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NCT Number: NCT03270488

Laser Therapy, Pain and Carpometacarpal Joint Osteoarthritis Treatment

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).

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Key information

Conditions

Thumb Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathological Conditions, Signs and Symptoms Physical Disorder Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Raquel Cantero

Málaga, Malaga, 29012, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laser

Other

Laser (power of 3.0w).

Placebo

Other

Laser (power 0,0w)

Primary outcomes

  1. Visual Analogue Scale (VAS)

    Time frame: 3 months

    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.

Secondary outcomes

  1. Key pinch strength

    Time frame: 3 months

    For measure pinch key we used Key pinch dynamometer. Pinch strength was less in patients with early thumb CMC OA. Key pinch had the most robust association with OA diagnosis. Tomas J et al. Weaker Functional Pinch Strength Is Associated With Early Thumb Carpometacarpal Osteoarthritis. Clin Orthop Relat Res (2016) 474:557-561 MacDermid JC, Wessel J, MacIntyre N, Galea V. The relationship between impairment, dexterity and self-reported disability of persons with osteoarthritis of the hand. J Hand Ther. 2008;21:427-8

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

Effects of Laser Therapy on Pain Intensity for Carpometacarpal Joint Osteoarthritis as a Isolated Treatment. A Randomized (Double-blind) Controlled Trial

Acronym: Laser

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 1, 2017
Registry last updated
Dec 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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