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NCT Number: NCT06535594

Efficacy Of Laser Acupuncture Combined With Physiotherapy In Tennis Elbow Syndrome

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.

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Laser Acupuncture

Other

Laser acupuncture therapy will be performed five times a week for 4 weeks using laser beam. The acupoints on the ear that will be treated with laser acupuncture therapy are Zhouliao (LI12), Chize (LU5), Quchi (LI11), Shousanli (LI10) and Ashi.

Physical Therapy

Other

Physical therapy method involved six elbow joint exercises. Patients performed the six exercises sequentially under guidance, each exercise performed five times, three times a day, gradually increasing weight until the movement was effective but below the pain threshold.

Primary outcomes

  1. The change of the Visual Analog Scale (VAS)

    Time frame: Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)

    Symptom scores will be assessed based on a visual analogue scale (VAS). It usually consists of a 10 cm line anchored at each end by descriptors. Patients will be classified into 1 of 4 groups (no pain (0 cm), mild pain (1-3 cm), moderate pain (4-7 cm), severe pain (8-10 cm)).

Secondary outcomes

  1. Proportion of intervention-related adverse events

    Time frame: Up to four weeks

    While laser acupuncture is generally considered safe, some patients may experience minor side effects at the application site. These can include skin redness or burns. Rarely, more serious complications like dizziness, headaches, and fatigue may occur. The study will closely monitor and document any unexpected adverse events associated with the procedure.

  2. The change of active range of motion of the elbow joint

    Time frame: Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)

    Active range of motion of the elbow joint measured using a goniometer.

Study contacts

Contact information is provided by the study sponsor or research team.

Sang Thanh Do, MD

CONTACT

[email protected]

+84948561030

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 2, 2024
Registry last updated
Aug 2, 2024

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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