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

Primary Purpose

Patellofemoral Pain Syndrome

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

chiropractic manipulative therapy

knee exercises

Graston Instrument Soft Tissue Mobilization (GISTM)

About this trial

This is an interventional treatment trial for Patellofemoral Pain Syndrome focused on measuring patellofemoral pain syndrome, chiropractic, knee pain, chiropractic manipulation, Graston Instrument Soft Tissue Mobilization(GISTM)

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Cleveland Chirpractic College Los Angeles

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

Patient Satisfaction Scale at 2 month follow up only

Full Information

NCT ID

NCT00401050

First Posted

November 16, 2006

Last Updated

April 16, 2010

Sponsor

Cleveland Chiropractic College

1. Study Identification

Unique Protocol Identification Number

NCT00401050

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Completed

Study Start Date

June 2006 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Cleveland Chiropractic College

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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 Group A will receive CMT to the knee only, exercise and soft tissue treatment (Graston Instrument Soft Tissue Mobilization hereafter GISTM) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Patellofemoral Pain Syndrome

Keywords

patellofemoral pain syndrome, chiropractic, knee pain, chiropractic manipulation, Graston Instrument Soft Tissue Mobilization(GISTM)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

chiropractic manipulative therapy

Intervention Type

Procedure

Intervention Name(s)

knee exercises

Intervention Type

Procedure

Intervention Name(s)

Graston Instrument Soft Tissue Mobilization (GISTM)

Primary Outcome Measure Information:

Title

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

Title

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 Measure Information:

Title

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

Title

Patient Satisfaction Scale at 2 month follow up only

Time Frame

Baseline, 6th Treatment, 2 Month Follow-Up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James W. Brantingham, D.C., PhD.

Organizational Affiliation

Cleveland Chiropractic College Los Angeles

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Chirpractic College Los Angeles

City

Los Angeles

State/Province

California

ZIP/Postal Code

90004

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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