Comparison Study of Two Chiropractic Treatment Protocols for Knee Pain Due to Patellofemoral Pain Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00401050
Recruitment Status : Completed
First Posted : November 17, 2006
Last Update Posted : April 20, 2010
Information provided by:
Cleveland Chiropractic College

Brief Summary:
The purpose of this study is to compare outcomes of combined chiropractic care in anterior knee pain patients with patellofemoral pain syndrome.

Condition or disease Intervention/treatment Phase
Patellofemoral Pain Syndrome Procedure: chiropractic manipulative therapy Procedure: knee exercises Procedure: Graston Instrument Soft Tissue Mobilization (GISTM) Not Applicable

Detailed Description:

Exercise is standard of care for PFPS but gives limited pain reduction and functional improvement. Previous manipulative therapy for PFPS (with and without exercise) has been limited to the patellofemoral joint alone. However, literature suggests additional manipulative therapy with exercise and soft-tissue treatment may give a better outcome. Further research is needed.

Therefore, this project is a pilot study to inform a future randomized controlled trial to determine if chiropractic adjusting of the full lower extremity (lumbosacral through foot) combined with exercise and soft tissue treatment (Protocol and group A) is superior to chiropractic adjusting of the knee (alone) combined with exercise and soft tissue treatment (Protocol and group B) in the treatment of patellofemoral pain syndrome. We will use the Anterior Knee Pain Scale (AKPS) and Visual Analogue Scale (VAS) as valid and reliable primary outcome measures, a functional measure (step-ups, step-downs and squats) and a Patient Satisfaction Scale (PSS - discharge or refer) as secondary outcome measures. This study will help establish the feasibility of conducting quality research at Cleveland Chiropractic College Los Angeles.

In this pilot study there will be two groups of 10 subjects each

  1. Group A will receive CMT to the knee only, exercise and soft tissue treatment (Graston Instrument Soft Tissue Mobilization hereafter GISTM)
  2. Group B will receive CMT to the lumbosacral, sacroiliac and (all) lower extremity joints, exercise and soft tissue treatment (GISTM).

Enrolled subjects will receive a total of 6 treatments. The primary endpoint will be a 2 month follow-up after the 6th treatment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Two Chiropractic Protocols for Patellofemoral Pain Syndrome: a Pilot Study
Study Start Date : June 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chiropractic
U.S. FDA Resources

Primary Outcome Measures :
  1. Anterior Knee Pain Scale (AKPS)before treatment, after last treatment and at 2 month follow up [ Time Frame: Baseline, 6th Treatment, 2 Month Follow-Up ]
  2. Visual Analogue Scale (VAS) before treatment, after last treatment and at 2 month follow up [ Time Frame: Baseline, 6th Treatment, 2 Month Follow-Up ]

Secondary Outcome Measures :
  1. a functional measure (step-ups, step-downs and squats) before treatment, after last treatment and at 2 month follow up [ Time Frame: Baseline, 6th Treatment, 2 Month Follow-Up ]
  2. Patient Satisfaction Scale at 2 month follow up only [ Time Frame: Baseline, 6th Treatment, 2 Month Follow-Up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • anterior, peri or retropatellar knee pain >3 months from at least two of the following: prolonged sitting, stair-climbing, squatting, running, kneeling, and hopping/jumping or overuse activities. Pain is relieved by rest.
  • insidious onset of symptoms unrelated to a traumatic incident; and
  • presence of pain on palpation of the patellar facets, on step down from a 25-cm step, or during a double-legged squat
  • other disorders such as OA, instability or medial meniscus injury must be ruled out
  • X-ray or MRI findings not required. There is no clear correlation between severity of complaints and arthroscopic or radiologic findings
  • A VAS-Worst pain of ≥ 5.0; a AKPS of ≥ 50.This reflects the current probability that less PFPS patients with less severity currently consult chiropractors for this disorder

Exclusion Criteria:

  • Patellar subluxation/dislocation
  • meniscal injuries
  • intra-articular pathology (ACL injury, etc)
  • ligament laxity
  • Osgood-Schlatters
  • Sinding-Larsen-Johanson syndrome
  • knee joint effusion
  • previous surgery on patellofemoral joint
  • illiteracy/inability to understand and answer questionnaires
  • inability to attend all treatment sessions
  • true locking of knee joint
  • a neurological disorder that influences gait
  • if taking medication, amount will be diarized - otherwise not allowed
  • foot orthotics allowed if already worn
  • arthritidies
  • bursitis
  • patellar tendonitis
  • older subjects > 45 years of age
  • subjects < 18 years of age
  • those that begin marked ↑ in physical activity during the course of the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00401050

United States, California
Cleveland Chirpractic College Los Angeles
Los Angeles, California, United States, 90004
Sponsors and Collaborators
Cleveland Chiropractic College
Principal Investigator: James W. Brantingham, D.C., PhD. Cleveland Chiropractic College Los Angeles

Responsible Party: James W. Brantingham, DC, PhD, Cleveland Chiropractic College Identifier: NCT00401050     History of Changes
Other Study ID Numbers: 06-15-06
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: April 20, 2010
Last Verified: April 2010

Keywords provided by Cleveland Chiropractic College:
patellofemoral pain syndrome
knee pain
chiropractic manipulation
Graston Instrument Soft Tissue Mobilization(GISTM)

Additional relevant MeSH terms:
Somatoform Disorders
Patellofemoral Pain Syndrome
Pathologic Processes
Mental Disorders
Joint Diseases
Musculoskeletal Diseases