NCT00401050

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 17, 2006

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 20, 2010

Status Verified

April 1, 2010

Enrollment Period

1.5 years

First QC Date

November 16, 2006

Last Update Submit

April 16, 2010

Conditions

Keywords

patellofemoral pain syndromechiropracticknee painchiropractic manipulationGraston Instrument Soft Tissue Mobilization(GISTM)

Outcome Measures

Primary Outcomes (2)

  • Anterior Knee Pain Scale (AKPS)before treatment, after last treatment and at 2 month follow up

    Baseline, 6th Treatment, 2 Month Follow-Up

  • Visual Analogue Scale (VAS) before treatment, after last treatment and at 2 month follow up

    Baseline, 6th Treatment, 2 Month Follow-Up

Secondary Outcomes (2)

  • a functional measure (step-ups, step-downs and squats) before treatment, after last treatment and at 2 month follow up

    Baseline, 6th Treatment, 2 Month Follow-Up

  • Patient Satisfaction Scale at 2 month follow up only

    Baseline, 6th Treatment, 2 Month Follow-Up

Interventions

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Chirpractic College Los Angeles

Los Angeles, California, 90004, United States

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • James W. Brantingham, D.C., PhD.

    Cleveland Chiropractic College Los Angeles

    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

Study Record Dates

First Submitted

November 16, 2006

First Posted

November 17, 2006

Study Start

June 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 20, 2010

Record last verified: 2010-04

Locations