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

NCT07178288 | Recruiting

• 1 other identifier: 32/1/2024/2025
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Tennis Elbow; Lateral Elbow Tendinopathy (Tennis Elbow); Pressure Pain Threshold (PPT); Conditioned Pain Modulation (CPM); Health Adult Subjects

Keywords

Lateral elbow tendinopathy (tennis elbow), pressure pain threshold (PPT), conditioned pain modulation (CPM)

Outcome Measures

Primary Outcomes (2)

• 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)

  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

  1 and half hours in a separate day (different to the PPT session day)

Study Arms (1)

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

Other: Physiological/measurement-validation study

Interventions

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.

PPT_CPM Arm

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hashemite University: lead

Study Sites (1)

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

Zarqa, Zarqa Governorate, 13115, Jordan

RECRUITING

Related Publications (2)

• 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.

  PMID: 29913755 BACKGROUND

• Bilika 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.

  PMID: 39273758 BACKGROUND

MeSH Terms

Conditions

Tennis Elbow; Ceroid lipofuscinosis, neuronal 1, infantile

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Study Officials

• Ahmad Muhsen

  The Hashemite University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmad Muhsen, PhD

CONTACT

+962788654656; muhsen_a@hu.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: September 17, 2025
• Study Start: September 10, 2025
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Soon after the study published in a peer reviewed journal.
• Access Criteria: Researchers interested in the field upon a resealable request from the PI, the dataset and/or the analyses will be shared.

Locations

JO (1)