NCT03101956

Brief Summary

The aim of this double blind, randomized, placebo-controlled clinical trial is to investigate the immediate effects of spinal manipulation on hip and knee muscle strength and pain-free deep squat range of motion in order to answer several conceptual and practical research questions

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2019

Completed
Last Updated

November 3, 2020

Status Verified

November 1, 2020

Enrollment Period

2.3 years

First QC Date

March 30, 2017

Last Update Submit

November 2, 2020

Conditions

Patellofemoral Pain SyndromeAnterior Knee Pain Syndrome

Keywords

Spine Manipulation

Outcome Measures

Primary Outcomes (2)

  • Muscle Strength using dynamometer

    Hand-held dynamometry involves the use of a dynamometer that is held by a tester and applied to the tested segment of a patient's body.

    1 Day

  • Score on European Quality of Life-5 Dimensions Questionnaire (EQ-5D)

    The EQ-5D-3L descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems

    1 Day

Secondary Outcomes (1)

  • Subject's report of pain on the Numeric Pain Rating Scale (NPRS) at rest

    1 Day

Study Arms (2)

L/S Manipulation Study Group

EXPERIMENTAL
Procedure: Lumbar Spine Manipulation

Control Group

ACTIVE COMPARATOR
Procedure: Lumbar Spine Manipulation Placebo

Interventions

Lumbar Spine ManipulationPROCEDURE

• The subject will be placed in sidelying on a treatment table. Facing the subject, the therapist will position the subject's superior thigh in flexion and rotate the subject's upper trunk to the opposite side. The therapist will place his cephalad forearm along the subject's superior lateral trunk and the caudal forearm along the subject's iliac crest and lateral hip. Lastly, the therapist will roll the subject towards himself or herself.

Also known as: Sidelying lumbosacral thrust joint manipulation
L/S Manipulation Study Group
Lumbar Spine Manipulation PlaceboPROCEDURE

The subject will be placed in sidelying on a treatment table. Facing the subject, the therapist will position both hips and knees in approximately 45° of flexion. The therapist will place his or her cephalad forearm along the subject's superior lateral trunk and the caudal forearm along the subject's iliac crest and lateral hip. Lastly, the therapist will roll the subject towards himself or herself.

Also known as: Sidelying lumbosacral thrust joint manipulation placebo
Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Referred to out-patient physical therapy for a knee condition and a chief complaint of anterior knee pain
  • Anterior knee pain with squatting
  • Agreed to be in the study and signed the informed consent document

You may not qualify if:

  • Presence of any medical 'red flags' suggestive of pain that is not of musculoskeletal origin
  • Osteoporosis or recent fracture of the hip or spinal joints
  • Spinal or hip joint surgery or prosthesis
  • Knee surgery on the affected knee within the last 6 months
  • Spinal instability (Grade II spondylolithesis or greater), spondyloarthritides, or severe spinal misalignment
  • Nervous system disease or disorder
  • Pregnant
  • Lumbar nerve root compression (any of the following signs present)
  • Positive straight leg raise (SLR) test less than 45°
  • Marked paresis involving a major muscle group of the lower extremity
  • Diminished, and asymmetric (lower than uninvolved side), lower extremity
  • muscle stretch reflex
  • Diminished or absent sensation to pinprick in any lower extremity dermatome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Study Officials

  • Michael D'Agati, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 5, 2017

Study Start

March 1, 2017

Primary Completion

June 21, 2019

Study Completion

June 21, 2019

Last Updated

November 3, 2020

Record last verified: 2020-11

Locations

US(1)