Pilot Study: Does Chiropractic Care Decrease Fall Risk in Older Adults

Musculoskeletal Equilibrium Clinical Trial

Official title:

Pilot Study: Does Chiropractic Care Decrease Fall Risk in Older Adults?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00497965
• Other study ID #: IRB-07252006
• Secondary ID: FCER 06-10-02
• Status: Completed
• Phase: N/A
• First received: July 5, 2007
• Last updated: April 16, 2010
• Start date: April 2007
• Est. completion date: December 2008

Study information

• Verified date: April 2010
• Source: Cleveland Chiropractic College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose is to study the effect of chiropractic care on balance in older adults.

Description:

The specific aims of this pilot study are to: 1) build a recruitment pool of older adults within the local community; 2) establish a protocol for long-term surveillance of falls for older adult chiropractic patients; 3) explore dose-response patterns to chiropractic care by comparing Berg Balance Scale scores at 12 months from baseline in three groups of older adults with impaired balance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Aged 65 or older

2. Able to stand steadily without assistance on one leg for an average of <5 seconds (determined by averaging the time for both legs)

3. Able to attend all scheduled sessions (by self-report)

Exclusion Criteria:

1. Non-ambulatory (wheelchair-bound); this precludes required balance testing; however, volunteers requiring assistive devices such as canes and walkers are not excluded

2. received chiropractic care or other manual care within the past three months (by self-report)

3. initiated exercise program for balance / lower body strength within the past month (by self-report)

4. contraindications to SMT or mild-exertion exercise, as determined by the clinician through physical exam and x-rays (if indicated). Contraindications include but are not limited to: signs and symptoms associated with vertebrobasilar insufficiency (including facial numbness, diplopia, drop attacks, dysphagia, and ataxia which are not fatiguable or habituable with repeated provocative head positioning); unstable or severe medical condition; severe osteoporosis, fracture or other osseous abnormalities; "high cardiovascular risk", i.e. persons with known severe cardiovascular, pulmonary or metabolic disease, or one or more major signs/symptoms suggestive of cardiovascular and pulmonary disease

5. absence of indications for SMT, as determined by the clinician through history, physical exam, orthopedic tests, and static and motion palpation. Indications for SMT include identification of decreased or increased spinal joint mobility usually accompanied by tenderness and muscle tension and spasm;

6. unable to understand English adequately to complete study forms and questionnaires, because we do not have study personnel fluent in other languages;

7. central causes of vertigo, including arteriovenous malformations, cerebral hemorrhage, brainstem vascular disease, tumors and demyelenating diseases.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Musculoskeletal Equilibrium

Intervention

Procedure:
• Chiropractic Manipulation

Behavioral:
• Balance Exercises

Locations

Country	Name	City	State
United States	Cleveland Chiropractic College Health Center	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Cleveland Chiropractic College	Foundation for Chiropractic Education and Research (FCER)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change scores for the BBS from baseline to 8 weeks will be compared with a one-factor analysis of variance. Post-hoc comparisons of means and associated confidence intervals will be evaluated using the Tukey test.		Through December 2008	No