Lateral Epicondylitis (Tennis Elbow)NCT07131423
Effectiveness of Extracorporeal Shockwave Therapy Based on Fascial Manipulation Theory for Lateral Epicondylitis
A study testing Standard extracorporeal shock wave therapy, CC points shock wave therapy and Shock wave therapy for the CC points and the lateral epicondyle in people with Lateral Epicondylitis (Tennis Elbow), run by ZHANG PENG at 1 site in China.
Trial summary
Goal: This clinical trial aims to find out if using fascial theory to guide shockwave therapy works better for treating "tennis elbow" (pain on the outer side of the elbow) compared to standard shockwave treatment. It will also check for any side effects. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Lateral Epicondylitis (Tennis Elbow)
- What is being tested?
- Standard extracorporeal shock wave therapy, CC points shock wave therapy and Shock wave therapy for the CC points and the lateral epicondyle
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2025to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persistent pain at the lateral epicondyle of the humerus for ≥ 3 months
- Pain is palpable at the lateral epicondyle of the humerus during examination
- Positive Thompson's test (i.e., the patient reports pain when performing resisted extension while slightly extending the wrist joint, flexing the fist, extending the elbow joint, and having the forearm in an ulnar deviation position)
- Positive Mill's test (i.e., the patient reports pain when performing resisted supination while slightly flexing the elbow joint, having the forearm in an ulnar deviation position, slightly extending the wrist joint, and flexing the fist)
- Pain occurs during resisted extension of the index finger
- Age between 18 and 65 years old. The participants in our study included those who were frequently active.
Who cannot join
- Tendon rupture, nerve root type cervical spondylosis, cubital or carpal tunnel syndrome, local infection, pregnancy, malignant tumor, bilateral tennis elbow, carpal tunnel syndrome, medial epicondylitis, elbow arthritis or instability, having systemic inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis, cognitive impairment making it difficult to cooperate, ipsilateral shoulder dysfunction, neurological abnormalities, radial nerve compression, arrhythmia or having a cardiac pacemaker implanted, diabetes, having received physical therapy and/or corticosteroid injections in the past three months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Goal:
This clinical trial aims to find out if using fascial theory to guide shockwave therapy works better for treating "tennis elbow" (pain on the outer side of the elbow) compared to standard shockwave treatment. It will also check for any side effects.
Read more
Main Questions:
Does treating fascial points (key tension areas in the arm) with shockwaves reduce pain more than just treating the elbow? Are there any temporary discomforts (like soreness or swelling) after treatment?
How It Works:
Researchers will compare three approaches:
Group A: Shockwaves applied only to the painful elbow area (standard treatment).
Group B: Shockwaves applied to 4 fascial points in the arm/shoulder (no elbow treatment).
Group C: Shockwaves applied to both the elbow and 3 fascial points.
Participants Will:
Receive 4 shockwave sessions (1 session every 5 days). Report pain levels, grip strength, and daily activities for 3 months. Attend follow-up visits to track progress.
Why It Matters:
If successful, this could lead to a more effective way to treat tennis elbow-by targeting the root cause of tension in the arm's connective tissue, not just the pain spot.
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Being tested
- Standard extracorporeal shock wave therapy, CC points shock wave therapy, Shock wave therapy for the CC points and the lateral epicondyle
- Keywords
- Fascial Manipulation, Extracorporeal Shockwave Therapy, Lateral Epicondylitis
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard extracorporeal shock wave therapyDevice
ESWT was performed using the Swiss DolorClast Master ESWT device in accordance with the guidelines of the International Society of Medical Shockwave Therapy. The treatment was carried out by a physical therapist with at least 5 years of ESWT experience. The patient sat with the shoulder abducted at 45°, the elbow flexed at 90°, and the forearm supinated. The shock waves were delivered in a circular motion, targeting the 2-3 most painful tender points within a 3 cm radius centered on the lateral epicondyle. A total of 2,500 pulses were administered per session (0.2 to 2 bar, 8 Hz, 2,500 pulses, with intensity adjusted according to the patient's tolerance). All patients received a total of 4 ESWT sessions, once every 5 days, over a period of 3 weeks.
CC points shock wave therapyDevice
The assessment was conducted by a 5-year or more experienced FM therapist, following the standard procedure of the FM organization. The process included conducting interviews, filling out assessment forms, performing movement checks, and conducting palpation. Four CC points covering the entire upper limb, including the shoulder area, were selected. The points were ranked based on the severity of the dense touch. The blackboard pen was used to mark the points on the patient's body. The same ESWT therapist as in Group A used the same shock wave treatment instrument to treat the four CC points. The most severe point received 800 shocks, the second most received 700 shocks, and the remaining two points each received 500 shocks. A total of 2,500 pulses (with an intensity of 0.2 to 2 bar, a frequency of 8 Hz, and the intensity adjusted according to the depth of the point and the patient's tolerance) were administered. This treatment was performed once every 5 days for 3 weeks.
Shock wave therapy for the CC points and the lateral epicondyleDevice
Carry out the same process as Group B, but only select the three most severe CC points for shock therapy. Also, rank them according to the severity of the touch examination-induced densification. The most severe point receives 600 pulses, the second most severe receives 500 pulses, and the third most severe receives 400 pulses. At the same time, treat the lateral epicondylitis pain area in the same way as Group A. Apply 1000 pulses to the pain area. The total number of shocks for all treatments is 2500 (with an intensity of 0.2 to 2 bar, a frequency of 8 Hz, and the intensity is adjusted according to the depth of the point and the patient's tolerance). The therapist performing the treatment is the same as those in Group A and Group B. The treatment is carried out once every 5 days for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Group A (Local ESWT): ESWT (2,500 impulses/session) at the lateral epicondyle point of maximal tenderness. Receives: Device: Standard extracorporeal shock wave therapy |
| Group B | Experimental | Group B (FM-guided ESWT): ESWT (2,500 impulses) at four Fascial Manipulation (FM)-selected Coordinating Centers (CCs) proximal to the epicondyle, with impulses weighted by tissue density. Receives: Device: CC points shock wave therapy |
| Group C | Experimental | Group C (Combined): Hybrid ESWT: 1,000 impulses at the epicondyle + 1,500 impulses at three FM-identified CCs. Receives: Device: Shock wave therapy for the CC points and the lateral epicondyle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grip strength
Participants will be required to adopt a shoulder-width stance, with their arms naturally hanging down and close to their bodies, and their elbows fully extended. The pain-free grip strength will be measured until pain occurs when the subject slowly squeezes the grip force gauge. The maximum grip strength will be measured at the maximum grip strength level. The average value of three consecutive trials will be calculated, with an interval of 20 seconds between each trial.
Measured: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
VAS(visual analogue scale)
Pain intensity over the past week (at rest, during activity, and at night) was evaluated using a 0-10 cm horizontal visual analogue scale (VAS), where 0 represented no pain and 10 represented the most severe pain imaginable.
Measured: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
PRTEE(Patient-Rated Tennis Elbow Evaluation)
Five items for pain (0 = no pain, 10 = the most severe pain imaginable) and physical function (six specific activity items and four daily activity items, 0 = no difficulty, 10 = unable to do), ranging from 0 to 100 points, with higher scores indicating more severe pain and greater functional loss.
Measured: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
PPT(pressure pain threshold)
The PPT was evaluated at two sites, namely the lateral epicondyle of the humerus and 1 cm lateral to the lateral epicondyle. The patient was in a sitting position, with the shoulder externally rotated by 30°, the elbow flexed at 90°, and the forearm, wrist and hand supported on the table. Under this posture, the PPT measurement was conducted three times for each condition.
Measured: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
Secondary outcomes (3)
Quick-DASH66
This questionnaire consists of eleven questions and uses a 5-point scale for scoring, similar to that of DASH. The total score and the scores of each module will be calculated on a 100-point scale, with higher scores indicating a worse condition. The reported minimum clinically important difference is 15.91 points.
Measured: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
Ultrasound shear wave elastography
Each patient was required to sit in front of the examiner, with the elbows flexed at 90°, the thumb pointing upwards, and to maintain a relaxed forearm position throughout the measurement process. The transducer was placed vertically on the skin surface at the lateral epicondyle of the humerus, in contact with the skin surface slightly using a coupling agent to avoid compression effects. The CET attached to the lateral epicondyle of the humerus was scanned in the longitudinal plane (parallel to the direction of the CET fibers) to obtain standardized images.
Measured: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
Participant satisfaction
The participants' satisfaction level with the progress of their condition will be determined using a validated 4-point Likert scale, ranging from "very satisfied", "somewhat satisfied", "somewhat dissatisfied" to "very dissatisfied".
Measured: Baseline, one week after all treatments, six weeks after all treatments, three months after all treanments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start25 Sep 2025 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral Epicondylitis (Tennis Elbow)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZHANG PENG
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongda Hospital
- Responsible party
- Sponsor-investigator, ZHANG PENG, Zhongda Hospital
- Investigators
- MING MA, Study director, Zhongda HospitalPeng 张, Principal investigator, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131423
- Sponsor's protocol ID
- 2025ZDSYLL214
- Status last verified
- Aug 2025
- First submitted
- 11 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Extracorporeal Shockwave Therapy Based on Fascial Manipulation Theory for Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT07131423
- Acronym / sponsor ID
- 2025ZDSYLL214
- Conditions
- Lateral Epicondylitis (Tennis Elbow)
- Keywords
- Fascial Manipulation, Extracorporeal Shockwave Therapy, Lateral Epicondylitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- ZHANG PENGUniversity, hospital or other
- Collaborators
- Zhongda Hospital
- Study start
- 25 Sep 2025 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 20 Aug 2025 (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.
Goal:
This clinical trial aims to find out if using fascial theory to guide shockwave therapy works better for treating "tennis elbow" (pain on the outer side of the elbow) compared to standard shockwave treatment. It will also check for any side effects.
Main Questions:
Does treating fascial points (key tension areas in the arm) with shockwaves reduce pain more than just treating the elbow? Are there any temporary discomforts (like soreness or swelling) after treatment?
How It Works:
Researchers will compare three approaches:
Group A: Shockwaves applied only to the painful elbow area (standard treatment).
Group B: Shockwaves applied to 4 fascial points in the arm/shoulder (no elbow treatment).
Group C: Shockwaves applied to both the elbow and 3 fascial points.
Participants Will:
Receive 4 shockwave sessions (1 session every 5 days). Report pain levels, grip strength, and daily activities for 3 months. Attend follow-up visits to track progress.
Why It Matters:
If successful, this could lead to a more effective way to treat tennis elbow-by targeting the root cause of tension in the arm's connective tissue, not just the pain spot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Standard extracorporeal shock wave therapyGroup A (Local ESWT): ESWT (2,500 impulses/session) at the lateral epicondyle point of maximal tenderness. |
| Group B | Experimental | Device: CC points shock wave therapyGroup B (FM-guided ESWT): ESWT (2,500 impulses) at four Fascial Manipulation (FM)-selected Coordinating Centers (CCs) proximal to the epicondyle, with impulses weighted by tissue density. |
| Group C | Experimental | Device: Shock wave therapy for the CC points and the lateral epicondyleGroup C (Combined): Hybrid ESWT: 1,000 impulses at the epicondyle + 1,500 impulses at three FM-identified CCs. |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Persistent pain at the lateral epicondyle of the humerus for ≥ 3 months
- Pain is palpable at the lateral epicondyle of the humerus during examination
- Positive Thompson's test (i.e., the patient reports pain when performing resisted extension while slightly extending the wrist joint, flexing the fist, extending the elbow joint, and having the forearm in an ulnar deviation position)
- Positive Mill's test (i.e., the patient reports pain when performing resisted supination while slightly flexing the elbow joint, having the forearm in an ulnar deviation position, slightly extending the wrist joint, and flexing the fist)
- Pain occurs during resisted extension of the index finger
Key exclusion criteria (1 listed)
- Tendon rupture, nerve root type cervical spondylosis, cubital or carpal tunnel syndrome, local infection, pregnancy, malignant tumor, bilateral tennis elbow, carpal tunnel syndrome, medial epicondylitis, elbow arthritis or instability, having systemic inflammatory diseases such as rheumatoid arthritis or ankylosing spondylitis, cognitive impairment making it difficult to cooperate, ipsilateral shoulder dysfunction, neurological abnormalities, radial nerve compression, arrhythmia or having a cardiac pacemaker implanted, diabetes, having received physical therapy and/or corticosteroid injections in the past three months.
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 |
|---|---|---|
| Standard extracorporeal shock wave therapyESWT was performed using the Swiss DolorClast Master ESWT device in accordance with the guidelines of the International Society of Medical Shockwave Therapy. The treatment was carried out by a physical therapist with at least 5 years of ESWT experience. The patient sat with the shoulder abducted at 45°, the elbow flexed at 90°, and the forearm supinated. The shock waves were delivered in a circular motion, targeting the 2-3 most painful tender points within a 3 cm radius centered on the lateral epicondyle. A total of 2,500 pulses were administered per session (0.2 to 2 bar, 8 Hz, 2,500 pulses, with intensity adjusted according to the patient's tolerance). All patients received a total of 4 ESWT sessions, once every 5 days, over a period of 3 weeks. | Device | Group A |
| CC points shock wave therapyThe assessment was conducted by a 5-year or more experienced FM therapist, following the standard procedure of the FM organization. The process included conducting interviews, filling out assessment forms, performing movement checks, and conducting palpation. Four CC points covering the entire upper limb, including the shoulder area, were selected. The points were ranked based on the severity of the dense touch. The blackboard pen was used to mark the points on the patient's body. The same ESWT therapist as in Group A used the same shock wave treatment instrument to treat the four CC points. The most severe point received 800 shocks, the second most received 700 shocks, and the remaining two points each received 500 shocks. A total of 2,500 pulses (with an intensity of 0.2 to 2 bar, a frequency of 8 Hz, and the intensity adjusted according to the depth of the point and the patient's tolerance) were administered. This treatment was performed once every 5 days for 3 weeks. | Device | Group B |
| Shock wave therapy for the CC points and the lateral epicondyleCarry out the same process as Group B, but only select the three most severe CC points for shock therapy. Also, rank them according to the severity of the touch examination-induced densification. The most severe point receives 600 pulses, the second most severe receives 500 pulses, and the third most severe receives 400 pulses. At the same time, treat the lateral epicondylitis pain area in the same way as Group A. Apply 1000 pulses to the pain area. The total number of shocks for all treatments is 2500 (with an intensity of 0.2 to 2 bar, a frequency of 8 Hz, and the intensity is adjusted according to the depth of the point and the patient's tolerance). The therapist performing the treatment is the same as those in Group A and Group B. The treatment is carried out once every 5 days for 3 weeks. | Device | Group C |
Primary outcome
Grip strength
Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
Participants will be required to adopt a shoulder-width stance, with their arms naturally hanging down and close to their bodies, and their elbows fully extended. The pain-free grip strength will be measured until pain occurs when the subject slowly squeezes the grip force gauge. The maximum grip strength will be measured at the maximum grip strength level. The average value of three consecutive trials will be calculated, with an interval of 20 seconds between each trial.
VAS(visual analogue scale)
Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
Pain intensity over the past week (at rest, during activity, and at night) was evaluated using a 0-10 cm horizontal visual analogue scale (VAS), where 0 represented no pain and 10 represented the most severe pain imaginable.
PRTEE(Patient-Rated Tennis Elbow Evaluation)
Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
Five items for pain (0 = no pain, 10 = the most severe pain imaginable) and physical function (six specific activity items and four daily activity items, 0 = no difficulty, 10 = unable to do), ranging from 0 to 100 points, with higher scores indicating more severe pain and greater functional loss.
PPT(pressure pain threshold)
Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
The PPT was evaluated at two sites, namely the lateral epicondyle of the humerus and 1 cm lateral to the lateral epicondyle. The patient was in a sitting position, with the shoulder externally rotated by 30°, the elbow flexed at 90°, and the forearm, wrist and hand supported on the table. Under this posture, the PPT measurement was conducted three times for each condition.
3 secondary outcomes
Quick-DASH66
Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
Ultrasound shear wave elastography
Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.
Participant satisfaction
Time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treanments.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
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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.
MING MA study director
Zhongda Hospital
Peng 张 principal investigator
Zhongda Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard extracorporeal shock wave therapy, CC points shock wave therapy and Shock wave therapy for the CC points and the lateral epicondyle in people with Lateral Epicondylitis (Tennis Elbow), run by ZHANG PENG at 1 site in China.
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 1 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: opening soon, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peng Zhang (+8615952087298, 502772262@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grip strength (time frame: Baseline, one week after all treatments, six weeks after all treatments, three months after all treatments.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2025.