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Patellofemoral Pain SyndromeNCT00401050

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

A study testing chiropractic manipulative therapy, knee exercises and Graston Instrument Soft Tissue Mobilization (GISTM) in people with Patellofemoral Pain Syndrome, run by Cleveland Chiropractic College at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Patellofemoral Pain Syndrome
What is being tested?
chiropractic manipulative therapy, knee exercises and Graston Instrument Soft Tissue Mobilization (GISTM)
Type of treatment
Surgery or procedure
How many people
31 participants
Where
1 siteUnited States
Study dates
Jun 2006to Dec 2007
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • Patellar subluxation/dislocation
  • meniscal injuries
  • intra-articular pathology (ACL injury, etc)
  • ligament laxity
  • Osgood-Schlatters
  • Sinding-Larsen-Johanson syndrome
Show all 20Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Cleveland Chirpractic College Los Angeles

    Los Angeles, California, 90004

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
chiropractic manipulative therapy, knee exercises, Graston Instrument Soft Tissue Mobilization (GISTM)
Keywords
patellofemoral pain syndrome, chiropractic, knee pain, chiropractic manipulation, Graston Instrument Soft Tissue Mobilization(GISTM)
Medical subject headings
Patellofemoral Pain Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • chiropractic manipulative therapyProcedure or surgery

  • knee exercisesProcedure or surgery

  • Graston Instrument Soft Tissue Mobilization (GISTM)Procedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Baseline, 6th Treatment, 2 Month Follow-Up

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

    Measured: Baseline, 6th Treatment, 2 Month Follow-Up

Secondary outcomes (2)

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

    Measured: Baseline, 6th Treatment, 2 Month Follow-Up

  2. Patient Satisfaction Scale at 2 month follow up only

    Measured: Baseline, 6th Treatment, 2 Month Follow-Up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2006 (estimated)
  2. Study startJun 2006
  3. Primary completionDec 2007
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00401050
Sponsor's protocol ID
06-15-06
Status last verified
Apr 2010
First submitted
16 Nov 2006
Last updated
20 Apr 2010
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing chiropractic manipulative therapy, knee exercises and Graston Instrument Soft Tissue Mobilization (GISTM) in people with Patellofemoral Pain Syndrome, run by Cleveland Chiropractic College at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00401050.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2010.

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