Lumbar Thrust-mobilization Effects on Hip Strength and Anterior Knee Pain

October 7, 2019 updated by: Messiah College

Lumbar Thrust-mobilization Effects on Hip Strength and Anterior Knee Pain, a Double Blind Randomized Control Trial

The purpose of this study is to investigate changes in lateral hip muscle strength as well as self-reported pain during the performance of three functional tests in patients with anterior knee pain following a lumbopelvic thrust-mobilization.

Hypothesis(es):

Lumbar thrust-mobilization will lead to increased lateral hip strength and decreased anterior knee pain during 3 functional activities (single leg step down, functional squat, drop jump).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The participant will complete a medical history form and undergo a brief physical exam of the lumbar spine and knees to include: lumbar range of motion and mobility testing, knee range of motion, palpation, and knee mobility testing. The participant will complete a hip strength test utilizing the Biodex System 4 Pro®. The participant will then perform three activities (single leg step down, squat, and drop jump from a 2 foot platform) and provide a self-reported knee pain measure with each activity. A sealed envelope indicating the intervention to be received will be given to the participant. An investigator blinded to the pre and post-measures will open the envelope indicating the intervention to be performed. The participant will be blinded to which intervention group they are categorized to. Th e participant will be positioned on a high-low treatment table to receive the assigned intervention. The participant will be positioned to receive either intervention 1 (thrust mobilization) or 2 (sham mobilization). The participant will either receive the thrust-mobilization or sham mobilization up to 2 times on the left and right side. An immediate re-test of hip strength will be conducted followed by performing the same three functional activities (single leg step down, squat, and drop jump from a 2 foot platform) while providing a self-reported pain measure after each activity. Follow-up measures at 15 minutes post-intervention and the final measure at 30 minutes post-intervention will be performed.

Study Type

Interventional

Enrollment (Anticipated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy males and females between the ages of 18 and 25 with non-traumatic anterior knee pain
  • Able read and write in English
  • Clearly understand the informed consent form

Exclusion Criteria:

  • Low back pain
  • Pregnant or may be pregnant
  • Previously diagnosed with spondylolisthesis,
  • Previously diagnosed with a herniated disc,
  • Signs and symptoms of nerve root compression
  • History of spine surgery
  • History of knee surgery
  • History of cancer
  • History of compression fracture
  • History of osteoporosis
  • History of osteopenia
  • History of a systemic disease
  • History of a connective tissue disease
  • History of a neurological disease
  • Pain with pre-manipulative hold
  • Positive findings on medical history form, or physical exam
  • Presence of anxiety during the procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lumbar thrust-mobilization
The investigator will perform a lumbar thrust-mobilization with the subject in right and then left sidelying position
Other: Lumbar-thrust mobilization
The intervention group will receive passive spinal rotational grade V thrust-mobilization, based on Maitland's approach. The intervention will be performed with the subject in right sidelying and left sidelying. The operator's palpating hand is placed over the L2-3 intervertebral space, and the other hand bends both legs of the participant up to the range at which the L2-3 midposition is found. The participant is then asked to straighten the lower leg and hook the upper leg over it with the upper leg's knee positioned over the side of the plinth. While the lower component is kept still, the participant's trunk is rotated until the hip starts to lift off from the plinth. The bottom hand and uppermost hand rest under a pillow and the chest wall, respectively. With the starting position settled, the operator stands behind the participant, takes up the slack within the spine and then provides a grade V thrust- mobilization while stabilizing the uppermost shoulder.
Other Names:
  • Grade 5 mobilization, manipulation
SHAM_COMPARATOR: Sham-mobilization
No lumbar-thrust mobilization will be performed. Subject will receive simple passive inter-vertebral range of motion.
Other: Sham thrust-mobilization
Subjects are positioned in right sidelying. The experimenter holds both knees with one arm while placing their opposite hand on the participant's lumbar spine. The experimenter performs 1 min of flexion and extension passive range of motion without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lateral hip strength
Time Frame: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
lateral isometric hip strength will be measured with Biodex system 4
Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
Change in pain with single leg step down
Time Frame: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention

Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a single leg step down.

The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.
Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
Change in pain with double leg squat
Time Frame: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention

Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a double leg squat.

The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.
Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention
Change in pain with drop jump from 2 foot platform
Time Frame: Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention

Subject will provide level of anterior knee pain via Visual Analogue Scale (VAS) while performing a drop jump from a 2 foot platform.

The VAS pain scale is a 0 to 10 scale, 0 indicates no pain, 5 indicates distressing pain, 10 indicates unbearable pain. Any whole number between 0 and 10 may be chosen. 0 is better and 10 is worse.
Pre-intervention, immediately following intervention, 15 min post-intervention & 30 min post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Messiah College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

November 1, 2019

Primary Completion (ANTICIPATED)

May 31, 2020

Study Completion (ANTICIPATED)

May 31, 2020

Study Registration Dates

First Submitted

October 1, 2019

First Submitted That Met QC Criteria

October 7, 2019

First Posted (ACTUAL)

October 8, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 8, 2019

Last Update Submitted That Met QC Criteria

October 7, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BergmannHumphrey

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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