NCT05689723

Brief Summary

The purpose of this study is to study the effects of lumbar manipulation on hip extension strength and jump height in healthy subjects. Procedures to be followed: First, the subject will be asked to complete a medical history form. Then they will be instructed on the procedure for strength and jump testing. Next, range of motion of the low back will be measured. Then hip strength will be measured using a digital handheld measurement tool. The subject will then be asked to jump as high as they can on a floor mat. The subject will then receive a sealed envelope indicating the intervention they will to receive, either the manipulation or a fake manipulation. Instructions will be provided, and the subject will be positioned on a treatment table to receive the intervention. At this point, they will either receive the manipulation or fake manipulation on the right and left side. An immediate re-test of hip strength will be taken, and the subject will again jump as high as they can on a floor mat. Follow-up measures of these tests will be completed again 20 minutes after the intervention is given.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 19, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

January 19, 2023

Status Verified

October 1, 2022

Enrollment Period

9 months

First QC Date

October 3, 2022

Last Update Submit

January 10, 2023

Conditions

Weakness, Muscle

Outcome Measures

Primary Outcomes (1)

  • Change in hip extension strength

    microFET 2 Manual Muscle Tester Hand Held Dynamometer

    immediately post instervention and 20 minutes post

Secondary Outcomes (1)

  • Change in jump height

    immediately post instervention and 20 minutes post

Study Arms (2)

Manipulation

EXPERIMENTAL

Left and right sidelyiing gaping high velocity low amplitude thrust mobilization

Procedure: Lumbar manipulation

Sham Manipulation

SHAM COMPARATOR

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 PROM without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying.

Procedure: Sham Manipulation

Interventions

Lumbar manipulationPROCEDURE

Left and right sidelyiing gaping high velocity low amplitude thrust mobilization

Manipulation
Sham ManipulationPROCEDURE

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 PROM without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying.

Sham Manipulation

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18 and 30
  • able to read and write in English and clearly understand the informed consent.

You may not qualify if:

  • currently have low back pain
  • pregnant or may be pregnant
  • previously diagnosed with spondylolisthesis, a herniated disc, or have signs and symptoms of nerve root compression
  • history of spine surgery
  • history of cancer, compression fracture, osteoporosis, osteopenia, or a history of systemic, connective tissue, or neurological disease,
  • pain with the pre-manipulative hold
  • positive findings on medical history form, or physical exam,
  • presence of anxiety during the procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Sueki DG, Cleland JA, Wainner RS. A regional interdependence model of musculoskeletal dysfunction: research, mechanisms, and clinical implications. J Man Manip Ther. 2013 May;21(2):90-102. doi: 10.1179/2042618612Y.0000000027.

    PMID: 24421619BACKGROUND

  • Wainner RS, Whitman JM, Cleland JA, Flynn TW. Regional interdependence: a musculoskeletal examination model whose time has come. J Orthop Sports Phys Ther. 2007 Nov;37(11):658-60. doi: 10.2519/jospt.2007.0110. No abstract available.

    PMID: 18057674BACKGROUND

  • Mintken PE, McDevitt AW, Cleland JA, Boyles RE, Beardslee AR, Burns SA, Haberl MD, Hinrichs LA, Michener LA. Cervicothoracic Manual Therapy Plus Exercise Therapy Versus Exercise Therapy Alone in the Management of Individuals With Shoulder Pain: A Multicenter Randomized Controlled Trial. J Orthop Sports Phys Ther. 2016 Aug;46(8):617-28. doi: 10.2519/jospt.2016.6319.

    PMID: 27477473BACKGROUND

  • McDevitt A, Young J, Mintken P, Cleland J. Regional interdependence and manual therapy directed at the thoracic spine. J Man Manip Ther. 2015 Jul;23(3):139-46. doi: 10.1179/2042618615Y.0000000005.

    PMID: 26309384BACKGROUND

  • Bergman GJ, Winter JC, van Tulder MW, Meyboom-de Jong B, Postema K, van der Heijden GJ. Manipulative therapy in addition to usual medical care accelerates recovery of shoulder complaints at higher costs: economic outcomes of a randomized trial. BMC Musculoskelet Disord. 2010 Sep 6;11:200. doi: 10.1186/1471-2474-11-200.

    PMID: 20819223BACKGROUND

  • Stupar M, Cote P, French MR, Hawker GA. The association between low back pain and osteoarthritis of the hip and knee: a population-based cohort study. J Manipulative Physiol Ther. 2010 Jun;33(5):349-54. doi: 10.1016/j.jmpt.2010.05.008.

    PMID: 20605553BACKGROUND

  • Pickar JG. Neurophysiological effects of spinal manipulation. Spine J. 2002 Sep-Oct;2(5):357-71. doi: 10.1016/s1529-9430(02)00400-x.

    PMID: 14589467BACKGROUND

  • Espi-Lopez GV, Arnal-Gomez A, Balasch-Bernat M, Ingles M. Effectiveness of Manual Therapy Combined With Physical Therapy in Treatment of Patellofemoral Pain Syndrome: Systematic Review. J Chiropr Med. 2017 Jun;16(2):139-146. doi: 10.1016/j.jcm.2016.10.003. Epub 2016 Nov 22.

    PMID: 28559754BACKGROUND

  • Grindstaff TL, Hertel J, Beazell JR, Magrum EM, Ingersoll CD. Effects of lumbopelvic joint manipulation on quadriceps activation and strength in healthy individuals. Man Ther. 2009 Aug;14(4):415-20. doi: 10.1016/j.math.2008.06.005. Epub 2008 Sep 20.

    PMID: 18805726BACKGROUND

  • Grindstaff TL, Hertel J, Beazell JR, Magrum EM, Kerrigan DC, Fan X, Ingersoll CD. Lumbopelvic joint manipulation and quadriceps activation of people with patellofemoral pain syndrome. J Athl Train. 2012 Jan-Feb;47(1):24-31. doi: 10.4085/1062-6050-47.1.24.

    PMID: 22488227BACKGROUND

  • Sanders GD, Nitz AJ, Abel MG, Symons TB, Shapiro R, Black WS, Yates JW. Effects of Lumbosacral Manipulation on Isokinetic Strength of the Knee Extensors and Flexors in Healthy Subjects: A Randomized, Controlled, Single-Blind Crossover Trial. J Chiropr Med. 2015 Dec;14(4):240-8. doi: 10.1016/j.jcm.2015.08.002. Epub 2015 Nov 6.

    PMID: 26793035BACKGROUND

  • Yuen TS, Lam PY, Lau MY, Siu WL, Yu KM, Lo CN, Ng J. Changes in Lower Limb Strength and Function Following Lumbar Spinal Mobilization. J Manipulative Physiol Ther. 2017 Oct;40(8):587-596. doi: 10.1016/j.jmpt.2017.07.003.

    PMID: 29187310BACKGROUND

  • Botelho MB, Alvarenga BAP, Molina N, Ribas M, Baptista AF. Spinal Manipulative Therapy and Sports Performance Enhancement: A Systematic Review. J Manipulative Physiol Ther. 2017 Sep;40(7):535-543. doi: 10.1016/j.jmpt.2017.03.014.

    PMID: 29191288BACKGROUND

  • Sandell J, Palmgren PJ, Bjorndahl L. Effect of chiropractic treatment on hip extension ability and running velocity among young male running athletes. J Chiropr Med. 2008 Jun;7(2):39-47. doi: 10.1016/j.jcme.2008.02.003.

    PMID: 19674719BACKGROUND

MeSH Terms

Conditions

Muscle Weakness

Interventions

Manipulation, Spinal

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsPhysical Therapy ModalitiesTherapeuticsRehabilitation

Central Study Contacts

Karl Bergmann, ScD

CONTACT

717-796-1800kbergmann@messiah.edu

Amy Humphrey, PhD(c)

CONTACT

717-796-1800ahumphrey@messiah.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2022

First Posted

January 19, 2023

Study Start

January 1, 2023

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

January 19, 2023

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share