NCT02700594

Brief Summary

Patients with painful knee conditions often present with hip muscle weakness. This weakness can lead to, and perpetuate, knee problems. Diminished strength causes movement impairments that can lead to pathology, functional limitations and disablement. In some cases, this hip muscle weakness is not caused by simple disuse and muscle shrinkage (atrophy). Hip weakness may be caused by an inhibitory mechanism that limits the force output of a muscle. The inhibition is reflexive and is in response to pain or joint dysfunction. Joint mobilization/manipulation can quickly reduce pain and improve joint function, possibly decreasing inhibition and increasing strength. Joint mobilization/manipulation may facilitate strength recovery. By restoring strength sooner, the patient may avoid the deleterious effects of prolonged muscle weakness and achieve quicker or better outcomes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Shorter than P25 for not_applicable

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

October 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2014

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
Last Updated

March 7, 2016

Status Verified

March 1, 2016

Enrollment Period

9 months

First QC Date

September 23, 2014

Last Update Submit

March 4, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in strength from baseline to immediately after intervention (maximum voluntary contraction (MVC) and measured by an electronic hand-held dynamometer)

    The primary dependent variable is the isometric muscle strength, measured in pounds, an interval level of measurement. Muscle strength will be determined by the maximum voluntary contraction (MVC) and measured by an electronic hand-held dynamometer

    1 Hour

Secondary Outcomes (1)

  • Change in pain from baseline to immediately after intervention (numeric pain rating scale (NRPS)

    1 Hour

Study Arms (2)

Hip mobilization

ACTIVE COMPARATOR

Prone posterior-to-anterior Grade IV hip joint mobilization: The subject will be placed in prone on a treatment table. The intervening physical therapist will place the heel of his hand on the greater trochanter of the femur on the involved side provide rhythmic anterior-directed force. The subject will receive 3 bouts of 30 seconds of continuous mobilizations with 10 seconds rest in between bouts. For the prone posterior-to-anterior Grade IV hip joint mobilization, the intervening therapist will perform all 3 bouts in the same position.

Other: Joint mobilization

Spine mobilization

ACTIVE COMPARATOR

Prone unilateral posterior-to-anterior Grade IV lumbar spinal joint mobilization: The subject will be placed in prone on the treatment table. The intervening physical therapist will place his thumbs on the transverse process, on the affected side, of the L3, L4 or L5 vertebrae and provide a rhythmic anterior-directed force. Prone unilateral posterior-to-anterior Grade IV lumbar spinal joint mobilization, the intervening therapist will perform 1 bout on each of L3, L4 and L5 for a total of 3 bouts

Other: Joint mobilization

Interventions

Mobilization and manipulation are manual therapy techniques" comprising a continuum of skilled passive movements to the joints and/or related soft tissues that are applied at varying speeds and amplitudes, including a small-amplitude/high- velocity therapeutic movement."16 The term joint mobilization, or nonthrust mobilization, often refers to slow, "rhythmic, repetitive passive movements to the patients' tolerance, in voluntary and/or accessory range and graded according to examination findings."

Hip mobilizationSpine mobilization

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age18-75
  • Referred to out-patient physical therapy for evaluation/treatment of a knee condition
  • 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
  • Spinal instability (Grade II spondylolithesis or greater), spondyloarthritides, or severe spinal misalignment
  • Nervous system disease or disorder
  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Bialosky JE, Bishop MD, Price DD, Robinson ME, George SZ. The mechanisms of manual therapy in the treatment of musculoskeletal pain: a comprehensive model. Man Ther. 2009 Oct;14(5):531-8. doi: 10.1016/j.math.2008.09.001. Epub 2008 Nov 21.

    PMID: 19027342BACKGROUND
  • Makofsky H, Panicker S, Abbruzzese J, Aridas C, Camp M, Drakes J, Franco C, Sileo R. Immediate Effect of Grade IV Inferior Hip Joint Mobilization on Hip Abductor Torque: A Pilot Study. J Man Manip Ther. 2007;15(2):103-10. doi: 10.1179/106698107790819927.

    PMID: 19066650BACKGROUND

Study Officials

  • Angela Stolfi, DPT

    Rusk PT Director

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2014

First Posted

March 7, 2016

Study Start

October 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

March 7, 2016

Record last verified: 2016-03