Clinical trial NCT03270488: Laser Therapy, Pain and Carpometacarpal Joint Osteoarthritis Treatment
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
Overall status: COMPLETED
Phase: NA
Conditions: Thumb Osteoarthritis
Pain
Physical Disorder
Keywords: Thumb
Osteoarthritis
Physical Therapy
Pain
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 61
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 3 months
Secondary outcomes:
measure: Key pinch strength
timeFrame: 3 months
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Raquel Cantero
state: Malaga
Study officials:
References:
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.