Clinical trial NCT06535594: Efficacy Of Laser Acupuncture Combined With Physiotherapy In Tennis Elbow Syndrome
Official title: The Potential Efficacy Of Laser Acupuncture Combined With Physiotherapy In Managing Pain And Improve The Elbow Active Range Of Motions Improve The Elbow Active Range Of Motion In 30 Tennis Elbow Syndrome Patients: A Pre - Post Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pain
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Tennis Elbow (TE) syndrome affects 1 to 3% of adults annually. The burden of TE syndrome continues to increase annually due to repeated microtrauma to the forearm extensor tendon. Treatment mainly includes anti-inflammatory pain medications, physical therapy, shockwave therapy, Laser acupuncture therapy, topical nitrates, elbow braces, and corticosteroid injections. Surgery is considered for cases where conservative treatment fails, including open and arthroscopic surgery.

Laser acupuncture (LA) is a new acupuncture technique using Laser beams to stimulate acupuncture points, offering a less invasive alternative to traditional needles and demonstrating therapeutic effectiveness. Recent Studies have shown that LA significantly improves pain in TE patients. Additionally, combining physical therapy for functional rehabilitation in treating TE syndrome plays an essential role in alleviating pain and restoring elbow joint function, preventing long-term stiffness. In practice, many hospitals apply a combination of LA and physical therapy to treat TE with considerable effectiveness, though it has not been thoroughly evidence-based.

Given the limitations in evaluating treatment effectiveness and the lack of published research discussing the analgesic effects of LA for TE syndrome, as well as to enhance the effectiveness of combining TCM and modern medicine, the investigators conducted the study Pain Reduction and Range of Motion Improvement of LA Combined with Physical Therapy in Patients with TE syndrome.

Detailed description: Patients with Tennis Elbow syndrome who have main symptoms such as pain and tenderness at the lateral epicondyle or radial head will be registered for this study. They will be treated with a combination of Laser acupuncture and physical therapy.

The intervention period is four weeks. Laser acupuncture and physical therapy will be performed five times a week.

Data on the Visual Analog Scale (VAS), Active range of motion of the elbow joint, and side effects of Laser acupuncture and physical therapy will be recorded before the study and weekly for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Individuals between the ages of 19 and 65 years with Tennis Elbow in one arm and pain persisting for at least 4 weeks.
* Individuals with tenderness limited to the elbow joint and surrounding area.
* Individuals reporting pain under resisted extension of the middle finger and wrist.
* Individuals with an average pain score of 4 or more (0-10) on the Visual Analogue Scale (VAS) in the week prior to the screening visit.
* Individuals who volunteered to participate in the study and signed a consent form.
* Experiencing elbow pain for more than four weeks.

Exclusion Criteria:

* Patients with previous elbow surgery, systemic diseases affecting joint mobility, or those who received any form of treatment for TE in the last three months.
* Patients requiring elbow joint replacement surgery.
* Patients with psychiatric disorders.
* Patients with elbow-related conditions other than TE: elbow trauma, elbow tuberculosis, cancer.
* Patients with unexplained skin abnormalities around the elbow joint, currently using immunosuppressive drugs, or on prolonged corticosteroid treatment.
* Patients with an acute illness requiring prior intervention.
* Individuals with a history of trauma, ligament damage, fracture, tumor, or surgery of the elbow joint.

Primary outcomes:
measure: The change of the Visual Analog Scale (VAS)
timeFrame: Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)
Secondary outcomes:
measure: Proportion of intervention-related adverse events
timeFrame: Up to four weeks
measure: The change of active range of motion of the elbow joint
timeFrame: Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)
Other outcomes:
Locations:
Study officials:
References:
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