Tennis ElbowNCT07178288
Assessment of Pressure Pain Threshold (PPT) and Conditioned Pain Modulation (CPM) After Effect in Patients With and Without Tennis Elbow (TE)
A study testing Physiological/measurement-validation study in people with Tennis Elbow and Health Adult Subjects, run by The Hashemite University at 1 site in Jordan.
Trial summary
This study at Hashemite University looks at how people with and without tennis elbow (AKA lateral elbow tendinopathy) feel pressure pain and how their bodies briefly "turn down" pain after a cold stimulus. Read more about this study
- Who is it for?
- Ages Up to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tennis Elbow, Health Adult Subjects, Lateral Elbow Tendinopathy (Tennis Elbow)
- What is being tested?
- Physiological/measurement-validation study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteJordan
- Study dates
- 10 Sep 2025to 30 Jun 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 Up to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with Tennis Elbow confirmed at initial assessment by the Primary Investigator (PI)
- Unilateral elbow pain > 6 weeks duration reproduced on at least two of the following tests:
- Palpation of the lateral epicondyle
- Isometric testing of the wrist extensors
- Middle finger extension test
- Passive stretch of wrist extensors
- Resisted hand gripping using a dynamometer
- Upper limb neurodynamic test-radial nerve bias (ULNDT-RN)
Who cannot join
- History of chronic pain conditions (e.g. fibromyalgia, irritable bowel
- syndrome, temporomandibular dysfunction, migraines)
- Neurological or sensory dysfunction (especially in the upper limbs)
- History of chronic musculoskeletal pain (e.g. arthritis, chronic low back
- pain)
- Contraindications to cold application (i.e. Reynaud's disease, diabetes)
- Current or long-term use of pain medication or anti-depressants
- Healthy Group The asymptomatic group included adults (18-65 years) without pain (acute or chronic) at least 3 months before the experimental sessions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jordan1 site, 1 recruiting
- Recruiting
The Hashemite University, Department of Physical Therapy; Community Rehabilitation Center Clinics
Zarqa, Zarqa Governorate, 13115
About this study
Official title: Measurement Properties and Temporal Stability of Conditioned Pain Modulation in Individuals With and Without Lateral Epicondylalgia
This study at Hashemite University looks at how people with and without tennis elbow (AKA lateral elbow tendinopathy) feel pressure pain and how their bodies briefly "turn down" pain after a cold stimulus. Participants complete brief questionnaires (basic demographics without names, a tennis-elbow symptom form, and a physical-activity form) and then have their pressure-pain threshold (PPT) tested with a handheld device that slowly increases pressure on standard spots near the elbow and wrist; they say when it first becomes painful. To test the body's built-in anti-pain system (conditioned pain modulation, CPM), one hand is placed in ice water (the cold-pressor task) and PPT is measured again at set times (before, during, and after the cold stimulus) to see how much pain sensitivity changes and how long that change lasts. Both PPT reliability and CPM after effect are measured in this study. The study findings may help improve future assessment and treatment of musculoskeletal pain conditions.
Read the detailed description
This is a quasi-experimental reliability and time-course study using digital algometry for PPT and the cold-pressor task for CPM. Primary outcomes include PPT reliability (with intraclass correlation coefficient (ICC), standard error of measurement (SEM), and smallest detectable change (SDC) and the duration of CPM after-effects (time to return toward baseline). Testing is planned in the Physiotherapy Clinic at the Community Rehabilitation Center, with a minimum sample noted in the application. The protocol emphasizes standardized sites, repeated measures at predefined time points, and storage of coded data on university systems.
- Conditions
- Tennis Elbow, Health Adult Subjects, Lateral Elbow Tendinopathy (Tennis Elbow), Pressure Pain Threshold (PPT), Conditioned Pain Modulation (CPM)
- Being tested
- Physiological/measurement-validation study
- Keywords
- Lateral elbow tendinopathy (tennis elbow), pressure pain threshold (PPT), conditioned pain modulation (CPM)
- Medical subject headings
- Tennis Elbow, Ceroid lipofuscinosis, neuronal 1, infantile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological/measurement-validation studyOther
Protocols PPT Reliability The assessor measured Pressure Pain Threshold; PPT, using an electronic digital algometer. Measurements will be taken at two test sites wrist at baseline, at 1, 3 and 5 minutes. Three PPT measurements were taken at each time point with a 15-20 seconds interval between each. Mean values will then be used in analysis.
Conditioned Pain Modulation In order to assess CPM, PPT was used as a tested stimulus on the painful arm (elbow and wrist). Baseline PPTs will assessed three times with an interval of 30 seconds between the repetitions. A Cold Pressure Task (CPT) will be used as the conditioning stimulus. Participants will be instructed to immerse their uninvolved hand in the ice water for 2 minutes. PPT will be measured at baseline pre and 1 minute during immersion to calculate CPM response, and then at various time points post immersion (minutes: 1, 5, 15, 30, 45, and 60) to determine the time point at which PPT returns to baseline.
| Study group | Role | What they receive |
|---|---|---|
| PPT_CPM Arm | Experimental | Procedure After completing self reported questionnaires, participants will attend a single test session where they undergo a Pressure Pain Threshold (PPT) test-retest protocol followed by a Conditioned Pain Modulation (CPM) testing protocol, with a rest period of 10 minutes in between. The experimental protocols will be performed by the same investigator. All instructions will be standardized Receives: Other: Physiological/measurement-validation study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold (PPT)
The assessor measured PPT (kPa) using an electronic digital algometer (Somedic AB, Sweden). Measurements will be taken at two test sites wrist at baseline, at 1 minute, at 3 minutes and at 5 minutes. Three PPT measurements were taken at each time point with a 15-20 seconds interval between each. Mean values will then be used in analysis.
PPT: the amount of pressure (measured with a handheld algometer in kPa) at the moment pressure first becomes painful.
Intra/inter-rater reliability of PPT: how consistent PPT readings are when the same/and another tester repeats the measurements (ICC, SEM)
Measured: The PPT session would take about 30min to be completed in one day.
Conditioned Pain Modulation (CPM)
In order to assess Conditioned Pain Modulation (CPM), Pressure Pain Threshold (PPT) is used as a tested stimulus on the painful arm (elbow and wrist). Baseline PPTs is assessed three times with an interval of 30 seconds between the repetitions. A Cold Pressure Task (CPT) is used as the conditioning stimulus. Participants is instructed to immerse their uninvolved hand in the ice water for 2 minutes. PPT is measured at baseline prior to CPT, after 1 minute during immersion (CPT) to calculate CPM response, and then at various time points post immersion (1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes) to determine the time point at which PPT returned to the baseline value. At each time point, PPT is measured three times with 15 to 20 second rest intervals in between. The mean value of the three measurements at each time point is used for statistical analysis. CPM after-effect (when the CPM effect returns to the baseline value) is calculated in minutes
Measured: 1 and half hours in a separate day (different to the PPT session day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start10 Sep 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hashemite University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Muhsen, The Hashemite University
- Investigators
- Ahmad Muhsen, Principal investigator, The Hashemite University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07178288
- Sponsor's protocol ID
- 32/1/2024/2025
- Status last verified
- Jun 2026
- First submitted
- 10 Sep 2025
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.
Publications
Oono Y, Nie H, Matos RL, Wang K, Arendt-Nielsen L. The inter- and intra-individual variance in descending pain modulation evoked by different conditioning stimuli in healthy men. Scand J Pain. 2011 Oct 1;2(4):162-169. doi: 10.1016/j.sjpain.2011.05.006.
PubMed 29913755Bilika P, Kalamatas-Mavrikas P, Vasilis N, Strimpakos N, Kapreli E. Reliability of Pressure Pain Threshold (PPT) and Conditioned Pain Modulation (CPM) in Participants with and without Chronic Shoulder Pain. Healthcare (Basel). 2024 Aug 31;12(17):1734. doi: 10.3390/healthcare12171734.
PubMed 39273758
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement Properties and Temporal Stability of Conditioned Pain Modulation in Individuals With and Without Lateral Epicondylalgia
- ClinicalTrials.gov ID
- NCT07178288
- Acronym / sponsor ID
- 32/1/2024/2025
- Conditions
- Tennis Elbow, Health Adult Subjects, Lateral Elbow Tendinopathy (Tennis Elbow), Pressure Pain Threshold (PPT), Conditioned Pain Modulation (CPM)
- Keywords
- Lateral elbow tendinopathy (tennis elbow), pressure pain threshold (PPT), conditioned pain modulation (CPM)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- The Hashemite UniversityUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 17 Sep 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.
This study at Hashemite University looks at how people with and without tennis elbow (AKA lateral elbow tendinopathy) feel pressure pain and how their bodies briefly "turn down" pain after a cold stimulus. Participants complete brief questionnaires (basic demographics without names, a tennis-elbow symptom form, and a physical-activity form) and then have their pressure-pain threshold (PPT) tested with a handheld device that slowly increases pressure on standard spots near the elbow and wrist; they say when it first becomes painful. To test the body's built-in anti-pain system (conditioned pain modulation, CPM), one hand is placed in ice water (the cold-pressor task) and PPT is measured again at set times (before, during, and after the cold stimulus) to see how much pain sensitivity changes and how long that change lasts. Both PPT reliability and CPM after effect are measured in this study. The study findings may help improve future assessment and treatment of musculoskeletal pain conditions.
Detailed description
This is a quasi-experimental reliability and time-course study using digital algometry for PPT and the cold-pressor task for CPM. Primary outcomes include PPT reliability (with intraclass correlation coefficient (ICC), standard error of measurement (SEM), and smallest detectable change (SDC) and the duration of CPM after-effects (time to return toward baseline). Testing is planned in the Physiotherapy Clinic at the Community Rehabilitation Center, with a minimum sample noted in the application. The protocol emphasizes standardized sites, repeated measures at predefined time points, and storage of coded data on university systems.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PPT_CPM Arm | Experimental | Other: Physiological/measurement-validation studyProcedure After completing self reported questionnaires, participants will attend a single test session where they undergo a Pressure Pain Threshold (PPT) test-retest protocol followed by a Conditioned Pain Modulation (CPM) testing protocol, with a rest period of 10 minutes in between. The experimental protocols will be performed by the same investigator. All instructions will be standardized |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Patients with Tennis Elbow confirmed at initial assessment by the Primary Investigator (PI)
- Unilateral elbow pain > 6 weeks duration reproduced on at least two of the following tests:
- Palpation of the lateral epicondyle
- Isometric testing of the wrist extensors
- Middle finger extension test
Key exclusion criteria (8 listed)
- History of chronic pain conditions (e.g. fibromyalgia, irritable bowel
- syndrome, temporomandibular dysfunction, migraines)
- Neurological or sensory dysfunction (especially in the upper limbs)
- History of chronic musculoskeletal pain (e.g. arthritis, chronic low back
- pain)
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 |
|---|---|---|
| Physiological/measurement-validation studyProtocols PPT Reliability The assessor measured Pressure Pain Threshold; PPT, using an electronic digital algometer. Measurements will be taken at two test sites wrist at baseline, at 1, 3 and 5 minutes. Three PPT measurements were taken at each time point with a 15-20 seconds interval between each. Mean values will then be used in analysis. Conditioned Pain Modulation In order to assess CPM, PPT was used as a tested stimulus on the painful arm (elbow and wrist). Baseline PPTs will assessed three times with an interval of 30 seconds between the repetitions. A Cold Pressure Task (CPT) will be used as the conditioning stimulus. Participants will be instructed to immerse their uninvolved hand in the ice water for 2 minutes. PPT will be measured at baseline pre and 1 minute during immersion to calculate CPM response, and then at various time points post immersion (minutes: 1, 5, 15, 30, 45, and 60) to determine the time point at which PPT returns to baseline. | Other | PPT_CPM Arm |
Primary outcome
Pressure Pain Threshold (PPT)
Time frame: The PPT session would take about 30min to be completed in one day.
The assessor measured PPT (kPa) using an electronic digital algometer (Somedic AB, Sweden). Measurements will be taken at two test sites wrist at baseline, at 1 minute, at 3 minutes and at 5 minutes. Three PPT measurements were taken at each time point with a 15-20 seconds interval between each. Mean values will then be used in analysis. PPT: the amount of pressure (measured with a handheld algometer in kPa) at the moment pressure first becomes painful. Intra/inter-rater reliability of PPT: how consistent PPT readings are when the same/and another tester repeats the measurements (ICC, SEM)
Conditioned Pain Modulation (CPM)
Time frame: 1 and half hours in a separate day (different to the PPT session day)
In order to assess Conditioned Pain Modulation (CPM), Pressure Pain Threshold (PPT) is used as a tested stimulus on the painful arm (elbow and wrist). Baseline PPTs is assessed three times with an interval of 30 seconds between the repetitions. A Cold Pressure Task (CPT) is used as the conditioning stimulus. Participants is instructed to immerse their uninvolved hand in the ice water for 2 minutes. PPT is measured at baseline prior to CPT, after 1 minute during immersion (CPT) to calculate CPM response, and then at various time points post immersion (1 minute, 5 minutes, 15 minutes, 30 minutes, 45 minutes, and 60 minutes) to determine the time point at which PPT returned to the baseline value. At each time point, PPT is measured three times with 15 to 20 second rest intervals in between. The mean value of the three measurements at each time point is used for statistical analysis. CPM after-effect (when the CPM effect returns to the baseline value) is calculated in minutes
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 26 Jun 2026.
- Background: PubMed 29913755Oono Y, Nie H, Matos RL, Wang K, Arendt-Nielsen L. The inter- and intra-individual variance in descending pain modulation evoked by different conditioning stimuli in healthy men. Scand J Pain. 2011 Oct 1;2(4):162-169. doi: 10.1016/j.sjpain.2011.05.006.
- Background: PubMed 39273758Bilika P, Kalamatas-Mavrikas P, Vasilis N, Strimpakos N, Kapreli E. Reliability of Pressure Pain Threshold (PPT) and Conditioned Pain Modulation (CPM) in Participants with and without Chronic Shoulder Pain. Healthcare (Basel). 2024 Aug 31;12(17):1734. doi: 10.3390/healthcare12171734.
- Individual participant dataSharing planned: Yes. The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.
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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.
Ahmad Muhsen principal investigator
The Hashemite University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiological/measurement-validation study in people with Tennis Elbow and Health Adult Subjects, run by The Hashemite University at 1 site in Jordan.
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 8 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 26 Jun 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 Jordan. 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 Ahmad Muhsen, PhD (+962788654656, muhsen_a@hu.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure Pain Threshold (PPT) (time frame: The PPT session would take about 30min to be completed in one day.). The study lists 2 primary outcomes in all. 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 NCT07178288, which also lists 2 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 26 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.