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NCT Number: NCT07178288

Assessment of Pressure Pain Threshold (PPT) and Conditioned Pain Modulation (CPM) After Effect in Patients With and Without Tennis Elbow (TE)

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.

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Key information

Conditions

Tennis Elbow Arm Injuries Ceroid lipofuscinosis, neuronal 1, infantile Conditioned Pain Modulation (CPM) Elbow Injuries Elbow Tendinopathy Health Adult Subjects Lateral Elbow Tendinopathy (Tennis Elbow) Muscular Diseases Musculoskeletal Diseases Pressure Pain Threshold (PPT) Tendinopathy Tendon Injuries Wounds and Injuries

Age range

Up to 60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hashemite University, Department of Physical Therapy; Community Rehabilitation Center Clinics

Zarqa, Zarqa Governorate, 13115, Jordan

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

TE Group

Inclusion criteria

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)

Exclusion criteria

  • 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.

Treatment and study plan

Physiological/measurement-validation study

Other

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.

Primary outcomes

  1. 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)

  2. 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

Study contacts

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

Ahmad Muhsen, PhD

CONTACT

[email protected]

+962788654656

Sponsors and collaborators

Lead sponsor

The Hashemite University

Other

Registry information

Official study title

Measurement Properties and Temporal Stability of Conditioned Pain Modulation in Individuals With and Without Lateral Epicondylalgia

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 17, 2025
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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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