NCT00254111

Brief Summary

The purpose of this study is to determine whether low level light therapy is effective in the treatment of osteoarthritis of the hand, when the treatment is applied to the hand by an individual in his or her own home.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2005

Geographic Reach
1 country

3 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
Last Updated

November 15, 2005

Status Verified

November 1, 2005

First QC Date

November 11, 2005

Last Update Submit

November 14, 2005

Conditions

Osteoarthritis

Keywords

osteoarthritishandlaserdevicehand painstiffness

Outcome Measures

Primary Outcomes (1)

  • Hand pain rating on the VAS at 10 days after treatment onset.

Secondary Outcomes (6)

  • Hand pain rating on the VAS at 6 weeks after treatment onset,

  • Hand Range of Motion measurements at 10 days after treatment onset and at 6 weeks after treatment onset,

  • Rescue medication use at 10 days after treatment onset and at 6 weeks after treatment onset,

  • Scores on the Michigan Hand Outcomes Questionnaire at 10 days after treatment onset and at 6 weeks after treatment onset,

  • Study outcome satisfaction rating at 10 days after treatment onset and at 6 weeks after treatment onset,

  • +1 more secondary outcomes

Interventions

Ultra Probe Laser SystemDEVICE

Eligibility Criteria

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

You may qualify if:

  • Clinical and radiographic diagnosis of osteoarthritis of the hand.
  • Hand symptoms such as pain, aching and stiffness present across the prior six months.
  • Willingness to use only Tylenol to relieve hand symptoms during the study.
  • Primary spoken language is English.

You may not qualify if:

  • Current use of narcotics, opiates, morphine, steroids.
  • Previous surgery to the hand.
  • Infection or wound in the hand.
  • Involvement in litigation, worker's compensation claim or receiving disability benefits because of osteoarthritis of the hand.
  • Participation in a research study during the prior 90 days.
  • Pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Proctology Associates

Phoenix, Arizona, 85014, United States

RECRUITING

Advanced Wellness Center

Long Beach, California, 90803, United States

RECRUITING

Advanced Chiropractic

Bloomington, Minnesota, 55437, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Kevin M Walls, M.B.A., RAS

    Regulatory Insight, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

July 1, 2005

Study Completion

July 1, 2006

Last Updated

November 15, 2005

Record last verified: 2005-11

Locations

US(3)