techniques(manually applied treatment techniques such as joint mobilization/manipulation, manual traction, soft tissue manipulations, passive stretching and range of motion). The investigators will do this in a randomized, multi-center, clinical trial. The investigators hypothesize that adding manual therapy techniques will be more clinically effective than exercise alone and that using booster sessions will maintain longer term clinical effects and be more cost-effective than not using booster sessions.

Conditions

Osteoarthritis

Keywords

Knee; Physical Therapy; Exercise

Outcome Measures

Primary Outcomes (1)

• Change in Western Ontario and McMaster University Osteoarthritis Index (WOMAC)

  Self report measure of pain, stiffness, and physical function for people with knee osteoarthritis.

  Change from baseline at 9 weeks, 1 year and 2 years

Secondary Outcomes (11)

• Cost/Utility Ratio

  2 years

• Change in Numeric Knee Pain Rating Scale

  Change from Baseline to 9 weeks, 1 and 2 years

• Global Rating of Change

  Change from baseline to 9 weeks, 1 and 2 years

• Change in Timed Up and Go Test Time

  Change from Baseline to 9 weeks and 1 year

• Change in 30 second time chair rise test.

  Change from Baseline to , 9 weeks, 1 year

Study Arms (4)

exercise

ACTIVE COMPARATOR

Subjects in this arm receive 12 exercise sessions in 9 weeks.

Other: Exercise

exercise + manual therapy

ACTIVE COMPARATOR

Subjects in this group receive exercise combined with manual therapy techniques for 12 sessions in 9 weeks.

Other: Exercise; Other: manual therapy

exercise + booster

EXPERIMENTAL

subjects in this arm will receive exercise sessions delivered with booster sessions (8 sessions in the first 9 weeks, 2 sessions at 5 months, 1 session at 8 months, and 1 session at 11 months).

Other: Exercise

exercise + manual therapy + booster

EXPERIMENTAL

Subjects in this arm will receive exercise combined with manual therapy techniques and booster sessions.

Other: Exercise; Other: manual therapy

Interventions

Exercise OTHER

The program starts with a 10 minute aerobic exercise warm-up (treadmill walking or stationary cycling). Subjects then perform a series of strengthening, stretching, and neuromuscular control activities which are core exercises for the program and mandatory. In addition to the above core exercises, therapists have the option to select additional optional exercise activities, based on the initial examination findings. These exercises will address strength or flexibility in the hip, and ankle if impairments are identified in the initial examination.

exercise; exercise + booster; exercise + manual therapy; exercise + manual therapy + booster

manual therapy OTHER

The manual therapy (MT)techniques are maneuvers that are applied with manual force from the treating therapist. The MT techniques will include a series of accessory motion techniques, manual stretching , and soft tissue manipulation (deep massage to muscles and connective tissues associated with knee function). Core techniques include anterior-posterior and posterior-anterior tibiofemoral translations, superior-inferior and medial-lateral patellofemoral mobilizations, knee flexion and extension mobilizations that may be combined with varus-valgus stresses,medial-lateral tibial rotations, manual stretching of the quadriceps, rectus femoris, hamstring, and gastrocnemius muscles, and soft tissue manipulations of the quadriceps, peri-patellar tissues, hamstring, hip adductors, and gastroc-soleus muscle groups. There are optional MT techniques for the hip, and foot and ankle joints that can be selected by the therapist based on initial examination findings.

exercise + manual therapy; exercise + manual therapy + booster

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Meet the American College of Rheumatology (ACR) clinical criteria for a diagnosis of knee OA. The ACR clinical criteria for knee OA includes knee pain plus 3 of the following 6 criteria:
• age \> 50 years,
• morning stiffness of \< 30 minutes,
• crepitus on active movement,
• tenderness of the bony margins of the joint,
• bony enlargement of the joint noted on exam,
• lack of palpable warmth of the synovium. Based on this criteria, a subject who is less than 50 years but has knee pain and 3 of the other 5 criteria would also be classified as having knee OA.

You may not qualify if:

• do not meet the ACR clinical criteria for knee OA,
• are scheduled for total knee arthroplasty (TKA) surgery,
• have undergone TJA surgery on any lower extremity joint,
• exhibit uncontrolled hypertension (i.e. individuals not currently taking medication for hypertension whose systolic blood pressure is greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg at rest),
• have complaints of low back pain or other lower extremity joint pain that affects function at the time of recruitment,
• have a history of neurological disorders that would affect lower extremity function (stroke, peripheral neuropathy, parkinson's disease, multiple sclerosis, etc.),
• are women who are pregnant.

Sponsors & Collaborators

• Agency for Healthcare Research and Quality (AHRQ): lead

Study Sites (3)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Army-Baylor University

San Antonio, Texas, United States

Location

Intermountain Healthcare

Salt Lake City, Utah, United States

Location

Related Publications (2)

• Bove AM, Smith KJ, Bise CG, Fritz JM, Childs JD, Brennan GP, Abbott JH, Fitzgerald GK. Exercise, Manual Therapy, and Booster Sessions in Knee Osteoarthritis: Cost-Effectiveness Analysis From a Multicenter Randomized Controlled Trial. Phys Ther. 2018 Jan 1;98(1):16-27. doi: 10.1093/ptj/pzx104.

  PMID: 29088393 DERIVED

• Fitzgerald GK, Fritz JM, Childs JD, Brennan GP, Talisa V, Gil AB, Neilson BD, Abbott JH. Exercise, manual therapy, and use of booster sessions in physical therapy for knee osteoarthritis: a multi-center, factorial randomized clinical trial. Osteoarthritis Cartilage. 2016 Aug;24(8):1340-9. doi: 10.1016/j.joca.2016.03.001. Epub 2016 Mar 10.

  PMID: 26973326 DERIVED

MeSH Terms

Conditions

Osteoarthritis; Motor Activity

Interventions

Exercise; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• G. Kelley Fitzgerald, PT, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Julie M Fritz, PT, PhD

  Intermountain Healthcare, Salt Lake City, UT

  PRINCIPAL INVESTIGATOR

• John D Childs, PT, PhD

  Army-Baylor University, San Antonio, TX

  PRINCIPAL INVESTIGATOR

• J. Haxby Abbott, PT, PhD

  University of Otago, Dunedin, New Zealand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Physical Therapy, University of Pittsburgh

Study Record Dates

• First Submitted: February 23, 2011
• First Posted: March 14, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

US (3)