NCT00632710

Brief Summary

The purpose of the present study was to assess the effectiveness of low-level laser therapy on the reduction in pain and improvement in function in the hands of patients with rheumatoid arthritis

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Jul 2004

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

July 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2008

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2008

Completed
Last Updated

March 11, 2008

Status Verified

March 1, 2008

Enrollment Period

1.4 years

First QC Date

February 7, 2008

Last Update Submit

March 4, 2008

Conditions

Keywords

rheumatoid arthritishandsrandomized controlledlow level laser

Outcome Measures

Primary Outcomes (1)

  • pain

    2 months

Secondary Outcomes (1)

  • function

    2 months

Study Arms (2)

b

EXPERIMENTAL

laser

Other: phototherapy

a

PLACEBO COMPARATOR

laser placebo

Other: phototherapy placebo

Interventions

The laser used was low-level Aluminum Gallium Arsenide (AlGaAs)diodo laser, at a wavelength of 785 nm (infrared), dose of 3 J/cm2, mean power of 70 mW, 3 sec. per point, laser beam of 0,06cm2, BIOSET brand - Indústria de Tecnologia Eletrônica Ltda -Rio Claro, Brazil.

Also known as: soft laser therapy
b

disconnected laser (same device - experimental group)

Also known as: soft laser placebo therapy
a

Eligibility Criteria

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

You may qualify if:

  • patients with RA
  • inflammatory condition of at least two hand joints among the wrists, proximal interphalangeal (PIP) joint and metacarpophalangeal (MCP) joint
  • visual analogue scale (VAS) for pain between 3 and 8 cm during activities of daily living
  • and being of either gender

You may not qualify if:

  • skin lesions at the application site
  • other illnesses affecting the hands; physiotherapy for the hands in the previous three months
  • joint injections in the previous three months
  • change in disease-modifying anti-rheumatic drugs in the previous three months
  • and change in corticosteroids in the previous month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Sao Paulo

São Paulo, São Paulo, 04023-900, Brazil

Location

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Sandra M Meireles, Physiother.

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2008

First Posted

March 11, 2008

Study Start

July 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

March 11, 2008

Record last verified: 2008-03

Locations