PainNCT06535594
Efficacy Of Laser Acupuncture Combined With Physiotherapy In Tennis Elbow Syndrome
A study testing Laser acupuncture and Physical therapy in people with Pain, run by University of Medicine and Pharmacy at Ho Chi Minh City.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Pain
- What is being tested?
- Laser acupuncture and Physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Conditions
- Pain
- Being tested
- Laser acupuncture, Physical therapy
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser acupunctureOther
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 therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Laser acupuncture + Physical therapy | Experimental | Laser acupuncture five times a week for a total of four weeks (20 sessions). Physical therapy three times a day, five times a week for a total of four weeks. Receives: Other: Laser acupuncture; Other: Physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of the Visual Analog Scale (VAS)
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)).
Measured: 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 (2)
Proportion of intervention-related adverse events
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.
Measured: Up to four weeks
The change of active range of motion of the elbow joint
Active range of motion of the elbow joint measured using a goniometer.
Measured: Assessments were conducted before intervention and after each intervention week throughout the four weeks (Week 0, Week 1, Week 2, Week 3, Week 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Aug 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Do Thanh Sang, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535594
- Sponsor's protocol ID
- 271/HDDD-DHYD
- Status last verified
- Jul 2024
- First submitted
- 27 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quah-Smith I, Williams MA, Lundeberg T, Suo C, Sachdev P. Differential brain effects of laser and needle acupuncture at LR8 using functional MRI. Acupunct Med. 2013 Sep;31(3):282-9. doi: 10.1136/acupmed-2012-010297. Epub 2013 Aug 6.
PubMed 23920052Haker E, Lundeberg T. Laser treatment applied to acupuncture points in lateral humeral epicondylalgia. A double-blind study. Pain. 1990 Nov;43(2):243-247. doi: 10.1016/0304-3959(90)91078-W.
PubMed 2087335Yoon SY, Kim YW, Shin IS, Kang S, Moon HI, Lee SC. The Beneficial Effects of Eccentric Exercise in the Management of Lateral Elbow Tendinopathy: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Sep 1;10(17):3968. doi: 10.3390/jcm10173968.
PubMed 34501416Dingemanse R, Randsdorp M, Koes BW, Huisstede BM. Evidence for the effectiveness of electrophysical modalities for treatment of medial and lateral epicondylitis: a systematic review. Br J Sports Med. 2014 Jun;48(12):957-65. doi: 10.1136/bjsports-2012-091513. Epub 2013 Jan 18.
PubMed 23335238Zhou Y, Guo Y, Zhou R, Wu P, Liang F, Yang Z. Effectiveness of Acupuncture for Lateral Epicondylitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pain Res Manag. 2020 Mar 20;2020:8506591. doi: 10.1155/2020/8506591. eCollection 2020.
PubMed 32318130Adly AS, Adly AS, Adly MS. Effects of laser acupuncture tele-therapy for rheumatoid arthritis elderly patients. Lasers Med Sci. 2022 Feb;37(1):499-504. doi: 10.1007/s10103-021-03287-0. Epub 2021 Mar 19.
PubMed 33738615Bisset L, Beller E, Jull G, Brooks P, Darnell R, Vicenzino B. Mobilisation with movement and exercise, corticosteroid injection, or wait and see for tennis elbow: randomised trial. BMJ. 2006 Nov 4;333(7575):939. doi: 10.1136/bmj.38961.584653.AE. Epub 2006 Sep 29.
PubMed 17012266Yi R, Bratchenko WW, Tan V. Deep Friction Massage Versus Steroid Injection in the Treatment of Lateral Epicondylitis. Hand (N Y). 2018 Jan;13(1):56-59. doi: 10.1177/1558944717692088. Epub 2017 Feb 1.
PubMed 28719982Ciccotti MC, Schwartz MA, Ciccotti MG. Diagnosis and treatment of medial epicondylitis of the elbow. Clin Sports Med. 2004 Oct;23(4):693-705, xi. doi: 10.1016/j.csm.2004.04.011.
PubMed 15474230Degen RM, Conti MS, Camp CL, Altchek DW, Dines JS, Werner BC. Epidemiology and Disease Burden of Lateral Epicondylitis in the USA: Analysis of 85,318 Patients. HSS J. 2018 Feb;14(1):9-14. doi: 10.1007/s11420-017-9559-3. Epub 2017 Jun 5.
PubMed 29398988Duncan J, Duncan R, Bansal S, Davenport D, Hacker A. Lateral epicondylitis: the condition and current management strategies. Br J Hosp Med (Lond). 2019 Nov 2;80(11):647-651. doi: 10.12968/hmed.2019.80.11.647.
PubMed 31707890
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06535594
- Acronym / sponsor ID
- 271/HDDD-DHYD
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser acupuncture + Physical therapy | Experimental | Other: Laser acupuncture, Other: Physical therapyLaser acupuncture five times a week for a total of four weeks (20 sessions). Physical therapy three times a day, five times a week for a total of four weeks. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser acupunctureLaser 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. | Other | Laser acupuncture + Physical therapy |
| Physical therapyPhysical 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. | Other | Laser acupuncture + Physical therapy |
Primary outcome
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)).
2 secondary outcomes
Proportion of intervention-related adverse events
Time frame: Up to four weeks
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 23920052Quah-Smith I, Williams MA, Lundeberg T, Suo C, Sachdev P. Differential brain effects of laser and needle acupuncture at LR8 using functional MRI. Acupunct Med. 2013 Sep;31(3):282-9. doi: 10.1136/acupmed-2012-010297. Epub 2013 Aug 6.
- Background: PubMed 2087335Haker E, Lundeberg T. Laser treatment applied to acupuncture points in lateral humeral epicondylalgia. A double-blind study. Pain. 1990 Nov;43(2):243-247. doi: 10.1016/0304-3959(90)91078-W.
- Background: PubMed 34501416Yoon SY, Kim YW, Shin IS, Kang S, Moon HI, Lee SC. The Beneficial Effects of Eccentric Exercise in the Management of Lateral Elbow Tendinopathy: A Systematic Review and Meta-Analysis. J Clin Med. 2021 Sep 1;10(17):3968. doi: 10.3390/jcm10173968.
- Background: PubMed 23335238Dingemanse R, Randsdorp M, Koes BW, Huisstede BM. Evidence for the effectiveness of electrophysical modalities for treatment of medial and lateral epicondylitis: a systematic review. Br J Sports Med. 2014 Jun;48(12):957-65. doi: 10.1136/bjsports-2012-091513. Epub 2013 Jan 18.
- Background: PubMed 32318130Zhou Y, Guo Y, Zhou R, Wu P, Liang F, Yang Z. Effectiveness of Acupuncture for Lateral Epicondylitis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Pain Res Manag. 2020 Mar 20;2020:8506591. doi: 10.1155/2020/8506591. eCollection 2020.
- Background: PubMed 33738615Adly AS, Adly AS, Adly MS. Effects of laser acupuncture tele-therapy for rheumatoid arthritis elderly patients. Lasers Med Sci. 2022 Feb;37(1):499-504. doi: 10.1007/s10103-021-03287-0. Epub 2021 Mar 19.
- Background: PubMed 17012266Bisset L, Beller E, Jull G, Brooks P, Darnell R, Vicenzino B. Mobilisation with movement and exercise, corticosteroid injection, or wait and see for tennis elbow: randomised trial. BMJ. 2006 Nov 4;333(7575):939. doi: 10.1136/bmj.38961.584653.AE. Epub 2006 Sep 29.
- Background: PubMed 28719982Yi R, Bratchenko WW, Tan V. Deep Friction Massage Versus Steroid Injection in the Treatment of Lateral Epicondylitis. Hand (N Y). 2018 Jan;13(1):56-59. doi: 10.1177/1558944717692088. Epub 2017 Feb 1.
- Background: PubMed 15474230Ciccotti MC, Schwartz MA, Ciccotti MG. Diagnosis and treatment of medial epicondylitis of the elbow. Clin Sports Med. 2004 Oct;23(4):693-705, xi. doi: 10.1016/j.csm.2004.04.011.
- Background: PubMed 29398988Degen RM, Conti MS, Camp CL, Altchek DW, Dines JS, Werner BC. Epidemiology and Disease Burden of Lateral Epicondylitis in the USA: Analysis of 85,318 Patients. HSS J. 2018 Feb;14(1):9-14. doi: 10.1007/s11420-017-9559-3. Epub 2017 Jun 5.
- Background: PubMed 31707890Duncan J, Duncan R, Bansal S, Davenport D, Hacker A. Lateral epicondylitis: the condition and current management strategies. Br J Hosp Med (Lond). 2019 Nov 2;80(11):647-651. doi: 10.12968/hmed.2019.80.11.647.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Laser acupuncture and Physical therapy in people with Pain, run by University of Medicine and Pharmacy at Ho Chi Minh City.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang Thanh Do, MD (+84948561030, dtsang@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06535594, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.