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

This study has been completed.
Sponsor:
Information provided by:
Cleveland Chiropractic College
ClinicalTrials.gov Identifier:
NCT00401050
First received: November 16, 2006
Last updated: April 16, 2010
Last verified: April 2010
  Purpose

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


Condition Intervention
Patellofemoral Pain Syndrome
Procedure: chiropractic manipulative therapy
Procedure: knee exercises
Procedure: Graston Instrument Soft Tissue Mobilization (GISTM)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Comparing Two Chiropractic Protocols for Patellofemoral Pain Syndrome: a Pilot Study

Further study details as provided by Cleveland Chiropractic College:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Visual Analogue Scale (VAS) before treatment, after last treatment and at 2 month follow up [ Time Frame: Baseline, 6th Treatment, 2 Month Follow-Up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Patient Satisfaction Scale at 2 month follow up only [ Time Frame: Baseline, 6th Treatment, 2 Month Follow-Up ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: June 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00401050

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

No publications provided

Responsible Party: James W. Brantingham, DC, PhD, Cleveland Chiropractic College
ClinicalTrials.gov Identifier: NCT00401050     History of Changes
Other Study ID Numbers: 06-15-06
Study First Received: November 16, 2006
Last Updated: April 16, 2010
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 19, 2014