High-Energy Laser in the Conservative Treatment of Rhizarthrosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
About this trial
Osteoarthritis (OA) is a degenerative joint disease that can affect the hands and is particularly debilitating when it involves the trapeziometacarpal joint (rhizarthrosis). It causes pain, deformity, limited movement and strength, joint instability, resulting in significant limitations in daily activities.Many conservative treatments, such as medications, therapeutic exercises, physical therapy, and orthoses, are effective for managing hand OA. For patients who do not respond to conservative treatments, surgical intervention will be necessary.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
arthrosis of the trapezoid-metacarpal with stage 1 or 2 of the Eaton-Littler radiographic classification and pain (recent radiograph within 6 months previously);
clinical picture that has been occurring for at least 6 months;
pain scored with VAS scale at least 4/10.
Disqualifiers
rheumatoid arthritis or outcomes of trauma in the affected area, contra-indications to treatment with laser therapy (neoplasia, pregnancy, thrombocytopenia, epilepsy, uncompensated heart disease or arrhythmia, pacemaker, local infections),
corticosteroid infiltration or physical therapy in the previous 4 weeks.
Trial design
Design model
Parallel
Treatments tested in this trial
THEAL:Ixyon XP (Mectronic, Bergamo, Italy)
Devicelaser therapy
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: High Intenisity Lasertherapy groupExperimental treatment 1 intervention
Group B: Exercise groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
recovery of pain
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time frame
change between baseline to 1 month2
recovery of pain
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time frame
change between baseline to 3 month3
recovery of pain
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time frame
change between baseline to 6 monthSecondary outcomes
1
functional recovery
The Functional Index of Hand Osteoarthritis (FIHOA) measures the effect of hand problems on function in terms of pain and disability.The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 30; the higher the score, the more limitation/pain/disability is present.
Time frame
change between baseline to 1 month2
functional recovery
The Functional Index of Hand Osteoarthritis (FIHOA) measures the effect of hand problems on function in terms of pain and disability.The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 30; the higher the score, the more limitation/pain/disability is present.
Time frame
change between baseline to 3 month3
functional recovery
The Functional Index of Hand Osteoarthritis (FIHOA) measures the effect of hand problems on function in terms of pain and disability.The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 30; the higher the score, the more limitation/pain/disability is present.
Time frame
change between baseline to 6 month4
disability recovery
The Disabilities of the Arm, Shoulder and Hand Score (QuickDash) contains 11 questions related to ability and pain in the past week. Scores range from 0 to 100; the higher the score, the greater the limitation/pain/disability
Time frame
change between baseline to 1 monthSponsors and contacts
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Source ClinicalTrials.gov