Laser Therapy, Pain and Carpometacarpal Joint Osteoarthritis Treatment

NCT ID: NCT03270488

Last Updated: 2018-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-24
• Study Completion Date: 2017-09-25

Brief Summary

Osteoarthritis (OA) is a chronic and prevalent joint disorder with great impact on quality of life and high economic burden. Although a number of conservative therapies have proven to be effective for the management of hand OA, only modest treatment effects were reported for most individual interventions. The aim of the proposed study is to assess the effect of laser therapy on pain, function and force in patients with carpometacarpal osteoarthritis (CMC OA).

Detailed Description

A randomized, controlled, single-center, double-blind, clinical trial, with 1:1 allocation ratio, were carried out involving patients diagnosis of CMC joint OA grade 1-2 (aged 18 years and above). Both assessor and statistician remained blinded. The research diagnostic criteria for carpometacarpal joint osteoarthritis was used to assess all individuals who agree to participate. All participants were submitted to a clinical examination and X-ray assessment of thumb base to determine carpometacarpal osteoarthritis grade. Based on the clinical and radiological findings, the participants were classified by a rheumatology. Those with CMC OA grade 2-3 were included in the study. The experimental group received laser therapy and control group received a placebo treatment.

The primary outcome measures was pain scores during daily living activities (DLA)- at the base of the thumb measured with VAS (Unidimensional measure of pain: 0-10 (0, no pain and 10, worst pain), and changes in hand function measured using the Quick-Dash questionnaire. Secondary outcome measures included changes in pinch strength. All outcome measures were collected at baseline, immediately following the intervention at 4 weeks and at 12 weeks following the end of the intervention.

Conditions

Thumb Osteoarthritis; Pain; Physical Disorder

Keywords

Thumb; Osteoarthritis; Physical Therapy; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Laser Group

Laser application three times a week for 4 weeks.

Group Type: EXPERIMENTAL

Laser

Intervention Type: OTHER

Laser (power of 3.0w).

Placebo group

The same equipment was used with a pen that emits a red guide light and a warning sound, but without the emission of a laser beam.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Laser (power 0,0w)

Interventions

Laser

Laser (power of 3.0w).

Intervention Type: OTHER

Placebo

Laser (power 0,0w)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women over 18 diagnosis of CMC joint OA in their dominan hand.
• State 1-2 according to the American College of Rheumatology.
• Pain intensity during activities of daily living (ADLs) of up to 4 of 10 on the visual analog scale (VAS)
• Ability to read or understand the patient information sheets.
• Ability to sign a consent form will be included in the study

Exclusion Criteria

• Neurologic disorder affecting the upper limb
• Previous treatment for their hand problem in the last 6 months including an intra-articular joint injection to wrist, fingers, or thumb
• Had fractures or a significant hand injury or previous surgery to the wrist, thumb or hand
• Finger tenosynovitis.
• Dupuytren disease.
• Psychological treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

Raquel Cantero-Téllez

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Raquel Cantero

Málaga, Malaga, Spain

Countries

Spain

References

Cantero-Tellez R, Villafane JH, Valdes K, Garcia-Orza S, Bishop MD, Medina-Porqueres I. Effects of High-Intensity Laser Therapy on Pain Sensitivity and Motor Performance in Patients with Thumb Carpometacarpal Joint Osteoarthritis: A Randomized Controlled Trial. Pain Med. 2020 Oct 1;21(10):2357-2365. doi: 10.1093/pm/pnz297.

Reference Type: DERIVED

PMID: 31807782 (View on PubMed)

Other Identifiers

UMalaga2

Identifier Type: -

Identifier Source: org_study_id