Laser Therapy, Pain and Carpometacarpal Joint Osteoarthritis Treatment (Laser)
Primary Purpose
Thumb Osteoarthritis, Pain, Physical Disorder
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Laser
Placebo
Sponsored by

About this trial
This is an interventional treatment trial for Thumb Osteoarthritis focused on measuring Thumb, Osteoarthritis, Physical Therapy, Pain
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.
Sites / Locations
- Raquel Cantero
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Laser Group
Placebo group
Arm Description
Laser application three times a week for 4 weeks.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Key pinch strength
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
Full Information
NCT ID
NCT03270488
First Posted
August 28, 2017
Last Updated
December 13, 2018
Sponsor
University of Malaga
1. Study Identification
Unique Protocol Identification Number
NCT03270488
Brief Title
Laser Therapy, Pain and Carpometacarpal Joint Osteoarthritis Treatment
Acronym
Laser
Official Title
Effects of Laser Therapy on Pain Intensity for Carpometacarpal Joint Osteoarthritis as a Isolated Treatment. A Randomized (Double-blind) Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
February 24, 2017 (Actual)
Primary Completion Date
June 15, 2017 (Actual)
Study Completion Date
September 25, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thumb Osteoarthritis, Pain, Physical Disorder
Keywords
Thumb, Osteoarthritis, Physical Therapy, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Laser Group
Arm Type
Experimental
Arm Description
Laser application three times a week for 4 weeks.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Laser
Intervention Description
Laser (power of 3.0w).
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Laser (power 0,0w)
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Key pinch strength
Description
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
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Raquel Cantero
City
Málaga
State/Province
Malaga
ZIP/Postal Code
29012
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31807782
Citation
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.
Results Reference
derived
Learn more about this trial
Laser Therapy, Pain and Carpometacarpal Joint Osteoarthritis Treatment
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