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

Patellofemoral Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00401050
• Other study ID #: 06-15-06
• Status: Completed
• Phase: N/A
• First received: November 16, 2006
• Last updated: April 16, 2010
• Start date: June 2006
• Est. completion date: December 2007

Study information

• Verified date: April 2010
• Source: Cleveland Chiropractic College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Patellofemoral Pain Syndrome
• Somatoform Disorders
• Syndrome

Intervention

Procedure:
• chiropractic manipulative therapy

• knee exercises

• Graston Instrument Soft Tissue Mobilization (GISTM)

Locations

Country	Name	City	State
United States	Cleveland Chirpractic College Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cleveland Chiropractic College

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anterior Knee Pain Scale (AKPS)before treatment, after last treatment and at 2 month follow up		Baseline, 6th Treatment, 2 Month Follow-Up	No
Primary	Visual Analogue Scale (VAS) before treatment, after last treatment and at 2 month follow up		Baseline, 6th Treatment, 2 Month Follow-Up	No
Secondary	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	No
Secondary	Patient Satisfaction Scale at 2 month follow up only		Baseline, 6th Treatment, 2 Month Follow-Up	No