NCT06534931

Brief Summary

The goal of this trial was to determine if a mid-thoracic high velocity low amplitude spinal manipulation improves force output in those with unilateral hip adductor weakness. The main aims were to determine if the intervention: Improved hip adductor force and muscle activation immediately and 48 h post manipulation compared to a control group. Improved gluteus maximus and latissimus dorsi force and muscle activation immediately and 48 h post manipulation compared to a control group. Strength and muscle activation of the hip adductors, hip extensors (gluteus maximus), and shoulder extensors (latissimus dorsi) were measured prior to, immediate after, and 48 hours after receiving a high velocity low amplitude manipulation to the thoracic spine. The manipulation was performed by a licensed chiropractor. A control group received a validated sham manipulation to the thoracic spine. Participants were blinded to group assignment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
Last Updated

August 2, 2024

Status Verified

July 1, 2024

Enrollment Period

2.1 years

First QC Date

July 30, 2024

Last Update Submit

July 30, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Hip adductor force (weak limb)

    Isometric force produced by the hip adductors in the weaker limb. Measured with a force transducer and reported in Newtons.

    Pre intervention, immediatly post intervention, 48 hours post intervention

  • Hip adductor muscle activity (weak limb)

    Mean muscle activity during isometric contraction. Measured with surface electrode and reported as a percentage of maximum activation.

    Pre intervention, immediatly post intervention

Secondary Outcomes (10)

  • Hip extension force (strong limb)

    Pre intervention, immediatly post intervention, 48 hours post intervention

  • Gluteus maximus muscle activity (strong limb)

    Pre intervention, immediatly post intervention

  • Hip extension force (weak limb)

    Pre intervention, immediatly post intervention, 48 hours post intervention

  • Gluteus maximus muscle activity (weak limb)

    Pre intervention, immediatly post intervention

  • Shoulder extension force (weak limb)

    Pre intervention, immediatly post intervention, 48 hours post intervention

  • +5 more secondary outcomes

Study Arms (2)

Manipulation

EXPERIMENTAL

Those in the intervention group received a high velocity low amplitude manipulation to the mid-thoracic spine provided by a licensed chiropractor.

Procedure: High velocity low amplitude thoracic spine manipulation

Sham

SHAM COMPARATOR

Those in the control group received a validated sham manipulation to the mid-thoracic spine. The sham manipulation was done so that there was minimal downward force applied to the spine.

Procedure: Sham

Interventions

Participants were supine on a treatment table. The chiropractor determined levels of apparent spinal dysfunction by means of static palpation. Participants were then asked to curl forward and bring their knees to their chest as the chiropractor placed a fist just inferior to the targeted level, anywhere between the T4 - T10 vertebrae. The participant was instructed to inhale and then exhale, at which point the chiropractor lowered the participant's torso back to the table and delivered a thrust using his body into his fist.

Manipulation
ShamPROCEDURE

A previously validated physiologically inert manual procedure to the thoracic spine

Sham

Eligibility Criteria

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

You may qualify if:

  • Unilateral hip adductor weakness, as assessed by manual muscle testing
  • Pain free hip motion
  • No contraindications to high velocity thoracic spine manipulation including:
  • Any known active cancer/ Metastatic Bone Cancer Osteoporosis or other metabolic bone disorders Signs of spinal cord compression Nerve root compression with increasing neurologic deficit Signs of Vertebrobasilar insufficiency/ cervical artery abnormalities Bleeding Diatheses Angina pectoris

You may not qualify if:

  • Current pain in the adductor muscle group
  • Past history of hip surgery
  • Past history of hip fracture
  • History of spine or rib fractures
  • Psoas muscle group (hip flexor) weakness as determined by manual muscle testing
  • Received a chiropractic manipulation in past week

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of New England

Portland, Maine, 04103, United States

Location

Related Publications (15)

  • Haavik H, Kumari N, Holt K, Niazi IK, Amjad I, Pujari AN, Turker KS, Murphy B. The contemporary model of vertebral column joint dysfunction and impact of high-velocity, low-amplitude controlled vertebral thrusts on neuromuscular function. Eur J Appl Physiol. 2021 Oct;121(10):2675-2720. doi: 10.1007/s00421-021-04727-z. Epub 2021 Jun 23.

    PMID: 34164712BACKGROUND
  • Christiansen TL, Niazi IK, Holt K, Nedergaard RW, Duehr J, Allen K, Marshall P, Turker KS, Hartvigsen J, Haavik H. The effects of a single session of spinal manipulation on strength and cortical drive in athletes. Eur J Appl Physiol. 2018 Apr;118(4):737-749. doi: 10.1007/s00421-018-3799-x. Epub 2018 Jan 11.

    PMID: 29327170BACKGROUND
  • Holt K, Niazi IK, Nedergaard RW, Duehr J, Amjad I, Shafique M, Anwar MN, Ndetan H, Turker KS, Haavik H. The effects of a single session of chiropractic care on strength, cortical drive, and spinal excitability in stroke patients. Sci Rep. 2019 Feb 25;9(1):2673. doi: 10.1038/s41598-019-39577-5.

    PMID: 30804399BACKGROUND
  • Niazi IK, Kamavuako EN, Holt K, Janjua TAM, Kumari N, Amjad I, Haavik H. The Effect of Spinal Manipulation on the Electrophysiological and Metabolic Properties of the Tibialis Anterior Muscle. Healthcare (Basel). 2020 Dec 10;8(4):548. doi: 10.3390/healthcare8040548.

    PMID: 33321904BACKGROUND
  • Niazi IK, Turker KS, Flavel S, Kinget M, Duehr J, Haavik H. Changes in H-reflex and V-waves following spinal manipulation. Exp Brain Res. 2015 Apr;233(4):1165-73. doi: 10.1007/s00221-014-4193-5. Epub 2015 Jan 13.

    PMID: 25579661BACKGROUND
  • Chilibeck PD, Cornish SM, Schulte A, Jantz N, Magnus CR, Schwanbeck S, Juurlink BH. The effect of spinal manipulation on imbalances in leg strength. J Can Chiropr Assoc. 2011 Sep;55(3):183-92.

    PMID: 21886280BACKGROUND
  • 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
  • Hillermann B, Gomes AN, Korporaal C, Jackson D. A pilot study comparing the effects of spinal manipulative therapy with those of extra-spinal manipulative therapy on quadriceps muscle strength. J Manipulative Physiol Ther. 2006 Feb;29(2):145-9. doi: 10.1016/j.jmpt.2005.12.003.

    PMID: 16461174BACKGROUND
  • Botelho MB, Andrade BB. Effect of cervical spine manipulative therapy on judo athletes' grip strength. J Manipulative Physiol Ther. 2012 Jan;35(1):38-44. doi: 10.1016/j.jmpt.2011.09.005. Epub 2011 Nov 10.

    PMID: 22079053BACKGROUND
  • Fernandez-Carnero J, Fernandez-de-las-Penas C, Cleland JA. Immediate hypoalgesic and motor effects after a single cervical spine manipulation in subjects with lateral epicondylalgia. J Manipulative Physiol Ther. 2008 Nov-Dec;31(9):675-81. doi: 10.1016/j.jmpt.2008.10.005.

    PMID: 19028251BACKGROUND
  • Dishman JD, Ball KA, Burke J. First Prize: Central motor excitability changes after spinal manipulation: a transcranial magnetic stimulation study. J Manipulative Physiol Ther. 2002 Jan;25(1):1-9.

    PMID: 11898013BACKGROUND
  • Hegedus EJ, Goode A, Butler RJ, Slaven E. The neurophysiological effects of a single session of spinal joint mobilization: does the effect last? J Man Manip Ther. 2011 Aug;19(3):143-51. doi: 10.1179/2042618611Y.0000000003.

    PMID: 22851877BACKGROUND
  • Lawrence MA, Raymond JT, Look AE, Woodard NM, Schicker CM, Swanson BT. Effects of Tibiofibular and Ankle Joint Manipulation on Hip Strength and Muscle Activation. J Manipulative Physiol Ther. 2020 Jun;43(5):406-417. doi: 10.1016/j.jmpt.2019.10.005. Epub 2020 Jul 20.

    PMID: 32703611BACKGROUND
  • Michener LA, Kardouni JR, Lopes Albers AD, Ely JM. Development of a sham comparator for thoracic spinal manipulative therapy for use with shoulder disorders. Man Ther. 2013 Feb;18(1):60-4. doi: 10.1016/j.math.2012.07.003. Epub 2012 Aug 9.

    PMID: 22883130BACKGROUND
  • Parkinson AO, Apps CL, Morris JG, Barnett CT, Lewis MGC. The Calculation, Thresholds and Reporting of Inter-Limb Strength Asymmetry: A Systematic Review. J Sports Sci Med. 2021 Oct 1;20(4):594-617. doi: 10.52082/jssm.2021.594. eCollection 2021 Dec.

    PMID: 35321131BACKGROUND

MeSH Terms

Conditions

Muscle Weakness

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were unaware of the existence of a control group.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Teaching Professor

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

November 8, 2021

Primary Completion

December 13, 2023

Study Completion

December 13, 2023

Last Updated

August 2, 2024

Record last verified: 2024-07

Locations