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

April 16, 2010 updated by: Cleveland Chiropractic College

A Randomized Clinical Trial Comparing Two Chiropractic Protocols for Patellofemoral Pain Syndrome: a Pilot Study

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90004
        • Cleveland Chirpractic College Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 6th Treatment, 2 Month Follow-Up
Visual Analogue Scale (VAS) before treatment, after last treatment and at 2 month follow up
Time Frame: Baseline, 6th Treatment, 2 Month Follow-Up
Baseline, 6th Treatment, 2 Month Follow-Up

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Baseline, 6th Treatment, 2 Month Follow-Up
Patient Satisfaction Scale at 2 month follow up only
Time Frame: Baseline, 6th Treatment, 2 Month Follow-Up
Baseline, 6th Treatment, 2 Month Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cleveland Chiropractic College

Investigators

  • Principal Investigator: James W. Brantingham, D.C., PhD., Cleveland Chiropractic College Los Angeles

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

December 1, 2007

Study Completion (ACTUAL)

December 1, 2007

Study Registration Dates

First Submitted

November 16, 2006

First Submitted That Met QC Criteria

November 16, 2006

First Posted (ESTIMATE)

November 17, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 20, 2010

Last Update Submitted That Met QC Criteria

April 16, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-15-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Patellofemoral Pain Syndrome

Clinical Trials on chiropractic manipulative therapy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe