Comparing Manipulation, Rehabilitation and Combination of the Two in the Treatment of Knee Osteoarthritis

NCT01188837 | Completed

• 1 other identifier: IRB-CCC08132010
• Study Type: interventional
• Target: 144
• Locations: 2 countries
• Sites: 2

Brief Summary

Common medical therapies for knee osteoarthritis are patient education, drug and physical therapy, exercise and surgery. These modalities may offer improvement but drugs and surgery carry significant risk. Manipulative therapy for KOA gives pain relief and increased function. However, research suggests addition of manipulative and soft tissue therapy (to the entire kinetic chain: lumbosacral, sacroiliac, hip, knee, ankle and foot joints), may give a better outcome. Exercise therapy is considered an effective and standard care for KOA.

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis, Knee; Manipulation Therapy

Outcome Measures

Primary Outcomes (2)

• McMaster Overall Therapy Effectiveness Tool

  15 months

• Western Ontario and McMaster Universities Osteoarthritis index

  15 months

Secondary Outcomes (2)

• Range of Motion

  15 months

• One Leg Standing Test

  15 months

Study Arms (3)

Full Kinetic Chain Manipulative Therapy

ACTIVE COMPARATOR

Other: Full Kinetic Chain Manipulative Therapy

Full Kinetic Chain Rehabilitation

ACTIVE COMPARATOR

Other: Full Kinetic Chain Rehabilitation

Full Kinetic Chain Manipulative Therapy with Rehabilitation

ACTIVE COMPARATOR

Other: Full Kinetic Chain Manipulative Therapy with Rehabilitation

Interventions

Full Kinetic Chain Manipulative Therapy OTHER

Treatment will focus on restoring knee flexion and extension by lesser grades of mobilization and patellar mobilization along with careful high velocity low amplitude axial elongation of the knee joint. Additionally, manipulative therapy will be applied where needed to the full kinetic chain using diversified techniques, such as HVLA manipulation or mobilization. This group will receive a total of 6 treatments over a 3 week period. Outcome measures will be taken at baseline, prior to the 4th treatment and at the one week follow-up. A 3 month follow-up will be done by mail, phone or email.

Full Kinetic Chain Manipulative Therapy

Full Kinetic Chain Rehabilitation OTHER

Rehabilitative therapy includes exercises, focused soft tissue treatment and stretch to the knee and the full kinetic chain where needed based upon functional assessment. Also included; patient advice, education and home exercise recommendations for managing their KOA. This group will receive a total of 6 treatments over a 3 week period. Outcome measures will be taken at baseline, prior to the 4th treatment and at the one week follow-up. A 3 month follow-up will be done by mail, phone or email. The rehabilitative therapy group will be required to attend the initial treatment/training, the 4th visit and 1 week follow-up. Treatments 2, 3, 5 and 6 are considered optional; they may be done at home

Full Kinetic Chain Rehabilitation

Full Kinetic Chain Manipulative Therapy with Rehabilitation OTHER

This arm is a combination of the manipulative therapy arm and the rehabilitative therapy arm. This group receives 6 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email.

Full Kinetic Chain Manipulative Therapy with Rehabilitation

Eligibility Criteria

• Age: 38 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Knee pain and crepitus with active motion and morning stiffness ≤ 30 min ages ≥ 38 and ≤ 80
• Knee pain and crepitus with active motion and morning stiffness \>30 minutes and boney enlargement ages ≥ 38 and ≤ 80
• Knee pain (mild to moderate) of 1 year duration and age ≥ 38 and ≤ 80 years of age and able to stand and walk (see informed consent)
• Diagnosis of concurrent subluxation/joint dysfunction (S/JD) complex a) Diagnosis of S/JD will be supported throughout using the PART(S) system 6).A patient must have a score of ≥720 mm on the WOMAC to be included (≥30%) 7).Additionally, KOA patients, who are + for the Berg Balance Scale (BBS) will be monitored as a subgroup (with OLST and BBS) at all clinic assessments.

You may not qualify if:

• Rule out: General and internal medical disorders such as significant visual disorders, severe vestibular disorders (i.e., Meniere's), neurological (including Alzheimer's and other degenerative brain and mental disorders, disease and dysfunction) peripheral sensory disorders (severe insulin dependent diabetes), knee and hip joint replacement on side of knee that is treated (case by case otherwise), RA, instability, fracture/ and severe osteoporosis, frank avascular necrosis with or without moderate or severe deformity, lumbar herniated disc and injury, severe balance and proprioception problems (i.e., inability to stand with and/or without marked spinal, knee or hip deformity) etc. Symptoms (moderate to severe) in both knees or hips (case by case), etc. Recent history of meniscal or other knee surgery (not less than 6 months). Severe/constant self reported knee crepitus. Severe loss of knee or hip ROM and or severe deformity (in valgus, varus etc) particularly with instability. Severe depression per Beck Depression Index. Marked or severe fear of chiropractic adjustments/manipulative and or exercise procedures. Breaks for treatment longer than 3-4 weeks depending on each circumstance or merit may be construed as non-compliance and may be excluded.

Sponsors & Collaborators

• Cleveland Chiropractic College: lead
• Durban University of Technology: collaborator
• Murdoch University: collaborator

Study Sites (2)

Cleveland Chiropractic College Health Center

Los Angeles, California, 90004, United States

Location

Durban University of Technology

Durban, South Africa

Location

Related Publications (4)

• Deyle GD, Allison SC, Matekel RL, Ryder MG, Stang JM, Gohdes DD, Hutton JP, Henderson NE, Garber MB. Physical therapy treatment effectiveness for osteoarthritis of the knee: a randomized comparison of supervised clinical exercise and manual therapy procedures versus a home exercise program. Phys Ther. 2005 Dec;85(12):1301-17.

  PMID: 16305269 RESULT

• Pollard H, Ward G, Hoskins W, Hardy K. The effect of a manual therapy knee protocol on osteoarthritic knee pain: a randomised controlled trial. J Can Chiropr Assoc. 2008 Dec;52(4):229-42.

  PMID: 19066697 RESULT

• Hoeksma HL, Dekker J, Ronday HK, Heering A, van der Lubbe N, Vel C, Breedveld FC, van den Ende CH. Comparison of manual therapy and exercise therapy in osteoarthritis of the hip: a randomized clinical trial. Arthritis Rheum. 2004 Oct 15;51(5):722-9. doi: 10.1002/art.20685.

  PMID: 15478147 RESULT

• Fish D, Kretzmann H, Brantingham JW, Globe G, Korporaal C, Moen J. A Randomized Clinical Trial to Determine the Effect of Combining a Topical Capsaicin Cream and Knee-Joint Mobilization in the Treatment of Osteoarthritis of the Knee. Journal of the American Chiropractic Association 8-23, August 2008.

  RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• James W Brantingham, DC, PhD

  Cleveland Chiropractic College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2010
• First Posted: August 26, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 9, 2012

Record last verified: 2012-08

Locations

ZA (1); US (1)