Tennis ElbowNCT07461311
Manual Therapy on Lateral Elbow Pain
A study testing Manual Therapy in people with Tennis Elbow, run by University of La Laguna at 1 site in Spain.
Trial summary
This randomised, controlled, double-blind experimental study is designed to evaluate the efficacy of a standardised manual physiotherapy protocol for treating lateral epicondylalgia of the humerus, commonly known as 'tennis elbow'. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Manual Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2025to Dec 2026
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of epicondylalgia.
- Pain on palpation of the epicondyle. Performed and measured with an algometer.
- Pain on isometric contraction against resistance of the wrist extensors (epicondylar muscles).
- Pain on contraction of the wrist and finger flexor muscles or pressure force. Performed and measured with a JAMAR manual pressure dynamometer.
- Pain on stretching-elongation of the epicondylar muscles or Mills test (wrist and finger flexion, forearm pronation and elbow extension).
- Pain during prono-supination movements of the forearm and/or flexion-extension of the elbow.
- Subjects must meet a minimum of 4 of the 5 inclusion criteria to be part of the study. In addition to the inclusion criteria, subjects must be between 18 and 60 years of age, able to answer questionnaires in Spanish, and give their written consent.
Who cannot join
- History of elbow fractures or cracks during the last twelve months.
- History of elbow dislocations and/or subluxations during the last twelve months.
- History of elbow surgery.
- Congenital and/or acquired elbow deformity.
- Organic elbow condition (osteoarthritis, arthritis).
- Radio-humeral bursitis.
Show all 19Show fewer
- Radio-humeral chondromalacia.
- Tear of the annular ligament.
- Detachment of the periosteum.
- Tendon rupture in the elbow.
- Metabolic or infectious arthropathy.
- Cervical pathology or cervicobrachial neuralgia.
- Bilateral elbow pain.
- Radial nerve compression neuropathy.
- Participating in professional or amateur sports.
- Having received treatment with injections, physiotherapy or manual physiotherapy for your condition during the previous 6 months.
- Pain lasting less than 6 weeks.
- Receiving other treatment during the study.
- Patient absenteeism from treatment. We define patient absenteeism as missing a treatment session and/or measurement. We do not count delays of less than 2 days in a treatment session and/or measurement as absenteeism.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Facultad de Ciencias de la Salud
San Cristóbal de La Laguna, Santa Cruz de Tenerife, 38200
About this study
Official title: Influence of Manual Therapy on Lateral Elbow Pain
This randomised, controlled, double-blind experimental study is designed to evaluate the efficacy of a standardised manual physiotherapy protocol for treating lateral epicondylalgia of the humerus, commonly known as 'tennis elbow'. The study will compare the results for patients receiving active treatment with those for a control group who will follow a watchful waiting approach. Secondary objectives include analysing the relationship between pain, grip strength and joint mobility in the elbow and cervical spine. A sample of healthy subjects will also be included to establish baseline data and measure the effects of the protocol in an asymptomatic population.
- Conditions
- Tennis Elbow
- Being tested
- Manual Therapy, Sham Manual Therapy
- Keywords
- physical therapy, manual therapy
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual TherapyOther
Manual techniques will be performed on the cervical and dorsal areas and the elbow, as well as on the soft tissues associated with these areas. High-speed techniques, stretching techniques, myofascial relaxation techniques and neural mobilisation techniques will be used.
Sham Manual TherapyOther
Mobilisation techniques will be performed without reaching the final parameters of joint movement in the same areas where manual contact is applied in the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Manual Therapy Protocol | Experimental | Manual techniques will be performed on the cervical and dorsal areas and on the elbow. High-speed techniques combined with stretching techniques, myofascial relaxation and neural mobilisation. Receives: Other: Manual Therapy |
| Sham Manual Protocol | Sham comparator | Mobilisation techniques will be performed without reaching the final joint movement parameters in the same areas where manual contact is applied in the intervention group. Receives: Other: Sham Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of Perceived Pain
Perceived pain intensity will be assessed during palpation, positive inclusion-criteria tests, and activities of daily living using the Visual Analogue Scale (VAS). The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "the maximum perceived pain"
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months
Secondary outcomes (2)
Range of Motion (ROM) of the Elbow and Cervical Spine
Assessment of elbow mobility (flexion, extension, pronation, and supination) and cervical spine mobility (flexion, extension, lateral flexion, and rotation) using goniometers and inclinometers. Results are reported in degrees (°), where higher values indicate greater mobility and improvement.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months
Grip Strength
Measurement of the strength of the wrist and hand flexors and extensors using a hand-held pressure dynamometer. Results are reported in kilograms (kg). Higher values indicate greater muscle strength.
Measured: Baseline, 6 weeks, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of La Laguna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan Elicio Hernández Xumet, University of La Laguna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461311
- Sponsor's protocol ID
- PI_53-14
- Status last verified
- Mar 2026
- First submitted
- 11 Jan 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Manual Therapy on Lateral Elbow Pain
- ClinicalTrials.gov ID
- NCT07461311
- Acronym / sponsor ID
- PI_53-14
- Conditions
- Tennis Elbow
- Keywords
- physical therapy, manual therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of La LagunaUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 10 Mar 2026 (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.
This randomised, controlled, double-blind experimental study is designed to evaluate the efficacy of a standardised manual physiotherapy protocol for treating lateral epicondylalgia of the humerus, commonly known as 'tennis elbow'. The study will compare the results for patients receiving active treatment with those for a control group who will follow a watchful waiting approach. Secondary objectives include analysing the relationship between pain, grip strength and joint mobility in the elbow and cervical spine. A sample of healthy subjects will also be included to establish baseline data and measure the effects of the protocol in an asymptomatic population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Therapy Protocol | Experimental | Other: Manual TherapyManual techniques will be performed on the cervical and dorsal areas and on the elbow. High-speed techniques combined with stretching techniques, myofascial relaxation and neural mobilisation. |
| Sham Manual Protocol | Sham comparator | Other: Sham Manual TherapyMobilisation techniques will be performed without reaching the final joint movement parameters in the same areas where manual contact is applied in the intervention group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of epicondylalgia.
- Pain on palpation of the epicondyle. Performed and measured with an algometer.
- Pain on isometric contraction against resistance of the wrist extensors (epicondylar muscles).
- Pain on contraction of the wrist and finger flexor muscles or pressure force. Performed and measured with a JAMAR manual pressure dynamometer.
- Pain on stretching-elongation of the epicondylar muscles or Mills test (wrist and finger flexion, forearm pronation and elbow extension).
Key exclusion criteria (19 listed)
- History of elbow fractures or cracks during the last twelve months.
- History of elbow dislocations and/or subluxations during the last twelve months.
- History of elbow surgery.
- Congenital and/or acquired elbow deformity.
- Organic elbow condition (osteoarthritis, arthritis).
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 |
|---|---|---|
| Manual TherapyManual techniques will be performed on the cervical and dorsal areas and the elbow, as well as on the soft tissues associated with these areas. High-speed techniques, stretching techniques, myofascial relaxation techniques and neural mobilisation techniques will be used. | Other | Manual Therapy Protocol |
| Sham Manual TherapyMobilisation techniques will be performed without reaching the final parameters of joint movement in the same areas where manual contact is applied in the intervention group. | Other | Sham Manual Protocol |
Primary outcome
Intensity of Perceived Pain
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months
Perceived pain intensity will be assessed during palpation, positive inclusion-criteria tests, and activities of daily living using the Visual Analogue Scale (VAS). The scale ranges from 0 to 10, where 0 represents "no pain" and 10 represents "the maximum perceived pain"
2 secondary outcomes
Range of Motion (ROM) of the Elbow and Cervical Spine
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months
Grip Strength
Time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months
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 10 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Therapy in people with Tennis Elbow, run by University of La Laguna at 1 site in Spain.
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 7 inclusion and 19 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: under way, not looking for participants, as of the sponsor's last update on 10 Mar 2026. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of Perceived Pain (time frame: Baseline, 6 weeks, 3 months, 6 months, 12 months). 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 10 Mar 2026; AzTrials last refreshed its copy on 1 Nov 2026.