Recruiting

Observational Study

Sponsor:

Andrews University

Code:

NCT04054869

Conditions

Neck Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Bio-mechanically correct manual therapy at the cervical atlanto-axial joints

Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints

Study Details

Brief summary:

Participants with limited neck rotation are recruited to determine if manual therapy (joint stretching) techniques applied in a bio-mechanically correct sequence will improve neck motion, function and pain better than if the manual therapy is applied in the opposite direction. Each participant will receive both the correct and the incorrect applications in randomized order with each treatment separated by 2-3 days. Improvement in neck motion, function and pain will be assessed after each session.

Conditions

Neck Pain

Study ID

NCT04054869

Start date

Nov 7, 2019

Status verified date

Nov, 2019

Completion date

Oct, 2020

Anticipated

Primary completion date

Oct, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • males or females between 18 and 80 years of age
  • 25 percent or greater asymmetry of active cervical range of motion rotation limited by pain and/or stiffness

Exclusion Criteria:

  • cervical surgeries or injections in the past one year
  • current manual or exercise treatment by another provider for neck pain
  • cervical manipulation/mobilization/trauma in past 3 months
  • cervical radicular or referred pain distal to the acromion
  • upper extremity neurologic myotome weakness or constant dermatomal numbness
  • pending litigation
  • signs of cervical myelopathy or vertebrobasilar artery insufficiency
  • use of prescribed anticoagulants or documented blood clotting disorder
  • alar or transverse ligament instability

Study Design

Enrollment

15 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bio-mechanically correct manual therapy (received first) arm

Participants will be randomized to receive manual therapy directed at the cervical spine atlanto-axial joints in the bio-mechanically correct direction followed by instruction in a home program to maintain this motion. Outcome measures will be assessed. Participants will return in 2-3 days and receive the opposite treatment and home program followed by outcomes assessment. Participants will return again in 2-3 days, outcomes will be assessed and the study will conclude. Participants will then be given the option to continue in formalized physical therapy if desired.

experimental: Bio-mechanically incorrect manual therapy (received first) arm

Participants will be randomized to receive manual therapy directed at the cervical spine atlanto-axial joints in the bio-mechanically incorrect direction followed by instruction in a home program to maintain this motion. Outcome measures will be assessed. Participants will return in 2-3 days and receive the opposite treatment and home program followed by outcomes assessment. Participants will return again in 2-3 days, outcomes will be assessed and the study will conclude. Participants will then be given the option to continue in formalized physical therapy if desired.

Interventions

Bio-mechanically correct manual therapy at the cervical atlanto-axial joints

Participant is seated in a firm backed chair. The treating physical therapist mobilizes both the ipsi-lateral and contra-lateral atlanto-axial spinal segments congruently to the direction of rotational loss.

Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints

Participant is seated in a firm backed chair. The treating physical therapist mobilizes both the ipsi-lateral and contra-lateral atlanto-axial spinal segments in-congruently to the direction of rotational loss.

Primary outcome measure

  • intra-visit change in cervical active range of motion rotation [ Time Frame: day 1: pre and post treatment change, day 3: pre and post treatment change ]

Central Contacts and Locations

Central contacts

Michael Williams, MPT

(317)757-9160mwilliams6@iuhealth.org

Greg Almeter, DScPT

(269)471-6552almeter@andrews.edu

Locations

Indiana University Health - West Hospital

Recruiting

Avon, Indiana, United States, 46123

Contacts

Michael Williams, MPT

317-217-3070mwilliams6@iuhealth.org

Nick Batuello, DPT

(317)217-3070nbatuello@iuhealth.org

More Information

Sponsor

Andrews University

Last update posted

Nov 29, 2019

Last verified

Nov, 2019

Keywords

  • neck stiffness
  • manual therapy
  • joint mobilization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Andrews University on 2019-11-29.