Clinical trial NCT05321654: Effects of Postural Education or Corrective Exercise on Forward Head Posture
Official title: The Effects of Postural Education or Corrective Exercise Intervention on the Craniovertebral Angle in Young Adults With Forward Head Posture: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural; Defect
Keywords: Forward Head Posture
Craniovertebral Angle
Corrective Exercise Program
Postural Education
Lead sponsor: Liberty University
Sponsor class: OTHER
Collaborators: name: National Academy of Sports Medicine
First posted: 2022-04-11
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective parallel randomized controlled trial with repeated measures
Primary purpose: PREVENTION

Brief summary: This randomized control trial examined the effects of postural education or corrective exercise intervention on the craniovertebral angle (CVA) in young adults with forward head posture (FHP). The objectives were 1: to investigate whether or not a corrective exercise program (CEP) consisting of self-myofascial release (SMR) + stretching; a CEP consisting of SMR + stretching + strengthening; or postural education (PE) had an effect on the CVA; 2. to determine which intervention yielded the greatest postural enhancement if a positive effect was observed in more than one intervention. \*\[note: SMR is a technique involving the self-application of pressure to fascia and muscle tissue for the purpose of enhancing flexibility, reducing muscle soreness, and influencing muscle relaxation\]. It was hypothesized that 4 weeks after receiving either CEP intervention or PE there would be a significant change in the CVA compared to a control group; and that there would be an intervention more effective than the others for improving the CVA. The null hypotheses were: there would be no CVA change after intervention in any of the groups; and there will be no intervention more effective than another for improving the CVA.

Detailed description: A total of 94 participants responded to invitations to voluntarily participate and completed the Physical Activity Readiness Questionnaire (PAR-Q+), followed by a questionnaire to rate their current stage of change (SOC) from the Transtheoretical Model adapted to assess exercise/postural modification behavior change (this will be discussed further in eligibility section). On this questionnaire, participants also responded to a yes/no question regarding if they have had a recent injury to their head, shoulders, or spine; or have ever been diagnosed with a pathology related to their cervical/thoracic spine or extremities, as part of exclusion criteria for the study. Participants then underwent a head posture screening performed by the primary investigator who is a licensed physical therapist in the Liberty University Biomechanics \& Motion Analysis Laboratory with the use of photogrammetry (use of a digital camera and software to measure posture) as described below.

Participants were asked to arrive at the lab wearing either a tank top or t-shirt, as well as to have their hair tied back if necessary. Height and weight were measured using a digital scale (Health-o-meter Professional, model 500KL, McCook, IL). Participants were instructed to sit comfortably on a stool with hands resting approximately two-thirds down their thighs with palms supinated and feet flat on the ground with hips and knees at 90 degrees; and to look straight ahead at an opposite wall in the laboratory. A digital camera (Canon Powershot, model SX540, Tokyo, Japan) was mounted and leveled on a tripod (Manfrotto, model 055, Cassola, IT) and placed three meters away from the subject. Two photographs were taken of participant's posture. Immediately after data capture, image files were uploaded into Kinovea video analysis software (version 8.15) for CVA assessment. CVA assessment will be discussed further in outcome measures section.

Seventy-nine participants met inclusion criteria (discussed in detail in future section) and were enrolled in the study. Randomization of participant group assignments was completed by the PI using a block randomization generator. Utilizing a sequence created by the block randomizer, the PI placed participants who met inclusion criteria into one of four groups: postural education (PE; n = 20), self-myofascial release + stretching (SMRS; n = 20), self-myofascial release + stretching + strengthening (SMRSS; n = 19), and control group (CG; n = 20). Details of these groups will be provided in future sections. A hard-copy of the sequence generator report was kept concealed in a manila folder and was only opened by the PI during group delegation.

Intervention duration was 4 weeks. Two weeks into the study, participants in intervention groups completed a mid-study questionnaire to assess intervention compliance. At the end of the study (after the completion of 4 weeks) participants in intervention groups completed a post-study questionnaire to assess intervention compliance. All study participants were asked to return back to the Biomechanics laboratory after the completion of the 4 week intervention period to undergo follow-up posture screening, which followed the same posture assessment procedures as described above.

Declarations of interest: This study was part of the requirements for completion of a Ph.D. dissertation (Concordia University Chicago) by David Titcomb, DPT.

Conflicts of interest: none.

Eligibility criteria: Inclusion Criteria:

* Completion of informed consent
* Craniovertebral angle ≤ 53 degrees
* Self-rating of Transtheoretical Model stage of change stage ≥ 3/5

Exclusion Criteria:

* Any musculoskeletal injury to the head, shoulders, or spine within the last six months
* Diagnosis of pathology related to the cervical spine, thoracic spine, or upper extremities
* Non-clearance for physical activity based on results of the 2020 PAR-Q+ questionnaire

Primary outcomes:
measure: Change in Craniovertebral Angle after 4 weeks
timeFrame: Baseline: On day 1 of study enrollment; Post-Intervention: Within 5 days after the end of the 4 week intervention period
Secondary outcomes:
measure: Midpoint Intervention Compliance
timeFrame: Assessed at the start of week 3
measure: Endpoint Intervention Compliance
timeFrame: Within 5 days after the end of the 4 week intervention period.
Other outcomes:
Locations:
city: Lynchburg
country: United States
facility: Liberty University
state: Virginia
Study officials:
affiliation: Liberty University
name: David A Titcomb, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Concordia University Chicago
name: Bridget F Melton, EdD
role: STUDY_CHAIR
affiliation: Concordia University Chicago
name: Theresa Miyashita, PhD
role: STUDY_DIRECTOR
affiliation: Concordia University Chicago
name: Helen W Bland, PhD
role: STUDY_DIRECTOR
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