Laser Therapy, Pain and Carpometacarpal Joint Osteoarthritis Treatment

NCT03270488 | Completed

• 1 other identifier: UMalaga2
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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).

Conditions

Thumb Osteoarthritis; Pain; Physical Disorder

Keywords

Thumb; Osteoarthritis; Physical Therapy; Pain

Outcome Measures

Primary Outcomes (1)

• Visual Analogue Scale (VAS)

  VAS has been shown to be a reliable and valid instrument for pain assessment which is used frequently for clinical and research purposes. It consists of a 10-cm line anchored at each end. The left-hand anchor reads 'no pain' and the right-hand anchor reads 'worst possible pain'; the patients marked a line to represent their pain level. EVA scale was development by Huskisson in 1974. Ensen MP, Karoly P. Self-report scales and procedures for assessing pain in adults. In: Turk DC, Melzack R (eds). Handbook of Pain Assessment. 2nd ed. New York, NY: The Guilford Press, 2001. pp. 15-34. Seymour RA. The use of pain scales in assessing the efficacy ofanalgesics in post-operative dental pain. Eur J Clin Pharmacol. 1982;23:441-4 Gatson-Johansson F. Measurement of pain: the psychometric properties of the Pain-O-Meter, a simple, inexpensive pain assessment tool that could change health care practices. J Pain Symptom Manage. 1996;12:172-81.

  3 months

Secondary Outcomes (1)

• Key pinch strength

  3 months

Study Arms (2)

Laser Group

EXPERIMENTAL

Laser application three times a week for 4 weeks.

Other: Laser

Placebo group

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Laser OTHER

Laser (power of 3.0w).

Laser Group

Placebo OTHER

Laser (power 0,0w)

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Raquel Cantero

Málaga, Malaga, 29012, Spain

Location

Related Publications (1)

• 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.

  PMID: 31807782 DERIVED

MeSH Terms

Conditions

Pain; Osteoarthritis

Interventions

Lasers

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: September 1, 2017
• Study Start: February 24, 2017
• Primary Completion: June 15, 2017
• Study Completion: September 25, 2017
• Last Updated: December 17, 2018

Record last verified: 2018-12

Locations

ES (1)